Last month, I attended a public meeting in D.C. where FDA/CDRH directors, medical device company leaders and academic researchers came together to design new ways to improve U.S. competitiveness in our industry. Pretty lofty goal. The group is called the Medical Device Innovation Consortium (MDIC) and it’s a novel creation, five years in existence, dedicated to continuous improvement for the benefit of patients, manufacturers, and our overall medical knowledge. I went with skepticism and returned a believer that things are truly improving on all these fronts.
It was an impressive list of speakers during this one-day conference. Scott Gottlieb, Director of the FDA led off with a talk describing the new mindset he and his team have towards improving FDA processes, responsiveness, and openness to working with device manufacturers. The meeting closed with Jeff Shuren, Director of CDRH explaining the accomplishments and next goals of the numerous working groups of MDIC. In between were intriguing round tables, break-out sessions and fireside chat interviews.
Several themes emerged, including the opportunities, challenges, and risks presented by advances in technology and their entry into the device space. We discussed the importance of and strategies for harnessing and policing the massive amounts of data being generated throughout the healthcare chain. Many conversations touched on how to keep the patient’s experience and well-being at the center of our work with so many other factors competing for our attention.
But more than any of these topics, what impressed me was the change I’ve seen in recent years in the relationship dynamic between industry and FDA. For most of my career, interactions between industry members and agency representatives could have been fairly described as cautious, mistrustful, and, too often, adversarial. In the past decade, however, I’ve witnessed a significant and positive paradigm shift in this area.
The mere existence of the MDIC is a sign of this progress. In its own words, “MDIC is the first-ever public-private partnership…with the sole objective of advancing medical device regulatory science.” The organization provides a platform for medical device regulators, industry members and advocates, and even citizens to interact around the most critical issues facing our industry today. If you’re interested in learning more, I’ve added links below to some of the more compelling topics discussed:
FDA Commissioner Scott Gottlieb signified the agency’s commitment to speeding the entry of new, effective, safe devices to market by highlighting of several initiatives that are helping to modernize and streamline the process. These include:
– FDA Payor Programs that facilitate communication between device manufacturers and payors (including Medicare and private insurers) beginning before device approval, speeding coverage and reimbursement decisions, and expediting patient access to new treatments.
– Draft Guidance on Humanitarian Device Exemption (HDE) Program that seeks to update FDA review procedures for devices intended to treat conditions affecting fewer than 8,000 individuals in the United States.
– Brand New Draft Guidance on Dealing with Uncertainty in Benefit-Risk Determinations for PMAs, De Novos and HDEs that seeks to better define these processes and apply a more scientific approach to decision-making under these circumstances.
As a 25+ year veteran of the device industry, I’m actively monitoring these initiatives at FDA with interest and optimism. I believe we are witnessing examples of government performing more efficiently and working to both protect patients and ensure their access to new and more affordable treatments.
Whether you see things the same way or not, I’d love to hear your take on these initiatives. Strike up a conversation with me and other colleagues by sharing this on LinkedIn or sending me an email at CScholl@Smithwise.com.
Though not yet available as I write this, you’ll be able to replay other 2018 presentations on MDIC’s site soon.
Director of Mechanical Engineering