Call For Papers Innovation and Protection: The Future of Medical Device Regulation



Event Date: 

05/7/20 to 05/8/20

Location name: 

Cambridge, MA


The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School

Call For Papers
Innovation and Protection: The Future of Medical Device Regulation

07 May 2020 - 08 May 2020, Harvard Law School, Cambridge, MA

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2020 annual conference: "Innovation and Protection: The Future of Medical Device Regulation." This year's conference is organized in collaboration with Timo Minssen, University of Copenhagen's Center for Advanced Studies in Biomedical Innovation Law (CeBIL); Nicholson Price, University of Michigan School of Law; and Christopher Robertson, James E. Rogers College of Law of the University of Arizona. This year's conference is organized in collaboration with the University of Copenhagen's Center for Advanced Studies in Biomedical Innovation Law (CeBIL) and the University of Arizona Health Law Program.

CONFERENCE DESCRIPTION: Medical devices have historically been less regulated than their drug and biologic counterparts. In the United States, the legislative framework regulating oversight of medical devices allows a moderate-risk device to be brought to market without evidence of safety or efficacy provided it is substantially equivalent to devices that were on the market in 1976 - which themselves may have never been evaluated for safety or efficacy (often referred to ask the 510(k) pathway). Post-market surveillance is also less onerous than its pharmaceutical counterpart, with an "alternative summary reporting" program allowing manufacturers to avoid public reports of certain types of problems prior to this year.

A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety issues. The Institute of Medicine in 2011 published a critique of the pathway allowing moderate-risk devices to be brought to the market in this fashion, and flagged a need for increased post-market review and surveillance. High profile recalls of medical devices, such as vaginal mesh products, along with reports globally of nearly two million injuries and more than 80,000 deaths linked to faulty medical devices, have raised public health critiques regarding the oversight of these products. Should we follow the recommendation of the Institute of Medicine to reduce the use of the 510(k) pathway, and, if so, what should replace it? In an era of big data, where we have the capabilities to better follow post-market incidents, what should post-market review look like? Overall, how do we balance protecting consumers with allowing manufacturers to bring their products to market?

Additionally, there is increased awareness that the nature of medical devices is rapidly changing. Devices have traditionally been hardware, but are now increasingly hybrids of hardware and software, or even software as a medical device (SaMD). Of course, software is revised much more frequently than hardware, especially when it involves machine learning. To address the challenges of overseeing SaMDs, the Food and Drug Administration (FDA) launched the software precertification program in 2017. The FDA also recently proposed a new framework to review ongoing artificial intelligence algorithm changes for device software, using a total product lifecycle approach to regulate these algorithms. What does a robust regulatory regime for medical device software look like in the coming years?

Across the Atlantic, the European Council approved new medical device regulations that will begin to fully apply in May 2020 and May 2022. These regulations are meant to address safety and effectiveness concerns, including increasing post-market surveillance, establishing an EU database on medical devices, and responding to some of the innovations that have occurred in the medical device field. These new regulations, coupled with the experiences of the FDA in the United States, suggest that medical device regulation overall faces some global challenges, including: the correct balance between patient protection and avoiding stifling business and innovation, the changing nature of medical devices to become increasingly software-based, and the difficulties of post-market surveillance. How might these concerns be expressed and successfully addressed in a variety of countries, each with a different medical device market?

Lastly, compared to the well-studied domain of pharmaceuticals, the regulation of devices presents at least an additional four challenges and areas of inquiry. First, devices are now also displacing some of the functions of physicians, which in the U.S. are traditionally regulated by the states. For example, the FDA recently approved a device to do autonomous screenings, deciding whether to refer patients to an ophthalmologist. The line between the regulation of devices and the regulation of the medical professions are becoming increasingly blurred. Second, although conflicts of interest are rampant in U.S. health care, they are particularly significant in the domain of medical devices. Physicians who frequently use medical devices often receive supplemental income directly from the device maker on a consulting or advisory basis, and also often have fee-for-service incentives to use the device. Third, even where FDA pre-market approval is required, the evidence base for the safety and efficacy of medical devices is substantially weaker than for drugs, given the lack of large, blinded, and randomized trials. These lacunae impinge the quality of physician prescribing decisions and undermine patients' informed consent. Fourth, medical devices have been a case study in the alternative mechanisms of administrative regulation versus tort liability, and the Supreme Court has in recent decades redrawn that line through its Federal preemption doctrine. For FDA-approved devices, compensation for injury remains an open question.

CALL FOR ABSTRACTS: We seek papers that offer innovative conceptualizations and advance inventive approaches. Abstracts should focus on the fresh contributions the presentation will make, including sketches of the supporting arguments. The abstract should include (but not be limited to) a paragraph summarizing the issue that will be addressed and any currently contending views about its resolution. Successful abstracts will explicitly address how the proposed presentation will address the ethical and/or legal challenges presented by the current regulatory regime for medical devices and/or how to adapt this regime for innovative medical device technologies.

TOPICS: We welcome submissions on both broad conceptual questions and more specific policy issues related to the regulation of current or future medical devices. Potential topics include:
- How should regulators strike the correct balance between protecting medical device users while fostering innovation in the field?
- The software precertification program heavily favors large technology companies with the resources to demonstrate a sufficiently robust culture of quality and organizational excellence to qualify for this pathway. Does this requirement needlessly disadvantage start-ups and smaller companies?
- The EU medical device regulations are voluntary until spring of 2020. What has been the impact of these regulations thus far, and how can we expect them to shape the European medical device market?
- What additional pathways and tools should be added to the evaluation of AI algorithms to ensure safety while preserving innovation in this rapidly developing field?
- What lessons can the United States and other countries learn from the new EU medical device regulations? What about regimes in other countries?
- What does a 21st-century medical device regulatory regime look like?
- Post-market surveillance is resource intensive. How can regulatory agencies best conduct these reviews, acknowledging the limits of their resources?
- What loopholes exist in medical device regulations, either in the U.S. or the EU, that should be addressed next?
- How should the large number of medical devices that were approved under more lax pathways, such as the 510(k) pathway, be regulated moving forward?
- What lessons from pharmaceutical regulation should be applied to medical devices? How different should the two regulatory regimes be?
- Considering the explosion of home health applications, how broadly should we define medical devices?

Please note that this list is not meant to be exhaustive; we hope to receive abstracts related to the conference's central question even if the particular topic was not specifically listed here. Proposals should demonstrate a clear linkage to all three aspects of the conference: medical devices, innovation, and regulation/law. Papers that focus on ethics should include substantial discussion of policy implications. Relatedly, law will be treated broadly to include governmental policy decisions more generally. Successful abstracts will propose or outline an argument/position, rather than merely stating a topic.

In an effort to encourage interdisciplinary and international dialogue, we welcome submissions from legal scholars and lawyers, bioethicists, philosophers, clinicians, medical researchers, disability rights advocates, public health practitioners, economists, government officials and staff, and others who have a meaningful contribution to make on this topic. We welcome philosophical and legal reflections from contributors across the world, but with preferences to contributions that are general, or United States- or European Union-focused. We welcome submissions from advocacy organizations, think tanks, and others outside academia, but emphasize that this is a scholarly conference, and abstracts/papers will be held to academic standards of argumentation and support.

HOW TO PARTICIPATE: If you are interested in participating, please send a 1-page abstract of the paper you would plan to present to as soon as possible, but not later than October 14, 2019. If your abstract is selected, your final paper will be due on March 27, 2020, and you will be assigned a presentation slot for the conference. All presenters must provide a full final draft in order to participate. Presenters are expected to attend the conference for its full duration. We will accept conference papers of all lengths and styles (e.g., law review, medical, philosophy, or policy journal, etc.), but presentations will be limited to 15 minutes. The conference will be held on Friday, May 8, 2020. We will pay travel expenses for presenters who must travel to Cambridge; co-authored papers must name a single presenter.

In the past, we have successfully turned several of our conferences into edited volumes (e.g., with Cambridge, MIT, Johns Hopkins, and Columbia University presses). It is possible, although not guaranteed, that conference presenters will publish their papers with us in an edited volume whose chapters will be limited to 5,000 words, including references. All presenters should plan on contributing their submission to any subsequent volume arising from the conference and should not submit an abstract if they anticipate this will be a problem. Previous conference participants have been able to publish their submissions in different formats in multiple venues, for example both as a short book chapter and a longer law review article. However, the version that will be used for an edited volume should not have been published previously or be planned to publish separately.

HOW TO REGISTER: Registration information is available on our website at Attendance is free and open to the public, but space is limited. Stay tuned for the conference agenda, which will be posted to our website once abstracts have been selected.

Stay tuned for the conference agenda, which will be posted here once abstracts have been selected. Want updates sent straight to your inbox? Sign up for our bi-weekly newsletter!

QUESTIONS: Please contact the Petrie-Flom Center with any questions:, 617-496-4662.

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).