December 24 arrived, and there was no Grinch.
The Healthcare reform, beat up and watered down as some would like to refer to it, passed anyway.
So what if it doesn't have everything that everyone wanted?
A 100 years and a handful of Presidents couldn't do it.
So, what if some healthcare reform passed in the U.S. Big deal, right?
Err... no.
If you have been paying any attention to details at all, you would notice that the world's richest nations have a way of influencing how healthcare is administered around the world.
Plus, there are other things to worry about. When I went back to India in 2006, one of the most shocking things I found was the fact that a lot of the insurance companies from the U.S. had sucked the life out of gullible patients and moved on to India and were now causing havoc there.
A few insurance companies with their hawkish wings clipped - not so bad.
That is why, we need to herald: History just happened.
Here is to your holidays, health and a happy future filled with hope and change!
A blog on medical devices, biotechnology, bioengineering, healthcare, etc. Join me on discussions about devices, regulations, the FDA, policies, law, and what not! Chaaraka is take on Charaka, an ancient Indian Physician of lore...
Thursday, December 24, 2009
Saturday, December 12, 2009
Quick Update: One more on MRSA - this time on potential cures
On my last post on MRSA, I had talked about how after having posted once, I was seeing MRSA everywhere (not the real stuff, just articles on it).
Interestingly, the trend continues. This past week, I came to know about the fact that researchers at the University of New Mexico and Sandia National Laboratories had come up with a new innovation in the war against MRSA.
They found that a single protein can alter the virulent MRSA and other bacteria into harmless versions of the same. This is effected by inhibiting the signaling molecules of the cell. It is believed that the breakthrough can prevent the bacteria from ever turning virulent.
Of course, the study has a long way to go, since this demonstration was done on a single bacterium after isolating it. Such isolation in healthcare settings are a long way away, but the fact that there is a promise is key.
Here is a story on this. The paper itself has been published in Nature Chemical Biology:
http://www.upi.com/Health_News/2009/12/04/Nipping-MRSA-in-the-bud/UPI-35051259963505/
Interestingly, the trend continues. This past week, I came to know about the fact that researchers at the University of New Mexico and Sandia National Laboratories had come up with a new innovation in the war against MRSA.
They found that a single protein can alter the virulent MRSA and other bacteria into harmless versions of the same. This is effected by inhibiting the signaling molecules of the cell. It is believed that the breakthrough can prevent the bacteria from ever turning virulent.
Of course, the study has a long way to go, since this demonstration was done on a single bacterium after isolating it. Such isolation in healthcare settings are a long way away, but the fact that there is a promise is key.
Here is a story on this. The paper itself has been published in Nature Chemical Biology:
http://www.upi.com/Health_News/2009/12/04/Nipping-MRSA-in-the-bud/UPI-35051259963505/
Monday, December 07, 2009
More on the MRSA Business - Opportunities and Updates
It is interesting how you barely notice something, and then you pay attention and you suddenly see it everywhere. Two weeks ago, I blogged here about haiwatchnews.com and MRSA in general and suddenly, here we are with more MRSA stuff.
I am reporting on two pieces of news in this post, the first of which represents another, smaller window of opportunity:
1. Community MRSA Vs. HAI-MRSA:
Community MRSA is the kind of bacteria that you pick up from "community" places - gyms, hotels, public restrooms, etc. Apparently community based MRSA is yet another arena of trouble just waiting to plunge itself upon us.
Analyzing data from 1999 to 2006, a certain Dr. Laxminarayanan and his colleagues looked at over 300 labs and concluded that community MRSA brought in by outpatients is complementing and not supplementing HAI-MRSA (the kind you get in the hospital setting).
This means that you are looking at an increased danger and cross-over of infections. While the percentage of HA-MRSA has remained steady, CA-MRSA has increased. You can read more of the details in the article linked at the end of the blog.
The Opportunity
In the last post, I talked about in-hospital devices and systems that might be designed to combat MRSA. In this particular blog, I would like to highlight the opportunity spectrum that exists in community situations, ranging from gymnasiums to hotels, to public restrooms and more.
In this opportunity space, however, it is not likely to design a disposable, clinical type of device. You would be thinking more in terms of either a disposable device, or better, a bioengineered solution where you could provide a mechanism that keeps equipment, their surfaces and so on, clean and free of community based MRSA and other strains. Given the threat from community MRSA, there is a wide market available in this space and the pitch should be easier to make, provided your solution is effective, elegant and cost effective.
2. Potentional breakthrough especially useful to fight resistant bacterial strains
A couple of days ago, I came across an article on BBC about a nifty discovery - a molecule that binds an enzyme in a bacterium in two sites, as opposed to one. This is supposedly a breakthrough that could help ensure that bacteria are unable to develop resistance to drugs at the same pace as they are doing now.
The whole principle was demonstrated through a natural molecule called "simocyclinone", supposedly made by soil bacteria. This molecule itself is not a drug, but it exhibits the above said phenomenon. More details are available in the B.B.C article.
In effect, I agree and believe this concept can be further extended in synthetic molecules.
How about molecules that bind on multiple sites on the AIDS virus and completely neutralize the virus, alongside slowing down it's ability to quickly evolve and develop resistance to the molecule (which is what the virus does now).
Such innovations will completely change medicine of the future and create new battlefields in the war on disease.
Excessive Regulation?
This clearly indicates that there is true promise. If you read the B.B.C. article, there is also talk about excessive regulation driving down research. I believe this is slightly misleading. I believe that the lack of an ample pipeline points to the fact that pharma companies and the VCs and stakeholders that prod them have been carried away by the promise of "blockbusters" for so long, they have left behind well meaning opportunities. Given all the shake up that has happened in 2009, there is a wide open playing field for anyone ready to buck the trends. Regulation comes into play only after Phase 0 has been completed really, so who are they blaming for the lack of a good number of molecules on the pipeline?
Conclusion
In effect, MRSA, whether acquired in healthcare settings or in community settings present a great threat in general. There is a wide open landscape for both device and drug players to break open into the field in many ways.
References:
1. The MedPage article on Community MRSA:
http://www.medpagetoday.com/HospitalBasedMedicine/Hospitalists/17162
2. The B.B.C. Article on double-binding molecules:
http://usproxy.bbc.com/2/hi/health/8393781.stm
I am reporting on two pieces of news in this post, the first of which represents another, smaller window of opportunity:
1. Community MRSA Vs. HAI-MRSA:
Community MRSA is the kind of bacteria that you pick up from "community" places - gyms, hotels, public restrooms, etc. Apparently community based MRSA is yet another arena of trouble just waiting to plunge itself upon us.
Analyzing data from 1999 to 2006, a certain Dr. Laxminarayanan and his colleagues looked at over 300 labs and concluded that community MRSA brought in by outpatients is complementing and not supplementing HAI-MRSA (the kind you get in the hospital setting).
This means that you are looking at an increased danger and cross-over of infections. While the percentage of HA-MRSA has remained steady, CA-MRSA has increased. You can read more of the details in the article linked at the end of the blog.
The Opportunity
In the last post, I talked about in-hospital devices and systems that might be designed to combat MRSA. In this particular blog, I would like to highlight the opportunity spectrum that exists in community situations, ranging from gymnasiums to hotels, to public restrooms and more.
In this opportunity space, however, it is not likely to design a disposable, clinical type of device. You would be thinking more in terms of either a disposable device, or better, a bioengineered solution where you could provide a mechanism that keeps equipment, their surfaces and so on, clean and free of community based MRSA and other strains. Given the threat from community MRSA, there is a wide market available in this space and the pitch should be easier to make, provided your solution is effective, elegant and cost effective.
2. Potentional breakthrough especially useful to fight resistant bacterial strains
A couple of days ago, I came across an article on BBC about a nifty discovery - a molecule that binds an enzyme in a bacterium in two sites, as opposed to one. This is supposedly a breakthrough that could help ensure that bacteria are unable to develop resistance to drugs at the same pace as they are doing now.
The whole principle was demonstrated through a natural molecule called "simocyclinone", supposedly made by soil bacteria. This molecule itself is not a drug, but it exhibits the above said phenomenon. More details are available in the B.B.C article.
In effect, I agree and believe this concept can be further extended in synthetic molecules.
How about molecules that bind on multiple sites on the AIDS virus and completely neutralize the virus, alongside slowing down it's ability to quickly evolve and develop resistance to the molecule (which is what the virus does now).
Such innovations will completely change medicine of the future and create new battlefields in the war on disease.
Excessive Regulation?
This clearly indicates that there is true promise. If you read the B.B.C. article, there is also talk about excessive regulation driving down research. I believe this is slightly misleading. I believe that the lack of an ample pipeline points to the fact that pharma companies and the VCs and stakeholders that prod them have been carried away by the promise of "blockbusters" for so long, they have left behind well meaning opportunities. Given all the shake up that has happened in 2009, there is a wide open playing field for anyone ready to buck the trends. Regulation comes into play only after Phase 0 has been completed really, so who are they blaming for the lack of a good number of molecules on the pipeline?
Conclusion
In effect, MRSA, whether acquired in healthcare settings or in community settings present a great threat in general. There is a wide open landscape for both device and drug players to break open into the field in many ways.
References:
1. The MedPage article on Community MRSA:
http://www.medpagetoday.com/HospitalBasedMedicine/Hospitalists/17162
2. The B.B.C. Article on double-binding molecules:
http://usproxy.bbc.com/2/hi/health/8393781.stm
Saturday, November 21, 2009
Looking for a lucrative, socially responsible healthcare opportunity? How about healthcare-associated-infections?
Last week I was invited to review a site by Kimberly-Clark on healthcare associated infections. As I started going through it, I was reminded of some news on the availability of federal funds for Healthcare Associated Infection remedies. I thought I would talk a little bit about both and let you know of the opportunity space ahead.
MRSA
A few years ago, MRSA entered our vocabulary and Hospital Acquired Infections or, as I guess the kids now call them "Healthcare-Associated Infections" became famous. Why did they become famous?
It was found out that the developed nations were not much better off than developing nations when it came to HAI. The condition is defined as infections that you pick up as a consequence of being treated in a healthcare setting, that is, infections that you did not have when you first went in for treatment.
It is also a big deal because the current strains of HAI that infect people are much more resistant than they used to be. Some scary statistics portend that more people die from HAI in the US than from AIDS itself, on an annual basis.
Just what the heck is MRSA?
MRSA, at least in the medical field stands for Methicillin-resistant Staphylococcus aureus. Over the last few decades hospitals have been treating every possible disease condition with antibiotics. Methicillin is just one such antibiotic in the same family as penicillin and is very commonly used in the treatment of staphylococcal bacteria. Over years of treatment, the bacteria, which have the freedom to evolve much quicker than we can, have developed an amazing amount of resistance to antibiotics.
Antibiotic resistant bacteria represent a deadly threat to anyone who comes under attack by them. As I mentioned before, people do not really stand much of a chance in this battle, and even if they recover, it is a long and hard battle. MRSA is just one example out of what really exists out there. It is also just one example of the possibilities that exist for drug-resistant microorganisms to evolve in the future with much more vigor than they have already done.
The Broader Outlook
Healthcare Associated Infection or abbreviated HAI, by definition, goes broader than MRSA and other resistant strains. Any disease condition acquired in a healthcare setting is termed HAI. This is key. Why?
It is quite possible that any strain of any microorganism that you pick up in a healthcare setting can be quite harmful to you. It is also not a function of healthcare to cure you of one condition and leave you with another, possibly worse.
How do we fight HAI?
Alright, now that you are reasonably scared, you might wonder as to the methods you can adopt to fight HAI, not just on a temporary basis, but on a more permanent basis. Let us take a look.
1. Awareness - The first step, as with everything is learning about and acknowledging the problem exists. Doctors, Hospital Managers and people in the general healthcare know the problem exists. However, there is more to awareness than simply acknowledging that it exists.
This is where I believe the website I mentioned, and similar efforts come into frey.
http://haiwatchnews.com/
It appears to be a website developed by Kimberly Clark, and while they themselves benefit from more awareness about HAI, I think it is a good move, and looks very much like well-fulfilled corporate social responsibility.
The impact information is all on the website - a predicted 100,000 deaths in the US, much worse across the world, and an annual impact of $6.7bn to the economy.
How exactly can awareness be spread? HAIwatchnews is part of a larger website:
http://www.haiwatch.com/
Haiwatch contains a lot of information, resources for clinical information and so on, that will not only be useful for people that work in healthcare, but also to you, the medical device designer.
2. Prevention
I am tempted to call this section "Opportunities" because you can take a look at the causes and think of them as opportunities. The three major HAI sources seem to be:
2.1.1 Ventilator Associated Pneumonia
2.1.2 Surgical Site Infections
2.1.3 Cross Contamination
Surgical Site Infections and Cross Contamination are rather easy to understand and obvious. Ventilator Associated Pneumonia happens in patients who have been intubated and have a tube flushing oxygen through to their lungs. Unfortunately, this opens up a can of microorganisms, so to speak, since this simply provides them direct access to the lungs, and consequently causes pneumonia.
So, the prevention part comes in two different ways:
2.2.1 Good medical/clinical practices, and
2.2.2 Medical Device and Bioengineered solutions
3. The Opportunity Landscape
Obviously, there are a few opportunities available in the landscape here:
How about, say better ventilation systems? A very good microfiber that rests in the tube as a one-way filter, filtering out particulate matter, bacteria and anything else that they can capture.
How about specific types of coating and sealing that make it impossible for bacteria to reside on hospital surfaces? This appears to be a tried and tired idea. Obviously, it's not working, so there are some big gaps somewhere, right?
There are several other brainstorms that I can think of (and you can pay me for.. :) ), but the general landscape is wide and is something more interesting to get into, rather than yet another half-baked, ineffective piece of drug-coated plumbing, balloon or cement that has you faking and contorting clinical trial results, lying to the FDA and other wonders that "major players" are constantly getting into....
4. Federal Funding
You didn't think I was going to wind you up and send you off empty handed, did you? Not at all!
The funding, about $40 million, is of course not directly available for the design of the next solution, but it is available for states to create awareness, improve processes etc. So, if you did develop a quick and "definitely not" dirty solution to the HAI problem, you could find it easy to convince healthcare service providers to apply for the funds that may in turn see your device or solution getting used...
http://www.fiercehealthcare.com/story/feds-offer-40m-stimulus-funds-fight-healthcare-associated-infections/2009-09-02?utm_medium=nl&utm_source=internal
And then again, there's the NIH, and of course the venture capitalists...
MRSA
A few years ago, MRSA entered our vocabulary and Hospital Acquired Infections or, as I guess the kids now call them "Healthcare-Associated Infections" became famous. Why did they become famous?
It was found out that the developed nations were not much better off than developing nations when it came to HAI. The condition is defined as infections that you pick up as a consequence of being treated in a healthcare setting, that is, infections that you did not have when you first went in for treatment.
It is also a big deal because the current strains of HAI that infect people are much more resistant than they used to be. Some scary statistics portend that more people die from HAI in the US than from AIDS itself, on an annual basis.
Just what the heck is MRSA?
MRSA, at least in the medical field stands for Methicillin-resistant Staphylococcus aureus. Over the last few decades hospitals have been treating every possible disease condition with antibiotics. Methicillin is just one such antibiotic in the same family as penicillin and is very commonly used in the treatment of staphylococcal bacteria. Over years of treatment, the bacteria, which have the freedom to evolve much quicker than we can, have developed an amazing amount of resistance to antibiotics.
Antibiotic resistant bacteria represent a deadly threat to anyone who comes under attack by them. As I mentioned before, people do not really stand much of a chance in this battle, and even if they recover, it is a long and hard battle. MRSA is just one example out of what really exists out there. It is also just one example of the possibilities that exist for drug-resistant microorganisms to evolve in the future with much more vigor than they have already done.
The Broader Outlook
Healthcare Associated Infection or abbreviated HAI, by definition, goes broader than MRSA and other resistant strains. Any disease condition acquired in a healthcare setting is termed HAI. This is key. Why?
It is quite possible that any strain of any microorganism that you pick up in a healthcare setting can be quite harmful to you. It is also not a function of healthcare to cure you of one condition and leave you with another, possibly worse.
How do we fight HAI?
Alright, now that you are reasonably scared, you might wonder as to the methods you can adopt to fight HAI, not just on a temporary basis, but on a more permanent basis. Let us take a look.
1. Awareness - The first step, as with everything is learning about and acknowledging the problem exists. Doctors, Hospital Managers and people in the general healthcare know the problem exists. However, there is more to awareness than simply acknowledging that it exists.
This is where I believe the website I mentioned, and similar efforts come into frey.
http://haiwatchnews.com/
It appears to be a website developed by Kimberly Clark, and while they themselves benefit from more awareness about HAI, I think it is a good move, and looks very much like well-fulfilled corporate social responsibility.
The impact information is all on the website - a predicted 100,000 deaths in the US, much worse across the world, and an annual impact of $6.7bn to the economy.
How exactly can awareness be spread? HAIwatchnews is part of a larger website:
http://www.haiwatch.com/
Haiwatch contains a lot of information, resources for clinical information and so on, that will not only be useful for people that work in healthcare, but also to you, the medical device designer.
2. Prevention
I am tempted to call this section "Opportunities" because you can take a look at the causes and think of them as opportunities. The three major HAI sources seem to be:
2.1.1 Ventilator Associated Pneumonia
2.1.2 Surgical Site Infections
2.1.3 Cross Contamination
Surgical Site Infections and Cross Contamination are rather easy to understand and obvious. Ventilator Associated Pneumonia happens in patients who have been intubated and have a tube flushing oxygen through to their lungs. Unfortunately, this opens up a can of microorganisms, so to speak, since this simply provides them direct access to the lungs, and consequently causes pneumonia.
So, the prevention part comes in two different ways:
2.2.1 Good medical/clinical practices, and
2.2.2 Medical Device and Bioengineered solutions
3. The Opportunity Landscape
Obviously, there are a few opportunities available in the landscape here:
How about, say better ventilation systems? A very good microfiber that rests in the tube as a one-way filter, filtering out particulate matter, bacteria and anything else that they can capture.
How about specific types of coating and sealing that make it impossible for bacteria to reside on hospital surfaces? This appears to be a tried and tired idea. Obviously, it's not working, so there are some big gaps somewhere, right?
There are several other brainstorms that I can think of (and you can pay me for.. :) ), but the general landscape is wide and is something more interesting to get into, rather than yet another half-baked, ineffective piece of drug-coated plumbing, balloon or cement that has you faking and contorting clinical trial results, lying to the FDA and other wonders that "major players" are constantly getting into....
4. Federal Funding
You didn't think I was going to wind you up and send you off empty handed, did you? Not at all!
The funding, about $40 million, is of course not directly available for the design of the next solution, but it is available for states to create awareness, improve processes etc. So, if you did develop a quick and "definitely not" dirty solution to the HAI problem, you could find it easy to convince healthcare service providers to apply for the funds that may in turn see your device or solution getting used...
http://www.fiercehealthcare.com/story/feds-offer-40m-stimulus-funds-fight-healthcare-associated-infections/2009-09-02?utm_medium=nl&utm_source=internal
And then again, there's the NIH, and of course the venture capitalists...
Thursday, November 12, 2009
Reblogging: Generic Pharma, European Union and a stunted India..
A few months ago, in June 2009 to be precise, I blogged lamenting how India was being really slow in responding to overt illegal acts such as the one where the Dutch seized an Indian shipment of blood pressure meds under false pretenses:
http://chaaraka.blogspot.com/2009/06/generic-pharma-why-india-should-stop.html
In that post, one of the things I had suggested India do is flex her muscles rather strongly in responding to such nonsense coming in from "Developed" nations.
Amicable Solutions
Consequentially, we have now heard, a whimper from the Indian Trade Minister (I would say ostensibly, it should have been India's Home Minister or Defense Minister and not some Trade Minister).
He says that India and Europe will solve this problem "amicably". Amicably, my bleeding right foot. There is now a lawsuit, which both India and Brazil have launched. This lawsuit has brought Europe's sudden amiability, not our trade minister.
I am glad, at a minimum to see this issue move forward, as slow as it is moving forward. However, the action or the current attitude of the Indian Government does not behoove well for permanent change.
http://www.reuters.com/article/rbssHealthcareNews/idUSDEL37021820091106
Permanent Change
The European Union is more like a bad version of the labor union. They have realized that innovation, production, productivity and such are now nearly impossible. Hence they harass US companies on one end and developing nations on the other.
Tolerating this behavior and looking for bizzarely unrealistic amicable solutions is not the right idea.
The seizure of Indian drugs at the Dutch shore wasn't a mistake.
It's almost been a year and there hasn't been a resolution, an apology or even an indication of remorse from the Dutch side.
Moral of the Story
The moral of the story is two-fold:
1. If you are a country looking to bully India, you don't have to try hard.
2. If you are looking at Europe's business plan, this is it.
http://chaaraka.blogspot.com/2009/06/generic-pharma-why-india-should-stop.html
In that post, one of the things I had suggested India do is flex her muscles rather strongly in responding to such nonsense coming in from "Developed" nations.
Amicable Solutions
Consequentially, we have now heard, a whimper from the Indian Trade Minister (I would say ostensibly, it should have been India's Home Minister or Defense Minister and not some Trade Minister).
He says that India and Europe will solve this problem "amicably". Amicably, my bleeding right foot. There is now a lawsuit, which both India and Brazil have launched. This lawsuit has brought Europe's sudden amiability, not our trade minister.
I am glad, at a minimum to see this issue move forward, as slow as it is moving forward. However, the action or the current attitude of the Indian Government does not behoove well for permanent change.
http://www.reuters.com/article/rbssHealthcareNews/idUSDEL37021820091106
Permanent Change
The European Union is more like a bad version of the labor union. They have realized that innovation, production, productivity and such are now nearly impossible. Hence they harass US companies on one end and developing nations on the other.
Tolerating this behavior and looking for bizzarely unrealistic amicable solutions is not the right idea.
The seizure of Indian drugs at the Dutch shore wasn't a mistake.
It's almost been a year and there hasn't been a resolution, an apology or even an indication of remorse from the Dutch side.
Moral of the Story
The moral of the story is two-fold:
1. If you are a country looking to bully India, you don't have to try hard.
2. If you are looking at Europe's business plan, this is it.
Saturday, October 31, 2009
The Stryker Brouhaha: How the FDA demonstrates that it was never loved as a child...
If you have not heard about Stryker's (latest) legal problems, the FDA is charging Stryker and a random collection of expendable Stryker executives with off-the-label marketing.
I will link one of the many reporting stories available on the issue at the bottom, and you can read for yourself as to how, apparently, Stryker executives knowingly promoted a cement approved with stringent restrictions on marketing for humanitarian use, for off-label use. They even provided Doctors with highly suggestive recipes and concoctions on how to use the cements.
As with most of Orthopedic products that have been riddled with poor design, kickback scheme accusations and marketing attitudes, a lot of patients suffered.
So, the FDA finally jumped in!
The charges and the possible punishment
And it has accused a total of 8 Stryker folks, half of whom are classed as "former" and include, among others a former president and a sales executive.
At the outset, this all seems like "action". The charges include "wire fraud, conspiracy, misbranding, and making false statements."
Take a closer look. What does it entail as an eventual form of punishment?
Nothing, er, next to nothing in the following order: Something, Nothing, Next to Nothing.
If convicted, Stryker will face the following extremely debilitating actions taken against it:
1. As quoted: "fines for Stryker of at least $500,000 for each count"
2. "Exclusion from federal and state healthcare programs".
Okay, you read it, now say it loud with me, "Are you joking"?
Is the FDA Joking?
With you, one who is not charged by the FDA, yes.
How far does $500,000 go in 2009?
For large companies, $500,000 is chuck change. Heck, it is lesser than any of the following:
1. The amount such companies pay for their lawyers (which didn't work for Pepsi whose lazy lawyers missed a court date and are now scrambling to get a $1.2bn charge dismissed) to simply go out and harass, among others, federal agencies, smaller companies, individuals (Charles Riegel anyone?) and such.
2. The amount medical device and pharma companies pay in a quarter to lobby Congress to forget patients and pass laws that will make sure the right amounts of donations are made to individual campaign funds.
3. The amount these companies spend in a year using weak patents and other methods to harass smaller companies.
4. The amount these companies pay their executives in a month!
5. The amount that will be spent in lawyers fees defending the current charges by the FDA!!
6. The amount device companies are paying to lobby against healthcare reform of any kind!!!
And, of course I can go on and on...
This clearly demonstrates something. The FDA is obviously out of touch with reality, somewhat like a bad parent in need of love from their children at all costs.
What should be the punishment?
You may even wonder if punishment is necessary. See a lot of these brazen executives move from company to company and take their despicable attitudes with them. They do not change, because there is nothing that makes it necessary. They then proudly promulgate and breed more such "executives".
Punishment needs to be debilitating.
Punishment should invoke shame.
Large organizations thrive on corporate image across several industries. Not so in medical devices. Take Orthrocare or Stryker for example - such companies have been involved in all kinds of lawsuits. They pay cursory fines and get away with anything. Many such companies then turn around and lobby against healthcare reform!
Punishment should invoke the need for attitude change.
The punishment needs to be proportional to the crime. It is one thing for Hollywood to make disturbingly emotional movies where one soldier, one victim is important and a whole town, a whole army rallies around them.
It is another, for companies to be let go for a small fine when they kill and otherwise disable patients with obvious disregard for law and ethics.
Growing up to the times
The meter-maids, not FDA, are supposed to hand out parking tickets. Companies need to be punished proportional to their crime. Crime, among medical device companies is systemic:
1. The entire Orthopedic industry (well, the 4 companies controlling 95% of the industry) was implicated in wonderfully disgusting "kick-back schemes". Nothing came of it, except minor fines.
2. Companies like Stryker have been abhorrent at clinical research (read my squeaky hips post linked below) or at respecting patents, and systematically get involved in lawsuits. As a result of the fact that every federal agency, including the judiciary system is filled with ineptitude to mete out the right amount of judicial punishment, they keep on, keeping on.
Sending the wrong message
With the current listness and a lack of any form of seriousness, the FDA is sending the following message: As long as you hang back and reserve a few million dollars in lawyer fees and a few hundred thousand dollars in fines for the FDA, you can get away with anything you want - cooking data, promoting off-label use, anything.
At this rate, you should soon see the bigger device companies to sell 5-hour energy pills, phallic extension pills and fake weight-loss drugs.
Heck, why not? Right?
Hope and Change
If Obama and Margaret Hamburg really want change, they need to start setting examples. As I stated above, the industry does have it's fair share of fearless, lying crooks. By cowering to the fact that these companies are large and fearless, the Government is doing no better than the previous administration, and is really not bringing about any form of measurable change.
When companies such as Stryker are brought to court based on real evidence of crime, they should be made to pay. There should be no room for such companies to express "disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter".
They should instead be "ashamed", rue the day they decided that bending the law was "cool", and should be forced to gouge themselves of their present attitudes.
If this is not what the Obama administration wants to do, then there will be no change, and soon the hope will whither away.
Grandma will have no insurance because that was lobbied against.
Grandma will get a squeaky hip that won't work and embarass her to no end.
Grandma will also get dysfunctional cements, stents and ICDs in her body.
And, instead of looking forward to their one hour of daily exercise, such "executives" will keep popping champaigne bottles everywhere...
References:
1. On the charges against Stryker: Click here
2. On Stryker's squeaky hips:
http://chaaraka.blogspot.com/2008/12/okay-kids-squeaky-hips-are-in-again.html
3. On Acumed Vs Stryker:
http://chaaraka.blogspot.com/2009/01/unfortunately-but-we-infringed-only.html
4. On Stryker's previous kickback settlements:
http://www.saundersblog.com/2008/01/stryker_settles_kickback_schem.html
I will link one of the many reporting stories available on the issue at the bottom, and you can read for yourself as to how, apparently, Stryker executives knowingly promoted a cement approved with stringent restrictions on marketing for humanitarian use, for off-label use. They even provided Doctors with highly suggestive recipes and concoctions on how to use the cements.
As with most of Orthopedic products that have been riddled with poor design, kickback scheme accusations and marketing attitudes, a lot of patients suffered.
So, the FDA finally jumped in!
The charges and the possible punishment
And it has accused a total of 8 Stryker folks, half of whom are classed as "former" and include, among others a former president and a sales executive.
At the outset, this all seems like "action". The charges include "wire fraud, conspiracy, misbranding, and making false statements."
Take a closer look. What does it entail as an eventual form of punishment?
Nothing, er, next to nothing in the following order: Something, Nothing, Next to Nothing.
If convicted, Stryker will face the following extremely debilitating actions taken against it:
1. As quoted: "fines for Stryker of at least $500,000 for each count"
2. "Exclusion from federal and state healthcare programs".
Okay, you read it, now say it loud with me, "Are you joking"?
Is the FDA Joking?
With you, one who is not charged by the FDA, yes.
How far does $500,000 go in 2009?
For large companies, $500,000 is chuck change. Heck, it is lesser than any of the following:
1. The amount such companies pay for their lawyers (which didn't work for Pepsi whose lazy lawyers missed a court date and are now scrambling to get a $1.2bn charge dismissed) to simply go out and harass, among others, federal agencies, smaller companies, individuals (Charles Riegel anyone?) and such.
2. The amount medical device and pharma companies pay in a quarter to lobby Congress to forget patients and pass laws that will make sure the right amounts of donations are made to individual campaign funds.
3. The amount these companies spend in a year using weak patents and other methods to harass smaller companies.
4. The amount these companies pay their executives in a month!
5. The amount that will be spent in lawyers fees defending the current charges by the FDA!!
6. The amount device companies are paying to lobby against healthcare reform of any kind!!!
And, of course I can go on and on...
This clearly demonstrates something. The FDA is obviously out of touch with reality, somewhat like a bad parent in need of love from their children at all costs.
What should be the punishment?
You may even wonder if punishment is necessary. See a lot of these brazen executives move from company to company and take their despicable attitudes with them. They do not change, because there is nothing that makes it necessary. They then proudly promulgate and breed more such "executives".
Punishment needs to be debilitating.
Punishment should invoke shame.
Large organizations thrive on corporate image across several industries. Not so in medical devices. Take Orthrocare or Stryker for example - such companies have been involved in all kinds of lawsuits. They pay cursory fines and get away with anything. Many such companies then turn around and lobby against healthcare reform!
Punishment should invoke the need for attitude change.
The punishment needs to be proportional to the crime. It is one thing for Hollywood to make disturbingly emotional movies where one soldier, one victim is important and a whole town, a whole army rallies around them.
It is another, for companies to be let go for a small fine when they kill and otherwise disable patients with obvious disregard for law and ethics.
Growing up to the times
The meter-maids, not FDA, are supposed to hand out parking tickets. Companies need to be punished proportional to their crime. Crime, among medical device companies is systemic:
1. The entire Orthopedic industry (well, the 4 companies controlling 95% of the industry) was implicated in wonderfully disgusting "kick-back schemes". Nothing came of it, except minor fines.
2. Companies like Stryker have been abhorrent at clinical research (read my squeaky hips post linked below) or at respecting patents, and systematically get involved in lawsuits. As a result of the fact that every federal agency, including the judiciary system is filled with ineptitude to mete out the right amount of judicial punishment, they keep on, keeping on.
Sending the wrong message
With the current listness and a lack of any form of seriousness, the FDA is sending the following message: As long as you hang back and reserve a few million dollars in lawyer fees and a few hundred thousand dollars in fines for the FDA, you can get away with anything you want - cooking data, promoting off-label use, anything.
At this rate, you should soon see the bigger device companies to sell 5-hour energy pills, phallic extension pills and fake weight-loss drugs.
Heck, why not? Right?
Hope and Change
If Obama and Margaret Hamburg really want change, they need to start setting examples. As I stated above, the industry does have it's fair share of fearless, lying crooks. By cowering to the fact that these companies are large and fearless, the Government is doing no better than the previous administration, and is really not bringing about any form of measurable change.
When companies such as Stryker are brought to court based on real evidence of crime, they should be made to pay. There should be no room for such companies to express "disappointed with this action and still hopes to be able to reach a fair and just resolution of this matter".
They should instead be "ashamed", rue the day they decided that bending the law was "cool", and should be forced to gouge themselves of their present attitudes.
If this is not what the Obama administration wants to do, then there will be no change, and soon the hope will whither away.
Grandma will have no insurance because that was lobbied against.
Grandma will get a squeaky hip that won't work and embarass her to no end.
Grandma will also get dysfunctional cements, stents and ICDs in her body.
And, instead of looking forward to their one hour of daily exercise, such "executives" will keep popping champaigne bottles everywhere...
References:
1. On the charges against Stryker: Click here
2. On Stryker's squeaky hips:
http://chaaraka.blogspot.com/2008/12/okay-kids-squeaky-hips-are-in-again.html
3. On Acumed Vs Stryker:
http://chaaraka.blogspot.com/2009/01/unfortunately-but-we-infringed-only.html
4. On Stryker's previous kickback settlements:
http://www.saundersblog.com/2008/01/stryker_settles_kickback_schem.html
Saturday, October 24, 2009
Starting up? How is your bootstrapping coming along?
You are motivated. You are passionate. You have the idea. You are backed by science. Yet, neither are the VCs caring much for you, nor is the Gates Foundation interested in funding your idea.
What do you do?
Well, for one you can blame the Government, the stars and everything in between and give up.
Or, you can bootstrap! Now, bootstrapping is easier said than done. How does one actually achieve the act of bootstrapping?
A couple of interesting articles
Let us go from the lateral to the core. The first article came out of inc.com which talks about how software companies are bootstrapping. Apparently, some of them (or at least the one fielded in the article) have an intriguing way of doing things. The software company does not actually design the software, but spends a few hundred dollars designing websites that tout the "potential" features of a product and wait till a customer actually demonstrates interest in "buying" the product.
It is not possible to wait for a patient to complain of pain till you design a device, I know, but remember, we are looking at analogies of intrigue, to prove the point - "it can be done".
The article goes on to describe the nitties and the gritties of software development by bootstrapping. Have a read (and don't touch that remote, we are not done yet):
http://www.inc.com/magazine/20091001/the-bootstrappers-guide-to-launching-new-products.html?partner=newsletter_Startup
Bootstrapping a biotech startup
You would think that a biotech startup would take a lot of investment, and would be impossible to start without VC or angel backing. I gave up on a few ideas myself. But, to even find an angel or a VC, you need a prototype, or some licensed IP and so on. Unless you have this, a bit of luck, a few PhDs, good luck, right?
Well, according to the article from The Scientist, Johnny Stine is out to prove you wrong. I am not going to refurbish the article and steal from The Scientist, but he has proven that "it" can be done. With about $45,000, he got the whole thing going. You should read and find out more about what and how he has managed to pull it off.
Here is The Scientist Article:
http://www.the-scientist.com/article/display/56006/
Bootstrapping Resources
eBay is a great source, but be sure to take a look at the following:
I Shopping Resources
1.1 Craigslist
Regardless of cheap efforts by attorney generals and ambitious Sheriffs, craigslist remains the best place to pick up stuff for free, or for nearly free prices. I have seen everything from microscopes to lathes being given away. Getting a fixer-upper is not a bad idea when you are bootstrapping.
1.2 Tech Recovery
A couple of years ago, there was a plant closure going on and someone told me about this website. They apparently buy stuff from plants or companies that are moving or going out of business and sell it to start ups and others for a really low price:
http://www.techrecovery.com/
1.3 Google Product Search (formerly Froogle)
I am not sure if Froogle has been formally retired, but I always thought it was a great idea. What if the stuff you are looking for is not available used on Craigslist? Even if it is available on eBay, among the hundreds of stores online, how do you know if you are paying the lowest possible price? How do you automate comparative shopping? Google Product Search, still in beta (like most of their other products are) can be put to use:
http://www.google.com/products
1.4. Others
Search locally for stores that sell used or heavily discounted items. For example, if you are in the San Francisco Bay Area, Halted Electronics on Central and Lawrence Expressways can get you some good bargains for electronics. Similarly, from March through October, there is the Electronics Flea Market:
http://www.electronicsfleamarket.com/
II Software and Internet Tools
As an entrepreneur, you need to be professional, and so you should not get into situations where you use any kind of "cracked" software and such. You are about to go and try have customers buy your products. How would you like it if someone walked off with your molecule or the catheter.
There are legitimate software applications out there that are either completely free or come for cheap. How can companies "give away" their product and still plan to stay in business? Well, they are hoping that you would do one or two things - either upgrade to their paid version when you can, or pay for service and support, or both.
Let us take a look at some that you already be aware of:
2.1 Clinical Trial Software
Within clinical trial software, my experience is limited, however, recently, FierceBiotechIT mentioned OpenClinica 3.0, which is an Open Source application (alongside a commercial enterprise version), that can be downloaded and modified for free.
http://www.openclinica.org/
2.2 Project Management - Open Workbench
Ah, the holy grail for a start up, especially for medical device and biotechnology companies. Open Workbench is an Open Source tool, and can be quite useful if you want to use some good practices and start dividing up your work into Projects and start the PM process sooner, rather than bandage it together later:
http://www.openworkbench.org/index.php
2.3 Brainstorming and Mind Mapping
Be it a better mousetrap or a new out-of-the-friggin'-box treatment for a disease that you plan to hash out, you need to create and protect your intellectual property. How do you brainstorm if your colleagues are out there, or if you want to do them on a laptop and you don't have access to the envelope or napkin, but a laptop...?
You mind map. Mind mapping software come in various sizes and shapes. Some allow you to make fish-bone diagrams, other allow you to perform free forms in other ways. I am providing you with a page that has a whole host of links here, some open source and some proprietary.
http://en.wikipedia.org/wiki/List_of_mind_mapping_software
2.4 Document Creation and Storage
2.4.1 Google
Google constantly keeps updating their products - and I am not even talking off the paid version. You can simply use the free tools and you have a set of portable documents that can be shared and distributed online. Google Documents are no substitute for the industry standard Microsoft Office, but they can serve as an excellent, online repository for data that you use every day, effectively allowing you to work from home or elsewhere.
Other Google products such as Google Sites can also help you come up with quick and dirty websites if they are necessary.
http://docs.google.com/
http//sites.google.com/
Google is not the only company with tools for online document storage and such. The biggest advantage is, if you are an addicted Gmail user, you can integrate the documents into your email system directly.
2.4.2 Zoho
When I was first introduced to Zoho, I was impressed by the simplicity of the tools. Take a look here:
http://www.zoho.com/
They offer everything from document storage to web conferencing and CRM with a lot in between.
2.4.3 OpenOffice
With Oracle's acquisition of Sun Microsystems, the future of OpenOffice is in question (as are the futures of MySQL, Java and several other products). However, for offline use, as a free office product, it is the best out there.
http://www.openoffice.org/
2.5 Free or Cheap Web Conferencing Tools
Through several helpful folks from my alumni list, I came across a handful of free to cheap web conferencing tools. Web conferencing allows you to work with folks across the globe and cuts down on meeting costs as well(remember, Zoho was already mentioned in the last section):
2.5.1 Dimdim
Dimdim is an open source tool, with a free basic web conferencing version and additional paid versions. I have not used this tool myself, so you will have to test this yourself.
http://www.dimdim.com/
2.5.2 Fuze Meeting
Again, a similar website, the free version does not appear to have as many features as Dimdim does, but it might be an alternative.
http://www.fuzemeeting.com/
2.5.3 Vyview
This appears to be yet another elegantly designed, ostensibly free tool that PC World seems to have rated. The competition in this area must be truly high:
http://vyew.com/site/index2
2.5.4 Open A Circle
Like Zoho, this company seems to offer a bundle that is not simply limited to web conferencing, but seems to extend to instant messaging, file storage, etc. They do recommend Internet Explorer or Firefox Mozilla, and a Windows Operating System (bootstrapping with expensive Apple computers would be paradoxical)
http://www.openacircle.com/
2.5.5 Jive
With so many free web conferencing tools, why bother mentioning something that is not free at a minimum? Because the base rate of $3 per user per month may be something you can think about if their product "suite" that seems to span across several verticals makes any kind of sense for you:
http://www.jivesoftware.com/products
2.6 Other web collaboration
2.6.1 Zenbe
Zenbe appears to help teams collaborate over multiple projects without a bunch of different emails going back and forth. It appears to be a form of revision management without actual revision management:
http://www.zenbe.com/
2.6.2 Notaland
This is an interesting tool that allows multiple users to create and update web pages, chat etc., serving as an online whiteboard.
http://notaland.com/
2.7 File Sharing and Storage
There are many file sharing and storage products out there, and many companies mentioned in prior sections also offer free storage, but just in case you need some more.
2.7.1 Yousendit
Yousendit Lite is a free file sharing mechanism for individuals that eliminates the need to buy online space or use an ftp application.
http://www.yousendit.com/
2.7.2 drop.io (free trial)
The company is offering a 30-day trial for what is otherwise a rather expensive proposition. However, the tool itself sounds like a very good idea - drop files worth 10OMB online and share them through multiple means.
2.7.3 SkyDrive
Obviously stung by competition (read Google), Microsoft is now trying to catch up. There could be some gold for you in the competition. SkyDrive offers 25GB of storage if you sign up with Windows Live!
http://skydrive.live.com/
2.8 CAD Tools
CAD Tools for medical device companies, should be chosen carefully. While there are free tools out there, CAD tends to be the backbone of product development and choices can affect you for a long time. CAD software do not play with each other all too nicely all the time, and if you choose the wrong application, you may have to spend a good deal of money on translation tools or simply, recreating your work.
That said, there are a couple of free tools worth mentioning with the above caution.
Google SketchUp
While this tool may not be very useful for the kind of serious CAD engineering typically requires, it is still a very easy one too use. So, take a look.
http://sketchup.google.com/
2.9 Free tools from Microsoft
I recently came across this at the Tech Republic, and I thought you might want to explore these and see if any may be of use to you:
http://blogs.techrepublic.com.com/10things/?p=1099
III. Educational Tools
You have your start up. It feels great. But how about some "back to school" time? Well, here goes.
3.1 OpenCourseWare
MIT kept up with it's promise and revolutionized education with the OCW project. With this, you can now become an arm-chair and laptop MIT student!
http://ocw.mit.edu/OcwWeb/web/home/home/index.htm
3.2 Stanford Engineering Everywhere
My alma mater on the other hand has been standing around, with hands tied, fists clenched and more. Finally, they have opened up a few engineering courses and have had the gall to come out with a press release. For a left coast school alum, somewhat painful to sit and watch. In any case, the classes that are free, are excellent!
http://see.stanford.edu/
3.3 Entrepreneurship Thought Leaders Seminars
While I lament the fact that Stanford hasn't opened up as much as MIT has, the ETL seminars have been free forever, and they offer an entrepreneur with a treasure trove of speeches, revelations, do's, dont's and everything else.
http://ecorner.stanford.edu/
3.4 Community Colleges
This may not pertain to entrepreneurs everywhere, but if you live in the US, there is probably a community college (or two) near where you live. If you are more of a hands-on learner, then your community college may be the one for you. Cheap and effective, enrolling can give you access to their classes, labs and libraries (be careful about software - licensing agreements will restrict you from using most educational software for commercial work).
3.5 Your Local Library
There have never been resources more useful than your local library. Your local library can be a city library, or even a library in a community college of University near where you live. With several ways to access materials from these libraries, you will save yourself a good chunk of change simply visiting and reading stuff off of libraries. You can also save on the lattes if you simply work from a library in case you are the kind of a person in need of "office space" (Moi, je suis flop myself in front of the TV tojours).
Local libraries may offer other benefits as well. For example, a local library belonging to the City of Menlo Park has a "free" bin of books donated by readers. If you are persistent enough, you could even pick up a copy of Science or the NEJM!
Friends of the Library
The Friends of City of Palo Alto Library, near where I live has a monthly book sales, where I have found several excellent books at throwaway prices.
City Libraries have "Friends" clubs that are usually registered as non-profits, which means you don't have to pay taxes when you buy from them. Recently, I found out that some of them also sell books at dirt prices online on Amazon.com!
3.6 Do-It-Yourself!
Hmmm, no, it's not late in the night or anything. Doing your own work can of course save you a lot of money and give you unparalleled insights into your ideas, it's pluses and minuses. A great starting point is the DIYBIO website. Ever since I joined the site, I have picked up so much! To be honest, I find their Google Group easier to use (I am an email jockey) than the forums that I rarely visit.
http://diybio.org/
3.7 Blogs and Newsletters
Depending on how much time you have, blogs and newsletters can help you quite a bit. I am constantly accessing them and listing them here seems impractical. Please browse to the right hand side of this blog's home page, http://chaaraka.blogspot.com for a full list.
Shameless plug it is, but I have kept it updated pretty well, even with some that I don't agree with!
IV. Tech Shop and Make Co-Operatives
Alright, how about machine tools for prototyping? Do you need to buy a whole new lathe or milling machine? Not if you live in certain areas. For example, in the San Francisco Bay Area (okay, I am not showing off, I truly live here), there is the Tech Shop, where you can take classes and sign up for the use of machine time:
http://techshop.ws/
They also have locations in Oregon and North Carolina. There are also make shops and community workspaces probably coming up in an area where you live!
IV. Give me more - Market Research, researching and some more
This is a tail ender, but I am going to introduce you to a very nifty tool - "Google Alerts". Google Alerts constitutes the sharpest tool in my collection of online research tools. Do you need to keep tabs on your competitors, or just know what is being written about your own company or your disease area?
Go to http://alerts.google.com
Set up an alert for say "Endometriosis" or "Medtronic", say what type of results you want - I usually choose "Comprehensive" to make sure I get everything on a topic. Then, you also want to say whether you want news items offered as they happen, or once a day. I tend to want to read things as they happen.
However, "as-it-happens" can overload your inbox. So, you might want to choose the digest form. You could also create filters and make sure the Google Alerts don't land on your inbox.
There, you now have your own, free of cost market research and competitive research tool!
V. Network, network, network
Yeah, what is "networking" doing in a post on bootstrapping? It is the old barn-raising again. You never know who has the answers to your problems and who may help you out. Bootstrapping means going beyond looking stuff up on Google and simply buying or renting them. There are dozens of companies and consultants who will offer free advice, solutions and products to make sure you give them a good hand and get to understand or buy them when you can or need them.
Most of the tools I have listed up here, I know of, only because I spend a lot of time on several odd networks, signing up for various types of blogs and constantly skimming and flipping through materials.
So, the next time you hear someone questioning the LinkedIns and the Facebooks of the world, you know what to say. Apart from the DIYBio, I have found the "sfmedengineers" Yahoo! Group to be quite useful:
http://groups.yahoo.com/group/sfmedengineers/
If you are a young entrepreneur, especially looking for ideas, you may want to network and participate and/or volunteer in events. You will get to meet a number of terrific people and learn quite a bit. Trust me, networking can never be wasteful.
Conclusion
I wrote this list keeping a medical device/biotechnology company in mind. Most of the tools pertain to start-ups in other areas as well. I have not tested all of the tools in here, but I have tried my hand on many of them. If you have specifically liked any, or have had problems with any, please leave a note.
I am also certain that I left out a lot of tools in here. If you know of tools that may help, please let me know. I realize that a blog post is hard to update, and I thought of a wiki - I have been planning a medical devices wiki but it will have to wait. In the meanwhile, I will release all these tools in the form of a concise eBook that will make it easy for me to revision manage and update. So, please let me know of tools and gaps in tools that you may want to see here.
For my next few releases of this type, I plan to write about other useful resources such as specific books and such.
What do you do?
Well, for one you can blame the Government, the stars and everything in between and give up.
Or, you can bootstrap! Now, bootstrapping is easier said than done. How does one actually achieve the act of bootstrapping?
A couple of interesting articles
Let us go from the lateral to the core. The first article came out of inc.com which talks about how software companies are bootstrapping. Apparently, some of them (or at least the one fielded in the article) have an intriguing way of doing things. The software company does not actually design the software, but spends a few hundred dollars designing websites that tout the "potential" features of a product and wait till a customer actually demonstrates interest in "buying" the product.
It is not possible to wait for a patient to complain of pain till you design a device, I know, but remember, we are looking at analogies of intrigue, to prove the point - "it can be done".
The article goes on to describe the nitties and the gritties of software development by bootstrapping. Have a read (and don't touch that remote, we are not done yet):
http://www.inc.com/magazine/20091001/the-bootstrappers-guide-to-launching-new-products.html?partner=newsletter_Startup
Bootstrapping a biotech startup
You would think that a biotech startup would take a lot of investment, and would be impossible to start without VC or angel backing. I gave up on a few ideas myself. But, to even find an angel or a VC, you need a prototype, or some licensed IP and so on. Unless you have this, a bit of luck, a few PhDs, good luck, right?
Well, according to the article from The Scientist, Johnny Stine is out to prove you wrong. I am not going to refurbish the article and steal from The Scientist, but he has proven that "it" can be done. With about $45,000, he got the whole thing going. You should read and find out more about what and how he has managed to pull it off.
Here is The Scientist Article:
http://www.the-scientist.com/article/display/56006/
Bootstrapping Resources
eBay is a great source, but be sure to take a look at the following:
I Shopping Resources
1.1 Craigslist
Regardless of cheap efforts by attorney generals and ambitious Sheriffs, craigslist remains the best place to pick up stuff for free, or for nearly free prices. I have seen everything from microscopes to lathes being given away. Getting a fixer-upper is not a bad idea when you are bootstrapping.
1.2 Tech Recovery
A couple of years ago, there was a plant closure going on and someone told me about this website. They apparently buy stuff from plants or companies that are moving or going out of business and sell it to start ups and others for a really low price:
http://www.techrecovery.com/
1.3 Google Product Search (formerly Froogle)
I am not sure if Froogle has been formally retired, but I always thought it was a great idea. What if the stuff you are looking for is not available used on Craigslist? Even if it is available on eBay, among the hundreds of stores online, how do you know if you are paying the lowest possible price? How do you automate comparative shopping? Google Product Search, still in beta (like most of their other products are) can be put to use:
http://www.google.com/products
1.4. Others
Search locally for stores that sell used or heavily discounted items. For example, if you are in the San Francisco Bay Area, Halted Electronics on Central and Lawrence Expressways can get you some good bargains for electronics. Similarly, from March through October, there is the Electronics Flea Market:
http://www.electronicsfleamarket.com/
II Software and Internet Tools
As an entrepreneur, you need to be professional, and so you should not get into situations where you use any kind of "cracked" software and such. You are about to go and try have customers buy your products. How would you like it if someone walked off with your molecule or the catheter.
There are legitimate software applications out there that are either completely free or come for cheap. How can companies "give away" their product and still plan to stay in business? Well, they are hoping that you would do one or two things - either upgrade to their paid version when you can, or pay for service and support, or both.
Let us take a look at some that you already be aware of:
2.1 Clinical Trial Software
Within clinical trial software, my experience is limited, however, recently, FierceBiotechIT mentioned OpenClinica 3.0, which is an Open Source application (alongside a commercial enterprise version), that can be downloaded and modified for free.
http://www.openclinica.org/
2.2 Project Management - Open Workbench
Ah, the holy grail for a start up, especially for medical device and biotechnology companies. Open Workbench is an Open Source tool, and can be quite useful if you want to use some good practices and start dividing up your work into Projects and start the PM process sooner, rather than bandage it together later:
http://www.openworkbench.org/index.php
2.3 Brainstorming and Mind Mapping
Be it a better mousetrap or a new out-of-the-friggin'-box treatment for a disease that you plan to hash out, you need to create and protect your intellectual property. How do you brainstorm if your colleagues are out there, or if you want to do them on a laptop and you don't have access to the envelope or napkin, but a laptop...?
You mind map. Mind mapping software come in various sizes and shapes. Some allow you to make fish-bone diagrams, other allow you to perform free forms in other ways. I am providing you with a page that has a whole host of links here, some open source and some proprietary.
http://en.wikipedia.org/wiki/List_of_mind_mapping_software
2.4 Document Creation and Storage
2.4.1 Google
Google constantly keeps updating their products - and I am not even talking off the paid version. You can simply use the free tools and you have a set of portable documents that can be shared and distributed online. Google Documents are no substitute for the industry standard Microsoft Office, but they can serve as an excellent, online repository for data that you use every day, effectively allowing you to work from home or elsewhere.
Other Google products such as Google Sites can also help you come up with quick and dirty websites if they are necessary.
http://docs.google.com/
http//sites.google.com/
Google is not the only company with tools for online document storage and such. The biggest advantage is, if you are an addicted Gmail user, you can integrate the documents into your email system directly.
2.4.2 Zoho
When I was first introduced to Zoho, I was impressed by the simplicity of the tools. Take a look here:
http://www.zoho.com/
They offer everything from document storage to web conferencing and CRM with a lot in between.
2.4.3 OpenOffice
With Oracle's acquisition of Sun Microsystems, the future of OpenOffice is in question (as are the futures of MySQL, Java and several other products). However, for offline use, as a free office product, it is the best out there.
http://www.openoffice.org/
2.5 Free or Cheap Web Conferencing Tools
Through several helpful folks from my alumni list, I came across a handful of free to cheap web conferencing tools. Web conferencing allows you to work with folks across the globe and cuts down on meeting costs as well(remember, Zoho was already mentioned in the last section):
2.5.1 Dimdim
Dimdim is an open source tool, with a free basic web conferencing version and additional paid versions. I have not used this tool myself, so you will have to test this yourself.
http://www.dimdim.com/
2.5.2 Fuze Meeting
Again, a similar website, the free version does not appear to have as many features as Dimdim does, but it might be an alternative.
http://www.fuzemeeting.com/
2.5.3 Vyview
This appears to be yet another elegantly designed, ostensibly free tool that PC World seems to have rated. The competition in this area must be truly high:
http://vyew.com/site/index2
2.5.4 Open A Circle
Like Zoho, this company seems to offer a bundle that is not simply limited to web conferencing, but seems to extend to instant messaging, file storage, etc. They do recommend Internet Explorer or Firefox Mozilla, and a Windows Operating System (bootstrapping with expensive Apple computers would be paradoxical)
http://www.openacircle.com/
2.5.5 Jive
With so many free web conferencing tools, why bother mentioning something that is not free at a minimum? Because the base rate of $3 per user per month may be something you can think about if their product "suite" that seems to span across several verticals makes any kind of sense for you:
http://www.jivesoftware.com/products
2.6 Other web collaboration
2.6.1 Zenbe
Zenbe appears to help teams collaborate over multiple projects without a bunch of different emails going back and forth. It appears to be a form of revision management without actual revision management:
http://www.zenbe.com/
2.6.2 Notaland
This is an interesting tool that allows multiple users to create and update web pages, chat etc., serving as an online whiteboard.
http://notaland.com/
2.7 File Sharing and Storage
There are many file sharing and storage products out there, and many companies mentioned in prior sections also offer free storage, but just in case you need some more.
2.7.1 Yousendit
Yousendit Lite is a free file sharing mechanism for individuals that eliminates the need to buy online space or use an ftp application.
http://www.yousendit.com/
2.7.2 drop.io (free trial)
The company is offering a 30-day trial for what is otherwise a rather expensive proposition. However, the tool itself sounds like a very good idea - drop files worth 10OMB online and share them through multiple means.
2.7.3 SkyDrive
Obviously stung by competition (read Google), Microsoft is now trying to catch up. There could be some gold for you in the competition. SkyDrive offers 25GB of storage if you sign up with Windows Live!
http://skydrive.live.com/
2.8 CAD Tools
CAD Tools for medical device companies, should be chosen carefully. While there are free tools out there, CAD tends to be the backbone of product development and choices can affect you for a long time. CAD software do not play with each other all too nicely all the time, and if you choose the wrong application, you may have to spend a good deal of money on translation tools or simply, recreating your work.
That said, there are a couple of free tools worth mentioning with the above caution.
Google SketchUp
While this tool may not be very useful for the kind of serious CAD engineering typically requires, it is still a very easy one too use. So, take a look.
http://sketchup.google.com/
2.9 Free tools from Microsoft
I recently came across this at the Tech Republic, and I thought you might want to explore these and see if any may be of use to you:
http://blogs.techrepublic.com.com/10things/?p=1099
III. Educational Tools
You have your start up. It feels great. But how about some "back to school" time? Well, here goes.
3.1 OpenCourseWare
MIT kept up with it's promise and revolutionized education with the OCW project. With this, you can now become an arm-chair and laptop MIT student!
http://ocw.mit.edu/OcwWeb/web/home/home/index.htm
3.2 Stanford Engineering Everywhere
My alma mater on the other hand has been standing around, with hands tied, fists clenched and more. Finally, they have opened up a few engineering courses and have had the gall to come out with a press release. For a left coast school alum, somewhat painful to sit and watch. In any case, the classes that are free, are excellent!
http://see.stanford.edu/
3.3 Entrepreneurship Thought Leaders Seminars
While I lament the fact that Stanford hasn't opened up as much as MIT has, the ETL seminars have been free forever, and they offer an entrepreneur with a treasure trove of speeches, revelations, do's, dont's and everything else.
http://ecorner.stanford.edu/
3.4 Community Colleges
This may not pertain to entrepreneurs everywhere, but if you live in the US, there is probably a community college (or two) near where you live. If you are more of a hands-on learner, then your community college may be the one for you. Cheap and effective, enrolling can give you access to their classes, labs and libraries (be careful about software - licensing agreements will restrict you from using most educational software for commercial work).
3.5 Your Local Library
There have never been resources more useful than your local library. Your local library can be a city library, or even a library in a community college of University near where you live. With several ways to access materials from these libraries, you will save yourself a good chunk of change simply visiting and reading stuff off of libraries. You can also save on the lattes if you simply work from a library in case you are the kind of a person in need of "office space" (Moi, je suis flop myself in front of the TV tojours).
Local libraries may offer other benefits as well. For example, a local library belonging to the City of Menlo Park has a "free" bin of books donated by readers. If you are persistent enough, you could even pick up a copy of Science or the NEJM!
Friends of the Library
The Friends of City of Palo Alto Library, near where I live has a monthly book sales, where I have found several excellent books at throwaway prices.
City Libraries have "Friends" clubs that are usually registered as non-profits, which means you don't have to pay taxes when you buy from them. Recently, I found out that some of them also sell books at dirt prices online on Amazon.com!
3.6 Do-It-Yourself!
Hmmm, no, it's not late in the night or anything. Doing your own work can of course save you a lot of money and give you unparalleled insights into your ideas, it's pluses and minuses. A great starting point is the DIYBIO website. Ever since I joined the site, I have picked up so much! To be honest, I find their Google Group easier to use (I am an email jockey) than the forums that I rarely visit.
http://diybio.org/
3.7 Blogs and Newsletters
Depending on how much time you have, blogs and newsletters can help you quite a bit. I am constantly accessing them and listing them here seems impractical. Please browse to the right hand side of this blog's home page, http://chaaraka.blogspot.com for a full list.
Shameless plug it is, but I have kept it updated pretty well, even with some that I don't agree with!
IV. Tech Shop and Make Co-Operatives
Alright, how about machine tools for prototyping? Do you need to buy a whole new lathe or milling machine? Not if you live in certain areas. For example, in the San Francisco Bay Area (okay, I am not showing off, I truly live here), there is the Tech Shop, where you can take classes and sign up for the use of machine time:
http://techshop.ws/
They also have locations in Oregon and North Carolina. There are also make shops and community workspaces probably coming up in an area where you live!
IV. Give me more - Market Research, researching and some more
This is a tail ender, but I am going to introduce you to a very nifty tool - "Google Alerts". Google Alerts constitutes the sharpest tool in my collection of online research tools. Do you need to keep tabs on your competitors, or just know what is being written about your own company or your disease area?
Go to http://alerts.google.com
Set up an alert for say "Endometriosis" or "Medtronic", say what type of results you want - I usually choose "Comprehensive" to make sure I get everything on a topic. Then, you also want to say whether you want news items offered as they happen, or once a day. I tend to want to read things as they happen.
However, "as-it-happens" can overload your inbox. So, you might want to choose the digest form. You could also create filters and make sure the Google Alerts don't land on your inbox.
There, you now have your own, free of cost market research and competitive research tool!
V. Network, network, network
Yeah, what is "networking" doing in a post on bootstrapping? It is the old barn-raising again. You never know who has the answers to your problems and who may help you out. Bootstrapping means going beyond looking stuff up on Google and simply buying or renting them. There are dozens of companies and consultants who will offer free advice, solutions and products to make sure you give them a good hand and get to understand or buy them when you can or need them.
Most of the tools I have listed up here, I know of, only because I spend a lot of time on several odd networks, signing up for various types of blogs and constantly skimming and flipping through materials.
So, the next time you hear someone questioning the LinkedIns and the Facebooks of the world, you know what to say. Apart from the DIYBio, I have found the "sfmedengineers" Yahoo! Group to be quite useful:
http://groups.yahoo.com/group/sfmedengineers/
If you are a young entrepreneur, especially looking for ideas, you may want to network and participate and/or volunteer in events. You will get to meet a number of terrific people and learn quite a bit. Trust me, networking can never be wasteful.
Conclusion
I wrote this list keeping a medical device/biotechnology company in mind. Most of the tools pertain to start-ups in other areas as well. I have not tested all of the tools in here, but I have tried my hand on many of them. If you have specifically liked any, or have had problems with any, please leave a note.
I am also certain that I left out a lot of tools in here. If you know of tools that may help, please let me know. I realize that a blog post is hard to update, and I thought of a wiki - I have been planning a medical devices wiki but it will have to wait. In the meanwhile, I will release all these tools in the form of a concise eBook that will make it easy for me to revision manage and update. So, please let me know of tools and gaps in tools that you may want to see here.
For my next few releases of this type, I plan to write about other useful resources such as specific books and such.
Friday, October 23, 2009
The Society for Partcipatory Medicine
I am not sure where it was (because it was everywhere), but I found a very interesting society, "The Society for Participatory Medicine". I became very intrigued and checked them out (and later joined the organization).
When I went to their "About" section, here is what I found:
"devoted to promoting the concept of participatory medicine by and among patients, caregivers and their medical teams and to promote clinical transparency among patients and their physicians through the exchange of information, via conferences, as well through the distribution of correspondence and other written materials."
I find this very interesting. As of now, I am not an ongoing patient, but I have felt that medicine needs to open up beyond the current structure of Government, Doctors and Insurers. Patients, after all, are the biggest stakeholder in the practice of medicine.
Patient Participation - A gap in need of filling
Among other things, one of the main drawbacks to the progress of medicine in the US and across the world, is the fact that most patients do not enroll in clinical trials. Of course, there are issues with patient education, advocacy, and yes, participation.
Thus, I found what the organization has as a goal, quite intriguing. While there are disease specific organizations and movements such as the American Cancer Society and societies for various diseases, there aren't many out there, explicitly advocating patient participation in general.
Apart from visiting Wikipedia and bugging their Doctors, patients need to pay more attention to how they are being treated, what treatments are being approved by the FDA, what standards the FDA is maintaining, the quality of the Doctors, the devices and the drugs used, Government, who is lobbying who for what (did you know that Bank Of America, a company you bailed out has been contributing to Congressmen and Congresswomen with your tax money?), what Congress is doing...
The list of what patients and the population (a.k.a. future patients) need to do make sure they have a say in the practice of medicine (or practice of health) is of course a mile long...
What else is Participatory Medicine?
Participatory Medicine is also Participatory Health. Responsibility is never a one way street (isn't that the cliche of the week?). Health involves eating right, exercising, staying away from recreational substances of all sorts. If we all did our bit, then we can participate in our health, which would reduce the need for us to participate as much in Medicine.
Interesting Fundraising Techniques
The Society for Participatory Medicine has a very interesting fundraising mechanism. Membership is paid, and if you join the organization in the fiscal first year, you get to call yourself a "Founding Member". I can only envision two results when you come across this - some intrigue and a sense of egoistic fulfillment.
Whatever be the case, I was intrigued enough to make myself a "Founding Member" without founding anything. In any case, I think the organization and it's objectives are very pithy. As a result, I have joined and hope that the organization achieves it's goals.
Fore more information:
http://participatorymedicine.org/about/
http://e-patients.net/
When I went to their "About" section, here is what I found:
"devoted to promoting the concept of participatory medicine by and among patients, caregivers and their medical teams and to promote clinical transparency among patients and their physicians through the exchange of information, via conferences, as well through the distribution of correspondence and other written materials."
I find this very interesting. As of now, I am not an ongoing patient, but I have felt that medicine needs to open up beyond the current structure of Government, Doctors and Insurers. Patients, after all, are the biggest stakeholder in the practice of medicine.
Patient Participation - A gap in need of filling
Among other things, one of the main drawbacks to the progress of medicine in the US and across the world, is the fact that most patients do not enroll in clinical trials. Of course, there are issues with patient education, advocacy, and yes, participation.
Thus, I found what the organization has as a goal, quite intriguing. While there are disease specific organizations and movements such as the American Cancer Society and societies for various diseases, there aren't many out there, explicitly advocating patient participation in general.
Apart from visiting Wikipedia and bugging their Doctors, patients need to pay more attention to how they are being treated, what treatments are being approved by the FDA, what standards the FDA is maintaining, the quality of the Doctors, the devices and the drugs used, Government, who is lobbying who for what (did you know that Bank Of America, a company you bailed out has been contributing to Congressmen and Congresswomen with your tax money?), what Congress is doing...
The list of what patients and the population (a.k.a. future patients) need to do make sure they have a say in the practice of medicine (or practice of health) is of course a mile long...
What else is Participatory Medicine?
Participatory Medicine is also Participatory Health. Responsibility is never a one way street (isn't that the cliche of the week?). Health involves eating right, exercising, staying away from recreational substances of all sorts. If we all did our bit, then we can participate in our health, which would reduce the need for us to participate as much in Medicine.
Interesting Fundraising Techniques
The Society for Participatory Medicine has a very interesting fundraising mechanism. Membership is paid, and if you join the organization in the fiscal first year, you get to call yourself a "Founding Member". I can only envision two results when you come across this - some intrigue and a sense of egoistic fulfillment.
Whatever be the case, I was intrigued enough to make myself a "Founding Member" without founding anything. In any case, I think the organization and it's objectives are very pithy. As a result, I have joined and hope that the organization achieves it's goals.
Fore more information:
http://participatorymedicine.org/about/
http://e-patients.net/
Thursday, October 22, 2009
What? The FDA and disorganized? But, how can that be...?!!
Yes, how can that be, since the Democrats, in their infinite wisdom, decided to shore up a faltering agency by dumping money and responsibility (read tobacco) on it?
What the hell am I going on about? Well, the New York Times came out with a story today about how Congressional investigators (and who exactly are these people? Are they the same ones also doling out my taxes to the FDA on the side?) have concluded that the FDA is disorganized, inept and derelict.
Don't simply say "What's new about that?" and move on.
The prelude
Apparently, aside from regulating Food, Drugs, Devices and now Tobacco (because it is food, I guess), the FDA must also punish fraudulent investigators. Now that's a tall order, especially considering that the FDA has already demonstrated unparalleled ability in the following areas:
1. Failure in the regulation of food
2. Failure in the regulation of drugs
3. Failure in the regulation of devices
In May, when the Obama administration was bringing gifts to Maryland, I lamented, along with several others on the need for the break-up of the FDA:
http://chaaraka.blogspot.com/2009/05/democrats-plan-to-fix-fda-give-them.html
Of course, no one in the Obama Administration wants to listen to you, unless you get on Fox TV and shout yourself hoarse. Some grass roots.
Anyhow, ours is not to ask, but to damn.
The problem:
The FDA is an overburdened organization with entrenched leadership. A bus load of NIH scientists and a truck load of cash will not solve the problem. Joint regulation of food, drugs, devices, tobacco, researchers and everything in-between is ridiculously infeasible.
While it is easy to make light of the FDA's failures, there is a reason why this problem happens:
1. The FDA has to take care of everyone of it's current burdens of making policy, coming up with regulations that enforce policies and rulings, report to Congress, etc.
2. The FDA has to deal with a global economy that results in devices and drugs manufactured in an an array of nations across Asia and Europe. The FDA needs to deal with fraud, counterfeit operations and GMP, GCP across the globe for anything used in the US.
3. The FDA is constantly dealing with issues and situations that have never been faced before. They need to hire and rely on outside "experts", who are usually non-existent. If they do exist, or thrust themselves in as subject matter experts, these experts usually come burdened with conflicts of interest.
All said and done, the main problem is an in-cohesive attitude towards the FDA, it's capabilities, the limitation and most of all, Congress doesn't really seem to care about action either.
While the last eight years were no party, I squarely blame the Obama administration for simply ignoring straightforward facts - the FDA is, er, "messed up".
Replacing a few embattled leaders doesn't mean much. It needs a thorough scrounging, from the inside out.
Reform the FDA
Reforming the FDA is not so tough:
1. Separate food, drug and device administrations into three separate federal organizations. Have the HHS directly, or through the CDC make sure they co-operate with each other. Or get a Czar, or a Don...whatever, just make it happen.
2. And yes, I may not be smarter than a 5th grader, but I do know that devices and drugs may sometimes be combined or classified differently. Fine - make sure that the agencies pick 50-50 on the committee for such special conditions and "deal with it". When Newton discovered gravity, people didn't run naked on the streets in shock (although, Archimedes did, well he was just crazy!)
3. Review who should be throwing "fraudulent regulators" out of business. I was a little beyond surprised to find out that the FDA was tasked with this. What about the justice department? After legalizing pot, crack, ganja, hashish, meth and moly, they do seem to have a lot of free time on their hands. Wouldn't preventing someone from doing research be something a bunch of lawyers did? Why is the FDA involved. Something is wrong here. I think even your golden retriever can see through this...
4. Do not simply pile stuff on the FDA and it's possible child organizations (if you take care of step 1, that is). It is not your once-a-week garbage truck. I cannot understand why the FTC couldn't take care of tobacco. Or maybe because it is not "food" and is directly related to "death and disease - in no particular order", why doesn't the CDC regulate this? Or maybe the HHS? I am not sure. But the FDA, to say this one more time, is not your "garbage truck".
5. More cash is not the answer. More cash means more taxes. More taxes mean more wastage. This is simply a case of divide and conquer.
6. With all the hope and change, I am sure we all got very teary eyed. Now, would be a great time to ground ourselves in reality. So, when people speak - LISTEN! If, in the course of discussions early this year, the Obama administration and/or Congress had paid any kind of attention to the clamor on splitting the FDA, all the world's Hernandezes and Campbells would now be out of a job.
Before we leave, here is some gobbledygook from the FDA as quoted by the NY Times Articles demonstrating unparalleled brain from body separation:
“The F.D.A. views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,”
and
“We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.”
Especially with the last comment pasted right above, who else thinks that rolling some StarTrek credit music is in order?
"We will take strong action"
Exactly when?
Two Saturdays from never?
Watch your tax dollars rotting....
The NY Times Article:
http://www.nytimes.com/2009/10/22/health/policy/22fda.html?_r=1&ref=health
What the hell am I going on about? Well, the New York Times came out with a story today about how Congressional investigators (and who exactly are these people? Are they the same ones also doling out my taxes to the FDA on the side?) have concluded that the FDA is disorganized, inept and derelict.
Don't simply say "What's new about that?" and move on.
The prelude
Apparently, aside from regulating Food, Drugs, Devices and now Tobacco (because it is food, I guess), the FDA must also punish fraudulent investigators. Now that's a tall order, especially considering that the FDA has already demonstrated unparalleled ability in the following areas:
1. Failure in the regulation of food
2. Failure in the regulation of drugs
3. Failure in the regulation of devices
In May, when the Obama administration was bringing gifts to Maryland, I lamented, along with several others on the need for the break-up of the FDA:
http://chaaraka.blogspot.com/2009/05/democrats-plan-to-fix-fda-give-them.html
Of course, no one in the Obama Administration wants to listen to you, unless you get on Fox TV and shout yourself hoarse. Some grass roots.
Anyhow, ours is not to ask, but to damn.
The problem:
The FDA is an overburdened organization with entrenched leadership. A bus load of NIH scientists and a truck load of cash will not solve the problem. Joint regulation of food, drugs, devices, tobacco, researchers and everything in-between is ridiculously infeasible.
While it is easy to make light of the FDA's failures, there is a reason why this problem happens:
1. The FDA has to take care of everyone of it's current burdens of making policy, coming up with regulations that enforce policies and rulings, report to Congress, etc.
2. The FDA has to deal with a global economy that results in devices and drugs manufactured in an an array of nations across Asia and Europe. The FDA needs to deal with fraud, counterfeit operations and GMP, GCP across the globe for anything used in the US.
3. The FDA is constantly dealing with issues and situations that have never been faced before. They need to hire and rely on outside "experts", who are usually non-existent. If they do exist, or thrust themselves in as subject matter experts, these experts usually come burdened with conflicts of interest.
All said and done, the main problem is an in-cohesive attitude towards the FDA, it's capabilities, the limitation and most of all, Congress doesn't really seem to care about action either.
While the last eight years were no party, I squarely blame the Obama administration for simply ignoring straightforward facts - the FDA is, er, "messed up".
Replacing a few embattled leaders doesn't mean much. It needs a thorough scrounging, from the inside out.
Reform the FDA
Reforming the FDA is not so tough:
1. Separate food, drug and device administrations into three separate federal organizations. Have the HHS directly, or through the CDC make sure they co-operate with each other. Or get a Czar, or a Don...whatever, just make it happen.
2. And yes, I may not be smarter than a 5th grader, but I do know that devices and drugs may sometimes be combined or classified differently. Fine - make sure that the agencies pick 50-50 on the committee for such special conditions and "deal with it". When Newton discovered gravity, people didn't run naked on the streets in shock (although, Archimedes did, well he was just crazy!)
3. Review who should be throwing "fraudulent regulators" out of business. I was a little beyond surprised to find out that the FDA was tasked with this. What about the justice department? After legalizing pot, crack, ganja, hashish, meth and moly, they do seem to have a lot of free time on their hands. Wouldn't preventing someone from doing research be something a bunch of lawyers did? Why is the FDA involved. Something is wrong here. I think even your golden retriever can see through this...
4. Do not simply pile stuff on the FDA and it's possible child organizations (if you take care of step 1, that is). It is not your once-a-week garbage truck. I cannot understand why the FTC couldn't take care of tobacco. Or maybe because it is not "food" and is directly related to "death and disease - in no particular order", why doesn't the CDC regulate this? Or maybe the HHS? I am not sure. But the FDA, to say this one more time, is not your "garbage truck".
5. More cash is not the answer. More cash means more taxes. More taxes mean more wastage. This is simply a case of divide and conquer.
6. With all the hope and change, I am sure we all got very teary eyed. Now, would be a great time to ground ourselves in reality. So, when people speak - LISTEN! If, in the course of discussions early this year, the Obama administration and/or Congress had paid any kind of attention to the clamor on splitting the FDA, all the world's Hernandezes and Campbells would now be out of a job.
Before we leave, here is some gobbledygook from the FDA as quoted by the NY Times Articles demonstrating unparalleled brain from body separation:
“The F.D.A. views any deviation from its high standards for developing or marketing drugs and devices as a potential threat to patient safety and public health,”
and
“We will take strong action against anyone who chooses to ignore or flout the legal requirements for the products we regulate.”
Especially with the last comment pasted right above, who else thinks that rolling some StarTrek credit music is in order?
"We will take strong action"
Exactly when?
Two Saturdays from never?
Watch your tax dollars rotting....
The NY Times Article:
http://www.nytimes.com/2009/10/22/health/policy/22fda.html?_r=1&ref=health
Sunday, October 18, 2009
The bad workmen, er, bloggers, er, authors that blamed the tool - A tale of sidewikis and pharma.
Hey, when you cannot report actual news, you can simply make something up right? Even if it is not remotely connected? Even if you are attacking the wrong problem or providing the wrong suggestions?
So, I have decided to take the plunge as well. See, we are now on a 24 hour news cycle. Everyone needs to be yelling, yelping, blogging, vlogging, twittering, facebooking, other-anatomical-region-book-ing, and what not.
When there are no new protests to protect "innovation" (read old wine in newstents bottles), or no new articles that Merck never wrote, or no new medical device company "consultants" to write about...
Well, you make something up.
And so is born the great panic of2012, er, "Sidewiki"!!!
Sidewiki
According to Google, "Google Sidewiki is a browser sidebar that lets you contribute and read information alongside any web page."
In an effort to take on the wikipedias of the world (hey, I can create panic too!), Google has created a tool that can run alongside IE and Firefox 2+ and allows you to add your own mis-truths, truthinesses, truthisms and possibly a few facts to web pages.
This will allow you to go on your favorite (or not) Pharma/Med Device Company's (or any other website for that matter) and leave notes about exactly what you think of them. You can also get creative and leave pieces of your mind as well. And otherstick-yer-nose-where-it-don't-belongers sidewiki users can join you in further glorifying these websites with their own colorful interpretations.
Pharma Companies, FDA and the manufacture of news
Now, let's make that into news.
How?
1. Sidewiki is this evil tool that allows the evil patients suffering from mild side-effects of drugs and devices such as permanent disability, blindness, cancer etc., get a chance to go to the websites of the companies that defrauded and/or hid data, or never cared enough to perform studies on the cheap plumbing, I mean stents they make, or companies that made their hips squeak - and spew venom!
2. Sidewiki is also this charming, deceptive tool that will suddenly convert well-meaning, trained marketing folks who have hitherto shown such unparalleled levels of responsibility, to suddenly go on their own companies' sidewiki sites and exaggerate claims of what the devices and drugs can do.
3. The FDA, which is currently well equipped and is doing such an excellent job of regulating itself and the growing list of industries ranging from tobacco to drugs and food, being regulated under it's able command will suddenly loose direction and debilitated and miss out on just this one aspect - the regulation of pharma companies and how they interact on sidewikis!
Should we treat the symptom or the disease?
Wait you say. Isn't it possible for the genius marketing weasels to go and cook things up on the sidewiki and get their companies in trouble? Or for all these patients to go write about what happened to them and prevent these wonderful ineffective drugs and devices from making their investors stinking rich?
Well, yeah. The answer is in the famous words of the pithy cliche, "Your bathtub is overflowing, do you clear the water first or turn off the faucet first?"
Let's look at both possibilities:
You see, inappropriately trained employees who are told to take a laissez-faire attitude on ethics - marketing personnel, telemarketers, bloggers, Presidents, Fox News Reporters and even the unicorns could end up doing the wrong thing.
Merck did it with the fake publications...
Glaxo did it by hiding the news of Avandia..
Then there were Celebrex, Vioxx and Yaz...
The FDA and Congress with the knee implant approvals..
The Obama Administration's "tort reform" with it's misplaced and unfruitful love for "bipartisanship". (Well, then why not simply embrace Fox News? That would be one hell of a bipartisan move. Equally useless, but definitely bipartisan!)
You see, irresponsibility is omnipotent - the medium is not the problem.
The "new headache" that you will read about in the articles I will link below, are after all, not new headaches. If people decided to be ethical and make it policy, at the macro-level, not with individual policies for twitter and Facebook, then the problem is solvable.
A matter of shame
Being regulated and chastised by the FDA for ethical failures should be seen as a matter of shame by the company, not a bright, bubbly, cheerful "You might have recently seen some Yaz commercials that may have been misleading. The FDA, weak, useless and unable to actually do anything by way of real punishment, has asked us to further confuse you idiots.."
Only a bad workman or blogger blames his/her or someone else's tools. Others, try to keep going back to the central theme - the state of the industry, as it is, should have never come to exist.
There is still time to fix it.
Companies can still choose right against wrong.
Now, to the second issue:
Don't fight disgruntled patients and bloggers
Man up! There is bad news about you because YOU covered something up. You released the stent without ever bothering to find out if it worked. You knew your diabetes drug was causing heart attacks. You threw in Doctors' names when they did not even touch the publication. You paid people to "consult" and concoct data for you. You and your Congressman forced the approval of a dysfunctional device. You approved the device...
YOU are the problem. Not dead and dying patients.
Exhort that - don't simply look to score random, nonsensical brownie points dissing sidewiki or facebook.
Links to a couple of articles:
Story 1
Story 2
If you decide that you don't care much for ethics, then maybe Las Vegas is the place for you, not the pharmaceutical industry. It doesn't matter if you are manufacturing or "reporting".
So, I have decided to take the plunge as well. See, we are now on a 24 hour news cycle. Everyone needs to be yelling, yelping, blogging, vlogging, twittering, facebooking, other-anatomical-region-book-ing, and what not.
When there are no new protests to protect "innovation" (read old wine in new
Well, you make something up.
And so is born the great panic of
Sidewiki
According to Google, "Google Sidewiki is a browser sidebar that lets you contribute and read information alongside any web page."
In an effort to take on the wikipedias of the world (hey, I can create panic too!), Google has created a tool that can run alongside IE and Firefox 2+ and allows you to add your own mis-truths, truthinesses, truthisms and possibly a few facts to web pages.
This will allow you to go on your favorite (or not) Pharma/Med Device Company's (or any other website for that matter) and leave notes about exactly what you think of them. You can also get creative and leave pieces of your mind as well. And other
Pharma Companies, FDA and the manufacture of news
Now, let's make that into news.
How?
1. Sidewiki is this evil tool that allows the evil patients suffering from mild side-effects of drugs and devices such as permanent disability, blindness, cancer etc., get a chance to go to the websites of the companies that defrauded and/or hid data, or never cared enough to perform studies on the cheap plumbing, I mean stents they make, or companies that made their hips squeak - and spew venom!
2. Sidewiki is also this charming, deceptive tool that will suddenly convert well-meaning, trained marketing folks who have hitherto shown such unparalleled levels of responsibility, to suddenly go on their own companies' sidewiki sites and exaggerate claims of what the devices and drugs can do.
3. The FDA, which is currently well equipped and is doing such an excellent job of regulating itself and the growing list of industries ranging from tobacco to drugs and food, being regulated under it's able command will suddenly loose direction and debilitated and miss out on just this one aspect - the regulation of pharma companies and how they interact on sidewikis!
Should we treat the symptom or the disease?
Wait you say. Isn't it possible for the genius marketing weasels to go and cook things up on the sidewiki and get their companies in trouble? Or for all these patients to go write about what happened to them and prevent these wonderful ineffective drugs and devices from making their investors stinking rich?
Well, yeah. The answer is in the famous words of the pithy cliche, "Your bathtub is overflowing, do you clear the water first or turn off the faucet first?"
Let's look at both possibilities:
You see, inappropriately trained employees who are told to take a laissez-faire attitude on ethics - marketing personnel, telemarketers, bloggers, Presidents, Fox News Reporters and even the unicorns could end up doing the wrong thing.
Merck did it with the fake publications...
Glaxo did it by hiding the news of Avandia..
Then there were Celebrex, Vioxx and Yaz...
The FDA and Congress with the knee implant approvals..
The Obama Administration's "tort reform" with it's misplaced and unfruitful love for "bipartisanship". (Well, then why not simply embrace Fox News? That would be one hell of a bipartisan move. Equally useless, but definitely bipartisan!)
You see, irresponsibility is omnipotent - the medium is not the problem.
The "new headache" that you will read about in the articles I will link below, are after all, not new headaches. If people decided to be ethical and make it policy, at the macro-level, not with individual policies for twitter and Facebook, then the problem is solvable.
A matter of shame
Being regulated and chastised by the FDA for ethical failures should be seen as a matter of shame by the company, not a bright, bubbly, cheerful "You might have recently seen some Yaz commercials that may have been misleading. The FDA, weak, useless and unable to actually do anything by way of real punishment, has asked us to further confuse you idiots.."
Only a bad workman or blogger blames his/her or someone else's tools. Others, try to keep going back to the central theme - the state of the industry, as it is, should have never come to exist.
There is still time to fix it.
Companies can still choose right against wrong.
Now, to the second issue:
Don't fight disgruntled patients and bloggers
Man up! There is bad news about you because YOU covered something up. You released the stent without ever bothering to find out if it worked. You knew your diabetes drug was causing heart attacks. You threw in Doctors' names when they did not even touch the publication. You paid people to "consult" and concoct data for you. You and your Congressman forced the approval of a dysfunctional device. You approved the device...
YOU are the problem. Not dead and dying patients.
Exhort that - don't simply look to score random, nonsensical brownie points dissing sidewiki or facebook.
Links to a couple of articles:
Story 1
Story 2
If you decide that you don't care much for ethics, then maybe Las Vegas is the place for you, not the pharmaceutical industry. It doesn't matter if you are manufacturing or "reporting".
Tuesday, September 01, 2009
Chaaraka is back!
Well, not Chaaraka, the great Indian Medicine Man of the ages, but this blog. About a month ago, I became incredibly pre-occupied, and was not able to blog much.
Meanwhile, in another part of the Galaxy, Google or Blogger or both lost it after being infected by a trojan (not of that brand), a virus, or something and designated, Chaaraka among other blogger blogs around the planet as "unsafe". After lamenting, screaming, begging, whining and performing other acts of wisdom, the blog is back up now. Read about it here
What happened in the interim?
As usual, stents were proved to be both effective and ineffective (Click here.
The "Gold Member" of Austin Powers fame, is now a "medical device" of "Saudi" Powers fame. Click here to find out about the phallus of the century.
And, we heard that Smoking may be "injurious to your health" but it is good for national healthcare spending....Click "aqui"
Elsewherefools the true winners in healthcare rushed in... ici!
Amazing what happens when you are gone, isn't it? Well, I am forcing myself to be back, even if I really am not able to be back yet...
What next?
Some insights into how to have a health-care debate! Watch out this space!!!
Meanwhile, in another part of the Galaxy, Google or Blogger or both lost it after being infected by a trojan (not of that brand), a virus, or something and designated, Chaaraka among other blogger blogs around the planet as "unsafe". After lamenting, screaming, begging, whining and performing other acts of wisdom, the blog is back up now. Read about it here
What happened in the interim?
As usual, stents were proved to be both effective and ineffective (Click here.
The "Gold Member" of Austin Powers fame, is now a "medical device" of "Saudi" Powers fame. Click here to find out about the phallus of the century.
And, we heard that Smoking may be "injurious to your health" but it is good for national healthcare spending....Click "aqui"
Elsewhere
Amazing what happens when you are gone, isn't it? Well, I am forcing myself to be back, even if I really am not able to be back yet...
What next?
Some insights into how to have a health-care debate! Watch out this space!!!
Sunday, July 12, 2009
Diabetic? Join Tudiabetes.com in a major test-off!
Diabetes is a systemic disease that most people have heard off, but do not fully understand. It is currently supposed to be affecting 24 million people in the United States, and similar numbers of people across the world. Most people with diabetes don't even know they are affected by it.
Folks with Diabetes need to regularly test their blood. This can be a painful process, and believe it or not, an entire industry has sprung up to help ease the pain. While that may be true, many diabetics are reluctant to test their blood sugar, or in general, adjust to life with diabetes.
Tu diabetes and Es tu Diabetes represented by http://tudiabetes.com and it's Spanish counterpart http://estudiabetes.com/
are websites run by the Diabetes Hand Foundation , whose founders and Social Entrepreneurs Manny Hernandez and Andreina Hernandez are very good friends of mine.
This excellent idea for the web communities was born because Manny, who is a diabetic himself, found a huge gap for people with diabetes to communicate with others easily online. This community now allows diabetics to discuss everything from the disease to medicine, policy to diets and recipes and a lot in between as well! These twin communities, in English and Spanish span vast memberships across the Americas and continue to grow every day.
On July 14, 2009, based on an incredible brain flash of one of the members of the community, Tu Diabetes is hoping to have 10,000 people test their sugar at the same time on a single day and report their sugar readings online.
What will this achieve?
It is very important for diabetics, their family members, colleagues and friends to understand the importance of checking blood sugar on a regular basis.
What advantages does checking blood sugar provide?
I am no medical professional, but let me lay out a few things as someone whose family has seen enough of diabetes:
Diabetes is an autoimmune disease which results either in over-production of insulin (known as Type 1) and limited production of insulin (Type 2) in the body. Insulin controls how much sugar is available in the blood. Sugar is necessary for all life activities and is essentially our fuel.
Imbalance of sugar regulation can lead to various issues. Low sugar can lead to loss of energy, and sometimes lead to a fit. High blood sugar causes it's own set of problems. The long term effects of diabetes can lead to obesity and cardiovascular risk, and has been linked to many disease conditions
Do not be alarmed!
If you get yourself diagnosed properly, and manage to check your blood sugar regularly and manage a healthy lifestyle, diabetes can be well managed, and you can lead a very long healthy life.
Thus, it is very important for school nurses, office personnel, the police, other community service professionals, near and dear ones, friends and even acquaintances to understand your needs as a diabetic.
Knowing your blood sugar levels - ideally, you should test yourself 4 times a day, can help you know and understand your highs and lows, and allow you to plan and adjust to your body's insulin propensity.
So, please go to tudiabetes.com today or tell someone you know!
Folks with Diabetes need to regularly test their blood. This can be a painful process, and believe it or not, an entire industry has sprung up to help ease the pain. While that may be true, many diabetics are reluctant to test their blood sugar, or in general, adjust to life with diabetes.
Tu diabetes and Es tu Diabetes represented by http://tudiabetes.com and it's Spanish counterpart http://estudiabetes.com/
are websites run by the Diabetes Hand Foundation , whose founders and Social Entrepreneurs Manny Hernandez and Andreina Hernandez are very good friends of mine.
This excellent idea for the web communities was born because Manny, who is a diabetic himself, found a huge gap for people with diabetes to communicate with others easily online. This community now allows diabetics to discuss everything from the disease to medicine, policy to diets and recipes and a lot in between as well! These twin communities, in English and Spanish span vast memberships across the Americas and continue to grow every day.
On July 14, 2009, based on an incredible brain flash of one of the members of the community, Tu Diabetes is hoping to have 10,000 people test their sugar at the same time on a single day and report their sugar readings online.
What will this achieve?
It is very important for diabetics, their family members, colleagues and friends to understand the importance of checking blood sugar on a regular basis.
What advantages does checking blood sugar provide?
I am no medical professional, but let me lay out a few things as someone whose family has seen enough of diabetes:
Diabetes is an autoimmune disease which results either in over-production of insulin (known as Type 1) and limited production of insulin (Type 2) in the body. Insulin controls how much sugar is available in the blood. Sugar is necessary for all life activities and is essentially our fuel.
Imbalance of sugar regulation can lead to various issues. Low sugar can lead to loss of energy, and sometimes lead to a fit. High blood sugar causes it's own set of problems. The long term effects of diabetes can lead to obesity and cardiovascular risk, and has been linked to many disease conditions
Do not be alarmed!
If you get yourself diagnosed properly, and manage to check your blood sugar regularly and manage a healthy lifestyle, diabetes can be well managed, and you can lead a very long healthy life.
Thus, it is very important for school nurses, office personnel, the police, other community service professionals, near and dear ones, friends and even acquaintances to understand your needs as a diabetic.
Knowing your blood sugar levels - ideally, you should test yourself 4 times a day, can help you know and understand your highs and lows, and allow you to plan and adjust to your body's insulin propensity.
So, please go to tudiabetes.com today or tell someone you know!
Wednesday, July 01, 2009
Blog Brief: Medical Technology Funding - relaying good news
I first saw this posted on the sfmedengineers group, and on searching, found out that Mediligence had this blog on medical technology funding. It appears that amidst all the bad news and coerced good news, medical device companies seem to be enjoying the cliched "green shoots".
Amidst shying VCs and dried up funding wells, $300mn for a month appears to be quite a sum for 2009. Hopefully, this also means there is some sanity to the ideas that are being funded. A cursory glance does show that it is not a bunch of stent companies that received money.
So, here's to hoping we are in for a period of rationality. One easy way to find out if irrationality has returned, obviously would be a good count of highly ambiguous device ideas, companies that don't even have device ideas, ideas or even an i, and of course, my favorite, stent companies.
Till then, let's hope we see some real medical needs be solved, as opposed to the future Madit-CRT in waitings. (Madit CRT - the act of "If at first you don't succeed or obtain a large population size, simply say everyone has a disease and implant a potentially volatile shock device close to their hearts".)
Here is the link to the companies that received funding in the past month:
http://mediligence.com/blog/2009/06/30/medtech-financings-total-300-million-in-june/
Amidst shying VCs and dried up funding wells, $300mn for a month appears to be quite a sum for 2009. Hopefully, this also means there is some sanity to the ideas that are being funded. A cursory glance does show that it is not a bunch of stent companies that received money.
So, here's to hoping we are in for a period of rationality. One easy way to find out if irrationality has returned, obviously would be a good count of highly ambiguous device ideas, companies that don't even have device ideas, ideas or even an i, and of course, my favorite, stent companies.
Till then, let's hope we see some real medical needs be solved, as opposed to the future Madit-CRT in waitings. (Madit CRT - the act of "If at first you don't succeed or obtain a large population size, simply say everyone has a disease and implant a potentially volatile shock device close to their hearts".)
Here is the link to the companies that received funding in the past month:
http://mediligence.com/blog/2009/06/30/medtech-financings-total-300-million-in-june/
Saturday, June 20, 2009
India's own agents of shame - Her own Doctors and "Government" Hospitals...
Women and children tend to be the worst affected victims of HIV and AIDS for the most part. It is disgusting when people take the women and children and demonize them for being HIV+. This is not new for India. When the children of HIV+ patients turned out to be HIV+ in Kerala, the parents of other children in the school took up a disgusting approach to the whole issue. The idiots acted just like the adjective I chose to describe them.
This recent incident, which happened in a Government Hospital in Jamnagar is extremely disturbing to say the least. There was once a time when I used to think that Doctors who practiced medicine commanded the highest echelons of respect and admiration. Disillusionment, as they say, can be a bitch. What with physicians and surgeons faking data and research, and now this...
A plan of action
The Indian Government needs to be very affirmative and strict about this. Unnecessary, misplaced belief systems and activism cannot be luxuries India can afford. Before the Indian medical practice also becomes infested with religious beliefs and other nonsense (yes, it's nonsense if you bring Jesus, Krishna or your favorite anti-abortion god to work with you) in the US, it is possible to stem the flow:
1. Medical practice must come with a strict licensing. If the license is suspended, then the physician/surgeon cannot practice. Of course, only the judiciary system and the medical board should be allowed to touch the licenses.
2. Religious beliefs and other systemic/cult based moral beliefs should not be permitted to allow a physician/surgeon/healthcare professional violate basic tenets, principles, guidelines and required acts of practice.
3. Licensing for practice should not be the burden of Doctors alone. Nursing, hospital administrators and others alike need to be held to appropriate licensing standards.
4. "Government" Hospitals need to lead by example. The Indian public has never received what can be deemed "Quality" care from Government Hospitals as such. In this day and age when India wants it's footprint recognized as a Global leader, this is simply not acceptable. These hospitals need to strive to the highest International standards of care. This is very much un-Utopian and achievable if acts like those that occured in Jamnagar are punished such that no sane person would try to repeat them if they wish to safeguard any professional future to their careers.
5. With specificity to HIV and AIDS, what the Indian Government does is criminal enough that we should let everyone currently in Parliament go... A paradigm shift (and no, I am not an MBA, so this phrase is being used with meaning) needs to take place. Nonsensical protests by parents against HIV+ children, any form of derision and parading must be met with fines and jail time alike. Wherever possible, if such protests and parading are performed by Government officials, they need to be unemployable by the Indian Government from that point forward automatically. If private firms act in a complicit manner to such acts of parading and disparagement, to the degree that they were complicit, their legal and physical existence must come into paucity.
Without such well marked moves, the Indian Government will be achieving nothing. If the "activists" really want to achieve something, they need to take this act to the Indian Parliament for attention - yesterday!
To throw up, visit:
http://www.indianexpress.com/news/Hospital-puts--HIV-positive---tag-on-pregnant-woman/479364
This recent incident, which happened in a Government Hospital in Jamnagar is extremely disturbing to say the least. There was once a time when I used to think that Doctors who practiced medicine commanded the highest echelons of respect and admiration. Disillusionment, as they say, can be a bitch. What with physicians and surgeons faking data and research, and now this...
A plan of action
The Indian Government needs to be very affirmative and strict about this. Unnecessary, misplaced belief systems and activism cannot be luxuries India can afford. Before the Indian medical practice also becomes infested with religious beliefs and other nonsense (yes, it's nonsense if you bring Jesus, Krishna or your favorite anti-abortion god to work with you) in the US, it is possible to stem the flow:
1. Medical practice must come with a strict licensing. If the license is suspended, then the physician/surgeon cannot practice. Of course, only the judiciary system and the medical board should be allowed to touch the licenses.
2. Religious beliefs and other systemic/cult based moral beliefs should not be permitted to allow a physician/surgeon/healthcare professional violate basic tenets, principles, guidelines and required acts of practice.
3. Licensing for practice should not be the burden of Doctors alone. Nursing, hospital administrators and others alike need to be held to appropriate licensing standards.
4. "Government" Hospitals need to lead by example. The Indian public has never received what can be deemed "Quality" care from Government Hospitals as such. In this day and age when India wants it's footprint recognized as a Global leader, this is simply not acceptable. These hospitals need to strive to the highest International standards of care. This is very much un-Utopian and achievable if acts like those that occured in Jamnagar are punished such that no sane person would try to repeat them if they wish to safeguard any professional future to their careers.
5. With specificity to HIV and AIDS, what the Indian Government does is criminal enough that we should let everyone currently in Parliament go... A paradigm shift (and no, I am not an MBA, so this phrase is being used with meaning) needs to take place. Nonsensical protests by parents against HIV+ children, any form of derision and parading must be met with fines and jail time alike. Wherever possible, if such protests and parading are performed by Government officials, they need to be unemployable by the Indian Government from that point forward automatically. If private firms act in a complicit manner to such acts of parading and disparagement, to the degree that they were complicit, their legal and physical existence must come into paucity.
Without such well marked moves, the Indian Government will be achieving nothing. If the "activists" really want to achieve something, they need to take this act to the Indian Parliament for attention - yesterday!
To throw up, visit:
http://www.indianexpress.com/news/Hospital-puts--HIV-positive---tag-on-pregnant-woman/479364
Wednesday, June 17, 2009
Health Insurance Companies to senate: Sorry, and screw you too!
At a time when health insurance is such a well debated and turbid issue in the United States, Health Insurance Companies out there seem to be acting in the most childish way possible - this in an effort to prove that they are better off left as they are --> in charge of our death and demise in the name of health!
Isn't it amazing? If you have acne or if you gain or lose a few pounds, you could lose health insurance.
The idea behind insurance is all wrong, and of course there is no intelligent fix for a bloated system in which MBA Jockeys earn more than the actual Doctors and Nurses that help you.
I will tell you what we need to do - force health insurance companies to do severe cost cutting. Here are a few suggestions on how to regulate the industry. I am sure not one of them will ever be implemented:
1. The Chief this and Chief that officers of any health insurance company should have been employed for at least 5 - 10 years as either Doctors and Nurses only. No MBAs with Oil Baron dads or Social Anthropology backgrounds permitted.
2. Device and Pharmaceutical reimbursement should be tightly regulated. Increases of over 10% in the reimbursement in any category must be audited.
3. On the subject of audits - one or the other of the hundreds of gobbledygook Federal Agencies should audit every one of these companies - their mechanisms to accept or reject 'surance.
Of course, none of this will happen. In any case, read 'em and weep:
http://edition.cnn.com/2009/POLITICS
/06/16/health.care.hearing/
This, as it where, is the state of affairs...
Isn't it amazing? If you have acne or if you gain or lose a few pounds, you could lose health insurance.
The idea behind insurance is all wrong, and of course there is no intelligent fix for a bloated system in which MBA Jockeys earn more than the actual Doctors and Nurses that help you.
I will tell you what we need to do - force health insurance companies to do severe cost cutting. Here are a few suggestions on how to regulate the industry. I am sure not one of them will ever be implemented:
1. The Chief this and Chief that officers of any health insurance company should have been employed for at least 5 - 10 years as either Doctors and Nurses only. No MBAs with Oil Baron dads or Social Anthropology backgrounds permitted.
2. Device and Pharmaceutical reimbursement should be tightly regulated. Increases of over 10% in the reimbursement in any category must be audited.
3. On the subject of audits - one or the other of the hundreds of gobbledygook Federal Agencies should audit every one of these companies - their mechanisms to accept or reject 'surance.
Of course, none of this will happen. In any case, read 'em and weep:
http://edition.cnn.com/2009/POLITICS
/06/16/health.care.hearing/
This, as it where, is the state of affairs...
Tuesday, June 09, 2009
Generic Pharma: Why India should stop babbling and rambling and start acting like the world leader it wants to be
The Premise
Very quickly: Stung by the fact that it is not just IT that India has a stereotypical leadership in, but also in generic pharma, Europe has resorted to shoddy tricks such as "customs seizures" on India's shipments of generics drugs.
The Rant
The 21st century is here. While a large portion of the world would like to look forward, Europeans would like to use "monopoly" and "copyright" to try and re-live the centuries past (and Australians will kill Indian students in merriment and no, of course they are not a racist nation, God forbid!).
You only have to pick up the paper to find out that Europe has issues with federal bailouts, Intel, Microsoft and anything with a remote chance of working. Why not? After all, it must be too hard to actually do work, right? Other than extremely expensive cars (whose manufacturers are also being bought up by Indians), what, if anything has Europe made by way of real global contribution in the recent past?
Or what, if anything is Europe going to be able to contribute by way of scientific progress or economic prowess? In a tiny continent where every island and street likes to call itself a country, they have joined forces to become a cabal of backward looking nonsense.
On to India
Of course, we all know that. But what is wrong with my fellow country men and women? We continue to launch "protests" while British Airways or the French Airports would treat us like dirt and Australians come out and kill us straight.
The days of groveling before the "master" are long gone my dear dinosaur-mother-land!
We need to wake up to a new Indian reality. Do we need motivation?
Just look at China. Ask one of the geniuses, anyone from the Clintons to Merkel to point a finger at China, which now wants to tell its folks what websites they can browse. We don't have to get to that level of ridiculousness, but we definitely need to start making a lot of noise - you know, like how we drive those Elephants off our streets.
If the Dutch seize our shipment or Frankfurt wants to sit on our pills for a month, how about suing them?
How about calling their Ambassadors and demanding an explanation?
How about summoning their Kings (the Dutch still have a King, go figure) and asking them some intriguing questions on discrimination?
How about holding up the next round of "World" "Trade" ""Talks"" till the European countries explicitly promise to stop nonsense-mongering?
Hey, how about a long, cold and slow investigation on Dutch and German shipments to India for "copyright violations"? Remember, the British taught us bureaucracy. How about using it other than on someone Indian?
The Congress got re-elected and Rahul Gandhi appointed "young and old" politicians to various ministries. Fine. How about appointing some aggressive and assertive folks that will push India out of the "East India" mentality into the 20-frigging-first-century.
It is so tired to be one among 1.08 billion (and counting) people with truck loads of market potential, a land size and definitely a population that is probably larger than Europe's and having to watch this unravel on a daily basis.
Of what use are Indian organizations and Associations if they cannot be alert and act assertively? We shouldn't become the catch-all filter for the West to harass us!
Whither the necessary spirit?
Reference:
http://economictimes.indiatimes.com/News/News-By-Industry/Pharma-firms-continue-to-face-patent-violation-charges-in-Europe/articleshow/4629307.cms
Very quickly: Stung by the fact that it is not just IT that India has a stereotypical leadership in, but also in generic pharma, Europe has resorted to shoddy tricks such as "customs seizures" on India's shipments of generics drugs.
The Rant
The 21st century is here. While a large portion of the world would like to look forward, Europeans would like to use "monopoly" and "copyright" to try and re-live the centuries past (and Australians will kill Indian students in merriment and no, of course they are not a racist nation, God forbid!).
You only have to pick up the paper to find out that Europe has issues with federal bailouts, Intel, Microsoft and anything with a remote chance of working. Why not? After all, it must be too hard to actually do work, right? Other than extremely expensive cars (whose manufacturers are also being bought up by Indians), what, if anything has Europe made by way of real global contribution in the recent past?
Or what, if anything is Europe going to be able to contribute by way of scientific progress or economic prowess? In a tiny continent where every island and street likes to call itself a country, they have joined forces to become a cabal of backward looking nonsense.
On to India
Of course, we all know that. But what is wrong with my fellow country men and women? We continue to launch "protests" while British Airways or the French Airports would treat us like dirt and Australians come out and kill us straight.
The days of groveling before the "master" are long gone my dear dinosaur-mother-land!
We need to wake up to a new Indian reality. Do we need motivation?
Just look at China. Ask one of the geniuses, anyone from the Clintons to Merkel to point a finger at China, which now wants to tell its folks what websites they can browse. We don't have to get to that level of ridiculousness, but we definitely need to start making a lot of noise - you know, like how we drive those Elephants off our streets.
If the Dutch seize our shipment or Frankfurt wants to sit on our pills for a month, how about suing them?
How about calling their Ambassadors and demanding an explanation?
How about summoning their Kings (the Dutch still have a King, go figure) and asking them some intriguing questions on discrimination?
How about holding up the next round of "World" "Trade" ""Talks"" till the European countries explicitly promise to stop nonsense-mongering?
Hey, how about a long, cold and slow investigation on Dutch and German shipments to India for "copyright violations"? Remember, the British taught us bureaucracy. How about using it other than on someone Indian?
The Congress got re-elected and Rahul Gandhi appointed "young and old" politicians to various ministries. Fine. How about appointing some aggressive and assertive folks that will push India out of the "East India" mentality into the 20-frigging-first-century.
It is so tired to be one among 1.08 billion (and counting) people with truck loads of market potential, a land size and definitely a population that is probably larger than Europe's and having to watch this unravel on a daily basis.
Of what use are Indian organizations and Associations if they cannot be alert and act assertively? We shouldn't become the catch-all filter for the West to harass us!
Whither the necessary spirit?
Reference:
http://economictimes.indiatimes.com/News/News-By-Industry/Pharma-firms-continue-to-face-patent-violation-charges-in-Europe/articleshow/4629307.cms
Wednesday, June 03, 2009
May the BPA Wars begin....An FDA review, an Industry cabal and the sweet smell of nexus
The FDA has never been one to stick to it's goals, objectives, responsibilities or duties in the last eight years or so. In the same spirit, last year, despite growing "concern" from scientists and consumer groups, it went ahead and approved BPA as safe for use in "baby food" nonetheless. If you ever wanted to recruit for a party that need people with no scruples or self-doubt, I guess you had to look at last year's FDA staff. Now which party would look to hire folks with such characteristics, eh?
The FDA's approval cannot be taken lightly, in wake of the following facts (Washington Post linked at the bottom):
1. BPA has been shown that BPA can be linked to a variety of cancers, infertility and other fun diseases.
2. BPA was found to leach into bottles even when used in cold temperatures.
3. Apparently, Harvard found out that people who drank regularly from BPA bottles had a 69% increase in BPA in their urine...
And, the FDA says it was safe for baby food.
The Present
Of many of the federal government's gambling hobbies, the FDA is becoming prime. Ignoring the nonsensical ruling, a few local governments started pressing on their own restrictions on BPA use. The strange bedfellows included Minnesota and Chicago. Apparently, yesterday, the California senate did the same thing. We may have no money left in my state, but even we think baby food needs protection!
Finally, Congress wanted to get into the game. It's amazing how fast Congress can act given it's dinosaurial origins...Waxman and Stupak, remarkably both Democrats (you should talk to your local Republican representative about what they think of your babies' health and future voting potential), wanted to know what the "new" FDA was going to do about it.
Progress or not, the one thing the new Obama FDA wants to review everything it's predecessor version did. At best, this is all the progress we can expect over the next eight years.
So, you think the party's over? Think not....
The Battle Ground
Nope, no Fallujah or Kabul here. This battle ground is the industry. I guess it consists of the American Chemistry Council (if you buy your kids a chemistry set, buy them an ethics set too..) and a host of guess-who's...
So what is their strategy? Apparently according to notes obtained by the Washington Post and confirmed by the people who were apparently in the meeting:
1. They would like to use fear tactics: "Would you like your babies to not have access to food?" as opposed to, I guess, urinating plastics.
2. Raising prices! You gotta pay more for BPA-free food. You now have a choice between using your food stamps or staying away from cancer and infertility. Rock and Hard Place, meanwhile, were reported to have lost most of their stock value.
3. Parade "pregnant young mothers" to talk about the safety of BPA. Never in the history of mankind have we relied on the public relations skills or the scientific progress of young pregnant mothers or pregnant young mothers (whatever the differnce is) on learning us the nice things babies urinating plastic can do for you...
Are there no alternatives?
You bet! There are alternatives. Apparently Japan has managed to throw BPA out of it's bottles and I guess lead out of its paints...
What is the war being fought over?
Brace yourself. The war is being fought over: "How foolish are Americans today"
1. If the FDA simply reviews last year's recommendations, and walks off with a ban on BPA - the story doesn't end there. Why did the recommendation change? If so, does it prove the old recommendation was indeed unscientific, politically motivated and does it reek of nexus? If so, who, if anyone, is going to pay?
2. If the industry wins, well...
Articles for review:
1. http://www.washingtonpost.com/wp-dyn/content/article/2009/05/30/AR2009053002121.html?hpid=topnews
2. http://www.foodproductiondaily.com/Quality-Safety/FDA-announces-BPA-safety-review/?c=hZd7lm1eoKjsNCZ8t7IWvg%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
The FDA's approval cannot be taken lightly, in wake of the following facts (Washington Post linked at the bottom):
1. BPA has been shown that BPA can be linked to a variety of cancers, infertility and other fun diseases.
2. BPA was found to leach into bottles even when used in cold temperatures.
3. Apparently, Harvard found out that people who drank regularly from BPA bottles had a 69% increase in BPA in their urine...
And, the FDA says it was safe for baby food.
The Present
Of many of the federal government's gambling hobbies, the FDA is becoming prime. Ignoring the nonsensical ruling, a few local governments started pressing on their own restrictions on BPA use. The strange bedfellows included Minnesota and Chicago. Apparently, yesterday, the California senate did the same thing. We may have no money left in my state, but even we think baby food needs protection!
Finally, Congress wanted to get into the game. It's amazing how fast Congress can act given it's dinosaurial origins...Waxman and Stupak, remarkably both Democrats (you should talk to your local Republican representative about what they think of your babies' health and future voting potential), wanted to know what the "new" FDA was going to do about it.
Progress or not, the one thing the new Obama FDA wants to review everything it's predecessor version did. At best, this is all the progress we can expect over the next eight years.
So, you think the party's over? Think not....
The Battle Ground
Nope, no Fallujah or Kabul here. This battle ground is the industry. I guess it consists of the American Chemistry Council (if you buy your kids a chemistry set, buy them an ethics set too..) and a host of guess-who's...
So what is their strategy? Apparently according to notes obtained by the Washington Post and confirmed by the people who were apparently in the meeting:
1. They would like to use fear tactics: "Would you like your babies to not have access to food?" as opposed to, I guess, urinating plastics.
2. Raising prices! You gotta pay more for BPA-free food. You now have a choice between using your food stamps or staying away from cancer and infertility. Rock and Hard Place, meanwhile, were reported to have lost most of their stock value.
3. Parade "pregnant young mothers" to talk about the safety of BPA. Never in the history of mankind have we relied on the public relations skills or the scientific progress of young pregnant mothers or pregnant young mothers (whatever the differnce is) on learning us the nice things babies urinating plastic can do for you...
Are there no alternatives?
You bet! There are alternatives. Apparently Japan has managed to throw BPA out of it's bottles and I guess lead out of its paints...
What is the war being fought over?
Brace yourself. The war is being fought over: "How foolish are Americans today"
1. If the FDA simply reviews last year's recommendations, and walks off with a ban on BPA - the story doesn't end there. Why did the recommendation change? If so, does it prove the old recommendation was indeed unscientific, politically motivated and does it reek of nexus? If so, who, if anyone, is going to pay?
2. If the industry wins, well...
Articles for review:
1. http://www.washingtonpost.com/wp-dyn/content/article/2009/05/30/AR2009053002121.html?hpid=topnews
2. http://www.foodproductiondaily.com/Quality-Safety/FDA-announces-BPA-safety-review/?c=hZd7lm1eoKjsNCZ8t7IWvg%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily
Sunday, May 31, 2009
Whither Chronic Tinnitus...
[Click on the following for Link to External Article]
As I was ambling along the western edges of the internet, I came across this post:
http://langhout.wordpress.com/
Since this is 2009, many a promising medical device company has had to wait on the sidelines because Venture Capitalists would rather react than act. This particular company called Silere Medical Technology, Inc. seems to be one of the many affected by the paucity of funding this year. However, it is always useful to dig a little deeper. So, I went digging...
The preface:
Silere seems to be in the process of developing a medical device, specifically an implantable neurostimulating prosthetic to cure chronic tinnitus. So, let's look at the dissection one by one.
What is tinnitus?
Tinnitus is a condition in which the patient experiences a ringing sensation of sound in the ears, even though a sound is not actually present. There are many types of Tinnitus - depending on sound type, body position etc. I do not wish to convert this into a pathology/epidemiology. Here is a brief, well written article on Tinnitus:
http://brneurosci.org/tinnitus.html
There are many pathological and non-pathological causes that lead to Tinnitus, and Chronic Tinnitus is the condition where the ringing can persist for long periods of time, and if untreated or if treatment is ineffective, can lead to significant problems, including cognitive decline, according to this ScienceDaily article:
http://www.sciencedaily.com/releases/2006/03/060310101636.htm
Treatments for Chronic Tinnitus
As such my research into medical devices specific to Chronic Tinnitus led me to a few interesting results:
1. This looks most promising - an agreement between Durect and Neurosystec:
http://www.newsrx.com/newsletters/Medical-Devices-and-Surgical-Technology-Week/2004-07-25/0725200433350QW.html
Durect is a publicly traded company and while Neurosystec's website is furtive about what they are working on, a patent search has revealed that as late as 2006, they had a drug delivery device for the inner ear on file.
2. The second result, is more direct at least, given that it deals with "electromagnetic stimulation of the inner ear with a weak electrical signal":
http://www.steinbeis-europa.de/index.php5?file=195&show=17546
3. This of course seems to be what is directly in line with Silere's objectives ( This is purely speculation on my part):
http://clinicaltrials.gov/ct2/show/NCT00876720
This particular clinical trial concerns itself with Transcranial Magnetic Stimulation for Tinnitus and other disease conditions. Apparently, low-frequency stimulation has been successful in the past, and based on that, the University is now turning to high-frequency stimulation. Given that this therapy is externalized, I am guessing Silere's implantable will be either a low-frequency or high-frequency stimulation device...that is, if at all, I am anywhere close to the real Kahuna.
What does competition mean?
Competition is always good, for a start-up, and all around for customers. Especially, for the start-up, it is a method to convince Venture Capitalists that this is not a hare-brain mad-scientist scheme, but a legitimate business model. It further allows the start-up to present its case and why it is better positioned to succeed and so on. This convinced me that Silere must be on the right path.
Whither the numbers?
This is the part that gets a little confusing for me. According to wrongdiagnosis.com and the NIH (slightly outdated numbers I guess), there are 13 million people suffering from Chronic Tinnitus in the United States. However, Silere states that there are over 50 million suffering from the condition, and about 13 million seek treatment.
http://www.wrongdiagnosis.com/t/tinnitus/stats-country.htm
Even if my data is outdated because it is from the '90s, it can't be that 37 million people developed Tinnitus in the median... So there is some confusion here that needs to be resolved. Still, Silere claims they are looking at a market of about 2.7 million folks. For an implanted device, that is a huge market. Even if Neurosystec, the existing drug therapies and others were to offer stiff competition, Silere, from a pure market standpoint, can hold its own.
Implantable Devices
The one fly in the ointment for me are implantable devices. Call me old fashioned, but it is not just me. I wonder if this has even a minor part to play in the reluctance of VCs. While a PMA regulatory path is always excellent for a company to stave off direct competition for a while, the pathway itself is expensive and may hold off VCs. Mixed in with the risk of recalls and such, this may be a drag on a device.
Of course, one could present some counterarguments:
1. In the most debilitating condition, (especially if you played the YouTube Videos linked on Silere's website), you would see that the noise can be hell to live with.
2. Drug delivery may not be effective and may bring with it, side effects of it's own.
3. A less invasive therapy, even surgery may not be the option for many patient populations with this disease. Surgical treatment does exist, however, the first one microvascular decompression is actually recommended for another condition and only provides add-on benefits for Tinnitus. The second procedure is specific to Meniere's Disease, and also involves the surgical injection of drugs - not spectacularly innovative.
All said and done, if Silere sticks to the implantable pathway, both FDA approval and capturing the attention of surgeons and the patient population represent a long pathway, which may deter some, if not all VCs.
On the other hand, it is quite clear that for companies such as Medtronic and St. Jude that already compete in the neurostimulation space, rather heavily, Silere may represent an attractive future acquisition target, especially in a rather lateral industry, adding to the acquirer's sales and revenue stream.
Software Sales
While reading up on Silere's strategy, I saw how they plan to allow these devices to adapt to new software to allow for modulating the stimulation program, and how they plan to sell it. I am not sure, but some VCs may see this as a digression rather than a branching sales stream. It would appear that if the software that provides stimulation were to improve, it would only make sense to make it available to all patients free of upgrade costs. Regardless of whether or not this makes for an acceptable strategy, there remains another question - how much of it's development efforts will Silere have to devote to software development and what margins of profit will it realize from this stream.
Alternative Funding?
Apart from grant applications, companies such as Silere could look into In-Q-Tel. A few days ago, there was a press release touting the fact that In-Q-Tel, a non-profit funding arm of the CIA had funded Sonitus Medical because it's products would be useful to the CIA and the military. Given how Tinnitus might have at least some of it's origins in the military, DARPA, CIA and such should only be more interested than not in what they are proposing, especially since it appears that they are able to layout how much the treatments would cost the VA system.
Conclusion
All said, I like what Silere is trying to do. There is a clear market, a well defined disease condition (unlike Fibromyalgia or PAD and other make-it-up-as-you-go diseases), a large patient population, competition and pre-existing clinical proof. They may also have to look into some of their development and sales strategy. And, yes, they seem to fall into the bracket of companies that have to struggle as the VCs wait it out.
Personally, I have felt the economy may start recovering sooner than later, and given how our doomsday conspirators are being quelled one way or another, maybe the VC market will pick up and a lot of firms can begin their process again...
As I was ambling along the western edges of the internet, I came across this post:
http://langhout.wordpress.com/
Since this is 2009, many a promising medical device company has had to wait on the sidelines because Venture Capitalists would rather react than act. This particular company called Silere Medical Technology, Inc. seems to be one of the many affected by the paucity of funding this year. However, it is always useful to dig a little deeper. So, I went digging...
The preface:
Silere seems to be in the process of developing a medical device, specifically an implantable neurostimulating prosthetic to cure chronic tinnitus. So, let's look at the dissection one by one.
What is tinnitus?
Tinnitus is a condition in which the patient experiences a ringing sensation of sound in the ears, even though a sound is not actually present. There are many types of Tinnitus - depending on sound type, body position etc. I do not wish to convert this into a pathology/epidemiology. Here is a brief, well written article on Tinnitus:
http://brneurosci.org/tinnitus.html
There are many pathological and non-pathological causes that lead to Tinnitus, and Chronic Tinnitus is the condition where the ringing can persist for long periods of time, and if untreated or if treatment is ineffective, can lead to significant problems, including cognitive decline, according to this ScienceDaily article:
http://www.sciencedaily.com/releases/2006/03/060310101636.htm
Treatments for Chronic Tinnitus
As such my research into medical devices specific to Chronic Tinnitus led me to a few interesting results:
1. This looks most promising - an agreement between Durect and Neurosystec:
http://www.newsrx.com/newsletters/Medical-Devices-and-Surgical-Technology-Week/2004-07-25/0725200433350QW.html
Durect is a publicly traded company and while Neurosystec's website is furtive about what they are working on, a patent search has revealed that as late as 2006, they had a drug delivery device for the inner ear on file.
2. The second result, is more direct at least, given that it deals with "electromagnetic stimulation of the inner ear with a weak electrical signal":
http://www.steinbeis-europa.de/index.php5?file=195&show=17546
3. This of course seems to be what is directly in line with Silere's objectives ( This is purely speculation on my part):
http://clinicaltrials.gov/ct2/show/NCT00876720
This particular clinical trial concerns itself with Transcranial Magnetic Stimulation for Tinnitus and other disease conditions. Apparently, low-frequency stimulation has been successful in the past, and based on that, the University is now turning to high-frequency stimulation. Given that this therapy is externalized, I am guessing Silere's implantable will be either a low-frequency or high-frequency stimulation device...that is, if at all, I am anywhere close to the real Kahuna.
What does competition mean?
Competition is always good, for a start-up, and all around for customers. Especially, for the start-up, it is a method to convince Venture Capitalists that this is not a hare-brain mad-scientist scheme, but a legitimate business model. It further allows the start-up to present its case and why it is better positioned to succeed and so on. This convinced me that Silere must be on the right path.
Whither the numbers?
This is the part that gets a little confusing for me. According to wrongdiagnosis.com and the NIH (slightly outdated numbers I guess), there are 13 million people suffering from Chronic Tinnitus in the United States. However, Silere states that there are over 50 million suffering from the condition, and about 13 million seek treatment.
http://www.wrongdiagnosis.com/t/tinnitus/stats-country.htm
Even if my data is outdated because it is from the '90s, it can't be that 37 million people developed Tinnitus in the median... So there is some confusion here that needs to be resolved. Still, Silere claims they are looking at a market of about 2.7 million folks. For an implanted device, that is a huge market. Even if Neurosystec, the existing drug therapies and others were to offer stiff competition, Silere, from a pure market standpoint, can hold its own.
Implantable Devices
The one fly in the ointment for me are implantable devices. Call me old fashioned, but it is not just me. I wonder if this has even a minor part to play in the reluctance of VCs. While a PMA regulatory path is always excellent for a company to stave off direct competition for a while, the pathway itself is expensive and may hold off VCs. Mixed in with the risk of recalls and such, this may be a drag on a device.
Of course, one could present some counterarguments:
1. In the most debilitating condition, (especially if you played the YouTube Videos linked on Silere's website), you would see that the noise can be hell to live with.
2. Drug delivery may not be effective and may bring with it, side effects of it's own.
3. A less invasive therapy, even surgery may not be the option for many patient populations with this disease. Surgical treatment does exist, however, the first one microvascular decompression is actually recommended for another condition and only provides add-on benefits for Tinnitus. The second procedure is specific to Meniere's Disease, and also involves the surgical injection of drugs - not spectacularly innovative.
All said and done, if Silere sticks to the implantable pathway, both FDA approval and capturing the attention of surgeons and the patient population represent a long pathway, which may deter some, if not all VCs.
On the other hand, it is quite clear that for companies such as Medtronic and St. Jude that already compete in the neurostimulation space, rather heavily, Silere may represent an attractive future acquisition target, especially in a rather lateral industry, adding to the acquirer's sales and revenue stream.
Software Sales
While reading up on Silere's strategy, I saw how they plan to allow these devices to adapt to new software to allow for modulating the stimulation program, and how they plan to sell it. I am not sure, but some VCs may see this as a digression rather than a branching sales stream. It would appear that if the software that provides stimulation were to improve, it would only make sense to make it available to all patients free of upgrade costs. Regardless of whether or not this makes for an acceptable strategy, there remains another question - how much of it's development efforts will Silere have to devote to software development and what margins of profit will it realize from this stream.
Alternative Funding?
Apart from grant applications, companies such as Silere could look into In-Q-Tel. A few days ago, there was a press release touting the fact that In-Q-Tel, a non-profit funding arm of the CIA had funded Sonitus Medical because it's products would be useful to the CIA and the military. Given how Tinnitus might have at least some of it's origins in the military, DARPA, CIA and such should only be more interested than not in what they are proposing, especially since it appears that they are able to layout how much the treatments would cost the VA system.
Conclusion
All said, I like what Silere is trying to do. There is a clear market, a well defined disease condition (unlike Fibromyalgia or PAD and other make-it-up-as-you-go diseases), a large patient population, competition and pre-existing clinical proof. They may also have to look into some of their development and sales strategy. And, yes, they seem to fall into the bracket of companies that have to struggle as the VCs wait it out.
Personally, I have felt the economy may start recovering sooner than later, and given how our doomsday conspirators are being quelled one way or another, maybe the VC market will pick up and a lot of firms can begin their process again...
Friday, May 29, 2009
A small business tip - credit under tight circumstances
[Click on the following for Link to External Article]
http://www.inc.com/magazine/20090501/loans-you-pay-every-day.html
This may not necessary apply to your medical device company, but it may apply to small businesses anyway. After having caused the financial "crisis", and been mildly punished, credit card companies are now pouting, raising interest rates, and in many cases simply shutting down credit to small businesses and individuals alike.
On Deck Capital is not necessarily your knight in shining armor, but at least it is a better alternative when capital runs dry.
I am not planning to re-hash the article here, because this is not that kinda blog :)
Go ahead and read the article, and be aware of the pitfalls, but do not take it from the banks - look for alternatives.
May your business live long and prosper....
http://www.inc.com/magazine/20090501/loans-you-pay-every-day.html
This may not necessary apply to your medical device company, but it may apply to small businesses anyway. After having caused the financial "crisis", and been mildly punished, credit card companies are now pouting, raising interest rates, and in many cases simply shutting down credit to small businesses and individuals alike.
On Deck Capital is not necessarily your knight in shining armor, but at least it is a better alternative when capital runs dry.
I am not planning to re-hash the article here, because this is not that kinda blog :)
Go ahead and read the article, and be aware of the pitfalls, but do not take it from the banks - look for alternatives.
May your business live long and prosper....
Thursday, May 28, 2009
Radiofrequency may be a way out for Barret's Esophagus after all...
[Click on the following for Link to External Article]
http://www.medpagetoday.com/Gastroenterology/GERD/14401
What is Barret's Esophagus?
Here is a simple and easy-to-follow web page on the disease:
http://digestive.niddk.nih.gov/ddiseases/pubs/barretts/
The esophagus has a sphincter which should technically allow passage of food (bolus) from the mouth to the stomach and prevent the motion backwards. Gastro-esophageal reflux (GER) is a condition where the sphincter stays open longer. This allows the acid from the stomach to rise, and causes heart burns, the ability to taste food near the back of the mouth etc.
When this condition happens more frequently, like more than 2 times a week, it is called GERD, a more serious condition, now qualified as Gastro-esophageal Reflux Disease.
In about 20% of people who have GERD, the lining of the esophagus, typically muscular, is now replaced with lining from the stomach. This is when the disease becomes Barret's Esophagus.
Barret's Esophagus and Dyslpasia
In a very small percentage of patients with Barret's Esophagus, (less than 1% according to the reference above), develop a rare form of cancer called esophageal adenocarcinoma. Carcinomas are cancers of tissue linings and walls.
Before this happens though, the tissue develops pre-cancerous cells leading to a tissue condition called dysplasia. As a result, regular biopsies are recommended. Usually though, the disease is noticed in later stages, and treatments are not very effective at that point. There is no indication that the current radiofrequency ablation technique would help those patients either.
Barrx Medical and their treatment
Barrx was started sometime in the year 2000 and has made this product commercially available since 2005. However, it looks like this particular study shows a lot of promise for the device.
Analyzing the study
Please read the Medpage article at the beginning of the blog for specific details. I want to discuss the key points of interest here:
1. The study was not the world's best - still, producing great results. The high-grade and low-grade nature of dysplasia in the patients randomized to be treated as opposed to the sham treatment was somewhat unnecessary. This is the first large trial with the device/treatment modality. Nothing significant can be gained from splitting patients up. It could have waited for a second study, and yes I know, they are expensive. They could have still noted down the grades and sought some sort of meaning. Right now, we don't really know of a big difference the treatment has on the grades. Plus, it only makes it harder for the device's reimbursement strategy, which I guess is not short of an uphill task.
2. The second point is somewhat moot, but worth a throw - we still need to wait for long term follow up.
3. The treatment was not a large scale energy wash - in patients that were randomized to be treated, dsyplasic and metaplasic (irregular, but not fully differentiated) lesions alone were treated. That is this was not a "paint" type of ablation procedure delivered over a large region.
I like the idea of a localized treatment. However, there is the confounding factor - do we know we got everything? In a preventive treatment setting, wouldn't being more conservative indicate higher value? This of course, needs to be balanced with factors such as anticipated side-effects.
3. As reported by the researchers themselves, the results are on somewhat of a fragile trend, at least right now. Of the patients that were treated, if one more patient had developed cancer or if one less person in the sham procedure group had not developed cancer, things would have been very different.
Of course the striking thing is, unlike our friendly, neighborhood stent trials, researchers and companies, this word came from the researchers themselves.
4. This treatment could definitely become first-in-line for patients with dysplasic or metaplasic Barret's.
5. What of course, would be the state with patients who have early stages of the disease?
This of course, is where the commercial challenges lie.
Will the physician community accept this as a reasonable preventive measure and recommend it?
Will the same significance persist in a larger patient population with longer follow up?
Will insurance reimbursement come through, especially for patients with the early stages of the disease?
What about the competition from medical management and others trying to play in this device/therapy space?
6. The most important thing helping anyone playing in the Colon cancer space for example, tends to be the large scale motivation for biopsies. How about Barret's and GERD? Will routine biopsy be recommended given the small percentage of folks developing cancer? If they do become routine, then Barrx will be in a great position. If not, no harm done, except there will be some missed opportunities in the white space.
Conclusion
Of course, challenges always lie ahead, but right now, things are looking good for Barrx and the treatment. Time will have to tell if everything that exists will hold and other things that are necessary will fall into place.
If the company continues to play it right, they could win over surgeons, reimbursement and find themselves on line for a good chunk of change.
The Post Script (P.S.) - Radiofrequency Ablation
Radiofrequency Ablation is a tired old horse that has been beaten to death quite a bit. Dozens of companies out there have done to radiofrequency what has been done to stents. Given a chance people would try stenting for everything from migraines to mania. In a similar fashion, for every conceivable disease radiofrequency/energy based destruction, albeit in many cases, without much attention being paid to rhyme, reason or scientific thought. It is one thing when when Google throws sphagetti on the wall, it is another when people try that with disease conditions.
Of course, the point there is that if some company X tried an energy delivery modality and failed, it doesn't mean much. At least, it does not always mean they failed for the right reasons, as has been demonstrated by several third-in-class, fourth-in-class devices and so on.
Based on the study's results, it is not too presumptuous to note that Barrx may at least be on the right path...
http://www.medpagetoday.com/Gastroenterology/GERD/14401
What is Barret's Esophagus?
Here is a simple and easy-to-follow web page on the disease:
http://digestive.niddk.nih.gov/ddiseases/pubs/barretts/
The esophagus has a sphincter which should technically allow passage of food (bolus) from the mouth to the stomach and prevent the motion backwards. Gastro-esophageal reflux (GER) is a condition where the sphincter stays open longer. This allows the acid from the stomach to rise, and causes heart burns, the ability to taste food near the back of the mouth etc.
When this condition happens more frequently, like more than 2 times a week, it is called GERD, a more serious condition, now qualified as Gastro-esophageal Reflux Disease.
In about 20% of people who have GERD, the lining of the esophagus, typically muscular, is now replaced with lining from the stomach. This is when the disease becomes Barret's Esophagus.
Barret's Esophagus and Dyslpasia
In a very small percentage of patients with Barret's Esophagus, (less than 1% according to the reference above), develop a rare form of cancer called esophageal adenocarcinoma. Carcinomas are cancers of tissue linings and walls.
Before this happens though, the tissue develops pre-cancerous cells leading to a tissue condition called dysplasia. As a result, regular biopsies are recommended. Usually though, the disease is noticed in later stages, and treatments are not very effective at that point. There is no indication that the current radiofrequency ablation technique would help those patients either.
Barrx Medical and their treatment
Barrx was started sometime in the year 2000 and has made this product commercially available since 2005. However, it looks like this particular study shows a lot of promise for the device.
Analyzing the study
Please read the Medpage article at the beginning of the blog for specific details. I want to discuss the key points of interest here:
1. The study was not the world's best - still, producing great results. The high-grade and low-grade nature of dysplasia in the patients randomized to be treated as opposed to the sham treatment was somewhat unnecessary. This is the first large trial with the device/treatment modality. Nothing significant can be gained from splitting patients up. It could have waited for a second study, and yes I know, they are expensive. They could have still noted down the grades and sought some sort of meaning. Right now, we don't really know of a big difference the treatment has on the grades. Plus, it only makes it harder for the device's reimbursement strategy, which I guess is not short of an uphill task.
2. The second point is somewhat moot, but worth a throw - we still need to wait for long term follow up.
3. The treatment was not a large scale energy wash - in patients that were randomized to be treated, dsyplasic and metaplasic (irregular, but not fully differentiated) lesions alone were treated. That is this was not a "paint" type of ablation procedure delivered over a large region.
I like the idea of a localized treatment. However, there is the confounding factor - do we know we got everything? In a preventive treatment setting, wouldn't being more conservative indicate higher value? This of course, needs to be balanced with factors such as anticipated side-effects.
3. As reported by the researchers themselves, the results are on somewhat of a fragile trend, at least right now. Of the patients that were treated, if one more patient had developed cancer or if one less person in the sham procedure group had not developed cancer, things would have been very different.
Of course the striking thing is, unlike our friendly, neighborhood stent trials, researchers and companies, this word came from the researchers themselves.
4. This treatment could definitely become first-in-line for patients with dysplasic or metaplasic Barret's.
5. What of course, would be the state with patients who have early stages of the disease?
This of course, is where the commercial challenges lie.
Will the physician community accept this as a reasonable preventive measure and recommend it?
Will the same significance persist in a larger patient population with longer follow up?
Will insurance reimbursement come through, especially for patients with the early stages of the disease?
What about the competition from medical management and others trying to play in this device/therapy space?
6. The most important thing helping anyone playing in the Colon cancer space for example, tends to be the large scale motivation for biopsies. How about Barret's and GERD? Will routine biopsy be recommended given the small percentage of folks developing cancer? If they do become routine, then Barrx will be in a great position. If not, no harm done, except there will be some missed opportunities in the white space.
Conclusion
Of course, challenges always lie ahead, but right now, things are looking good for Barrx and the treatment. Time will have to tell if everything that exists will hold and other things that are necessary will fall into place.
If the company continues to play it right, they could win over surgeons, reimbursement and find themselves on line for a good chunk of change.
The Post Script (P.S.) - Radiofrequency Ablation
Radiofrequency Ablation is a tired old horse that has been beaten to death quite a bit. Dozens of companies out there have done to radiofrequency what has been done to stents. Given a chance people would try stenting for everything from migraines to mania. In a similar fashion, for every conceivable disease radiofrequency/energy based destruction, albeit in many cases, without much attention being paid to rhyme, reason or scientific thought. It is one thing when when Google throws sphagetti on the wall, it is another when people try that with disease conditions.
Of course, the point there is that if some company X tried an energy delivery modality and failed, it doesn't mean much. At least, it does not always mean they failed for the right reasons, as has been demonstrated by several third-in-class, fourth-in-class devices and so on.
Based on the study's results, it is not too presumptuous to note that Barrx may at least be on the right path...
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