Device Industry Interacts with Government During MDIC Annual Public Forum
by Jennifer French, senior contributing editor
June 2020 issue
As with so many conferences held in 2020, the MDIC Annual Public Forum has transformed itself from a multi-day in-person event to a series of virtual meetings. The Medical Device Innovation Consortium is a public-private partnership that focuses on advancing medical device regulatory science for the benefit of the end-user or patient. This consortium is unique to the medical device landscape since it encourages industry collaboration with federal agencies like the FDA, CMS, and the NIH while also working with non-profit and advocacy organizations. The Annual Public Forum virtual event includes weekly one-hour sessions spanning from June 18 through September 24. Here we offer highlights of the first two sessions followed by a preview of sessions to be held throughout the summer.
The June 18 session kicked off this year’s event with opening remarks from MDIC president and CEO Pamela Goldberg. Goldberg provided some highlights of MDIC’s accomplishments in regulatory science over the past year. In the area of clinical science, MDIC has made strides with clinical diagnostics to advance testing technology, developing tools and best practices for early feasibility studies, and advancing the science of patient input.
The consortium’s annual report provides resources and references of collaborative publications to incorporate patients’ lived experiences and preferences into the development and advancement of medical device technologies. Their data science initiatives include a variety of programs that coalesce around methodologies, tools, and analyses to accelerate clinical science and aid in monitoring device safety, quality, and effectiveness. Such programs include cybersecurity, computational modeling, and digital pathology. Goldberg also highlighted the National Evaluation System for Health Technology Coordinating Center (NESTcc), which is a collaboration with FDA/CDRH that brings together stakeholders to develop real-world evidence to improve regulatory and clinical decisions.
This first session also included an informal “fireside chat” with FDA Commissioner Stephen Hahn. Prior to taking the helm at the FDA in December, Hahn was a cancer clinical physician and researcher practicing in the University of Pennsylvania system and later with the MD Anderson Cancer Center. Due to his prior experience with oncology and radiology, he became familiar with the distinct differences between drug and device development. Top of mind is how FDA is responding to the COVID19 pandemic.
Hahn talked about the FDA’s emergency use authorization program and how the FDA evaluates treatments under this program by assessing what datasets are needed to make an initial authorization and what needs to be collected post-approval. On that topic, Goldberg and Hahn discussed the NESTcc program and the valued partnership between the two organizations and how it can impact industry. The core focus of the program is technology innovation and understanding the systemic barriers that hinder development.
Goldberg mentioned the growing need in diagnostics and how AI and machine learning could impact device development. Hahn added that these tools will also help to modernize the FDA’s approach to data analysis. “The FDA is committed to public health. We are a learning organization and promise transparency to the American public.”
The second meeting in the series dovetailed on the previous session. Moderated by MDIC board chair and CVRx CEO Nadim Yared, this session resembled a CDRH town hall. Jeff Shuren, CDRH director, kicked off the session talking about how the center is engaging in efforts for treating COVID19. He reviewed some of the 763 issued EUAs and 765 that are under consideration. A year ago, CDRH only reviewed one. Shuren also highlighted the important relationship between his agency and MDIC. “We have over 110 FDA staff members involved with MDIC,” he said, “impacting areas of medical device regulatory science.” Each of the six areas were presented by their respective heads. Michelle Tarver, director of patient science engagement, talked about the driver for patient input in many areas of her division including the PEAC program, incorporating PPI into feasibility study design, developing patient-driven registries as well as harnessing social media for a richer engagement with patient populations.
Andrew Farb, CMO of the Office of Product Evaluation and Quality, addressed the early feasibility studies program for IDE regulations and patient access to EFS. The program objective is to increase U.S. participation in early clinical studies of innovative medical devices with published guidance for IDEs of first-in-human studies. The program has more than doubled IDE submissions over the last six years and more than 75 percent of EFS IDEs gain an approval decision. The majority of the approvals are in cardiovascular and neurological devices. In the EFS program their goal is “60/60/60”—an IDE approval in 60 days, IRB contract in 60 days, and patient enrollment in 60 days.
Other CDRH speakers in the town hall meeting included Jessica Wilkerson addressing cybersecurity and threat-modeling training. Real world evidence and the NESTcc collaboration with MDIC was presented by Dan Canos. Francisco Vicenty presented the Case for Quality program, which was launched in 2011 with MDIC along with their medical device information and analysis sharing platform, for performance tracking and analysis. Sara Brenner discussed several diagnostics programs, including COVID SHIELD designed to harmonize the data captured during the pandemic.
Anindita Saha closed the session, stressing the importance of “collaboration in health economics and access for patients with their perspectives.” The partnership with MDIC is helping facilitate access to help with the reimbursement framework. Each of these CDRH areas and programs will have dedicated sessions in this series with more content in coming sessions.