Technical illustration of a respirator device

Why Medical Device Regulation?

By Carmel Shachar

The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.

Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.

Of course, overregulation can be as harmful as underregulation. If the pendulum swings too far the other way, to impose very stringent requirements on any company bringing a medical device to market, we will close off important innovation. For example, we do not want the regulation of digital devices to be so onerous as to lock start-ups and smaller companies, the entities most likely to generate innovative products, out of the market. A challenge for articulating a 21st century medical device regulatory regime will be finding the right balance between protecting consumers while also supporting innovation in this industry.

Our May 8, 2020 conference on this topic will host scholarship exploring the challenges in regulating modern medical devices. If this sounds like an event you’d like to participate in, we urge you to submit your abstract by October 14, 2019. For further details please see the call for abstracts available on our website. While this is primarily a legal and bioethics focused conference, we welcome presenters from a variety of disciplines and appreciate diverse perspectives.


Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, with support from the Oswald DeN. Cammann Fund at Harvard University. Co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL) and the University of Arizona Health Law Program. This event is supported in part by a Novo Nordisk Foundation grant for a Collaborative Research Programme (grant agreement number NNF17SA027784).


Carmel Shachar

Carmel Shachar

Carmel Shachar, JD, MPH, is the Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. She is responsible for oversight of the Center’s sponsored research portfolio, event programming, fellowships, student engagement, development, and a range of other projects and collaborations. She is Co-Lead of the Center’s Involvement with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center.

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