Robert J. Kerwin is approaching three decades as general counsel with IAMERS (the International Association of Medical Equipment Remarketers and Servicers). In conversation with HCB News, he reflects on the evolution of the independent medical equipment service industry, the regulatory battles that shaped it, and the relationships that kept him engaged along the way.

Kerwin discusses everything from right-to-repair advocacy and FDA recognition of independent servicers to memorable moments from his earliest IAMERS presentations — including a power outage that nearly ended his involvement before it began.

HCB News: As you approach your 30th year as General Counsel to IAMERS, can you reflect on any highlights?

Robert J. Kerwin: Without a doubt the greatest continuing highlight has been getting to know the IAMERS members. Whether they live and work in Kansas, New Jersey, Germany, Australia or India, they are amongst the hardest working people I have known. As a group, I have to say, they treat pretty much everyone, starting with their staff and their customer hospitals, with enormous respect. Patient safety is really a priority and when you meet them, you find that out pretty quickly.

HCB News: Okay, I want to get back to that, but first how did you get involved with IAMERS?

RK: I was representing lenders in all phases of their business including equipment leasing/financing issues and I was asked by one of the lenders if I would be willing to speak to a diagnostic imaging trade association in Dallas on legal issues, that group was IAMERS.

HCB News: I presume that your presentation in Dallas went well?

RK: Actually, it was a disaster. Halfway through my slide presentation, there was a power outage. I mean the lights went out and the projector didn’t work and it took a little while for the hotel technical crew to restore power. When I attempted to resume my presentation, I was told the educational program was behind schedule and that I could circulate my slides if I wanted to. I thought that was the beginning and end of my involvement.

HCB News: So how did you manage to stay involved?

RK: Well, I got to know some of the members who actually posed a variety of legal questions to me so I knew that people were listening. For the next twelve years, I volunteered my time with IAMERS in helping it legally to get off the ground and participating as a non-voting member of the IAMERS Board of Directors and …I finally got to finish my legal issues presentation. Still, I came to learn that they love to play jokes on lawyers and in particular, this lawyer.

HCB News: Any particular project or projects stand out?

RK: After many many meetings with IAMERS members and with clinical staff, it became apparent that IAMERS really needed to launch educational efforts to combat the enormous disinformation that had been advanced about independent sellers, and servicers’ competence and safety efforts. So, over the years I assisted IAMERS in highlighting the importance in the hospital ecosystem of using independent servicers and that hospitals should have choices beyond simply always using the manufacturer’s more expensive servicing team.

HCB News: Is there regulatory support for these points?

RK: In 2018, the FDA tackled the question, among others, as to whether independent servicers were safely undertaking medical device servicing. That FDA Report to Congress noted essentially that independent servicers were indeed critical to the healthcare ecosystem and that the number of reported adverse events was under 1%.

In 2021, the FTC in its own report entitled ‘Nixing the Fix’ noted that some manufacturers across various industries had denied access to repair information and that the reasons offered for this conduct were not supported.

Also I was pleased that the U.S. Librarian of Congress recognized an exemption to the Digital Millennium Copyright Act (“DCMA”), the Library of Congress (the “Library”) exempting certain classes of copyrighted works, e.g., medical software in devices like CT scanners and MR machines, from anti-circumvention provisions of the DCMA. Getting information for device repair should not always be so difficult.

HCB News: Can you point to any major highlights from your time with IAMERS up to now?

RK: One highlight with a qualification… I was honored to be asked by IAMERS to present its views as to ‘Right to Repair’ and pending legislation to the U.S. House of Representatives Energy and Commerce Subcommittee.

HCB News: What’s the qualification?

RK: Well, in the midst of my testimony to the House Subcommittee, my daughter texted me to let me know that she could see on C-SPAN or some other channel the bald spot on the back of my head when I was answering questions. I was good-naturedly ribbed about that when I finished my testimony.

HCB News: Has your role as general counsel changed over the years?

RK: As we have a substantial number of European and International IAMERS members, my role has changed to also work with them as many of these members are experiencing some of the same issues. I am also serving as IAMERS representative to the European Commission Medical Device Coordination Working Group on Post Market Vigilance and Surveillance.

HCB News: What does that involve?

RK: Since the EU meetings typically start at 9:30am Brussels time, the hardest part is getting up at 3:30am. to listen to the live feed. And yet it is so worth it as the MDCG meeting is composed of both regulators and industry who are trying to come up with best practices to implement the European MDR.

HCB News: What do you see as the key issues facing IAMERS now and in the future?

RK: Well, I am fortunate to work with a great friend in IAMERS president Diana Upton. We discuss what is going on… on a nearly daily basis. Whether its upcoming legislation, advancing the interests of IAMERS members, preparing for our meetings… there are no shortage of issues in 2026. Helping our members adopt best practices is a continued challenge particularly as there is much left to be written about AI and the role of legacy medical devices.

HCB News: With three decades under your belt, do you ever think about retirement?

RK: No. When you truly enjoy what you do and the people you do it with… one doesn’t think of it as merely a job. I have taken a short sabbatical from time to time to teach at international law schools, including most recently in Poland. I also teach swimming to adults two days a week. Moreover, there remains much to be done. Of course, I will continue to work with our members… and I know I can also expect the ‘lawyer’ jokes to continue as well.

This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: https://www.dotmed.com/news/story/66349