No Simple Answers

Wednesday, June 30, 2010

"Early-stage device companies need a special, refined regulatory pathway for truly novel technologies," explained Paul LaViolette, a venture partner at SV LifeSciences ... "The pathway must be robust, collaborative and predictable"
The Gray Sheet, 6/28/10

You can't blame them for trying, I suppose. We all want a regulatory system that is both special and predictable. That is both novel and robust. And then we want a pony and a big-kid bicycle.

I'd like to be in Paris right now, sipping fine wine and dining on pastries. So why am I in a hotel in Maryland, killing time before a public meeting? Because being a grown-up is not just about understanding what you want, but deciding what trade-offs you're willing to make. I'd rather be in Paris, but the truth is, it's more important to me to be here.

I really do hope that more VCs and CEOs take an interest in how FDA really works and choose to bring serious, actionable plans to the table. FDA is not infallable nor do they believe they are. They are in this for the same reason most of us are: to represent a particular set of interests that need to have a voice in how medical technology advances. They are not opposed to understanding how they could improve the quality of their work.

That said, let's knock it off with the simplistic proposals, folks. Becoming a real participant in something as complex and important as FDA oversight of diagnostics begins with a willingness to engage the details.

A proposal that specifies outcomes but doesn't even acknowledge the difficult choices may as well be delivered in Klingon. That's about how seriously it will be taken by the people who are actually involved. 

If we want an FDA that is responsive to our concerns, we should start by considering the world from their point of view. It's tactically smart and good manners besides. 

It is possible to influence the regulatory process. It's even possible to navigate it to your advantage. But to recognize those opportunities, it's necessary to put down the PowerPoint slides and see the world as it really is. There are no simple answers here.


Tags: FDA 101, Industry

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