On April 23, IAMERS celebrated its 33rd birthday with its annual meeting held at the Charleston Place Hotel in Charleston, South Carolina. As usual, the meeting was well attended by senior management from the ISO Community, OEMs and Sellers/Servicers from across the country. IAMERS President Diana Upton gave special recognition in her welcoming remarks to the several founding IAMERS members who were present and have attended each and every meeting for thirty-three years. “We are indebted to them for their considerable efforts to advance the industry and for their continued focus on patient safety.”

The Annual Meeting included a keynote presentation from U.S. Nuclear Regulatory Commissioner David Wright, a cancer survivor who offered heartfelt remarks about the importance of the work that IAMERS members (and others that service medical equipment) undertake. Commissioner Wright also shared that his daughter was also a cancer survivor, both of whom know firsthand about the benefits of diagnostic imaging.

U.S. FDA Compliance Analyst Katelyn Bittleman provided an informative update on FDA matters. As Katelyn had in the past, she also took time to explain important concepts such as manufacturer recalls and FDA’s role in monitoring the recalls. Katelyn also fielded questions on the Remanufacturing Guidance and updated members as to QMSR, which has now replaced the longstanding GMP regulation and brought the agency more in line with the internationally recognized standard found in ISO 13485. As Medinnova CEO Hiren Desai observed: “Katelyn explained some pretty complicated regulatory concepts in a way that was straightforward and easier to understand. We appreciate that she took the time from her busy schedule.”

Speaking of complicated subjects… Scott Trevino, Trimedx Senior Vice President of Cybersecurity, skillfully tackled in overview ‘Artificial Intelligence in Medicine’. Scott traced the adoption of AI, particularly as to imaging and radiology and offered some thoughts as to the use of data and models to forecast and healthcare decisions. Scott also offered some aspirational ideas about further adoption in the healthcare ecosystem including with respect to remote patching in light of the widely acknowledged device vulnerabilities. While he predicted enhanced BMET productivity and expected further integration of AI into CE workflows, he also acknowledged the bad actors who are also using AI. We would do well to follow Scott’s cautions to learn best practices and stay up to date with the quickly changing technology landscape.

IAMERS was fortunate to have Greg Garcia, Executive Director of the government recognized critical infrastructure public private partnership known as the Healthcare Coordinating Council Cybersecurity Working Group also speak to the members. HSCC is recognized as a national driver of cybersecurity best practices in healthcare. Healthcare is unfortunately the #1 target of cybercriminals. Yet in a few short years, Greg and his team have built a coalition of 470 healthcare providers, med tech companies and health IT entities to identify and mitigate cyber threats. The white papers developed by the HSCC are widely used when creating best cybersecurity practices. IAMERS has been privileged to participate in the HSCC and was honored when Greg presented to IAMERS President Diana Upton a challenge coin recognizing IAMERS support for cybersecurity. As East Coast Medical CEO Jimmy Kallam commented “cybersecurity is always a continuing daily concern”.

Craig Henderson of Sodexo Healthcare also presented in a most engaging way about ‘Why You Can’t Audit Your Way to Customer Loyalty’. An excellent speaker, Craig, offered candid insights which began and ended with how some companies excel in large part because of their quite sincere way of keeping their customers satisfied. As Craig noted, this is -an easy concept to describe and a challenging concept to routinely carry out. Craig had everyone engaged (and laughing) on this issue and reminded us that in the end its about showing your true commitment to making things work and, as always, patient safety.

IAMERS Board member Julie Mardikian, of Quality 13485, a compliance leader and auditor of ISO 13485 systems, followed Craig with some important takeaways about how to use corporate governance and accountability to drive customer retention and loyalty. Her presentation dovetailed nicely with Craig’s as she stressed that successful ISO compliance begins at the top of the C-Suite and is a pivotal part of winning the business.

To follow this accomplished faculty and speak about topics from tariffs to indemnity clauses was like my worst nightmare. In light of the recently announced process for tariff reimbursements (which is still evolving) and the widespread use of indemnity clauses to pass risk to others, I peppered the audience with a pop quiz on these issues—winners to receive a Starbucks card. And as a lawyer, I acknowledge there were some trick questions (with more than one right answer), so at this point I probably owe a few more cards to those who answered correctly. They will however have to wait to collect their cards for our next North America meeting which is scheduled 5-7 May 2027 in beautiful Montreal!

 

About the author: Robert Kerwin is IAMERS General counsel. The above article is a summary of his impressions from the April 22-24, 2026, IAMERS meeting and is not to be construed as legal advice.

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/66313