AIMBE’s Industry Council, chaired by Dr. SuPing Lyu, is leading the charge to highlight the importance of Per- and Polyfluorinated Substances (PFAS) to the medical device industry. These so-called “forever chemicals” are rightfully being scrutinized to protect our health and environment; however, a very small number of these chemicals play critical roles in making sure that our medical devices save tens of millions of patients’ lives. On January 30, 2024, AIMBE hosted a roundtable meeting to gather stakeholders to discuss the use of PFAS in medical devices and how they may be impacted by supply and pending regulatory changes. Perspectives including suppliers/processors of PFAS, medical device companies (users of PFAS), federal agencies (e.g., FDA, NIH, NIST, EPA, etc.), academia, public health, policy, and more were represented. The goal of the session was to increase the understanding and awareness of the impacts of PFAS supply and regulatory changes across these different landscapes. A congressional lunch briefing, hosted by AIMBE, was held on the same topic to educate lawmakers and staffers about the importance of fluorinated polymers to live-saving medical devices.

At the state level, AIMBE Fellows, Dr. Nadine Ding (Abbott) and Dr. Bill Wagner (University of Pittsburgh), presented to the Maine State Chamber of Commerce on the importance of PFAS in medical devices in the context of Maine’s PFAS in Products Law which mandated that manufacturers of products containing intentionally added PFAS disclose their presence to the Department of Environmental Protection (DEP) by January 1, 2023 (later extended to 2025). It also prohibited the sale of such products if they failed to report and set a ban on all products containing intentionally added PFAS starting in 2030, with few exceptions. Drs. Ding and Wagner discussed the impact this law would have on medical devices and patients. Following their impactful comments, on April 16, 2024, Maine Governor Janet Mills approved significant revisions to the PFAS in Products Law. The amendments eliminate the reporting obligation unless the DEP determines that the use of PFAS in the product is deemed “currently unavoidable.” They also remove the deadline for such notification and establish exemptions from the law for specific products containing intentionally added PFAS. Importantly, medical devices were included on the list of exemptions.

CURRENT CHAIR

SuPing Lyu, Ph.D.

Chair 2023 – 2025

Bakken Fellow and Distinguished Scientist
Medtronic

For outstanding contributions to the development of biomaterials and medical devices serving millions of patients, and for eminent professional service.

PAST CHAIRS

Virginia Giddings, Ph.D.

Chair 2021 – 2023

Senior Director, Advanced Technology Exploration
Edwards Lifescience

For outstanding contributions to medical device research and product development and innovative technology commercialization for global health care.

Nadine Ding, Ph.D.

Chair 2019 – 2021

Volwiller Fellow
Abbott Laboratories

For technological and leadership contributions to bringing next generation drug eluting stents to millions of patients.

M. Allen Northrup, Ph.D.

Chair 2017 – 2018

CEO
MIODx, Inc.

For outstanding contributions to bio-analytical and actuator-based micro-technologies, and for entrepreneurship in clinical diagnostics and homeland security.

Susan Drapeau, Ph.D.

Chair 2015 – 2016

Senior Director, Business Development & Strategy
Vericel Corporation

For outstanding contributions to the innovation and development of clinical therapies to treat spinal, musculoskeletal and oral-maxillofacial diseases.

Walt Baxter, Ph.D.

Chair 2013 – 2014

Senior Principal Scientist
Medtronic Neuromodulation Therapy Delivery

For development of novel algorithms elucidating mechanics of implanted medical devices and major contributions to academia-industry collaboration and professional development.

David R. Jones

Chair 2011 – 2012

Former Director Quality, Regulatory and Compliance
Philips Home Healthcare Solutions

For having several invited peer reviewed papers for the IEEE and Quality and Realiability International.

Robert J. Miller, Ph.D.

Chair 2010

Senior Vice President
Sigilon, Inc.

For leadership in developing valuable medical products from natural sources in the fields of implantable devices, diagnostic tests and purification systems.

Joseph C. Salamone, Ph.D.

Chair 2006 – 2008

Chief Scientific Officer
Rochal Industries

For substantial scientific, technological, and commercial contributions to contact lenses and ophthalmic devices.