510(k) Action Items: FDA 25, Industry 0

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On 19 January 2011, the FDA unveiled its much-awaited proposal for changes to the 510(k) process.  Medical device industry representatives were generally pleased with the modest scope of the proposal. In a press release, AdvaMed president Stephen J. Ubl called the plan “clearly a good first step that will address some of the major problems with the program.” Mark Leahey, President and CEO of the Medical Device Manufacturers Association (MDMA) commended “FDA leadership and staff for working with various stakeholders in an open and constructive process to develop consensus proposals that improve patient access to safe and effective therapies.”  The NY Times quoted Medtronic CEO William A. Hawkins as stating “This is a more balanced approach that sends a positive signal to industry that the F.D.A. is engaged, listening and concerned.”

Patient safety advocates were underwhelmed. Public Citizen’s Sidney Wolfe stated “the FDA is not being forceful enough about improving the safety and effectiveness of new devices.” Dr. Rita Redberg (UCSF, Editor of Archives of Internal Medicine) told theHeart.org that she is “worried about the implanted high-risk devices that are getting cleared without any data. There are lots of examples of stents, inferior vena cava filters, heart valves, that are [cleared through 510(k) but] not low risk.”

But is the FDA’s modest proposal really a good outcome for the device industry?

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Venture Capitalist Bloggers

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You can’t be a credible social media venture capitalist if you’re not an active social media user.  Blogs and twitter are the social media of choice, and VC’s have created a lot of content worth reading.  On my blogroll I’ve included some of my favorites, but now you can find the comprehensive list of all VC blogs at the Venture Capital (VC) Blog Directory – 2011 Edition, put together by Larry Cheng of Volition Capital.  Thanks to Ty Danco for pointing it out.

Note that only a handful of life science VC’s have blogs.  Savvy tech VC’s have figured out that blogging and tweeting can help build their VC (and personal) brand, creating dealflow and entrepreneur interest.  Life science VC’s are once again behind the curve.  Let’s hope for a change in 2011.

Medical Device Entrepreneur Readings

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Over the weekend, a friend asked what one book I would recommend to guide a first-time entrepreneur. I replied that just one book was not sufficient. My friend suggested Michael Porter‘s Competitive Strategy, which I agreed was an excellent choice. I also told him I’d address the question more fully on my blog, so that’s today’s post.

The Launching Tech Ventures Reading List

Fortunately, local entrepreneur and investor Ty Danco recently pointed out an amazing reading list for first time entrepreneurs. Harvard B-School Professor Tom Eisenmann is developing an MBA class called Launching Tech Ventures, and he posted his well-curated course reading list on his blog Platforms and Networks. As Ty says, the list makes me wish I was back in school.   While you’re working through the list, don’t skip Eisenmann’s earlier compendium of the web’s best advice for entrepreneurs.  For tech start-ups, Eisenmann’s recommendations are unsurpassed.

For medical device entrepreneurs, Eisenmann’s list isn’t quite enough, so I’ve put together a few suggestions from my own experience. Leave me a comment telling me what I missed or if you disagree with my choices.

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Fresh Money: 2010 Q4

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On his blog, Michael Greeley recently wrote “My guess is the VC industry will have raised between $10 to $12 billion in 2010 ($28 billion was raised in 2008). From 2008 through 2011 we will have witnessed the VC industry being cut in half.”  Ouch.

Less money raised means fewer deals will be done. In addition, longer times-to-exit force VC’s to reserve larger portions of their funds for each portfolio company.   For medical device startups, the fundraising environment is as rough as it has ever been.

All the more reason to raise money from VC’s that have relatively new funds. These new funds have longer time horizons, and don’t have to support past (aging) VC firm investments. How do you find these funds?

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A Changing Landscape in Medical Devices

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The usual suspects (Medtronic, St. Jude, J&J, Boston Scientific, Olympus, Stryker, Zimmer, Covidien, GE Healthcare, Hologic and others) continued their usual growth-via-acquisition strategies in 2010. Last year I wrote about two of the more notable medical device exits: St. Jude’s option to purchase CardioMEMS, and Medtronic’s deal to acquire Ardian.

However, a less-noticed acquisition in December 2010 may turn out to be the most notable medical device deal of all. This relatively small acquisition heralds the entry of a significant new player into the medical device industry, and marks the beginning of a shift in the geographic landscape of the medical device industry.

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