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Challenges and solutions to advancing health equity with medical devices

Nature Biotechnology volume 41, pages 607–609 (2023)Cite this article

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In October 2022, the US Food and Drug Administration (FDA) proposed updating its Breakthrough Devices Program (BDP) to reduce disparities in health and health care1. Created by Congress in 2016, the BDP is intended to expedite developing and authorizing devices that diagnose or treat life-threatening conditions and represent technologies that either lack approved alternatives or offer substantial advantages when compared to existing modalities2. Breakthrough designations are coveted by manufacturers, who receive special access to senior FDA staff during premarket development, priority review that shortens regulatory review time periods, and automatic eligibility for supplemental Medicare payments following authorization. Additionally, to enable expedited authorization of breakthrough devices, the FDA accepts greater uncertainty about device risks and benefits during premarket review, with the expectation that manufacturers collect further data in the postmarket setting after authorization. As of 31 December 2022, the FDA has granted 760 breakthrough designations and authorized 62 of these devices3.

The FDA is now proposing to broaden eligibility for the BDP — and the program’s associated regulatory and financial benefits to manufacturers — to include devices that could promote and advance health equity. The agency argues that such devices fulfill the BDP’s statutory criteria of “provid[ing] for more effective treatment or diagnosis” by using design features that address factors causing health and health-care disparities (for example, phenotypic variation or geographic barriers to access)1. The proposal comes in wake of new directives by Congress and actions by the FDA to promote clinical trial diversity and reduce health disparities4,5. These disparities gained attention during the COVID-19 pandemic, which illustrated how differential access to certain medical devices (for example, ventilators) and variable performance of some technologies across race and ethnicity (for example, pulse oximeters) can contribute to worse outcomes for underserved populations6,7. While such disparities warrant action, the FDA’s BDP proposal does not address the systemic factors underlying them (for example, device access and affordability). Furthermore, although policies to advance health equity for medical devices are needed, the FDA’s proposal to expand expedited review of technologies with greater uncertainty about clinical benefits and risks does not guarantee that disparities-focused breakthrough devices will actually promote and advance health equity. In this Correspondence, we examine core equity considerations for medical device regulation and apply these insights to the proposed FDA reforms for breakthrough-designated medical devices.

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Author information

Author notes

  1. These authors contributed equally: Kushal T. Kadakia, Vinay K. Rathi.

Authors and Affiliations

  1. Harvard Medical School, Boston, MA, USA

    Kushal T. Kadakia

  2. Department of Otolaryngology–Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, Boston, MA, USA

    Vinay K. Rathi

  3. Section of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA

    Reshma Ramachandran & Joseph S. Ross

  4. Yale Collaboration for Regulatory Rigor, Integrity, and Transparency, Yale School of Medicine, New Haven, CT, USA

    Reshma Ramachandran & Joseph S. Ross

  5. Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA

    James L. Johnston

  6. Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA

    Joseph S. Ross

  7. Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA

    Joseph S. Ross

  8. University of California, San Francisco School of Medicine, San Francisco, CA, USA

    Sanket S. Dhruva

  9. Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, San Francisco, CA, USA

    Sanket S. Dhruva

  10. Department of Medicine, San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA

    Sanket S. Dhruva

Authors
  1. Kushal T. Kadakia
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  2. Vinay K. Rathi
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  3. Reshma Ramachandran
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  4. James L. Johnston
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  5. Joseph S. Ross
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  6. Sanket S. Dhruva
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Corresponding author

Correspondence to Kushal T. Kadakia.

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Competing interests

K.T.K. reports having previously been employed at Cleveland Clinic London, Google (via Adecco) and the FDA and receiving consulting fees from the National Academy of Medicine. V.K.R. reports having been employed by F-Prime Capital. R.R. receives research funding from Arnold Ventures supporting the Yale Collaboration for Regulatory Rigor, Integrity, and Transparency and the Stavros Niarchos Foundation through Yale Law School for a project entitled “Re-envisioning Publicly Funded Biomedical Research and Development.” She serves as a consultant for the ReAct-Action on Antibiotic Resistance Strategic Policy Program based at the Johns Hopkins Bloomberg School of Public Health, funded by the Swedish International Development and Cooperation Agency. J.L.J. declares no competing interests. J.S.R. reports receiving research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the FDA for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882) and from the National Heart, Lung and Blood Institute of the US National Institutes of Health (R01HS025164, R01HL144644); in addition, J.S.R. reports serving as an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. S.S.D. reports receiving research support from the Department of Veterans Affairs Health Services Research and Development (1IK2HX003357), the National Evaluation System for Health Technology Coordinating Center (NESTcc), Arnold Ventures, and the National Institute for Health Care Management. J.S.R. and S.S.D. serve on the Medicare Evidence Development & Coverage Advisory Committee.

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Kadakia, K.T., Rathi, V.K., Ramachandran, R. et al. Challenges and solutions to advancing health equity with medical devices. Nat Biotechnol 41, 607–609 (2023). https://doi.org/10.1038/s41587-023-01746-3

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