So, healthcare reform was passed. In the tradition of Vice Presidents who use the "F" word, it is a big F*ing deal.
Trashing Healthcare Reform
Some companies obviously did not like that. Take 3M for example. According to Star Tribune, 3M's public spokesperson said this, "it could prompt the company to stop making certain devices or pass the tax on to patients or providers in the form of higher prices" (Not a direct quote, mind you).
What will happen now?
It is simple. Someone else will simply do one of the following:
1. Carefully observe the products on which 3M passes the cost to patients and start a price war.
2. Simply take over whatever 3M has stopped producing.
Yeah, what about patents and such? Sure, imagine a situation where a company stops producing medical devices because it wants to feed to a "tea party" syndrome respite with uncivilized, drivel. Top that off with them going after competition that wants to take over where they left off. PR Disaster, anyone?
Simply because you are a big, glorified sticky-note manufacturing company doesn't mean you can get away with crap. Yeah, of course, if you watch some of the inane comments on the article whose link is supplied at the end of this blog, obviously this feeds to people who have a lot of time to comment on articles.
These people, "with a lot of time to comment on articles" do not usually tend to be "share holders". Let's try to watch 3M and some of these other naysayers whine their way out of a market because they don't like progress.
What can entrepreneurs do?
1. Be on the prowl: Watch for unreasonable price rises by companies that make devices. This is 2010. People have very little tolerance for nonsense based on political whims. Hospitals, clinics and even direct consumers everywhere would only be too happy to take up a better offer from a competitor who offers quality products at better pricing and consistency of delivery.
2. The IP brouhaha: Look for gaps in the intellectual property of such large companies. As such, you should be doing this routinely. While patents are great business weaponry, they are essentially double-edged swords. It is not uncommon knowledge that unreasonable application volume, a lack of leadership and patent examination skills has the USPTO issuing a larger number of patents than they should be. Look for freedom to operate and opportunities to exploit existing patents.
Do not worry yourself about examples such as the nonsensical patent battles on stents. The irony there, I believe, is none of the devices work and the companies fight each other in court over IP, but gang together whenever a new study comes out showing they just aren't effective.
Every patent has an expiry date associated to it, and yes, the period can be extended, but you can brainstorm, examine and if you pick on the details enough you can fight your "market leaders" by diluting their patents alongside blocking them off with derivative work and your own patents.
The basic requirement? Understand IP better and hire a good lawyer.
3. Not just cheaper, better: I know I said cheaper is good, but how about better as well? When was the last time you looked at the tongue depressor and said how can we make this better? There are a lot of "medical devices" out there, that are very basic and with a few changes could definitely inject new energy in their marketing and sales.
Not every device needs a major revolution. High volume, low margin products can represent an opportunity for you to quickly innovate, sell them to a larger company that can extend it's product line and move on to other avenues.
Helmets: For example, helmets are medical devices. Can you make them more convenient to use, and maintain or improve on safety? Every day there are newer materials, newer manufacturing processes and other innovations. Incorporating these innovations can make your product functionally better, more accessible or maybe even simply lighter. When you inculcate such changes into high-volume products, you can easily recover any minor cost increases involved in such devices.
Blood Glucose Monitors: Let us take one of my favorite devices for example. There are so many devices out there in the market. Companies are constantly trying to innovate by making lances less painful, the blood volume required lesser, eliminating coding for strips and so on and so forth.
Yes, the holy grail lies in a possible non-invasive meter, or a move toward Hb1Ac meters. You could still brainstorm small innovations that lead to big change. Of course you need to make sure you don't become the Blockbuster while Netflix forges ahead either.
4. Do not fear regulation, embrace it: Look, regulation is not going to go away. Do not buy into the fear mongers. If they had their way, you could simply make anything you want and poke any patient with anything you cook up, regardless of effectiveness or side effects. How would you feel if your device ended up on a few thousand patients and you woke up one day to find that your device had left them blind, hurt or otherwise impaired because of sloppy oversight? How would you feel if you lobbied for such sloppiness to begin with?
Why is it so hard to do proper testing for the devices that you want to put out there? Because the VCs may not fund this? Let's get a few things straight:
4.1 Innovation is expensive, and is not happening at the rate at which new markets should or can be forged. For the VCs or other investors to simply turn their back on the cost to success is not going to be an option for long. This has happened in the past and the consequences have not been good. I am sure everyone is a little wiser from past experience.
4.2 Regulation reform, as weak as it may be, is here to stay. So, all your angels and VCs have to go with the flow - there is nowhere else to go. Don't buy into this crap that medical device innovation will leave the US shores. Barely anything happens outside the US, and how many guesses do you want to name the world's largest device market?
4.3 The pharmaceutical market and the biotechnology market and the companies involved went through this problem. They did turn their back on innovation. The result? Stagnation.
It is charming to think that someone will toy around with some frozen meat and a hammer in a garage and make the next "big bang" happen, but it is going to be harder, it is going to take more effort and more money. None of the stakeholders can take a chance on "Yeah, this thing is going to take more money than it used to, so let's drop it". And the real VCs are not waiting for this to happen.
So when someone tries to sell you tea, go for a latte instead.
Regulation will change, if it overreaches it will be dialed back. Make it a part of the business planning and execution process. Don't wait there looking for Obama's birth certificate - that does not have your medical device roadmap.
5. Embrace progress: Seriously, what would be the point of being in the medical devices industry if you are not committed to people's health? If you are not committed to Universal Health, you cannot even get into the mindset of finding a "cure". You will be stuck in a rut that involves simply fighting change - regulation, reform and such.
You will simply be replaced. Just like 3M would be if it stopped making devices.
So, what would you rather do?
Reference:
http://www.startribune.com/business/89306612.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aUUsZ
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...
Showing posts with label medical device opportunities. Show all posts
Showing posts with label medical device opportunities. Show all posts
Saturday, March 27, 2010
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...
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