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AIMBE FDA Scholars Program

The AIMBE Scholars Program is no longer accepting applications.

Overview

The AIMBE Scholars Program enables distinguished post-doctorates in biomedical engineering fields to serve as expert advisors to policy makers at the FDA. Scholars learn how to apply their experiences from the lab bench to inform regulatory policy decisions. AIMBE Scholars work side-by-side with the most influential decision makers at the agency–from reviewers to FDA scientists to Center directors. They inform public policy through their knowledge of the latest cutting-edge research and technological innovations. Scholars receive training about regulatory science and policy and build relationships with key government stakeholders. Scholars extend the capacity of the FDA and work toward streamlining regulatory processes at the agency through a variety of projects. They may be involved in standards development and the development of metrics to evaluate and inform agency programs and decision-making.

Some biomedical engineers participating in the AIMBE Scholars Program return to their academic, government, or industry careers–with greater understanding of the connections between public policy and translational science–while others go on to build new careers in regulatory policy.

The goals of the AIMBE Scholars Program are to:

(1) Advance regulatory science at FDA in order to improve the quality and efficiency of regulations governing the medical device sector, and lower the cost of regulation;

(2) Strengthen the connections between bioengineering and the scientific enterprise, industry, and the regulatory processes that governs the medical device sector; and

(3) Train rising leaders in the field to learn first-hand about the regulatory processes that encompass the medical device total product life cycle.

AIMBE Past President Dr. Gilda Barabino and Scholars visit with Dr. Robbie Barbero, White House Office of Science and Technology Policy (OSTP)

Scholars visit with Dr. Omar Ishrak, Medtronic CEO and supporter of the program, at the corporate headquarters in Minneapolis.

AIMBE's FDA Scholars at the Center for Devices and Radiological Health

Click on Scholars Below to Read Narratives of their Experiences



  • Jason Ryans, Ph.D.
    2018-2019 Scholar
    Dr. Ryans' Bio
    I contributed to the development and implementation of a modernized 510(k) pathway known as the Safety and Performance Based Pathway.


  • Reid D’Amico, Ph.D.
    2018-2019 Scholar
    Dr. D'Amico's Bio

    I supported the cybersecurity team's policy and technical efforts to promote safe and effective medical devices throughout the ecosystem.



  • Kathryn Drzewiecki, Ph.D.
    2017-2018 Scholar
    Dr. Drzewiecki's Bio

    I contributed to the development of quality management tools, specifically SWIFT documents, to assist in the implementation of cross-cutting policies within CDRH.



  • Matthew Jacobsen, Ph.D.
    2017-2018 Scholar
    Dr. Jacobsen's Bio

    I assisted in efforts to develop the Medical Device Development Tools (MDDT) program to support sponsors in regulatory submissions.



  • Mary Clare McCorry, Ph.D.
    2017-2018 Scholar
    Dr. McCorry's Bio

    I work to develop a robust pediatric medical device ecosystem.



  • Joseph Shawky, Ph.D.
    2017-2018 Scholar
    Dr. Shawky's Bio

    I collected and analyzed medical device servicing information to create policies that promote patient safety.



  • Brittany Caldwell, Ph.D.
    2016-2017 Scholar

    I analyzed patient perspective evidence in regulatory submissions to the FDA. 



  • Christine Cezar, Ph.D.
    2016-2017 Scholar

    I led a multi-center effort to ensure efficient and consistent review of innovative combination products and other emerging technologies.



  • Chelsea Gregg, Ph.D.
    2016-2017 Scholar

    I assisted in efforts to improve the quality and consistency of FDA's regulatory policies toward medical devices. 



  • Robert Allen, Ph.D.
    2015-2016 Scholar
    I contributed to streamlining the reclassification of medical devices from class III to class II to ultimately improve patient access to safe and effective medical devices.


  • Allen Chen, Ph.D.
    2015-2016 Scholar
    I analyzed the use of Patient-Reported Outcome Measures (PROMs) in pre-market device submissions to improve the medical device review process.


  • Douglas Dumont, Ph.D.
    2015-2016 Scholar
    I assisted in efforts to develop a National Medical Device Evaluation System that leverages real-world evidence to support regulatory decision-making and device innovation.


  • Sonja Fulmer, Ph.D.
    2014-2015 Scholar
    I led and supported the implementation of recommendations aimed to improve consistency of the medical device review process.


  • Chris Medberry, Ph.D.
    2014-2015 Scholar
    I helped evaluate how standards are used in FDA pre-market submissions and devised systems aimed at making it easier and more efficient for submitters to use standards.


  • Maria Murray, Ph.D.
    2014-2015 Scholar
    I worked on creating metrics to determine the impact of regulatory science research at the FDA.

Program Details

The AIMBE Scholars Program is a highly competitive program, consisting of one-year immersion experiences from October 1 to September 30 in the Center for Devices and Radiological Health (CDRH) within the U.S. Food and Drug Administration (FDA) on the White Oak Campus in Silver Spring, MD. AIMBE facilitates the Scholars experience throughout the program year.  The program includes an orientation to public policy, as well as opportunities to network with regulatory and R&D leaders in both industry and government. Scholars are provided with a yearly stipend of $70,000, plus allowances for moving expenses to Washington and attendance at scientific conferences throughout the program-year.

Application Information

Applicants to the AIMBE Scholars Program must hold a PhD-level degree in biomedical or biological engineering or a related field, be a U.S. citizen, and have an excellent record of achievement. A current U.S. passport and valid driver’s license are required.

Who should apply?

Early career candidates that have a desire to learn first-hand about the regulatory processes and decision-making efforts at FDA in order to advance their career goals. Preference provided to candidates interested in pursuing careers in industry, government, regulatory affairs, and/or R&D. This opportunity is most suited to early-career candidates within 5 years of receipt of their Ph.D.

How do I apply?

Applications require: (1) a Statement of interest (1,000 word maximum) that describes the applicant’s background and qualifications for the program, basis for interest in the program, including policy areas or issues of interest and skills to be acquired, and career goals, including how the program would support those goals and (2) a current C.V. Applications materials must be submitted online by December 5. Dissertations must be successfully defended and degrees conferred by August 31 to participate.

Conflict of Interest

AIMBE Scholars are not allowed to have any conflict of interest (COI) or outside involve­ment with FDA regulated products during their appointments. This includes any outside activities (paid or voluntary) such as research or business in FDA regulated products such as drugs and medical devices. Scholars must follow FDA guidelines regarding COI, financial involvement, and research involve­ment that apply to all FDA employees.

Questions? Contact:

Sarah Mandell, AIMBE Director of Public Policy and Strategic Partnerships

Program@aimbe.org

202-496-9661

Rush Holt, Ph.D., former Congressman from New Jersey’s 12th District and CEO, American Association for the Advancement of Science (AAAS) connects with Scholars during their 2-day public policy orientation.

Program Sponsors

AIMBE is pleased to partner with industry, academia, and FDA for this unique program placing post-docs at the Center for Devices and Radiological Health (CDRH). Our direct sponsors are highlighted below: