Electronics
It is important to look for a partner that truly understands the demands of healthcare.
AI-enabled imaging systems to smart devices. The aim is to support clinicians across the patient journey and help usher in a new era of precision medicine. Exciting though that might be, today’s medtech companies have a big task on their hands. As the medical devices sector begins to blur its boundaries with the electronics and IT sectors, OEMs are facing a long list of challenges not traditionally associated with healthcare. These include component selection, supply continuity, software management, cybersecurity and regulatory documentation. “The challenge is no longer only whether a device performs its core clinical function,” notes Schaepkens. “It is also whether the device can be manufactured consistently, updated responsibly, protected appropriately, integrated into clinical and IT environments and supported over a long life cycle. In healthcare, these requirements are amplified because reliability, quality and compliance are fundamental.”
Partnering up
For some OEMs, these challenges are leading them to reconsider their entire way of doing business. In the past, they might have purchased specific electronic components from a vendor. Today, they are moving away from procurement-based models and towards fuller-scale collaborations.
“The shift is being driven by complexity,” says Schaepkens. “As devices become more connected and software-enabled, the electronics content becomes more sophisticated, and the pace of change in components, connectivity and computing platforms continues to accelerate. For many OEMs, the question becomes: where do we create the most value ourselves, and where can an expert manufacturing partner help us move with speed and discipline?”
For those who choose to work with an electronics manufacturing services (EMS) partner, there are many potential benefits. EMS partners bring specialist skills and resources that would be difficult to secure in-house. Alongside electronics expertise, these can
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include supply chain management, test development, manufacturability and production at scale. “That can help OEMs focus internal resources on system architecture, clinical workflow, user experience, regulatory strategy and the differentiated capabilities that matter most to customers,” says Schaepkens. According to a report by Mordor Intelligence, the electronics manufacturing services (EMS) market for healthcare and medical devices is projected to grow at a 7.1% CAGR from 2026 to 2031, reaching about $90bn by 2031 from around $63.8bn in 2026. This growth is largely due to the increasing complexity and miniaturisation of medical electronics, as well as OEMs’ growing willingness to enter outsourcing relationships. The report states that, while most of these relationships are traditional contract manufacturing partnerships, a growing number of OEMs are opting for hybrid or turnkey contracts – arrangements that give more responsibility, but also shift more risk, to the EMS partner. It suggests that these types of contracts may be particularly appealing to resource-constrained, mid-tier firms. But even where the OEM wants to maintain a high level of control, it may be prepared to delegate more tasks than in the past. Schaepkens notes, for instance, that an EMS partner may support design-for-manufacturing input, printed circuit board assembly, test fixture development, component sourcing, production scaling and life-cycle support. The OEM retains ownership of areas such as risk management and regulatory strategy, as well as accountability for the final product.
“In practice, the boundary depends on the product, regulatory classification, technology maturity and the OEM’s internal capabilities,” says Schaepkens. “What matters most is clarity. Each party needs to understand what it owns, how decisions are documented, how design changes are governed and how risks are escalated. In a regulated environment, a vague hand-off is not enough.”
A meeting of minds
So how can an OEM and its EMS partner work together most effectively? As far as Schaepkens is concerned, the most important point is to start early. A connected medical device is not simply a stand-alone device that will eventually be plugged into a network. Rather, it is part of a wider system and needs to be engineered as such. That means factors such as data flow and risk management need to be considered from the outset. “Electronics expertise needs to be embedded much earlier in the design process,” says Schaepkens. “Decisions about architecture, sensors, compute, connectivity and manufacturability are strategic decisions, not just technical implementation details.” Take cybersecurity, a key consideration for connected medical devices and one that must be addressed from day one. While the OEM remains accountable, the EMS partner must do everything it can to support compliance.
www.medicaldevice-developments.com
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