By David Francoeur
Over the coming year, multiple industry stakeholders will continue contributing perspectives and updates related to the evolving Right to Repair (RTR) discussion. The medical equipment service community – including OEMs, HTM teams, and independent service providers – is collectively navigating a period of significant change.
Healthcare organizations are facing growing complexity in maintaining safe, compliant and reliable medical equipment that supports clinical teams and patient care. At the same time, the industry is experiencing a well-documented workforce challenge. OEM service teams, independent service organizations (ISOs) and in-house HTM departments are all contending with limited availability of experienced technical resources.
The professionals who have long ensured equipment uptime, patient safety and regulatory compliance – often under challenging conditions – are approaching well-earned retirement. Replacing that level of expertise remains a shared concern across the industry, as new talent is entering the field at a slower pace and requires time to develop advanced competencies.
CURRENT STATE OF RIGHT TO REPAIR IN HEALTHCARE
Right to Repair continues to gain national attention. However, its application to healthcare technology remains more nuanced than in consumer or automotive sectors because of the unique safety, regulatory and cybersecurity responsibilities associated with medical devices.
At a high level:
• State-Level Activity: Several states have enacted digital Right to Repair laws focused primarily on consumer electronics, appliances and automotive equipment. These laws typically address access to parts, tools, service documentation and diagnostic software.
• Medical Device Considerations: Most state RTR statutes exclude medical devices, except for states which include coverage for powered wheelchairs. These exemptions point to the reality that repair rules for medical devices are distinct, and include considerations for patient safety, FDA oversight and cybersecurity protections. As a result, hospitals and HTM teams are not currently covered under these laws.
• Federal Dialogue: Federal agencies and policymakers continue to examine issues related to competition, service access and total cost of ownership. Ongoing discussions include:
o Appropriate access to service documentation and software
o Cybersecurity safeguards and software controls
o Long-term sustainability of OEM service models
o Guidance around what constitutes remanufacturing
To date, no comprehensive legislation has been enacted
• FDA Perspective: The FDA has reaffirmed that safe, effective third-party servicing – when performed in accordance with applicable standards – does not inherently increase patient risk. This position underscores the importance of qualified service providers, strong quality systems and proper documentation across all service models.
• OEM Evolution: Many OEMs are actively adapting to changing customer needs and operational realities. Examples include:
o Expanded or tiered service offerings
o Selective access to diagnostic tools or technical documentation
o Policy adjustments driven by customer feedback, workforce constraints and uptime expectations
WHAT THIS MEANS FOR HTM PROFESSIONALS TODAY
• Right to Repair should be viewed as an ongoing dialogue, not a single legislative outcome.
• Service access decisions must balance safety, cybersecurity, compliance and operational efficiency.
• Incremental progress and pilot approaches are more likely than abrupt change.
• Strong collaboration, standardized processes, cybersecurity discipline, and demonstrated service quality will be essential to building trust across stakeholders.
BOTTOM LINE
Right to Repair is influencing important conversations about transparency, access and sustainability in medical device service. For HTM, progress will continue to be measured and collaborative, shaped by regulation, workforce realities and shared responsibility for patient safety.
From a long-standing industry perspective, one principle remains clear: OEMs, non-OEM service providers and in-house HTM teams are mutually dependent. No single group can meet the demands of modern healthcare alone. Sustainable success will require continued partnership, open communication and a shared commitment to safe, effective patient care.
