To support this shift, the industry will need broader access to full-service documentation, diagnostic tools (including necessary software keys from OEMs), fair and equitable access to device training and the ability to purchase repair parts. To support this, OEMs must prioritize designing for serviceability from the outset, making components easily accessible and ensuring designs safeguard proprietary intellectual property while simultaneously allowing for device servicing.

Whether hospitals, OEMs or third-party providers service a medical device, they must meet the same expectations for training, documentation and audit readiness because patient safety depends on it.


HCB News: As a leader who has helped shape policy and quality initiatives, what key guidance would you offer to healthcare organizations trying to build a culture of quality and safety that can adapt to rapid changes in service models and technology?
HD: Quality is not simply a department; it is a mindset, and it is everyone’s responsibility. My advice is to embed quality into every layer of decision-making, especially as service models evolve. This means involving your quality team in vendor selection, repair tracking, equipment lifecycle planning and technician training requirements. Furthermore, avoid waiting for regulations to dictate your actions. Build a proactive culture now, one that prioritizes patient safety and system performance even amid change. Adaptability is important, but not at the expense of consistency. Healthcare organizations can embrace innovation and cut costs while maintaining safety and reliability, provided they have the appropriate systems, partners and mindset.

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