Right to Repair

By Matt Skoufalos

In the medical equipment manufacturing space, proprietary information is powerful. The investments required to bring a life-saving technology to market are often measured in the hundreds of thousands or millions of dollars, and the opportunity to profit from those investments isn’t always guaranteed in a free-market economy, or at least, not for long.

When it comes to extending the functional, useful life of those products, whether through preventive maintenance or repair, there’s a secondary revenue-generation opportunity. The skilled professionals who administer the repairs must be highly trained in not only the general modality of the equipment, but the specific device models themselves. The former skill set may be developed with an aftermarket or third-party business, often referred to as an independent service organization (ISO), whereas the latter increasingly can only be delivered by the original equipment manufacturer (OEM). 

That’s because, as the budgets of healthcare organizations are increasingly stretched, they’re seeking any opportunity they can find to conserve costs, including contracting with ISOs for their medical device servicing and maintenance. For years, this wasn’t a fight that OEMs pursued particularly relentlessly; it wasn’t uncommon for a veteran OEM service professional to find a second career as an ISO, working on the same kinds of equipment they’d maintained for years under their own banner.

However, as customers’ purse-strings tightened, OEMs sought to recapture market share they’d relinquished to the ISOs they hadn’t previously regarded as competition. But they didn’t seek to compete on price; instead, they took the tack that the proprietary ownership of their intellectual property was being undermined in contravention of their legal rights. That set up a battle for the courts and the legislatures over whether ISOs were competent to do the work of fixing OEM equipment without risking patients’ lives, or whether ISOs were filling a necessary role in repairing devices that OEMs either couldn’t support, or declined to do at a rate healthcare organization could afford.

The question central to the conflict is still unresolved. It distills to the fundamental issue of whether the owner of a piece of technology has the right to repair it after purchasing it, and secondarily, what role the OEM might be obligated to play in facilitating that repair when the technology in question is a life-saving medical device.

Nathan Proctor, senior director of the Campaign for the Right to Repair at the Public Interest Research Group (PIRG), said that the battle for medical device owners to legally repair and maintain their own equipment seems to have produced different messaging around the issue.

Previously, OEMs had painted a picture for lawmakers and the courts that third-party servicing of medical equipment is dangerous, and that anything less than repair or maintenance provided by the manufacturer constitutes negligence or ineptitude representing serious patient risks. When the data didn’t support that contention, the OEM argument shifted to the claim that all servicing should be regulated through the U.S. Food and Drug Administration, Proctor said. 

“Because GE, Philips, and Siemens are paying fees to the FDA, and they’re regulated as manufacturers, they’re saying they’re safe, but those who aren’t regulated should not be allowed to make repairs,” he said. “It’s basically outlawing third-party repair.” 

“To me, there’s an obvious incentive from the manufacturers to completely eliminate competition from service,” Proctor said. “There’s huge money stakes here, just like everything in American healthcare.”

As the manufacturing businesses “have completely organized their money” and rely on “brass-knuckle tactics,” Proctor believes the ISO sector must comparably rally its institutions to push back on the issue. Thus far, however, the Right to Repair movement hasn’t found its federal legislative champion. 

“We started pushing for Right to Repair for the military,” Proctor said. “I interviewed several military biomeds talking about being at field hospitals in Afghanistan and not being able to get service keys from manufacturers. They had Marines coming in, and they needed a CT scan to save their lives, just to be told that they have the wrong [service] contract.”

Proctor believes that there may be inroads to be made in convincing the U.S. Department of Defense and Congress that supporting Right to Repair in cases such as these is necessary, and from that foothold, build a case that the broader issue doesn’t just exist under battlefield conditions.

“People should be able to fix the stuff they’ve purchased,” he said; “that includes hospitals and the U.S. military. There’s nothing magical or special about what manufacturers can do. They hire the same kinds of people doing the same kinds of work, and competition is beneficial. You don’t have to run a good company to compete in a monopolized environment.” 

Although there’s been little appetite to develop a federal law around Right to Repair, the concept has gained traction for consumer products at the state level. Right to Repair legislation has been introduced in all 50 states as of February 2025, but so far, only five states – New York, Colorado, Minnesota, Oregon, and Colorado – have passed them, and those laws don’t specifically include provisions for medical devices.

To Proctor, that means there’s more room for ISOs to step up and rally support for the cause from other stakeholder groups, including healthcare organizations. What could help, he said, is whether they’re ready to step forward with data that can illustrate the extent of their maintenance challenges in terms of service failures, costs, and down time — precisely the kinds of information that hospitals track internally but are reluctant to present to the public. 

“It’s very challenging to share data,” Proctor said; “I don’t know anyone who’s willing to talk about this stuff publicly. We need the healthcare organizations to support this thing because ultimately, they’re the customers. If they’re letting the manufacturers steer them into uncompetitively priced service contracts, that’s what’s going to make or break long-term efforts to expand medical device servicing.”

Proctor relayed an anecdote involving a healthcare technology management professional who defended switching to an ISO for device maintenance because it lowered his parts failure rate and halved the cost of his repairs. The OEM challenged that decision as risky to patient health; instead the institution’s CFO responded that the ISOs were outperforming the OEM contract in terms of equipment uptime and maintenance costs.

“Lawmakers need to understand that hospitals are making deliberate decisions about what is best in a very challenging operation to service medical needs,” Proctor said. “[Healthcare organizations] can’t even choose to save money if they want to, even if it means improving the quality of the healthcare that they’re delivering.” 

Eric Massey, regional director of field service operations for Crothall Healthcare, an ISO headquartered in Wayne, Pennsylvania, said his personnel are more than capable of repairing and maintaining the medical devices they’re tasked with servicing. Their greatest hurdle is often getting access to the manufacturer-controlled parts, software keys, and technical manuals that are necessary to effectuate the work. OEMs are required by the FDA to provide basic service documentation to ISOs working on equipment repairs; what they get beyond that varies by manufacturer. 

“I have very little need to reach out to the OEMs on old technology, but there’s certain things that we’re locked out,” Massey said. “The thing that’s frustrating is that I have OEM-trained engineers who can work on these systems, and they won’t give us that access.”

Massey said he’s familiar with OEMs using what he described as “scare tactics” to denigrate the quality of technicians employed by independent service organizations and the work that they perform. He agreed that there can be a gulf between a veteran, qualified service professional and an amateur who doesn’t have the requisite level of skill to do the work. But when every technician in the same field is lumped in with one another as an excuse to run down their qualifications collectively, he bristles at the implications.

“My techs get proper training and are more than capable on their own,” Massey said. “We have a large, national support system, and remote access [technical support] has made it easier. We work with our part vendors to forward-stock parts; we’re fixing these systems, most of them, in the same day.”

“We teach our techs to troubleshoot at the component level,” he said. “If they left and went to GE and now, they get the special service key, they’re better equipped because of the training they got from us. At GE, they learn how to use the service key that tells them what parts to replace. Our techs know the schematics, the service manual, everything. They have our national support to help them understand these systems.”

“By OEMs not allowing us to service that equipment, that’s really affecting patient care,” Massey said. “The hospital owns that equipment, and I feel it should be up to the hospital who services that device.”

ISOs like Crothall typically save healthcare organizations anywhere from 15 to 20 percent over OEM service contracts, but Massey offered that their true value lies in providing high-quality professionals to do the work of equipment maintenance. In a field where talent is stretched thin, and reinforcements are difficult to source, not only are both business entities competing for the same customers, they’re also pooling talent from the same sources.

“We’re going head-to-head against [the OEMs],” Massey said. “A lot of people like working for us better because there’s more opportunity with us than the OEM, because we do everything from biomed up to imaging.” 

“They train in specific CTs and MRI, whereas we train our engineers on multiple modalities,” he said. “I feel our programs are a lot better. We have a lot better engineers; we compete very well against them. They’re losing a lot of business to us, and they’ve dropped their prices considerably over the last two years to compete against us.”

Nonetheless, Massey said, he’d prefer to be in a hybrid service arrangement – or something more cooperative than exists currently – which would leverage the strengths of both ISOs and OEMs in service to healthcare organizations and their patients. Rather than competing to reinforce or challenge a monopoly, he said it would be more efficient to leave service on newer technologies to the manufacturers and allow ISOs to facilitate onsite repairs in places where OEMs aren’t able to be present physically. 

“We’re all for working with the OEM; they’re not for working with us,” Massey said. “I believe a hybrid model is good; newer technology should be serviced by them, older by us. I think right now government is the best bet to getting the stuff quickly. We need service keys and anything to fix this at a reasonable cost.”

Another critical consideration for the Right to Repair issue involves what’s to be done with devices that OEMs regard as “end of life” as far as their obligation to support such equipment past a certain amount of time. Some well-maintained medical devices may have lifespans measured in a decade or longer, but OEMs may decline to service them or provide replacement parts for most of them any longer than seven years after their release.

“They’re bringing the end-of-life down, and I think that’s backfiring,” Massey said. “We can service these systems for 12 to 15 years.”

Just as AdvaMed is the advocacy arm of OEM interests, the International Association of Medical Equipment Remarketers and Servicers (IAMERS) represents the ISO world and its constituent businesses. Attorney Rob Kerwin, who serves as counsel for IAMERS, believes that the issue of Right to Repair has both never been more timely, and yet is not a legislative priority in Congress.

“While it may be important for OEMs, ISOs, and healthcare organizations, it’s challenging to get the legislators to focus on this area because of the many other matters on Congress’ plate,” Kerwin said. 

Kerwin points out that, in its decision on the Digital Millennium Copyright Act (DMCA), the Librarian of Congress has exempted access and use of medical equipment servicing manuals; however, that exemption is being challenged in the courts, and ISOs are following closely along. The European Data Act contains some relevant parallels that similarly have yet to be interpreted on the issue of Right to Repair. 

“Could we have a situation where the multinational medical device companies are required to share service access information in Europe, but are permitted to restrict access to ISOs?” Kerwin asked. 

“Will legislators and regulators take note that, for all the hyperbole, there has been no real uptick in the reporting of adverse events? If OEM positions are truly about patient safety, why would some of the manufacturers not readily share equipment manuals with the hospitals and the servicers the hospitals choose?”

Moreover, Kerwin said, the industry of medical equipment repair has been defined by consolidation, not just within each business apparatus, but with OEMs purchasing ISOs. To him, that raises the question: “If independent servicers were so unreliable, why are they being bought by the major device owners?” 

“The reality of the marketplace is that many hospitals can’t afford new equipment with struggling budgets, post-COVID financial challenges, challenging CMS reimbursement,” Kerwin said. “Therefore, legacy medical equipment is still very attractive.”

When purchasing medical devices, hospitals want a turnkey solution, Kerwin said. They often measure total cost of ownership against functional concerns including cyber-security, compatibility with existing systems, and residual value at the point of sale or retirement from active use. He believes that manufacturers that restrict access to their technologies for the purposes of maintenance may well face “diminished interest” in hospital and group medical practice purchases. 

“All of this should send an economic message that it makes business sense to let hospitals chose their own servicing paths without such restrictions,” Kerwin said.

“We have very sophisticated buyers who know the lay of the land, and if the only ones who can repair the equipment are the OEMs, that’s a cost that has to be figured,” he continued. “The market situation remains challenging, and the sophistication of all the parties is great. We are still making the case that we need fundamental, level playing fields, because healthcare and hospitals deserve choices.” •