Electronics
Strong EMS partners bring robust quality systems, engineering depth, supply chain discipline, cybersecurity awareness and more.
“An EMS partner can help by supporting secure manufacturing processes, controlled access to production environments, component traceability, software and firmware handling, test integrity and documentation needed to support the OEM’s regulatory and quality obligations,” says Schaepkens. “They can also help identify supply chain risks that may affect the security or resilience of the device over time.”
Beyond that, he feels it is important to look for a partner that truly understands the demands of healthcare. After all, this industry leaves little room for error.
“Strong EMS partners bring robust quality systems, engineering depth, supply chain discipline, cybersecurity awareness, documentation practices and a culture of continuous improvement,” he says. Just as important is how the teams work together. “The best partners are proactive,” says Schaepkens. “They surface risks early, bring data to problem- solving, understand the importance of standard work, and are willing to collaborate across engineering, quality, regulatory, sourcing and manufacturing teams. That is especially important when products must be supported for many years in highly regulated clinical environments.”
Simply put, this is not just about building electronics at scale. It is also about operating with rigour, transparency and accountability. “It is not simply outsourcing production; it is building an operational model that supports consistency and resilience,” says Schaepkens.
Care with confidence
These kinds of questions are likely to remain top of mind for some time. As digitalised health systems and smart devices become more prevalent, the advantages are mounting. These include greater diagnostic accuracy, enhanced monitoring of existing conditions and greater patient engagement. For healthcare systems, there is no going back to an analogue age.
www.medicaldevice-developments.com
As a result, Schaepkens thinks the convergence of hardware, software, AI-enabled workflows, connectivity and service models will shape the next generation of medical devices. Devices will, of course, need to be effective in their own right. But they will also need to work within broader ecosystems of data, imaging, diagnostics and workflow solutions. “The standout devices of tomorrow will not be defined only by individual specifications,” says Schaepkens. “They will be defined by how well they fit into clinical workflows, how they support decision- making, how they can be updated and serviced, and how they help health systems manage complexity. For OEMs, this means designing for the full life cycle from the start.”
He points out that, in healthcare, success does not simply equate to building a smaller or more connected device. Rather, it lies in building a solution that can operate in real clinical environments and help clinicians deliver care with confidence. “At GE HealthCare, we see this as part of the broader shift from fragmented technology towards connected, intelligent and disease-specific healthcare solutions,” he says. “The opportunity is to make technology feel less like another burden for clinicians and more like an integrated part of care delivery – helping bring data together, supporting more efficient workflows and enabling more precise care across the patient journey.”
As sensor technologies improve, connectivity methods become more powerful, and AI becomes ever more capable, the shift towards digitisation is only likely to gather pace. For OEMs and their partners alike, one of the most important capabilities will be adaptability, with partnership models evolving in tandem with the technology.
“As devices become smarter and more connected, OEMs and EMS partners need to work together earlier, more transparently and with a deeper understanding of the clinical and regulatory environment,” Schaepkens concludes. ●
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