Friday, December 31, 2010

What will your 2011 medical device design resolutions be?

Well, 2011 is here, in some places already and where I am, it is slowly rolling in. Other than a couple of major resolutions/goals, I hit most of my spots in 2010, at least partly. I had similar results in 2009 and so on, so I am not averse to making goals and giving them a shot.

Remember goals are dreams with deadlines - and no, it's not corny. Maybe you have worn a bit with all the goal setting, but hey, what is wrong with dreaming and throwing some numbers or expectations on them? So, give it a shot!

Medical Device Design: You could be in sales, marketing or in non-profits that moan and groan about regulations all day - all important functions, but I thought I would make this post just about medical device design. After all, this is an example post and I am sure you can make your own goals up!

Oh, and look out for Goal 0 at the end!

Goal 1: Reveal your passions - to your conscious self!

Are you sure that medical devices is/are your passion? If so, what's your motivation? A personal event? Just the science, the challenge? Whatever it is, get to know it. And yeah, if you have been in it for a while and/or you have had some passion fatigue, it is still not a bad idea to take a couple of minutes recharging the "why" and the "how" of your participation in this mess...

Goal 2: Understand the disease/diagnostic/treatment area thoroughly

You probably already know this. You cannot effectively design for atrial fibrillation if you don't understand what the underlying disease is. And yes, sometimes we do not know exactly why something happens, but it is important to keep up with the latest and greatest theories and hypotheses behind a disease condition.

Yes, you may only be working on lung resection, but it behooves you to look into the cancer stem cell theory. You would be surprised at what you can glean.

Goal 3: Understand anatomy and physiology

Of course, goes without saying right? Just take care of it - maybe you should be taking a class, or taking that class again, or just going through the flash cards a second time...

Goal 4: What's that darn CFR 21, code say what?

Ah yes, those regulations. Well, maybe this year, we won't let someone else take care of it, especially since things are changing. The more you know, the better. And remember, the world and our times are changing. Don't stop with the US - look at EU, Japan and the developing world...

Goal 5: Read, read and then read again, learn and teach!

No matter how much you know, there is always room to grow. What do you know - that rhymes! There is so much to read out there - blogs, websites, regulations and so much more. How about a class on DFM? Maybe something about sustainability. Whatever it is that allows you to grow through change, go ahead....

Goal 0: Perk up!

Yes, someone got greedy, then they got bailed out and the economy is bad, the regulations are killing innovation (really, really, not), China is growing, and on and on and on it goes. If you have bought into any of this nonsense as the reason to sit and wait for "things to pick up", well, guess what, by the time you realize things actually have and by the time you start jogging, someone else will be running.

Write that executive summary, sharpen that presentation, test that prototype, get that resume reviewed - just get moving. What do they say - "Don't do something, just stand there!", right?

This is why Goal 0 is down here - because, let's end all this negativity, and this year on a high note, and that is how 2011 should begin. Yes, you will read this in 2011, so what?

This is time for change, time to push, time to run, walk, trod, jog and somehow get to that extra mile, maybe a mile and a half...and hopefully we see each other!

Wishing you all the success in 2011 and beyond!


Image Source: http://www.psdgraphics.com/file/happy-new-year-2011.jpg

Saturday, December 25, 2010

A heartwarming story, a foundation and a few medical device challenges for the future

It bodes well for my spirit to take a break from the usual tug-of-war nonsense between the regulators and the regulated and all that other stuff and rehash a great story from San Jose Mercury News about a man who has found new life through a new limb...

The Story

San Jose Mercury News carried a very intriguing and interesting story about Johnny Nguyen, a local man who went through a terrific accident and suffered from severe burn injuries and had to lose his left arm, an elbow and all the fingers of his right arm in the consequential surgeries.

You should really read the rest of the story in the article referenced below. It is well written with a human touch, something that is rare in journalism nowadays.

Finding a prosthetic

Postulated severally in science fiction and future facing non-fiction, the 21st century is a time where losing a limb doesn't necessarily have to be permanent. However, this is easier said than done.

For one, development of efficient prosthetic devices that mimic a functional human arm, as opposed to a rudimentary hook (which is what Johnny started wearing initially following his surgeries) is very expensive.

Secondly, one has to find a way to afford these devices. Here are a couple of observations I made from the article, which, of course I cannot substantiate with proof from elsewhere:

1. Johnny's friends tried to contact several organizations that make such prosthetic devices. Enigmatically, the article mentions that the company from Scotland responded. I wonder what happened to all the US companies that were contacted. I also wonder how many companies develop prosthetic devices in the US....if there are enough companies developing such prosthetic devices locally, why have they not responded?

2. Johnny appears to have been someone that interested the company that did pay for his device, so that they could use his case to study how to use the prosthetic devices in situations involving other fire injury victims. Given the paucity of people within the US that normally sign up for any experimental therapies or in many cases, clinical trials at all, shouldn't local companies scramble to enroll people like Johnny as quickly as possible?

Bionic Touch Foundation

Johnny's friends who successfully teamed up to get him his prosthetic have realized the challenge that the device is going to be expensive for most people who will need them. They have a lofty goal of helping anyone in need of finding an upper limb. They are also offering academic help with regards to the writing needs of those who are looking for a prosthetic. All their efforts deserve a sound pat on the back.


Future Device Challenges

Now that we have gotten all the inspiring stuff out of the way, I thought it might be worthwhile taking a look at some of the challenges facing people who NEED the medical devices and not the ones that MAKE them. The ones that make them, have enough help from dubious "non-profits" already!

Most of the challenges have been discussed previously, but I thought there would be no harm in presenting them again:

1. Accepting the need for trials and experiments: If there is one place where people seem to especially fail, it is in enrolling in new trials. If enough people do not provide support to new procedures and new experiments, science, engineering and medicine cannot progress adequately. Treat yourself less as a victim, and more as a patient and try to find out how you can help yourself and at the same time, if possible, lay the course for the future.

2. Advocacy: I know, I am not making my points in an ideal order, but if more people had paid attention to the healthcare reform debate rather than saying "eh, politics is not for me", maybe things would be better. The cost of devices is dictated by several factors and many of these can be controlled by a conscious citizenry. In other countries, similar struggles will start soon enough. Keep your eyes and ears open, and act, not react. I came across a Chinese proverb that says, "Dig the well before you are thirsty" - enough said!

3. Identify the true leaders among companies: If it takes a company from Scotland to respond to customers with the customer's interest in mind, so be it. Such a company has risen above it's former peers and should be recognized thus. It is also really important to point out which companies fail to respond to customers, at least to provide information. This will let people make their own judgment on who leads and who follows the 90-day magical number dance...

4. Fundraising: All said and done, there will always be therapies and devices that will be necessary, will ride ahead of the reimbursement curve and will be expensive no matter what. Patients and their friends must look to creative ways to engage the local community and the wider populace in raising funds. Look to stories of success to emulate and improve upon with brainstorming.

5. Support Science and R&D: It is appalling that even in this day and age, science faces the same threat as it did in what some folks fondly like to try and forget as the "dark ages". Having politicians dictate science policy has very few tragic parallels in human behavior. Seek, demand and support sound science, research and funding that foster medical progress.

It is very heartening to read such stories of success, and one would hope to see fewer accidents and more success stories of the sort outlined here...

References:

1. San Jose Mercury News: http://www.mercurynews.com/ci_16932213?source=most_viewed&nclick_check=1

2. Bionic Touch Foundation: http://www.bionictouchfoundation.org/

3. Touch Bionics: http://www.touchbionics.com/

Friday, December 17, 2010

Quick Post: Are others (guests) allowed to post on this blog?

One of the many tools I use with this blog is "skribit". It is a really cool tool and I guess it's usage will grow over time. The tool, when installed as a widget allows readers and passers-by to leave notes on what they would see a blogger write about.



Of course, it appears that this tool seems to be growing gradually...or maybe not many of the readers here having been noticing..please do! Tell me what you want to write about (be decent now) and I will try to fit it in. It would be my pleasure to know what it is that people are looking for. I do look at the keyword searches that land people here, but that is not as accurate as someone saying.. "do this"!

To learn more about skribit, visit: http://skribit.com/

Are guest posts allowed?

Absolutely! We have already done this before, and I have learned a couple of lessons and I will state my sparse ground rules, but yes, given how busy I am, and my other web design and blogging demands, I would love guest posts!

The Rules

The first rule is, there are rules..alright, that's a bit much. Here goes:

1. Please keep things related to medical devices, biotechnology, bioengineering, entrepreneurship, synthetic biology or some such thing that people who read this blog might find relevant and interesting. It might be good if you and I discussed things beforehand.

2. No plagiarizing - no copying papers etc. Please provide sufficient references. You don't have to be an MLA expert or an "Endnote" jockey, just make sure you clearly mention where anything quoted comes from!

3. Keep it interesting and honest. Interesting is hard to define and is more a "post-production" revelation than anything else. Honesty is really important! If you want your product, service or company pitched, it is probably better to just ask me, and I will do it if it is credible and/or interesting. If you are posting for a class project, then mention it. Do let people know who you are and where any of your fiduciary responsibilities might be.

I always say, honesty may or may not be the best policy, but it is fairly good!

That's it -hopefully that was simple and useful. I will leave this as a sticky on the sidebar for future reference!

Until next time!

Thursday, December 16, 2010

Entrepreneurship Opportunities: The Health 2.0 challenge for 2011 is announced

Preface - the perspectives

Depending on your perspective about things going on around you, you can basically take one of two approaches - you could go the "Advamed/NFIB" route, constantly groaning loudly across the internet about how bad things are going to get with the FDA's half-hearted attempts at fixing it's fast and loose ways of approving poorly designed devices...or you could simply hunker down, accept the fact that the economy is bad, and the better approach, especially when there are gaps in between career moves, that you could "try"!


The Health 2.0 Jazz

The Health 2.0 challenge is yet another Government conspiracy. The Department of Health and Human Services t(hat plans to help Congress pull the plug on the Grandma that you abandoned in Florida) supported the Community Health Data Initiative (CHDI) in announcing the Health 2.0 challenge. It works really easy - you either submit a challenge, or join a team working on a challenge and try to solve the challenge, online and offline.

The online part is where you work on the problems on an ongoing basis. If you go to the code-a-thons, then you are working on the offline part.

Fees and such

There are fees involved, but it looks like the fees get waived if you are a start-up that hasn't raised more than $1mn, or if you are an established company with more than $1mn in revenues.

And there it is, the first code-a-thon is on January 29, 2011 in the San Francisco Bay Area. Other events appear to take place in Washington DC and Boston (a fresh break from the FDA's "public" meetings). Of course, if you are simply reading this for paranoia, here is something you should know - the first code-a-thon will happen at the Mountain View Google campus! Wink, wink!

I have never cherished repeating basic facts verbatim, so I encourage you to visit the link at the end of this article. 

The Opportunity

If you are in the business of mulling health data across the internet, or in the EMR/EHR/HIT space, then such challenges are a great way to showcase your skills, the creativity, thought process and other assets. Competitions, games, barcamps, business plan contests etc, are a great way for you to boost your confidence, hone your skills, showcase your talents, seamlessly integrate this with that and fit square pegs into round holes...you get the idea!

And finally -

If you are participating in the 2011 challenge, give me a holler. I still feel bad missing the last one.

Until next time!

Reference:

http://health2challenge.org/

Saturday, December 11, 2010

Healthgamescamp - liveblog; part 2 - break time!

It's about 5:00pm now. And we are on a break...it has been so much fun playing. As part of the game, we broke off into many groups, working on problems ranging from environment health, where yours truly ended up to diabetes, stress reduction and positive thinking! It has been a great ride, looking at how to convince the various stakeholders including the fun lover, the caregiver, the freakonomist, the healthcare-misbehaviorist and the game builder among several other things. For each of these categories of stakeholders, we had to decide how we were going to do the convincing...and now here are some photos for you.





Healthgamescamp - liveblog: "It's crazy and wild and fun"

"It's crazy and wild and fun" - that is what David, one of the co-organizers has to say. I would agree. The event started at about 1:00pm, with the usual exercise where we all created "visual doodles" to paste on our upper bodies and carry on our selves as we walked around, chatted and engaged in making friends.

So far we had a couple of warm up exercises, including demo games from volunteers on converting first time customers into repeat, loyal customers and one on dating...go figure!

We followed up with an idea session, where we threw up ideas on 3x5s and now are going through a grouping exercise followed by a pitch of our skills in specific areas related to the groups of games...oh fun. Here are a few images for your reference.









More to follow! Watch this space

Healthgamescamp, San Francisco is tomorrow, barcamps and more...

Healthgamescamp is a barcamp organized specifically to create digital and non-digital games specifically geared towards creating a positive change in people's health behavior. Any barcamp can be fun and of course this is truly fun for yours truly, so, yes, I am going and I thought I would do a "pre" post.

Of course, some of you are wondering...

Whatever is a barcamp?

In the spirit of open, barcamps have come to be "unconferences" or user-generated conferences. Of course, I could go on and on plagiarizing wikipedia and fatten this post, but I will link it here for you to read. Suffice it to say, the concept of open conferences, run by user generated ideas is a really cool thing. If you wish to disagree...well maybe you should pay thousands of dollars and fly to some island off-season.!

As usual, the first barcamp happened here in Palo Alto, and things have gotten, er big. They have also grown from one field to many. Learn more here:

http://en.wikipedia.org/wiki/BarCamp

HealthGamesCamp

HealthGamesCamp is organized by David Schafran, a great acquaintance with experience doing some excellent work for Villagro in India, and Julian Keith Loran of the Innovation Management Institute, whom I am yet to meet.

The idea of this specific unconference is to bring together all kinds of folks ranging from healthcare professionals to policy product managers to mHealth gurus and beyond. Of course, I am not aware of who the attendees are yet, but I will try to do a post-event blog and try to highlight all the exciting things I learn about!

Alright, only a few more hours left..

Monday, November 22, 2010

Are you an entrepreneur? A job seeker? Where are your major hurdles coming from?

A big hello to everyone. It has been a while since I have posted, but I am hoping to post more in the coming week. Remember, it is both the National Diabetes Month and the National Lung Cancer Month. More on this later. Last week, I fell behind my email and everything else, as it seems common nowadays.

A video on jobs - on or off topic?

Combing through and cleaning up, I came across an interesting video. I am not sure how accurate it is, and I am not sure if it is on-topic or off-topic. Personally, I feel that there are some lessons to be learned here, for any kind of entrepreneur, or for folks who are interested in real social change and not simply "mob by association".

First, the video

To preface, this video is very cynical and the Southern drawl appears to be accentuated to the point of entertainment, but the video provides you with examples ranging from the mundane to the bizarre, talking about how local and state governments hinder start-ups and the creation of jobs!

Watch it here:



Some thoughts for the entrepreneur

1. Let's go with my golden rule. Do not believe or trust anyone wholeheartedly. There are too many organizations out there that are extremely politicized.

2. As an entrepreneur, you can sit there and wish that all the paperwork and regulations would go away. However, you need to think in terms of what you can do in the near future and over time. In the near future, as you burn through precious, yet limited resources, you should make sure your success is not impeded by bureaucracy.

If you have a choice of location, then try to find out where you can locate your organization. If not, focus on working within your region's legal maze.

Get help, not rhetoric

Starting up? In most places, you are not alone. You can choose what you will have - rhetoric or real help. Nowadays, I see hundreds of formal and informal organizations crop up everywhere - ranging from meaningful non profits to informal online groups. Not all the advise you hear is right, relevant or good, but you can filter through the messages with enough effort. I have posted about a couple in the past and as and when I find relevant groups I will post them here. I am sure a web search will turn up more resources elsewhere as well.

3. The long term - what can you do?

Whether you succeed or fail, there is something that happens every 2 - 4 years (and if you are in other parts of the world, the message about bureaucracy still holds) - we call them elections. Make sure that you send a very clear message to your Congressperson, the state legislators, the mayors and councilors that your vote and the vote of like-minded entrepreneurs hinges on them making some real changes to "business as usual". This is so much better than empty rhetoric!

4. Who changes the world?

For every Gandhi (and yes, I have immeasurable respect for him) there are silent masses that followed them, motivated them and supplemented them to move the world forward. So it is indeed entrepreneurs and individual businesses that dictate change, not governments small or large or the parties that steal votes from them...so go out there and make those changes!

5. Read, read and read some more. This is the best way to keep yourself up to date on all that is going on around you - new law, new regulations and even stuff that people pull because they are insensitive to your difficulties. Since you are a small business owner, you don't have an army of lawyers to identify what affects you and what doesn't. So, prepare!

Reference:

http://ij.org/citystudies

Sunday, November 14, 2010

The World Diabetes Day is here

November is Diabetes Awareness Month (incidentally, it is also the Lung Cancer Awareness Month) and this year, November 14th is the World Diabetes Day.

Diabetes, or originally Diabetes Mellitus derived it's name from the sweet taste of urine that was used as a diagnostic by the Romans. As a disease, it is no stranger to human civilization and has afflicted humans for a while now.

Type 1: As an autoimmune disease, Diabetes Type I, is inherently a disease where the body simply cannot produce insulin via the "islets of Langerhans" thus unable to produce enough energy needed for subsistence. This disease is more prevalent in young children and in adults. Through insulin therapies, this disease can be managed, but is debilitating nevertheless.

Type 2: Diabetes Type 2, typically has an adult onset. In this condition, the body is simply unable to produce enough insulin to convert sugar into energy, or the cells do not use the insulin as expected. Type 2 is the more prevalent form, has been diagnosed in 24 million Americans (an estimate upped form 21 million) and is expected to afflict more people, who are probably simply unaware of it. In countries like India, and among Indians everywhere it has reached epidemic proportions as well.

Some of the causes include unhealthy life styles, eating and working habits and so on. People with rice based diets of Asian origin appear to be afflicted by this disease more often.

Type 3: Is there a type 3? New research has shown that a certain number of children with Type 1 Diabetes also show tendencies for Diabetes Type 2. This is a risky condition and thus, even though it has been statistically delineated, has been assigned it's own category. The "double diabetes" as it is known is attributed to patients being overweight and a general lack of awareness.

Apart from this, gestational diabetes refers to the onset of diabetes during pregnancy. Gestational diabetes may then prolong throughout the mother's lifetime and can become Type 2 diabetes at that point.

Awareness

The biggest gap, when it comes to diabetes stems form a lack of awareness. Diabetes would be diagnosed in a lot more people if only they were made aware of diabetes and the symptoms and the predispositions.

One has to remember that people with diabetes Type 2 may not even have the symptoms sometimes. Please refer to the American Diabetes Association (ADA) website for a list of symptoms to watch out for either type of diabetes:

http://www.diabetes.org/diabetes-basics/symptoms/

You should consider taking a Diabetes Risk Test:

http://www.diabetes.org/diabetes-basics/prevention/diabetes-risk-test/

The World Diabetes Day website also lists some risk factors:

http://www.worlddiabetesday.org/the-campaign/diabetes-education-and-prevention/diabetes-risk-factors

You should also look at some of the warning signs here:

http://www.worlddiabetesday.org/the-campaign/diabetes-education-and-prevention/diabetes-warning-signs

TuDiabetes:

My friends at TuDiabetes ( http://www.tudiabetes.org ) a non-profit organization focused on Diabetes Awareness, Actions and other Campaigns have a video for you!

Saturday, October 23, 2010

DIYBio gets a little more local...Bangalore just got one - is there one in your area?

You must be living in a cave disconnected from the internet, "smart" phones and Government paranoia, if you haven't heard of "DIY"bio...the new movement where citizens create fluorescent cats, third arms and pet Homo zombius'es...(there may be people trying to do these things, but this is not what the DIYBio movement is about, but hey, since logic and commonsense are not essential to our politicians or to those who do very little to serve or protect us..)

What is DIYBio?

Most revolutions in human science and society took off with home-grown innovations. While Kings commissioned large sums of money and bounties, it took James Watt with his steam engine, the Wright brothers with their flight, and the Curies with their home-grown chemistry lab (I mean literally, the innovation of a century in radiology was cooked up by the Curies working their asses off in a shack offered up by skeptical University folks). And then we have the perennial "garage start up" dream...so much so that now we have a company named "Willow Garage".

Yet, one field had lacked this spunk - enter a bunch of hitherto disparate folks trying to do a "garage" bio or life-science company. Like so many people blind to this, it took a report of Government paranoia (suits showing up at people incubating eggs and so on), I learned about the group through a string or articles that just multiplied the story to create a din loud enough for me to sit up and pay attention.

Since then, of course I have joined the groups, watched our local DIYBio group , "BioCurious" gain funding pledges and I have generally been enjoying the fraternity of research.

The essential idea, globally and locally is to cause revolutions in the life sciences that promote both basic research and cures. This spans the gamut, ranging from fundamental biology to genetics and personalized medicine!

Of course, there is more, however, I am not going to write a pompous essay - just visit the links at the end of this post to learn more about the DIYBio movement!

Bangalore DIYBio:

Localization is important to invite new people into the fore, get the intimidation and information overloads that the 21st century has wrought on us down to an acceptable level and allow for explosive growth. While local groups have been popping up everywhere, the Bangalore group, as far as I can tell, is a first for India. Congratulations to Deepan Chakravarthy for starting the group!

There is a lot of programming talent in India. I am sure the lifesciences in various forms are also attracting enough attention. Consequentially, I hope that this group can bring these folks together, locally in India.

The value of collective bargaining

When I first came to the US as a graduate student (and even a little before that), one of the clear causes for such success in the US became quite self-evident: "associations", "societies" and the whole lot.

Of course, there are times when groups such as NFIB and Advamed are up to no go..ahem, hmm, let's go back to the main topic.

Individually, it would be so hard for folks to do things. By grouping together, we can motivate each other, share ideas, and present forums that can be societal, technical and as it seems to be quite necessary with most endeavors nowadays, political as well!

India does have quite a handful of associations and societies. However, a lot more need to come up. I saw a handful pop up - HeadStart, the local barcamp groups, the OCC or Open Coffee Club groups and so on. With a population continuously hungry to put India on the 21st century map, I think such associations including the DIYBio Bangalore group, that may currently look small and frail are doing their job.

So my question to you: Do you have a DIY-Anything group locally?

Especially, do you have a DIYBio group that is local to where you live? If so, have you joined and contributed? How about starting one if it is necessary?

Do-It-Yourself-er, with a lot of friends, it's easy!

Setting up a new group is not tough. Here are a few things you could do to get started:

1. Find out if you have folks interested in starting one. Join the diybio group (link at the end of the post, I promise). Ask who else is working on "bio" stuff locally.

2. Find out if there are local Universities that have folks doing the same thing. Attend lectures, go to meetings and chat people up.

3. Simply start a group - then blog, tweet, holler and draft your friends as volunteers (that's right!) to either join, or get the word out.

4. Conduct simple meetings, demos, educational events - there is a lot on the playbook that the folks who have already done it at Biocurious and other organizations that can talk to you about - reach out!

So, let's get to some resources.

Resources

1. The DIYbio Google Group:

http://groups.google.com/group/diybio

2. DIYBio website:

http://diybio.org/

3. Find local DIYBio Groups:

http://diybio.org/local/

4. The Bangalore DIYBio Group:

http://groups.google.com/group/diybio-bangalore


5. DIYBio on Grouply:

http://diybio.grouply.com/

Thursday, October 21, 2010

Thinking of starting a business? You may have a tax break or two to take advantage of!

As has now become usual, I have so many excuses as to why I am not regularly posting here. I apologize – aside from all my travails and super-secret projects, I now have a cat, squeaky, and I have been trying to making him feel at home, while invading his privacy through a blog at http://yamanoor.com/blog/ .

Back to the futurepresent, I read this Bloomberg businessweek article and I thought I would pass on the tip to you. The tip has to do with available tax deductions if you start your business this year.

Sitting on the fence? Have you been drinking a lot of tea and avoiding starting that company you have been thinking about? Well, there is new regulation that appears poised to push you over the fence.

The tax break, according to the article, appears to come in three forms – startup expense benefits, capital expenditure benefits, bonus depreciations and additional depreciations. The original article and additional links are available at the end of this post.

1. Startup Expenses – It appears that the annual deduction allowed to be claimed for businesses is usually $5,000, and this year, in an effort to get more people started, it is $10,000. It appears that this holds true only for 2010. It also appears to cover a range of startup expenses such as legal expenses, accounting expenses, marketing expenses and so on, as quoted by someone, on the Businessweek article.

2. Capital Expenditure Benefits – In 2010 and 2011, companies that invest less than $2 million in capital investments can now deduct up to $500,000 in taxes. It appears this is phased down northwards of $2 million. This looks like an especially sweet deal if you are already in business. If you are just starting up, this may not be as useful, but still worth something.

3. That pesky health insurance - Yes, that pesky thing that has turned half of us into zombies who would rather panic than apply logic. Well, unless you hit yourself in the head, healthcare has always been a problem. The new law helps you if you are a sole proprietor or a single person LLC , in 2010 (and only this year) you will be able to deduct your healthcare expenses.

This is a one-time bitter-sweet benefit, and may still benefit a few of you out there! There are other large and small benefits that the White House touts. Remember, if you do start up, and hire hitherto unemployed folks, there is another benefit in there for you.

Other benefits from starting up

1. There are a lot of folks with a lot of ideas up there. However, as the much beaten cliché says, “ideas are dime a dozen”. Of course, you will tell me you are passionate, and you will get out there and build a company and you know what the gap is and how you are going to fill it and so on – Good! Now, if you actually register a company and start paying taxes, this will definitely help you. You now have a deadline – no more excuses! Get out there and do it.

2. Benefits dry up if you do not use them. From Karen Klein’s well written articles, I deduce that some of these benefits, such as the temporary healthcare deduction have been won through a lot of battles – and are still temporary in nature. I know it doesn’t make sense for companies that employ a team of folks, but as long as you are a lone ranger out there, be a good one, register start-up and take advantage. This will let the Government consider expanding benefits for other lone rangers – perhaps, even for your next start up!

3. Yes, it appears that a lot of people are touting their anger out there. The recession has ended, yet growth is slow. Yet, the morrow belongs to folks who tough it when times are not as good, as opposed to people who wait and wait till the tide comes in….

Till next time!

References:

1. http://www.businessweek.com/smallbiz/content/oct2010/sb20101019_201595.htm

2. http://www.businessweek.com/smallbiz/content/oct2010/sb20101011_393281.htm

3. http://www.whitehouse.gov/the-press-office/2010/09/10/fact-sheet-president-obama-has-signed-eight-small-business-tax-cuts-law-

Thursday, September 23, 2010

The Healthcare bill of rights is here...

Preface: Once again, I have to apologize for not being able to blog here, and this time it involves travel to the Seattle area, but I hope to get on my feet soon.

Introduction: I have signed up to receive updates from the local Congresswoman Anna Eshoo. Today, she forwarded me this set of rights, billed as, so to speak, "The Healthcare bill of rights". I thought it is fairly important for anyone involved in healthcare to go through them, so I am going to share them with you.

Oh, and these are the rights that the Republicans and the Tea Party would like to repeal, just so you know.

* Your health coverage cannot be arbitrarily cancelled.
The new law prohibits insurance plans from rescinding your coverage when you get sick, except in cases of fraud or an intentional misrepresentation of facts. (Applies to all insurance plans.)

* Your child cannot be denied coverage due to a pre-existing condition.
Insurance plans are prohibited from both denying coverage and limiting benefits for children based on a pre-existing condition. This applies to all employer plans and new individual plans.

* Your health plan cannot put a lifetime limit on your health coverage.
The new law outlaws lifetime limits. No longer will a family go broke or lose their home just because a loved one has an accident or becomes ill. This applies to all insurance plans.

* Your health plan’s annual limits will phase out.
Over the next three years, the new law phases out annual limits ensuring that the coverage of hundreds of thousands of Americans will no longer be cut off right when they need it most. This applies to all employer plans and new individual plans.

* Your child can stay on your health plan up to age 26.
Insurance plans that offer family coverage will be required to allow young people up to their 26th birthday to remain on their parents’ insurance plan, at the parent’s choice. This applies to young people who do not have access to their own employer-sponsored coverage.

* You have the right to choose your own doctor.
Patients are guaranteed their choice of primary care doctor within their plan’s network of doctors, including OB-GYNs and pediatricians without a referral. This applies to new plans.

* You have the right to access out-of-network emergency room care.
Insurance plans will not be able to charge higher cost-sharing for emergency services that are obtained outside of a plan’s network. This applies to new plans.

* You have the right to appeal denied coverage.
Insurance companies are prohibited from denying coverage for needed care without a chance to appeal to an independent third party. This applies to new plans.


Commentary: Essentially, I think this is a good set of rights and a good start. It will help coverage, and increase revenues for medical device companies, regardless of what Advamed would like to have you believe. In the long run, this will serve as a model of comparison for developing nations trying to implement healthcare reform.

Of course, post elections we will see some cheesy attempts to repeal the law, more display of testosterone and so on...until next time!

Sunday, August 29, 2010

Come join me for a workshop on "The Rules of Brainstorming"

Preface: Again, I apologize to everyone for the paucity in posts. As some of you might know, I have been working incessantly on a project and that has kept me from being able to gain any traction on blogging here. As the blogging gets tougher, I have decided to add a tweet specific to the blog so that I can still share quick updates on devices and such.

You can follow "devicology" on twitter:

Follow devicology on Twitter

Of course, there are not many tweets there yet, but watch the space for more.

Looking for innovative ideas?

Ideas, they say are dime a dozen. Well, who is to say what the current exchange rate is? If you are looking at a start-up or even a project that needs you to design a device, a mechanism, a set of mechanisms and/or processes and methods, you need innovative ideas. Many times you need to be innovative to beat your competition, and sometimes, simply because the solution demands creative thinking.

But, how do we get good ideas? Some people seem to have a practiced way of getting to ideas, so is "ideation" something that you are born with?

Wrong!

Brainstorming!

Brainstorming is the best way to open up your creativity and come up with innovative ideas for your projects, your companies and so on.

While there are many opinions floating around, the baseline is simple - encourage creativity and "out of the box" thinking, do not judge while the session is still on and do not "direct" the meeting.

Of course, I have a few other ideas that I would like to throw in - keep the topics broad first, narrow them later, or in later sessions, provide avenues for creative exploration through colors, toys and such, and feed your people!

Brainstorming is an exercise - so the more you train appropriately that is, the better you can get at it. Take it from me, I have seen this lead project ideas to great success in many different situations - this is the point of the workshop - practice, exercise!

Set at the Crossroads Cafe in San Francisco on September 13, 2010 thanks to the efforts of Eri Gentry, the founder of BioCurious ( http://biocurious.org/index.php?title=Main_Page ), we will discuss the rules for a couple of minutes, brainstorm a broad topic as a group exercise and then given enough interest, we will break into smaller groups and discuss further topics.

Here is the link for the event:

http://www.meetup.com/BioCurious/calendar/14576734/

I hope you can join us!

About BioCurious:

BioCurious is THE DIYBio group for Silicon Valley and in general, the Bay Area. Currently the group is seeking funding to find a near permanent home. You can find out more about them here:



Yours truly's previous FDA regulation class and pitch appear in the video as well...

Monday, August 02, 2010

A prototyping tip & a quick update

Hello everyone!

First, the update:

Yours truly is engrossed in more than one project, and has taken quite a break (I haven't posted in almost 2 months if you haven't noticed). I kept telling myself I will get back to blogging, but I have decided that isn't happening anytime soon. So, I thought I am going to jump in and start blogging again. I am also going to announce the "Summer of Blogging" shortly, but enough with the egotism...

Prototyping Tip - Don't throw away your failures!


Yours sincerely (thought I will try a variation on the previous paragraph, ahem) has recently had a chance to do a lot of prototyping - you know strutting around the lab, hurting yourself with things that look nothing like what your final product is going to be?

Anyway, cynicism aside, prototyping is always so much fun, next only to storming the brain for ideas of course. Part of the pleasure of prototyping is that you are typically breaking new ground, so many mistakes may occur.

20,000 non-bulb materials - the Edison cliche

Edison was arguably the biggest patent troll according to some people, intimidating peers and stifling innovation. However, he left a lot for us to delve in terms of cogitating about persistence, prototyping and such.

Though we may never know exactly what he said about never giving up on the path to inventing the light-bulb, but persistence in innovation is necessary. One has to stare failure in it's face and move on!

However, do we simply record our failures and discard them?

No! From your failures, you can learn a lot:

1. What exactly is the definition of failure in your prototype? Did it not fail to turn out at all? Did it fail to appear unlike what was expected out of it? Did the prototype fail in terms of functionality?

2. If your prototype failed under process/manufacture/putting it together, can you repeat it? Can you identify the flaws in your development process?

3. If your prototype failed functionally, what led to the failure? Is your failure related to how you built the device/application etc., or is it related to how you used it?

Record it anyway!

The very first thing you should be doing is answering those questions and recording those answers. These answers should go in your lab notebook. Two weeks from now, or six months from now, you don't want to be asking yourself what was going on.

Patent it anyway

A couple of years ago, I attended a meeting of the "Bio2Device" group locally and Karen Talmadge, the wizard of Kyphoplasty mentioned something to the following effect: "Don't simply patent your way of doing it, patent all the ways that could cause the same effect". In a simple sense, if you are thinking about using radiofrequency to burn the tumor, don't stop there - think of microwaves, photo therapy, embolization and so on...I hope you get the point. You may not get everything granted, so make sure your claims are constructed properly and you try to reduce things to practice appropriately.

The reason I brought this up, is because your prototype may not work because at the moment, you may not have the right method of building it, or the right set of steps to accomplish the functionality required of your device - and you can fend off someone else who might want to compete with you using one of your discarded ideas!

Lather, Rinse and Repeat

Finally, try to re-work your prototype! Don't take one failure as the final answer. If you made enough effort, maybe you will get it to work, or you will find out why it won't work...very valuable information!

Monday, June 07, 2010

Want to help out a biotech hackerspace AND learn about medical device regulations? Come to my class...

Yes, that's right...someone thought of a hacker-space for Biotechnology and Medical Device players! And, curiously enough, they named it "Biocurious". Yes, get over what the name reminds you about - after all, as a clever marketing ploy, it does make you sit up and notice..

Biocurious was founded by Eri Gentry, and it currently operates out of a garage while awaiting more founding support to mature into a full blown facility somewhere in the San Francisco Bay Area. Having been spoiled with hacker spaces, Maker Faires, Tech Shops and the like, yours truly, among many others has become very attracted to the idea.

Playing in the life science space is never as easy as developing a Facebook app and raking in millions, and it probably never will be. A lot of biotechnology labs and incubators have popped all over the place. They plan to take huge chunks of your company and cash, mostly because it does get that expensive sometimes.

Do-It-Yourself, cheaper...

A hacker space for life science companies is the appropriate experiment at this point. If you look at big pharmaceutical companies, they are stuck in their own rut of Ms and As with no real focus on any innovation. Venture Capital companies are minimizing risk by investing in "safe bets" while entrepreneurs pine away.

Imagine how much of an impetus it would be if you could rent a space very cheap, rent and share equipment and "schmooze" with like-minded folks. Biocurious is positioned appropriately to achieve this. You could be a serious entrepreneur, or someone who wants to make your cat fluorescent (okay, the last one is just a cruel joke), and you would find Biocurious the right space for you.

Of course Biocurious is well founded on the principles of "Safety First", open source and all that is well and good with hacker spaces.

To learn more, go here: http://biocurious.org/index.php?title=Main_Page

Education for hobbyists and entrepreneurs alike

Apart from providing space, equipment support, safety and good vibes, Biocurious also provides a framework for hobbyists and entrepreneurs to teach each other. You can see the list here:

http://biocurious.org/index.php?title=Classes


As you can see, I have volunteered to teach a class on FDA regulations, for life science companies and medical device companies alike. So, let's take a look. I am going to copy and paste the summary of what I wrote in there later, but here's the gist.

Introduction to FDA Regulations

This is an introductory class. So, if you know little or nothing, or simply want to come and help out Biocurious with more than the suggested minimum of $10 (I am not getting any of this!), then come and have a listen.

If you are wondering what you should do after receiving a Form-483 report, this may not be for you...

The idea is not to rant about how the FDA is out to kill innovation or any of that stuff. Our goal in this class will be to develop an idea of the ways and means by which you can work within the regulatory framework from the very beginning of your drug/device/biologic/diagnostic development process.

The goal is to layout the regulatory map and discuss any questions and answers.

Although it mostly repeats, here is the class summary:

The Business of Drug and Device Development – what you need to know about regulation and the approval process

Tuesday, June 22nd | 6:00 - 9:00 PM


Srihari Yamanoor

As an entrepreneur, one of the most important balls you will juggle will be regulation. As you get more serious about your endeavor and seek funds you will notice that investors and others will seek out your “regulatory plan”. It is key to develop a thorough understanding of the regulatory process, what the FDA looks for, and the strategies companies adopt to ensure as smooth an approval process as possible.

The class will discuss the approval processes primarily focused on drugs and medical devices. We will talk about the different stages of the approval process involved in therapeutics. This will be followed by a discussion on medical device approval process. We will discuss the various classes of medical devices, how to determine the classification of your device.

Frequently, your devices and drugs will go through clinical trials in Europe, Mexico and other locations. We will discuss the need for this, how to initiate clinical trials in these locations, and how to work with the FDA throughout the process to ensure that the trials meet the standards for safety and effectiveness, essential for approval.

We will also discuss the regulatory process that is in flux at the FDA.


Cost: $10 suggested contribution. All proceeds will be used to support the lab.

Stop By!

So, once again, if you are local to the Bay Area, consider marking off June 22nd on your calendar and stopping by! If you have any questions, let me know. I hope to see you come there and support Biocurious!!

Here is the link again: http://biocurious.org/index.php?title=Classes

Monday, May 17, 2010

Blog brief: Inventables - a nice resource for your medical device projects

Recently, I was contacted by Zach Kaplan, the CEO of "inventables.com", a clean, fast website that allows you to look for specific materials and technologies. They have a significant medical section that I did find interesting. It is not an exhaustive link, mind you, but I think it has great potential to get there.

To keep things very simple, I tested out some very simple keyword searches:

1. My favorite (not) "stent"

2. Bone cement

3. Camera (a pleasant surprise on the results) and so on.

With these tests I found some valuable information on the certain materials and manufacturing technologies. If you have been in the industry for a while, you may react with a yawn, but if you are new, I believe the site holds quite a bit of promise. Things load fast and the information is there to tag you.

When I hit larger terms such as phlebotomy or atria or even something mundane as heart, I did not get good results. I won't blame the website though, it is a factor of learning to search for stuff. As it is, many times, when you are working on device projects, you are at a loss as to where to start the search. The thing to note is, having inventables as one of the places to go to, might not be a bad idea.

When you do get search results, you are now in touch with vendors. If you are a small vendor trying to reach a wider market, this may not be a bad idea at all. I am sure there is a path to organic evolution where we will land on the right search results that will lead to the right products and/or information.

Conclusion:

I think like many of those emerging tools, inventables shows great potential!

Reference:

https://www.inventables.com/

Friday, May 07, 2010

MedTech: A great bioscience resource for folks in New York

Whether you are working on a medical device company, a biotechnology company or a pharmaceutical company, and regardless of your size, you will always need resources. You may not want to "fly" someone in a few times a year and fret about the bills. Everyone talks about networking, but it is always good to have a backbone to rely on.

Recently, I was contacted by Jill Zimmerman, the director of marketing and communications at MedTech, a non-profit trade association serving bioscience companies in New York. MedTech has an interesting model. There is a very clearly laid out strategy to serve bioscience companies in New York. Memberships are collected from participating organizations, rather than from individuals, which I guess makes for a more sustainable model with better outreach.

MedTech also has an impressive strategy to serve it's members, including public outreach, marketing and promotion of the industry and networking.

http://www.medtech.org/media/documents/2009/3/MedTech_Vision_Mission_Strategic_Priorities.pdf

So, if you are moving to the New York Area and starting afresh, it may not be a bad idea to check out and see if your organization already participates in MedTech.

Events and Such

You can never have enough life science events, ever. So, looking at the rather impressive roster of events that MedTech, I am a bit jealous, positively speaking :).

You can find out more here:

http://www.medtech.org/events/list.aspx?cat=0

If you are new to CAPA or just need a refresher, events like this might be for you:

http://www.medtech.org/news/mediaroom.aspx?recid=1566

They also listed a webcast coming up for 5/12. I almost never have time for these things even though I promise myself I will. I still signed up, and will try my best to make it to this one.

Conclusion

Networking in interdisciplinary bioscience fields is very, very important. Find organizations such as MedTech that serve you locally, and when you find them, don't let go. Do you know of other resources that would be useful to folks? Please share them with me!

Reference:

http://www.medtech.org/

Tuesday, May 04, 2010

Silicon Valley Business of Engineering - A great event and resource for local medical device folks and others...

The Silicon Valley Business of Engineering is a great meet-up group put together by
Elise Engelhardt (LinkedIn profile here ) who, in my opinion is a great power networker and leader. Among many others, I attended the first meeting today and it was a great success!

The event was sponsored by two groups, Ozen Engineering (website here) and STM, aptly named Service To Mankind ( website here ). Instead of using their generous sponsorship as a platform to rave about themselves, both Metin Ozen of Ozen Engineering and Floyd Bertagnolli of STM kept their presentations very brief and informative (I learned something exciting, which I hope to share with you in a separate post).

The group's future events would be a great resource for engineers, not only medical device folks, but others as well. I ran into a host of service providers, consultants and so on. It was inspiring to meet some very entrepreneurial folks as well.

I networked with a bunch of folks, some of whom were kind enough to share in great detail how they charged for consulting, how they came up with the plans and so on. I also spent a good deal of time talking to another former Apple employee on the care they pay in engineering their products. The whole event was very educational for me. I hope to run into some of you at the next event!

I think this is a great beginning and a wonderful resource for engineers in the Silicon Valley, to carry on, as the title says, with the business of engineering.

Local Resources

1. Silicon Valley Business of Engineering

http://www.meetup.com/BusinessofEngineering/

2. Silicon Valley Engineering Council on LinkedIn

http://www.linkedin.com/groups?gid=46760&trk=myg_ugrp_ovr

3. MedDevice Engineers, Bay Area on LinkedIn

http://www.linkedin.com/groups?gid=2126&trk=myg_ugrp_ovr

4. American Society of Mechanical Engineers, Santa Clara Valley on LinkedIn

http://www.linkedin.com/groups?gid=1300&trk=myg_ugrp_ovr

5. "sfmedengineers" on Yahoo! Groups

http://tech.groups.yahoo.com/group/sfmedengineers/


Do you know of other resources? If so, let me know and I will post them here.

Until next time...

Monday, May 03, 2010

Starting a medical device company? You are better off without some of these "VC"s!

When I first learned about "entrepreneurship" and "venture capital" it didn't make much sense to me. Over time, I thought these "VCs" would be respectable old ladies and gentlemen with graying hair and gold-rimmed spectacles full of worldly knowledge just waiting to share that with young people.

What can I say? I was 23.

A few years of "schlepping" business plans of varying sizes and forms later, I don't think so. Oh wait! Am I losing any future opportunities to beg around for money with quaint little PowerPoint presentations?

Well, let's put it this way. No one who cannot take some criticism is considered grown up and I really don't want to share my future business ideas with over-grown Peter Pans. I am sure there are good VCs and there are bad VCs. Good VCs look for returns from functional business plans...

Surveys gone wild

What got me riled up anyway?

Apparently VCs local to New England responded anonymously to a survey conducted by MassDevice. Their fundamental rant? Healthcare reform is not the problem, the FDA and it's reform is! And I am not singling out this survey, I have seen such "responses" before as well.

Apparently, the FDA is considered so risky that some of these "anonymous" VCs don't even invest in companies that have FDA "exposure".

What the hell kind of a medical device company does not have FDA exposure?

Maybe, the ones that make tongue depressors and bike helmets. I gotta tell you, there's not much margin in tongue depressors - China's got it covered anyway, and I still worry that we don't check Class I devices enough to make sure they don't end up with a fun cornucopia of Lead, Cadmium and Melamine.

If we scare people enough, they will make the FDA back off...

First things first. If any of these glorified pawn brokers look at your business plan and say they are "concerned" because of your "FDA Exposure", step away slowly and gently.

A venture capitalist who does not understand the approval process is not worth anything for you regardless of how many buckets of money they promise will show up on the term-sheet. It is not just the entrepreneur that needs to understand the importance of an FDA approval to your very existence.

FDA approval is not a "risk management" issue or a "price pressure" issue or any of the pretty little CYA-terms they teach you at the MBA-for-real-dummies school.

The entrepreneur who founds the company, brings in angel and VC money should know this. The CEO planted by the VC firm needs to know this. The Board of Director needs to know this. The people you hire need to know this.

The Right Perspective - Interview your VCs before you take their money

I don't want to poach MassDevice, so I want you to read about these VCs yourself. Unlucky for you, you don't know who they are so that you can avoid them like er, we will just move on.

You plan to interview your VP of R&D right? You plan to interview the M.E. interns and the engineers and the clinical folks and the assemblers and such, right?

You will talk to Joe and Sarah before you hire Vinny to help you with V&V correct?

Well, do the same thing for the VCs.

Interviewing the VCs - The questions to consider

Tough times can lead to good change. Be part of the change. Until you stare the horse in the mouth, you won't know if she is a gift-horse. To help weed out the unfavorable horses, here are some things to consider:

1. Try to have a frank conversation with your future investors. Be respectful, but assertive. Watch for signs of gentle prodding to "cut corners" on the regulatory side or the ethical side.

2. Snoop around - talk to other organizations that have taken money from these investors. Find out how the board meetings go. Find out what kind of pressure they have been under.

3. Well before you get the term sheet, your VCs will do a background check on you. Don't hesitate to do the same. You really need to know where your money is coming from.

What the hell am I saying? Isn't this 2010 where money is scarce and because of price-pressure and R&D profit ratio blah blah...

Yeah, right. Look, for all the things these guys say about how pharma and biotech are winners and how running around naked "exposing" yourself to the FDA is making you look bad (don't actually expose yourself to the FDA, it won't help), trust me, who are they kidding?

Understand the real game

First off, if you have been paying close enough attention, investing in pharmaceutical and biotechnology plans have moved into a rather complex arrangement. Nowadays no one does the classic angel plus A through F rounds that you learn in MBA schools.

Sometimes, companies get lucky and rather do single large rounds of $100 - $150 million. That is more than what a good, ethical medical device company would ever need to raise on it's way to profitability.

Other times, smaller pharmas enter into "milestone agreements" simply because the clinical trials needed for their success make them so hot, that even the VCs cannot handle them. So, really, ask again, who are they kidding?

I read all these surveys and by gosh, will medical device investment ever return again?

Ever since the healthcare reform looked like it would pass, a whole bunch of folks have taken to this notion that we are all idiots. They keep throwing tea bags and dumb rationale at us to foist their empty threats.

In truth, the economy will recover - the recession ended some time late last summer or thereabouts. Good ideas will get funded. Then the bad ideas will get funded. Everyone will want their hand in the cookie jar(yes, I am all about those cliches). And that is why these VCs want to be "anonymous".

If you have been in the funding scene recently at all, you might have noticed a few changes. Primarily, you might have noticed some very competitive and knowledgeable VC firms from China. Yeah, they hurt us from below and from the top. And remember, it's not just the Chinese. The Venture Capital business is one of egotistical trust in one's own ability to spot the next "Google" or "Provenge" or "tiny plumbing fragments made of metal".

Do you really think our friendly, neighborhood, anonymous VCs will simply sit around with their hands tied?

So to you I say: you should keep writing those patents, keep working in those labs, keep bootstrapping your business (look at my old posts, or talk to me if you want to know more about DIY-bio) - simply, keep at it!

Good investors, and once the bad ones have thrown their money on video game companies, there will be more good ones left than bad ones, will continue to invest in plans. They will not throw childish tantrums about reform. If the 510 (k)process takes longer, they will wait.

Why?

They know that as the entrepreneur, you will do the right things. You will plan for the delays. You will plan for the changing landscape. You will contact the FDA well ahead of time (refer to my post immediately preceding this) and set up a channel of communication. They know you will hire people focused on Bayesian methods to assess clinical trials and have an ethical stance towards the regulatory process.

They know, that the rules of the game may change, but the game remains the same - profitability and public health, not the tea party agenda.

Health Reform - Are the American Public Losers?

Unfortunately, we all tend to get carried away at various points in time. So, there are a lot of people sitting around drinking tea while the Democrats are too busy being chicken and not explaining things in perspective. Of more relevance to us, we have seen regular scenes like this play out:

1. Companies like 3M say they will stop making medical devices due to the "high" cost of reform. You can read my response to such pearls cast upon us here.

2. Companies like Caterpillar and AT&T have taken "charges" blaming health reform for their higher costs. Funny, the "charges" are actually tax benefits...

3. And now, this. Firms making "anonymous" statements about how the FDA went from being a regulatory agency to an anathema.

The magic formula

All it really takes is for entrepreneurs, investors, more importantly the pressure applying politicians (ReGen anyone?) and federal employees to be more responsible, and ethical of course.

Any business person or entity has a choice. Move with the wind, or go into oblivion...

Conclusion

It is all and well to talk about price pressures, time lags in reimbursement and how much the Americans tend to lose by being healthy (huh, you say?).

How will you feel if you went along with this song and dance and later find out that the FDA has yet again bowed to pressures and approved another sub-standard device?

How would you feel if that device was used to operate on you, or worse still left in you? Or someone you love?

How would you feel if you later found out, you have no way to recover any of your losses because of "Federal pre-emption"?

That, my dear friend, is the day you would have lost...

See, I can scare you too. It is only too easy, if you are willing to scare.

To my anonymous VC friends lurking around the dark back alleys of New England and elsewhere, let me tell you, most entrepreneurs are street smart, and in the case of medical device firms, school smart as well. If you think we are dumb enough to join you in leaving "health reform" hatred graffiti across the internet...

Reference

http://www.massdevice.com/news/local-vcs-more-worried-about-fda-moves-healthcare-reform

Where is medical device approval headed? The horse's mouth speaks...

Preface I capitalized on a unique opportunity to attend an event conducted by the Stanford Students Biodesign group ( link ) featuring Elias Mallis, the Chief of Cardiac Electrophysiology and Monitoring Branch (CEMB) at the Division of Cardiovascular Devices in the FDA (ah, the layer cake).

I found Elias Mallis to be very forthcoming and honest with sharing facts and thoughts on the FDA, the medical device approval process and answered questions with quite a bit of patience (yours truly asked the most questions).

You can read his profile here .

The event was well attended and consisted of a very brief 32,000 ft. overview of the FDA medical device approval process followed by an extensive question and answer session.

I am going to regurgitate and clean up my copious notes for your benefit here.

Highlights of the Presentation

The objective of the presentation is to break down the barriers on the impressions people may have about the FDA. There are essentially four steps to the medical device approval process:

1. Check if what you have is a medical device. There are many devices that may not necessarily be medical devices as approved and regulated by the FDA.

2. Does the FDA regulate this medical device?

3. Conduct all the tests the FDA asks for.

4. The FDA reviews, evaluates and approves or disapproves the device application.

Some notable points on the approval process:

Once again, the talk was mainly for students, so there may be quite a few things in here that you may already be quite familiar with.

1. Many times, companies call the FDA when they have a new product idea and they don't know how the FDA will regulate the product. The FDA guides them accordingly. It is suggested that companies call the FDA sooner rather than later. With PMA devices, the companies should contact the FDA as early as possible. However, Elias suggests that even with 510(k) devices that require animal trials, the companies should consider calling the FDA before rather than after the trials.

2. The FDA will suggest tests based on the device being brought to approval. For example they might suggest a host of mechanical engineering tests for catheter based products. If you are designing an energy delivery device, they might ask you to do some thermal modeling.

For newer devices, the FDA might decide to test beyond the bench. In all cases they try to limit the use of animal testing. For an ablation catheter meant to treat cardiac conditions the FDA might ask the company to assess models with the beating heart modality with a thermal model. (Srihari's note - I did something like this in the past myself and if you need more information, get in touch with me). They also assess important issues such as - does the ablation catheter create enough of a lesion? Does it present the danger of perforating the heart?

3. Clinical Testing: For devices that may need clinical testing, lots of interaction with the FDA is required. Primarily, the specific purpose of the clinical trial needs to be identified, for example, atrial fibrillation. The FDA specifically looks at the following:

3.1 The safety and effectiveness of the device
3.2 The risks and benefits of treatment
3.3 Acute procedural end-point: What the device treats or causes during the procedure
3.4 The long-term end point of the device.

3.5 The FDA needs the clinical trial to evaluate if the device was able to evaluate and create a conduction path. They would like a one year follow up for the durability of treatment.

3.6. The FDA also looks for known issues such as pulmonary vein stenosis. These commonly occur when ablation is used to treat atrial fibrillation. The FDA needs for the rate to be measured so that it can be ensured the rate is not too high.

4. Application Evaluation: As a final step, the company approaches the FDA with a marketing application. The FDA evaluates this, usually with a team that includes maybe a biomedical engineer, a veterinarian sometimes if animal studies were involved, a cardiac electrophysiologist, a material scientist and other specialists. Often, the FDA also consults with outside experts such as practicing physicians for newer devices.

4.1 The team of scientists in each device group at the FDA may have anywhere between 5 - 20 pending applications typically. The applications may go through faster or slower depending on the class of the application. PMA devices are evaluated at the highest level through an elaborate process and typically need a panel discussion.

5. The 510 (K) process has existed for as long as the FDA has been approving devices. The burden of proof with this process is for the company to show that the device is equivalent to existing devices. This applies to Class I and Class II devices, and the application could be small containing information on engineering tests, animal tests and rarely clinical tests.

5.1 Some subjective stuff: Most devices go through the 510 (k) process. Since the new leadership showed up at the FDA, the process is under re-examination. Elias states "there is a lot of truth to the fact that the 510 (k) process works well". For the fringe, areas are pushed, some of the procedure, and some of the aspects of the PMA process involved in the device application.

5.2 What about the changes? Apparently, the center is trying to be more transparent. If there are any changes to the 510 (k) process, we will know by the end of summer. Things may be more of a "continue on" with some changes and enhancements - some of them smaller, easier changes and some more expansive.

5.3 From Three to Four Classes

One of the things the FDA is apparently contemplating is introducing a 4-class system, as opposed to the 3-class system.

Class I would still be exempt

Class III will still include PMA devices, and

Class II devices will likely split into Class IIa and Class IIb devices. The FDA will decide what level of evidence is needed for each class. Apparently this the kind of stuff that makes people like Elias "lose hair and make what's left to turn grey".

The FDA's goal in all this apparently, is to improve public health.

Apparently, very few 510 (k) devices are rescinded, an example being the hair implant device that was recently rescinded.

5.4 Restructuring Predicate Devices

There is usually a problem when someone comes up with 10 devices for the predicate devices and the resulting device looks nothing like any of the 10 devices referred to in the original. These are some of the areas that the FDA wpuld like to scale back on.

6. What about the FDA not receiving enough feedback on the 510 (k) review process?

This was a question posted by a member of the audience. He had apparently read somewhere the FDA was not receiving enough feedback. There was the usual shout out by companies claiming that everything is well with the 510 (k) process and to leave everything alone.

However, the FDA is looking for specific comments.

Srihari's interjection on feedback

At this point in the lecture, I decided it was worth stepping in and letting my views known about the FDA's meetings and their rather ineffective concentration in the Maryland/Washington D.C. Area. I have mentioned this before in a previous post:

http://chaaraka.blogspot.com/2010/01/challenging-pre-market-approval-process.html

Response from Elias: Elias did respond that the FDA likes to come to the West Coast and usually their absence on the left coast (what he jokingly referred to as the "other country") is a resource constraint. He did mention that it is possible that the FDA "may" come to Stanford University in the Fall.

Promises, promises. Yes, I am not too happy about that. For a Federal agency to receive billions in funding and claim that it is too resource starved to visit folks across the country during a very public review of it's procedures - things don't look good. This sort of high and mighty horse sitting could have been eliminated if the Obama administration had taken some of the good advice rolled out last year and split the agency. You will see a little more of why this is so, as you look further in the notes.

7. Has there been any palpable change from the front end of the FDA after a change in the leadership?

There has been a shift in philosophy from the center. The previous leader Dr. Schultz had certain views on science and these are being given a fresh look. Due to multiple layers at the FDA, there have not been palpable changes to the day-to-day operations.

Srihari's Note: Another excellent reason to have broken down the FDA. Look at the multiple layers and tell me it is a good sign.

8. Specific changes?

8.1 510 (k) devices may be upgraded or downgraded. About 25 devices, including for example AEDs that were traditionally PMAs are now eligible for 510 (k) applications. This is mainly because the FDA has enough knowledge about the functioning of the devices. Apparently, the FDA is not necessarily looking to "up" devices of any sort.

8.2 The FDA would like to make the line between type II and type III devices much more clear rather than the fuzzy line that is the norm now. This may mean that certain devices may need clinical studies or more studies in general.

In general, when looking at the equivalence the FDA asks three questions:

1. Does the device have the same intended use as the equivalent device referred to in the application?

2. Does the device have the same technological aspects as the equivalent device?

3. Is the testing done on the device in application appropriate for the type of uses stated in the application.?

The questions are likely to remain the same, however, the FDA is likely to take a closer look at the questions and the answers to make the equivalence decision.

9. Clinical Trials

Clinical trials are very expensive. Given that how does the FDA account for the protocols and for tests done outside the US?

The FDA looks at safety and effectiveness. The EU looks for safety more rigorously and in Elias' opinion, the Japanese FDA is more rigorous than the US.

A lot of evidence for the devices approved by the FDA comes from outside the US. The FDA looks at some key aspects:

9.1 The clinical trials should be the same as those that would be conducted in the US.

9.2 The diagnosed patients must be similar to the patients in the US. In the past apparently, a heart failure transplant device was clinically tested in Norway. Though the device was very successful there, it was rejected by the FDA. The rejection had to do with the fact that the patience in Norway were generally healthier than the US.

9.3 One of the disadvantages for the FDA as far as studies performed in Asia are concerned, is the fact that there is no way for the FDA to review the protocols.

9.4 The major problems include the fact that the FDA needs a strong dialog with those conducting the clinical trials and needs them to report periodically. The other problem, as previously stated would be that the patient conditions are not translatable.

Elias went back to an earlier point. The FDA would like to do preventive maintenance rather than fix things. If possible the FDA should open the dialog even before animal studies. The FDA, according to him are fans of dialog and communication. Apparently the FDA has had a long standing program of meeting with the sponsors.

10. What will the FDA do to diversify trial participants?

Based on the fact that Elias had stated that the FDA wished to do something about there being far fewer women enrolled in clinical trials, I asked this question.

Elias responded that there is no directive to have race/gender quotas. However, the FDA is conducting public workshops for trial sponsors and the medical community.

Apart from this, a 2007 law mandates the FDA support innovation in pediatrics. A lot of the devices developed for adults are essentially used off-label for children and the FDA lacks a good level of understanding. The FDA would like to change this.

11. Off-label use and the FDA

Someone asked about the FDA's take on off-label use. Elias started with a good example in a field he understands clearly.

Ablation devices have a history of approval that spans 16 years. The first generation of devices were very simple. Such devices have been off-label since about the year 2000 for atrial fibrillation.

The FDA would like to bring all these off-label uses under clinical trials. However, patients would face the dilemma of choices - they are rather interested in being treated rather than being part of a clinical trial.

Apparently the No. 1 problem for Elias as branch chief has been getting off-label devices to be clinically approved. Apparently the first such device, manufactured by Biosense Webster got to go on-label for a previously off-label application about a year ago. (I have no way of confirming this yet.)

The FDA would like to tackle off-label use, however it would not like to tread on how the medical community expands usage. The FDA is happy where the program is currently.

12. Sham studies and such

Someone asked Elias to comment on the tests that the FDA will look into in the future. Elias reminded everyone that devices are not drugs (no pun intended) and as such, using devices you cannot readily do shams. It would be unethical.

The typical test includes a single arm study, comparing the device being tested to existing, approved devices. Elias does not see a change in the direction of the trial design for medical devices. A sham control may be required if needed, but it would be rare. Of the 25 PMAs that the cardiovascular group has been seen, Elias does not remember seeing a sham.

13. How are devices audited?

At the beginning of the talk, Elias brought up a joke about being a federal agency like the IRS and wanted to show how the FDA is different from them. Raking that up, a member of the audience wondered if, like the IRS, the FDA audits device firms and the data submitted.

Elias responded that data is approved mostly as submitted for the approval process. The audit is mainly performed to the integrity of the data. Since over 4,000 510 (k) applications and 50 PMAs are processed each year, and given that the deadlines are tighter.

Data collection and case report forms are available for off-label use. For most studies, a degree of follow-up is required.

14. Comparative Effectiveness

Someone wanted to know if the FDA is looking into needed comparative effectiveness. Elias reminded everyone that the FDA focuses mostly on approvals and for now it does not have any plans other than the fact that it is being discussed internally.

15. Will the FDA outsource the due diligence process?

Elias stated that he hasn't heard of any such moves. A program that uses 3rd party auditors and inspectors started about 10 years ago. For now, Elias stated that he takes pride in the current level of expertise present within the FDA.

16. Does the FDA care about patents?

In response to this rather obvious question, Elias stated that the FDA does not really care about patents. He did say that one could draw certain similarities between the patenting process and the FDA regulatory process. He said that many times people from the patent office come to work at the FDA.

Elias stated that the FDA recognizes that the approval process is quite burdensome for companies. Hence they have partnerships with the FDA equivalents at Canada, Japan, Australia and China.

He did say that they tried other efforts such as global harmonization which have not be quite as successful.

17. The FDA's authority

To test the water's I brought up the recent ReGen knee replacement approval process and given the companies statement that the FDA does not have the authority to rescind it's approval, asked what Elias thought of that.

To my relief, Elias asserted that the FDA does have such authority. He also did say that they do not like to throw their weight around (why, I would never understand).

He gave a good explanation of the ReGen problem and stated just that the results of the panel re-examination were yet to be known.

Conclusion

Phew! Are you still with me? All in all, I think that was a great presentation, with some candid answers. It was quite useful for current students and folks like me as well. Through the notes, I hope you benefit some as well.

Though it did not do much to rejoice about the direction the FDA is taking, there is always hope for the future. I will try to make this post available as a pdf document to make for easy reading...

Friday, April 02, 2010

Off Topic: Bad at medical practice? Want to sit on it and gain cheap attention? Violate the Hippocratic oath and assail Obama

Frankly, I don't know how discussing unfit Doctors should not be allowed to practice is off-topic on a medical device blog, since the industry counts on Doctors going through years of medical school and making sure that their "doors always stay open".

Seeking Cheap Attention

Whether it is lack of talent or a desire to be on TV, even if it is just Fox, there are a lot of people who will do anything. This particular "Doctor" in Florida left a notice to his patients that had voted for Obama to go get healthcare elsewhere.

I really hope they do.

Why self-regulation never works

Unfortunately, because of how the medical profession licenses and regulates itself, we cannot do anything to fellows like Dr. Cassell or the Doctor who allowed the "octo-mom". They are still allowed to "practice".

Ethical behavior is seen as a line item in the medical profession. This news item has been around for so many hours and so far almost none of the medical associations have derided his behavior...

Who else is to blame?

Of course, we know that just like with everything, there are idiots among Doctors too. For those medical colleges that may be handing out medical degrees online to their students, there is some such thing as the Hippocratic Oath.

Oh well, I do not blame Doctors like this for their cheapness.

We need to find out what University awarded this fellow his degree, and if any of us are his Alma Maters' Doctors' patients, we need to stop going to all of them.

How much sicker than this can it get? Unfortunately, we miss two things:

1. We cannot punish arrogant stupidity

2. We cannot reform this type of "sickness" no matter what.

And therein lies the rub....

Saturday, March 27, 2010

New Medical Device Opportunity: You can benefit from empty threats made by companies that don't like healthcare reform

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