Purdue University shattered last year’s attendance record during the virtual Indiana Clinical and Translational Sciences Institute (CTSI) winter retreat on Friday, February 26. More than 500 people registered for the conference, hosted by the Purdue University Weldon School of Biomedical Engineering. The theme of the event was, “Navigating the Regulatory Pathway for Medical Devices: A Conversation with the FDA, Clinicians, Researchers, and Industry Experts.”
Rather than having a traditional keynote presentation, Purdue University leaders invited Jeffrey Shuren, MD, JD, Director of the Center for Devices and Radiological Health (CDRH) at the FDA, to participate in an interactive keynote question and answer session. Shuren said he appreciated this opportunity to connect with the audience.
“I liked the less formal, more flexible approach,” said Shuren. “It gave me a chance to get invaluable feedback and insights while allowing me to address a wide range of issues. Hopefully, attendees found it useful and engaging.”
Shuren said he enjoyed the retreat and felt that it was a great opportunity to connect with technology developers, researchers, and others interested in the medical technology space. After participating in the event, he offered words of encouragement for Indiana researchers.
“If you are developing a novel medical device or a new tool to evaluate a novel medical device, come talk with the FDA early to get our input and answers to your questions,” said Shuren. “We are a resource for you and want to help.”
“The Q&A with Dr. Shuren was a highlight of the day,” said Aaron Lottes, PhD, associate professor of engineering practice, biomedical engineering at Purdue University. “He provided valuable insights on the activities that FDA/CDRH is undertaking to encourage and facilitate medical device innovation as part of their mission to both protect and promote the public health. Dr. Shuren also gave us forward-looking thoughts on how we can continue to collaborate to improve medical device development and translation.”
This retreat featured opportunities for researchers and industry partners to connect with key leaders from the FDA, who participated in each aspect of the event. More than 200 of the participants came from industry partners, including Indiana life science companies, creating opportunities for future collaboration.
“Our goal is to use the retreat and discussions therein as a springboard for an academic-industry-government alliance in regulatory science that facilitates the regional development of medical devices,” said George Wodicka, PhD, who is the deputy director of the Indiana CTSI for the Purdue University campus.
The retreat also featured four parallel workshops:
- Pediatric Medical Devices
- Diagnostics and Disease Detection
- Digital Health and Wearable Devices
- Invasive and Implantable Devices
“The breakout sessions were a wonderful way to connect with smaller groups of academic, clinical, industrial, and regulatory representatives interested in a specific topic,” said Craig Goergen, PhD, Leslie A. Geddes Associate Professor of Biomedical Engineering at Purdue University. “For example, the pediatrics breakout discussion focused partially on how to improve IRB review requirements of products that qualify for FDA’s Humanitarian Device Exemption (HDE).”
Participants in these workshop sessions were able to focus in on specific areas of expertise with a smaller group of people, offering another opportunity to make connections. As part of the Diagnostics and Disease Detection workshop, the ongoing COVID-19 pandemic became part of the conversation.
“COVID-19 has changed the way both the FDA and manufacturers think about developing diagnostics,” said Jacqueline Linnes, PhD, Marta E. Gross Assistant Professor of Biomedical Engineering at Purdue University. “The FDA has done much to demystify and democratize the application process and has authorized the first ever at-home respiratory collection and the first ever at-home molecular tests. They now hold weekly Town Halls to discuss the rapidly changing COVID-19 landscape, and have created templates for step-by-step application information for COVID-19 diagnostic test applicants this last year.”
The Invasive and Implantable Devices breakout session focused on the challenges of bringing high-risk medical devices to market, which can impact large-scale manufacturers and emerging academic startups. They also discussed the impact of COVID-19 on clinical trials and the regulatory approval process
“The experienced panelists from FDA, Cook, and Emory University highlighted the opportunities to use breakthrough designation and de novo classification to accelerate translation from bench to bedside,” said Hugh Lee, PhD, associate professor of biomedical engineering at Purdue University. “They also highlighted the need for a better understanding of the payer requirements and the importance of engaging with the FDA early.”
Tommy Sors, PhD, Indiana CTSI navigator for Purdue University, said an important takeaway from the retreat workshops is that researchers need to communicate earlier and more frequently with the FDA to more plan technology transfer strategies and accelerate the process of translation.
“This retreat was a tremendous success that will benefit our translational investigators for several years to come,” said Sors. “It marks the start of a broader conversation with FDA and our industry partners that will ultimately channel the translation of our innovations into the commercial space.”
While the virtual format offered several opportunities, such as connecting with speakers and attendees from across the country, Purdue University leaders will be happy to return to in-person events in the future.
“I look forward to the opportunity to build stronger relationships with people that I have only met virtually, and also to have the opportunity for impromptu conversations and meetings that are not (yet) readily feasible with virtual meetings,” said Lottes.