Sometimes, the best path forward involves a small step backward.
Joe Hage had been presenting 10x medical device shows for several years. If you have attended any of Joe’s shows, you know that he gathers great content, keeps the audiences engaged, and makes sure the entire experience is fun! Earlier this year, Joe seized the opportunity to meld his 10x franchise with MDTX. That was the first show that I participated in for Joe and, while I felt pretty positive about the event, Joe was not completely satisfied. So, in mid-October, he went back to his 10x roots in San Diego.
This was not the first time that Joe had gone in a different direction for the benefit of others. Many of us were members of the Medical Devices Group on LinkedIn, which Joe created. But when LinkedIn’s policies became problematic for the group, Joe moved quickly to set up a new site, away from LinkedIn. If you are one of the 350,000+ members, but haven’t made the move to the new group, what are you waiting for?
Lance Black is the Innovation Lead at Texas Medical Center in Houston (TMC). I have done some consulting work for medical device companies in the Houston area, but I had no idea that TMC is the largest medical center in the world. Black explained its history — how land was donated to encourage the development of hospitals and research institutions, ultimately resulting in today’s sprawling, 2.1-square-mile campus.
Here are just a few of the staggering statistics for TMC: 10 million patients per year, 180,000 surgeries per year, 25,000 babies born each year, 9,200 patient beds, and 50,000,000 developed square feet. As Innovation Lead, Black always is looking for new solutions to unmet clinical needs, and he is very open to collaboration. TMC spends millions of dollars on medical device innovation annually, with players ranging from industry titans to the smallest of start-ups.
Sarah Wright is the Director of Global Customer Support and Healthcare Informatics at ResMed; she spoke about her initiative to utilize all available data to get to the truth of the customer experience, and to evolve overall offerings to best meet those needs. Wright discussed leveraging customer support to develop a holistic view of the end-user, drawing from real-life examples and actionable insights to improve the patient experience via optimized support systems.
Wright uses voice-of-the-customer surveys to collect customer feedback and to work directly with customers and internal teams, ensuring feedback is shared across sales, marketing, and product management. This part of her presentation was so refreshing, as so many of us have experienced the broken link between patient feedback and internal parts of our organization. Often, marketing professionals can be unaware of patients’ true needs and experiences when creating new marketing requirements, and design engineers are sent off to imagine a new device without understanding its use environment.
My own presentation at the conference covered the FDA De Novo process. This intriguing intermediate pathway, purported to be between the 510(k) and PMA, was created as part of the FDA Modernization Act (FDAMA) of 1997 for innovative, low-risk devices. While this seemed like a move in favor of innovation, the medical device industry was slow to warm up to this alternative, and many viewed it as a confusing “black hole” to be avoided at all costs.
Between 1997 and 2012, only 78 De Novo applications were submitted, a lowly average of just over five per year. The medical device industry submitted 500 PMAs and 40,000 510(k) submissions in that same period.
One difficulty within the De Novo process over these 15 years was the lack of a direct De Novo application process. A company had to file a 510(k), receive a not-substantially equivalent (NSE) response from the FDA, and then file for De Novo. This was confusing, took additional time, and the process was not predictable. Medical device companies were experiencing highly variable response times from the point of filing their submission to the eventual granting of the De Novo decision.
The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 removed the requirement for a 510(k) NSE response prior to De Novo submission, and usage of this pathway began to climb. From 2013 to 2017, there were 121 De Novo submissions — a substantial increase in average to just under 25 per year. In the past year, there have been numerous press releases indicating successful De Novo approvals for devices and IVDs, but my interviews with some of these companies indicate the time required for the FDA to grant a De Novo continues to vary widely.
Two extremes of these experiences have been detailed in previous articles on Med Device Online: in June, I wrote of Curetis’ positive experience, wherein the company was granted its De Novo within the statutory expectation of 120 days. More recently, and representing the other end of the spectrum, I wrote about Avenu Medical’s disheartening experience. After the company filed its De Novo submission, FDA required them to file an IDE and to complete a clinical study. After the study was complete and the results were provided to the FDA, Avenu experienced additional delays and unresponsiveness from the agency. The company’s De Novo was granted, but not until five years had passed from the date of De Novo submission.
A third company with whom I spoke had an experience somewhere in the middle — though certainly closer to an acceptable threshold, as its De Novo was granted about eight months after submission. This relatively small sampling of De Novo experiences would seem to indicate that the variability of review time has remained high. The 10x audience was curious regarding how much these companies engaged the FDA prior to filing De Novo applications. Many wanted to know if these companies sought feedback from the FDA early in their development process via pre-submission meetings. Could there be a correlation between early dialogue and shorter review duration? Nope — all of the companies had early dialogue with the FDA, yet they still experienced disparate review durations.
Finally, if you missed the 10x show, you also missed me opening my talk on the De Novo process with a revised version of the Regulatory Blues, similar to the version I opened with at MDTX in April. For those of you in the audience that have used the FDA De Novo process in recent years, please tell us in the comments section below about your experience with the process — please include how long it took for the De Novo to be granted.