Initiative at Dartmouth
Innovation and Collaboration in Action:
Accelerating The Medical Device Development Process
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.
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.
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
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
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.
Dartmouth’s 3D-Initiative is uniquely positioned to establish the Scholars Program. The 3D-Initiative will leverage contacts throughout the medical device ecosystem along with an extensive cross-campus network of faculty from the Geisel School of Medicine, the Thayer School of Engineering, the Tuck School of Business, The Dartmouth Institute and Dartmouth College, to support the Scholars Program.
3D-Scholars will be active clinicians from device driven fields within three to ten years from completing clinical training and must be a US Resident. Scholars must commit to 100% participation in the five retreats and monthly seminars as well as individual work (~6 hrs/week). The 3D Initiative is committed to recruiting Scholars from diverse backgrounds including physicians practicing in diverse care settings with clinical expertise in device reliant specialties.
The 3D Scholars certificate tuition has been set at
$50,000 USD per scholar.
The Program will be promoted broadly, through
presentations at national medical society annual
meetings, e.g. American College of Cardiology,
American College of Surgeons, adds in prominent
medical journals and social media. The goal is
to enroll 8-12 scholars in the year-long certificate
Application Information and Selection Process
Fellows will be announced at RAPS Convergence 2023 in Montreal, Canada.
Provide ongoing representation as a leader at RAPS regulatory programs and other scientific meetings
Participate in forums covering key issues and trends facing the profession
Serve and lead the regulatory profession and RAPS
Assist in developing future RAPS leadership
Mentor new and/or junior RAPS members and other regulatory professionals by providing guidance and advice
To be eligible, candidates must:
Have an active RAPS membership
Individuals currently employed at a health authority are excluded from this membership requirement
Have a minimum of 10 years of extensive regulatory knowledge and breadth of experience in the profession, including healthcare and related products—medical devices, pharmaceuticals, biologics and nutritional products
Have a history of dedication to—and an interest in continuing to build and shape—the future of the regulatory profession
RAPS Fellows are selected annually by a peer group, the RAPS Fellows Selection Committee. When reviewing applications, the Fellow Selection Committee focuses on the applicant’s:
Achievement of excellence in regulatory competence.
Contribution to the profession, especially beyond the routine and daily job expectations.
Concrete plans to continue contributing to the profession in the future.
In October, fellows will be announced and recognized at RAPS Convergence 2023 in Montreal, Canada.
Reasons why some past applications did not result in Fellow recognition:
Failure to clearly communicate the case for selection
Failure to follow instructions or directly address the selection criteria
Insufficient years of experience
Contributions to the profession not sufficient/sustained
To apply, you will be required to submit the following documents:
Summary CV (Max 2 pages)
Outline of research to be undertaken (Max 3 pages including timeline plan or Gantt chart, figures and references), making the scientific case for support and setting out the need for a non-clinical post doctoral researcher in the host's clinical neuroscience research program
Description of research sponsor’s program and facilities (Max 1 page)
Statement of career intentions (Max 1 page)
Letter of support from the Head of the Department or Director of Institution in which the fellowship would be held.
Financial summary, including statement of basic salary, total sum requested, and confirmation that the department or institute can support consumables and other costs necessary to
undertake the work.
Complete the General Candidate Information Form so we have your general contact information and know that you are interested in applying.
Download the Fellows Application Form. Be sure to complete all fields (incomplete applications will not be reviewed).
The Fellows Application Form consists of questions about the candidate’s:
Contributions to the regulatory community
Regulatory work history
Regulatory management and leadership experience
Knowledge and breadth of regulatory issues
Plans for advancing the regulatory profession
Credentials and references (please note that the Fellows Committee reserves the right to contact your references to verify the information supplied in your application).
Submit completed Fellows Application Form to Julie Gordon, Director, Membership, RAPS at email@example.com is now closed we encourage you to submit in 2024.
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