Initiative at Dartmouth
Innovation and Collaboration in Action:
Accelerating The Medical Device Development Process
3D-SCHOLARS PROGRAM
CLINICIAN LEADERS WITH A SOPHISTICATED UNDERSTANDING OF MEDICAL DEVICE DEVELOPMENT
The growing demands on our healthcare system, brought about by an aging population and shrinking resources, require new technologies to better meet our patients' medical needs. To this end, we must develop partnerships between academic medicine, regulators, and industry to develop new therapies efficiently. This requires a corps of active clinicians with a sophisticated understanding of the medical device development process. Dartmouth is leading this effort to address this widely-recognized need.
The Curriculum outlined below has been developed in close collaboration with the Center for Devices and Radiologic Health (CDRH) at the FDA and leaders throughout the medical device ecosystem.
Need: Medical device development is a highly technical and complicated capital-intensive process requiring industry to work closely with regulators at the FDA. The ability to address patients’ needs requires a current understanding of the clinical environment. Though device developers and the FDA have deep competency in development and regulatory processes, the ecosystem is often frustrated by the inability to maintain a current understanding of the quickly changing clinical environment. To address this need, the 3D-Initiative is developing the 3D-Scholars certificate program.
Goal: The 3D-Scholars program will equip active clinicians with an understanding of the device development and regulatory process to provide regulators and the medical device community with guidance and leadership.
3D SYMPOSIUM
How we got here
For twenty years, Dartmouth Health, and the Geisel School of Medicine, has convened an unique and preeminent annual think tank meeting for the medical device ecosystem which includes leaders representing the clinical, business, governmental, financial and legal sectors. The 3D Symposium led by Dr. Aaron Kaplan, Professor of Medicine at the Geisel School of Medicine, is an internationally respected program. This annual forum provides an opportunity to exchange ideas and address common challenges as the community – academics, clinicians, regulators, investors, industry-strives to bring new life-saving technologies to market.
Building on the success of the Symposium, the Geisel School of Medicine and Dartmouth Health is establishing The 3D-Initiative at Dartmouth with the goal of advancing the medical device development process to improve the health of our patients. The Initiative’s initial focus will be the 3D-Symposium and establishing the 3D-Scholars Program.
The Program comprises five 1-week long retreats complemented by monthly half-day seminars.
I. 3D Scholars Boot Camp (Summer)
Dartmouth College, Hanover, NH
Week long residence on the Dartmouth Campus with didactic sessions featuring Dartmouth (Geisel & Tuck) and outside faculty (FDA and Industry) providing basic background.
Week 1 Sample Agenda
II. Regulatory 101 (Fall)
CDRH/FDA, White Oak Campus, Silver Spring MD
Week long residence at CDRH/FDA comprising didactic training along with introduction to leaders representing key components of the regulatory
process.
III. Start-up 101 (Winter)
Fogarty Innovation,
Mountain View, CA
Week long residence in the Bay Area with intense deep dive at Fogarty Innovation, along with visits to leading Sand Hill Road Venture Capital Firms.
IV. Medical Device Companies and Original
Equipment Manufacturers (Spring)
Minneapolis/St Paul, MN
Week long residence includes visits to leading corporate manufactures and original equipment manufacturer suppliers
V. Cap Stone Presentations/Graduation (Fall)
Dartmouth College, Hanover, NH
Two day meeting on the Dartmouth campus held prior to 3D Symposium. Scholars will present their Cap Stone Project and celebrate graduation.
Each Scholar will be assigned a device for which they will create a
development plan and prepare a mock 510(k) regulatory submission.
The development plan will be critiqued by FDA reviewers and industry experts.
TEAM
