Dartmouth Health experts—alongside leaders from the FDA, industry, and academics—are driving innovation and forging collaboration in device development through the Dartmouth Device Development (3D) Scholars program.
"3D Scholars is a one-year certification program that connects active clinicians from across the U.S. who practice in device-driven fields with experts in the device development community," said Aaron V. Kaplan, MD, FACC, FSCAI, FNAI, interventional cardiologist at Dartmouth Health and director of the Dartmouth Device Development Initiative. "The goals of the program are twofold: We want to help clinicians understand the device development and regulatory processes and provide regulators and members of the medical device community with access to guidance and leadership from practicing physicians."
The 3D Scholars program accepts 8 to 12 participants each year. It includes five week-long retreats and monthly half-day seminars focused on all aspects of the device development ecosystem—including the regulatory process, venture capital, start-ups, insurance, manufacturing, financing, and more.
"Each scholar will be assigned a device case study and will develop a clinical/regulatory development plan, culminating in a simulated FDA presubmission meeting," said Dr. Kaplan. "Throughout the process, scholars will receive guidance from advisors who represent clinical, regulatory, and industry sectors."
To kick off the 3D Scholars program, Dartmouth Health hosts an annual 3D symposium featuring didactic sessions, research presentations, and networking. Dr. Kaplan works collaboratively with Dartmouth Health electrophysiologist, colleague, and emerging device development leader Emily P. Zeitler, MD, MHS, to coordinate the 3D Symposium and 3D Scholars program. Dr. Kaplan shares, "It's a complex system, and 3D Scholars equips active clinicians to navigate it—creating future device development leaders who can serve as experts in the trenches."