Rubbing Elbows with FDA Medical Device Chief Jeff Shuren

I was fortunate to be part of a small group that was invited to meet Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, at the Johns Hopkins Hospital this week. He spoke with us for about an hour before giving a public talk later that afternoon. Both events left me inspired and excited about how the FDA is continuing to evolve and change for the better. My takeaways were:

1. First-in-human testing is a scary and hard step for almost all early-stage device companies. Many go overseas to get a CE mark and test in Europe. The FDA is working hard to fix that by strengthening everything that surrounds clinical trials. An example: The median time for approval of a full IDE has dropped from about 15 months in 2011 to one month today. Very cool!

2. The ‘give me a stone’ model is going away. You used to deal with the FDA in a stage-gate fashion. You pulled together material and threw it over the fence, hoping you got it right and that they would not ask for more. The FDA is now working to create a much more interactive, flexible, risk-benefit type process that looks at the overall value proposition of a new product. Amazing!

3. The FDA is looking hard at balancing how much material is needed pre-market vs. post-market. This is a big one. Where it makes sense, they are trying to limit (reduce) the data needed pre-approval (for PMAs and de novo), with a caveat that the manufacturer provide more data post-market. I love that.

4. The FDA gets that the patients and the payers are part of the equation. They are bringing them all to the table, along with industry, to better ensure the market actually wants and will pay for new technologies. Check out the Medical Device Innovation Consortium, as well as a Patient Engagement Advisory Committee. Ingenious.

5. One of Jeff’s slides noted that “…90% of all data in the world has been generated in the past two years.” Pretty incredible. Our ability to innovate and create better healthcare will be tied to how well we adjust to this “big data revolution.” Jeff talked about ways to share and crowdsource knowledge that is currently siloed or hidden altogether. Might be hard to make industry play along, but it’s a great idea.

Jeff’s talk was extraordinarily broad and insightful regarding where the FDA is now and where we all need to go as a healthcare industry. I’m sure my points don’t do it justice; download his presentation and see what you think. Or better yet, find out when he is giving a similar talk and see him in person. Well worth the trip.

Brian Lipford


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