If you haven’t heard, the FDA has been publicizing their newly launched Medical Device Innovation Pathway. Besides the standard press releases, FDA’s Center for Devices and Radiological Health (CDRH) has created a 53-minute video starring Dr. Jeffrey Shuren, director of CDRH (see below) to spread the word. But, is the FDA really capable of fostering innovation outside a token project each year?
If you watch the FDA video, including its introduction from FDA commissioner, Dr. Margaret Hamburg, you will hear some lofty goals tossed around, including:
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
- New process that has broad implications on how the FDA does business
- Important step for our industry
- Catalyst for innovation; incentivizing innovation
- Half the review time for Premarket Approval Applications (PMA’s)
- A network of experts supporting the process
- Strengthening the nation’s research infrastructure
- Frontend-loading the FDA resourcing and earlier interaction with sponsors
Wow! Sounds too good to be true, especially for anyone that has dealt with CDRH over the last 10-years. Is this the same CDRH that I once witnessed force an innovative glaucoma implant to perform a clinical trial in blind people despite no known failure mode that would lead to blindness. Most companies don’t even consider performing a pilot clinical trial in the US due to the FDA. Why? Because the FDA traditionally is unable to effectively balance the risk-benefit ratio and review team members have no accountability.
The press releases and video suggest that truly pioneering technologies can be managed more efficiently without actually changing any FDA standards for approval. There’s no magic. Something has to give… and that’s more resources dedicated to these projects, earlier and more often. I would say, reading between the lines, “only one or two projects can be accepted into this process each year.” But, I don’t have to because Dr. Shuren admits this fact in the video when answering one of the questions from the cadre of media reporters on the phone line.
All this work for a single project per year? This is starting to sound like an initiative more for optics than improving the FDA. The process sounds like a major FDA overhaul to the average citizen despite the very few feel-good products that will come out of the process, which the FDA can further PR. For example, the first accepted submission is conveniently a government project. The Defense Advanced Research Project Agency (DARPA) has been developing an incredible robotic arm that will substantially restore a missing limb’s function. What red-blooded American will not be thrilled to see our wounded warriors healed through technology?
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With the U.S. economy slow to emerge out of the financial crisis, the FDA has been bashed for bringing down one of the few areas of commerce that the U.S. still globally dominates, medical devices. So, the FDA is responding. Unfortunately, since Dr. Shuren does not have a quick fix for the FDA’s real deficiencies that affect the vast majority of devices, he’s giving America what it loves to hear… a success story.
Related articles
- FDA medical devices update increases class I reporting requirements (medcitynews.com)
- New FDA 510(k) medical device reviews will now be ‘smarter’ (medcitynews.com)
- FDA medical device complaints up, but disputes were down (medcitynews.com)
Healing Innovation is a resource for clinician innovators. The main site - HealingInnovation.com - provides an overview of the various aspects and issues facing clinician innovators.
