The right to repair battle between medical device original equipment manufacturers (OEMs) and independent service operators (ISOs) will continue into 2026.
OEMs and ISOs remain at a "standoff," Advanced Medical Technology Association (AdvaMed) board member and Fujifilm Sonosite President and CEO Rich Fabian told AuntMinnie.
In an interview to close out 2025, Fabian and Patrick Hope, AdvaMed's Medical Imaging Technology Division executive director, discussed the top three policy issues facing the trade group as the new year begins.
Right to repair
First, AdvaMed will continue the right-to-repair fight on behalf of industry "in terms of having consistent standards and procedures around what it takes to repair equipment, qualifications of the operator, the service person, and the documentation process," Fabian explained. "As industry, we're all held to a very high standard. This is complex equipment with very high stakes, and the high stakes in medtech are getting an accurate interpretation of an image."
To that end, AdvaMed insists that people working on the equipment are properly trained and that repair is documented, Fabian added. "We're going to continue that fight because we think it's important for patient care," he said.
Industry is not trying to squeeze out the little guy, noted Fabian. "We're looking to hold everybody in the industry, regardless of if they are an OEM or a repair company, to the same standard."
Fabian said stakeholders are looking at all options for compromise and moving forward for imaging overall.
Executive director of AdvaMed Medical Imaging Patrick Hope (left) and AdvaMed board chair Rich Fabian discussed the industry group's top three policy issues for 2026.
"Perhaps in a different direction instead of being on very hard positions on either side," he said. "Different options that meet somewhere in the middle will be a more positive path forward. If we open up dialogue, we can make meaningful progress in 2026."
Hope, a Virginia legislator in addition to his role at AdvaMed, distinguished the right to repair issue: On the one hand, it's a medical technology issue. On the other, it's a consumer electronics issue. "We're not talking about x-rays and MRIs and ultrasounds landing in the landfill," Hope said, as is the case on the personal tech side.
Also, if medical device manufacturers are required to register and report to the U.S. Food and Drug Administration (FDA), servicers should be required to as well, Hope told AuntMinnie, adding that the trade group continues to pursue FDA oversight of third-party servicers, especially remanufacturers.
AdvaMed has highlighted "remanufacturing" of a medical device among its key issues. Beyond servicing, remanufacturing is when a significant alteration is made to a device's performance, safety specifications, or its intended use, changing the device from what was legally marketed as approved, cleared, or authorized by the FDA.
Hope noted that language was included in reports to the FDA’s FY 2026 Appropriations Bill passed by Congress and signed into law on November 12, 2025 -- language relative to the remanufacturing issue.
AdvaMed has proposed that the FDA publish a comprehensive report on the implementation of its 2024 medical device remanufacturing final guidance, including inspection summaries, enforcement actions, and documentation of instances of remanufacturing.
"They probably get a lot of reports from companies seeing this," Hope said. AdvaMed also wants to know whether the FDA's 2024 guidance has increased establishment registrations or 510(k) submissions by remanufacturers, he added. "So we can see what more authority perhaps we need and how the FDA is working on what guidance they've already issued."
The FDA must also address concerns about potential misinterpretation of the guidance, ensuring independent servicers understand their regulatory obligations, according to Hope, who, along with Fabian, anticipates an FDA report coming soon.
AI and AI reimbursement
A second policy issue for AdvaMed in 2026 revolves around AI, AI reimbursements, and proposed legislation.
"We're providing the healthcare industry with a lot of value," Fabian said. "And as an industry, we need to get reimbursed so we can continue to develop and add value because otherwise, we're going to see a slowdown, which none of us want to see in innovation, as we all believe in AI."
The Health Tech Investment Act (HR 6197 / S 1399) has been proposed to create a vehicle for AI reimbursement. If enacted, the legislation will assign all FDA-approved AI-enabled medical devices to a new technology ambulatory payment classification (APC) in the Hospital Outpatient Prospective Payment System (OPPS).
Proponents say the Health Tech Investment Act will form a stable payment pathway for algorithm-based healthcare services delivered through devices that use AI, machine learning, or other similarly designed software.
"For particular products that are FDA approved, that can prove clinical value or patient value, then they would get reimbursed for a period of five years," Hope explained. "And that would give them the ability to make proofs of their effectiveness for reimbursement. Something that would make your office more efficient, that would not be reimbursed. Something you can show would prove clinical patient value would be a candidate for reimbursement."
Tariffs
Tariffs round out AdvaMed's top 3 policy issues for 2026.
"If we take a look at tariffs a year ago, we weren't really talking about it," Fabian said. "Now we are, and it's definitely adding costs to the medical device industry and specifically to imaging companies. If you think about the complexity that we live in with supply chain, this is not something any of us can move from point A to point B quickly or cost-effectively."
Fabian shared a glimpse of how tariffs impact Fujifilm Sonosite. Based in Bothell, WA, near Seattle, the company manufactures ultra-high frequency micro-ultrasound technology. Its transducers are made in the U.S., Fabian said. However, components of the company's products are sourced in various countries, where tariffs vary in terms of their financial impact on the company, he added.
"Of course, we'd love to be able to reduce our tariffs to zero," Fabian said. "But as we take a look, the regulatory path that we have to get through to resource, re-qualify every vendor -- even if it's a screw that's used -- is tremendously difficult and complex, moving it from one location to another.
"When you're dealing with very complex coaxial cables that are only manufactured in China or some other part of the world, it's nearly impossible to find a short-term solution to change supply chain for our industry," Fabian continued. "As an industry, we're struggling with tariffs. Every dollar of tariff digs directly into our operating profit."
In closing, Fabian remarked that the imaging industry is underappreciated.
"Not too many years ago, we used to talk about exploratory surgery, when you couldn't see or didn't know what was going on," Fabian explained. "I've not heard of exploratory surgery in decades, and it's because of the tremendous value that imaging can quickly, effectively, efficiently, and reliably provide to the healthcare system."
The "mic drop moment" for imaging is to just think about the tremendous value that it provides and the partnerships with clinicians providing unparalleled information to treat patients better, Fabian concluded.
