Current Events in Custom Medical Electronics

Custom medical electronics increasingly form the control, sensing, communication, and power-management backbone of modern medical devices. No longer supporting components, they can encompass everything from a device’s circuit boards and embedded systems to the sensors, power systems, connectivity, and controls that make it function.

From wearable and portable technologies to surgical systems, monitoring platforms, and implantable devices, OEMs rely on specialized electronics to deliver greater performance in smaller, more connected packages. They can be found in a variety of medical devices, particularly where standard, off-the-shelf electronics can’t meet the device’s size, performance, power, connectivity, or clinical requirements.

At the same time, requirements around reliability, cybersecurity, regulatory compliance, power management, and manufacturability continue to shape development strategies. Medical electronics sit at the nexus of increasingly sophisticated device functionality, demanding clinical requirements, and complex manufacturing considerations.

To explore the opportunities and challenges surrounding custom medical electronics, MPO gathered nine industry experts representing key areas of the electronics design and manufacturing ecosystem:

• Chris Clark, senior principal applications engineer at Flexible Circuit Technologies
• Theresa Gavin, quality manager at Flexible Circuit Technologies
• Paul Matteri, director of engineering at LEMO USA
• Joe Rosenblum, director of marketing at Keystone Electronics
• Derek Rossberg, regional business development manager at Flexible Circuit Technologies
• Erich Stein, Sr. engineering services director at Jabil
• Clint Thornhill, sales director at P1 Technologies
• Michael Tucci, president and CEO at Micro Group
• Greg Tuers, president at RAM Technologies

Sam Brusco: What trends are driving demand for custom electronics in medical devices today?

Chris Clark: The biggest trend we see is for devices that support minimally invasive surgical procedures, especially for PFA (pulsed field ablation). Historically, this has been accomplished with a circuit at both the proximal and distal ends, connected by tiny 46awg wires. These wires carry the energy for the PFA as well as the signals used for mapping. The trend is to replace the wires and their connections with one flex circuit end to end, thereby eliminating the connection points.

Paul Matteri: The complexity of diagnostic and therapeutic treatments continues to increase, which requires more complex signals, software, and higher data rates. Fiber optics are becoming more common, and the fiber media converters must be customized to fit within catheter handpieces or connector bodies. We’ve also seen increasing demand for integrating custom circuitry and chips on a flex board or PCB as part of a connector termination, helping medical device OEMs increase performance in a smaller, more efficient package.

Erich Stein: Healthcare is becoming increasingly connected, data-driven, and patient-centric, which requires electronics tailored to the device’s specific needs rather than relying on off-the-shelf components. Our customers are pursuing smaller, more portable, and more intelligent devices, so they need custom electronics that can support advanced sensing, wireless connectivity, power management, and data processing in compact form factors.

We also see continued growth in digital health solutions like remote patient monitoring, wearable technologies, and minimally invasive interventions. These applications often require highly specialized electronic architectures to meet unique clinical, usability, and performance requirements. At the same time, advances in components, software, and sensor technology are enabling medical devices to capture and analyze more data than ever before, creating new opportunities to improve patient outcomes.

From a manufacturing perspective, custom electronics also help OEMs differentiate products, improve reliability, and navigate evolving supply chain challenges by optimizing designs around long-term component availability and lifecycle management.

Clint Thornhill: The primary drivers are rapid miniaturization and the explosive growth of in-home patient care, treatment, and monitoring devices. OEMs require increasingly intricate components to support data-intensive, wearable applications like glucose monitors, continuous medication delivery devices, and nerve stimulation systems designed to treat chronic pain outside of a clinical setting. There’s also a major trend toward supply chain consolidation, where medical device innovators want to shift away from fragmented tier-two sourcing. This has significantly accelerated the demand for vertically integrated contract manufacturers who can deliver everything from printed circuit board assembly (PCBA) and injection molding to final box builds under a single certified roof.

Michael Tucci: Healthcare is entering a new era where medical devices are no longer defined solely by their mechanical or therapeutic function. Increasingly, they’re becoming intelligent systems capable of sensing, processing, communicating, and generating meaningful clinical data. Several trends are accelerating this evolution, including continued miniaturization of sensors, advances in AI, and the rapid acceleration of computation—driving a race to capture as much information as possible during procedures, with devices serving a dual function as both therapeutic tools, like PFA systems, and data acquisition platforms capable of mapping anatomy and physiological activity in real time.

Perhaps the most significant shift, however, is the emergence of hybrid medical devices. Tomorrow’s products won’t simply deliver therapy—they’ll simultaneously sense, measure, communicate, and provide real-time clinical feedback. A smart catheter, for example, is becoming both a therapy delivery system and a diagnostic platform. This convergence of mechanics, electronics, software, and data is fundamentally changing what medical devices can do—and how they must be designed and manufactured.

Greg Tuers: Medical devices are being asked to provide more computing power in smaller, quieter packages. Advanced imaging, AI-enabled analysis, robotics, and connected systems increase processing and power requirements, while OEMs continue to push for smaller footprints, lower heat, and greater efficiency. That combination often makes a standard component a poor fit and creates demand for electronics tailored to the device.

We also see increased attention to supply-chain resilience, component longevity, and domestic support because medical platforms typically remain in production much longer than consumer products.

---

From product launches to M&A and manufacturing trends, the MPO Source delivers the medtech news you need twice a week. Subscribe here!

---

Brusco: What differentiates custom medical electronics from electronics designed for other industries?

Matteri: Medical electronics must survive exposure to harsh sterilization processes. Most industries wouldn’t consider autoclaving their electronics, for example. The combination of high temperatures mixed with the potential of exposure to steam rapidly degrades most electronics. Some even use that as a stress test to cause failure of their components. In medical equipment, the components need to function after several dozen to hundreds of cycles.

Joe Rosenblum: As far as Keystone is concerned, there’s no fundamental distinction between a custom product built for a medical application and one built for another industry—at the board and component level, the function is the same. The exception is environments requiring autoclave sterilization, which do call for more resilient materials and platings, such as passivated 316L stainless steel or autoclave-tolerant polymers like PEEK, along with connector plating (typically gold over a nickel or palladium barrier) engineered to resist repeated high-heat, high-humidity cycles without delaminating.

Derek Rossberg: While the manufacturing process is largely the same, medical applications often require specialized materials and coatings to ensure biocompatibility, particularly for patient-contacting devices. For example, while Electroless Nickel Immersion Gold (ENIG) is the most common surface finish, nickel-free alternatives are often specified to eliminate the risk of allergic reactions.

Another key difference is circuit length. Many catheter manufacturers are replacing traditional wire harnesses with extended-length flex circuits that run from the proximal to distal end of the catheter. This reduces assembly time, increases electrode density, and improves reliability by eliminating solder joints. Manufacturing flex circuits up to 2 meters long with 50 µm (0.002”) trace and space requires specialized equipment and advanced process controls.

Finally, medical devices demand significantly higher quality standards, inspection, documentation, and full traceability. To ensure patient safety and regulatory compliance, manufacturers typically follow certifications such as ISO 13485 and higher-reliability standards like IPC-6013 Class III.

Stein: Medical electronics operate in a uniquely demanding, strictly regulated environment. Unlike many consumer or industrial products, medical devices directly impact patient safety, which means reliability, traceability, quality, and regulatory compliance are built into every stage of the product lifecycle, from design and development to manufacturing and sustaining.

Medical device electronics must often function flawlessly over long periods of time, under varying environmental conditions, and sometimes within the human body. Design decisions must navigate the complexities of biocompatibility, risk management, electromagnetic compatibility, cybersecurity, sterilization compatibility, and regulatory requirements. 

Jabil conducts a survey every other year on digital healthcare. We’ve seen a shift over time where, at first, healthcare OEMs predicted they would work with tech companies on digital products, but more OEMs are choosing traditional CMOs who bring experience in the regulated healthcare ecosystem. The tech method of “failing fast” doesn’t work when the product is a pacemaker. 

Ultimately, success in medical electronics requires a combination of engineering expertise, quality systems, regulatory understanding, and manufacturing discipline that extends well beyond traditional electronics assembly.

Thornhill: Custom medical electronics must adhere to a strict zero-tolerance failure rate, as they directly impact life-critical patient outcomes. Unlike standard consumer or commercial electronics, medical components require exact biocompatibility, strict sterile barrier packaging, and the ability to withstand demanding surgical environments or sterilization cycles. Every custom cable assembly, connector overmold, and advanced sensor component must maintain absolute signal integrity without risk of degradation or interference. Because of these high stakes, every stage of medical electronics manufacturing demands a level of precision, traceability, and material validation that standard commercial assembly lines simply cannot provide.

Tucci: The engineering objectives are fundamentally different. In industries like automotive and aerospace, electronics are often designed to survive hundreds of millions of cycles over many years while operating in harsh environments of vibration, temperature extremes, moisture, and contamination. Medical devices present a very different challenge. Many advanced catheter systems and other minimally invasive devices are intended for a single sterile procedure. They may only be used once, but during that procedure they must perform flawlessly while meeting the highest standards of safety, reliability, and regulatory compliance.

At the same time, physicians don’t interact with these devices as consumers interact with electronics—they rely on them as an extension of their own hands. The ergonomics, tactile feedback, steering response, and overall “feel” of the device remain just as important as the intelligence embedded within it. The best medical electronics are often the ones the physician hardly notices because they enhance, rather than interrupt, the clinical experience.

That is what makes medical electronics unique. The challenge isn’t simply integrating sensors or software into a product—it’s balancing sophisticated electronics with intuitive mechanical performance, uncompromising quality, manufacturability, and the confidence that every device will perform exactly as intended when a patient’s outcome depends on it. Oftentimes, this means less about PCB or software differences and more about the interfaces and interactions between the increasing number of disparate components required.

Tuers: The primary difference is the consequence of failure. In a typical commercial product, a power interruption may be an inconvenience; in a medical device, it can interrupt a procedure or affect essential performance.

Medical electronics therefore require additional attention to isolation, leakage current, electromagnetic compatibility, thermal performance, reliability, and fault protection. They also require much more disciplined documentation and change control. A component substitution that might be routine in another industry could require a formal risk review and additional testing in a medical device.

Brusco: What are the biggest manufacturing challenges unique to medical electronics?

Clark: Catheter applications typically require ultra-tiny etched features and uncommonly long lengths for flex circuits. Flex circuits are produced on very similar equipment to rigid PCBs, and much of that equipment isn’t made to handle very long circuits. For this reason, much of the standard PCB equipment must be replaced with specialized or custom processing machines to support this market. 

The challenge has been to modify the processes and equipment to accommodate the needed lengths of 1.5 meters or more while simultaneously being able to support conductor widths and spacing of 50 µm or less. Advancements have come in the way of better targeting, imaging, and the ability to run these larger panels through the equipment without damage.

Matteri: A unique manufacturing challenge is managing electronic components when they go obsolete and must be replaced. Consumer electronics phase out all the time and people buy a new device. Most medical device programs last one to two decades, or more. The chips the designers choose at the start of the program will likely not be the same ones used by the end of the product’s lifecycle. This leads to several updates and requalification throughout the life of the program. It can cause havoc on a manufacturing line when a new component no longer fits in the same package that the old component did. This will often require new process development, updated procedures, and downtime until it can be resolved.

Rosenblum: Environments requiring sterilization call for more resilient, often exotic materials, tighter zero-defect quality standards, and lifecycle testing data that isn’t available for off-the-shelf or “commercial” components. We are frequently asked to deliver extreme miniaturization of its battery connectivity components, driven by the rising power requirements and shrinking PCB real estate common to new medical device designs.

Stein: One of the biggest challenges is balancing innovation with compliance. Medical device manufacturers continuously push the boundaries of miniaturization, connectivity, and functionality, but every new technology must be introduced within a highly regulated environment where product quality and patient safety cannot be compromised.

Miniaturization presents significant manufacturing complexity. As devices become smaller, component density increases, assembly tolerances tighten, and testing becomes more challenging. Incorporating sensors, wireless communication capabilities, and sophisticated electronics into compact devices requires advanced manufacturing processes and specialized expertise.

Supply chain management is another critical challenge. Medical devices often remain on the market for many years, while electronic components can become obsolete much sooner. A key strength is how we develop proactive strategies to manage component lifecycle risks without disrupting product availability.

Finally, maintaining complete traceability, process validations, and consistent global quality standards across complex manufacturing networks is essential. The challenge isn’t simply producing electronics, but producing them consistently, at scale, and in a way that satisfies stringent regulatory and quality expectations worldwide.

Thornhill: The biggest engineering challenge is balancing extreme miniaturization with robust mechanical reliability, particularly when handling delicate, sensitive electronics. Ensuring the survival and functional integrity of these integrated components during high-density, mixed-technology encapsulation requires highly specialized automated placement, rigid cleanroom controls, and real-time 3D AOI inspection. 

Matching the speed of device innovation with traditional tooling timelines can be a massive bottleneck for OEMs during the prototyping and validation phases. P1 actively solves this by deploying advanced Mantle 3D automated toolmaking in-house, which allows us to print precision steel mold inserts and cut tooling lead times from months to weeks, bridging the gap between prototype and high-volume cleanroom production.

Tucci: One of the biggest challenges isn’t the electronics themselves—it’s that many organizations are still trying to bring intelligent, sensor-enabled medical devices to market using manual processes designed for mostly mechanical products. This isn’t new; many industries attempt to retain familiar paradigms for as long as possible before recognizing a new approach is required. We see that transition beginning in medical technology today, where the mismatch between keeping the old manual labor model and the clear need to design smart devices for automated manufacturing is becoming increasingly apparent.

We’ve seen this transformation before. In automotive electronics, early sensor manufacturing relied heavily on manual wire bonding and labor-intensive assembly. As products became more sophisticated, manufacturers evolved to automated wire bonding, post-reflow clip connections, and ultimately solderless compliant-pin technologies that improved reliability while simplifying manufacturing. The electronics advanced—but just as importantly, the manufacturing philosophy evolved with them, abandoning manual processes as incapable of meeting performance and scale requirements and fully committing to automation as the foundation for scalability and consistency.

Medical devices are now reaching a similar inflection point. The companies that recognize this shift earliest will develop products faster, reduce technical risk, and most importantly outperform competitors who still believe they compete through labor rather than intelligent manufacturing.

Tuers: One of the biggest challenges is balancing competing requirements: greater power density, a smaller footprint, low temperatures, minimal acoustic noise, long service life, and regulatory compliance—often at production volumes that don’t support consumer-electronics economics.

Component obsolescence is another major concern. Medical OEMs may need the same design for a decade or longer, while individual electronic components can have much shorter commercial lives. Early collaboration between the device manufacturer and electronics supplier is critical because thermal, EMI, cabling, and mechanical-fit issues become considerably more expensive to resolve after system integration.

Brusco: How do regulatory requirements shape electronics design and manufacturing decisions?

Theresa Gavin: Device manufacturers must meet real-life uses of medical devices to meet demands of form, fit, and function while balancing increased of regulatory scrutiny on patient safety and environmental concerns on materials and packaging. Demands for both second- and third-tier electronic suppliers have increased due to device classification changes in the last few years. Design and manufacturing engineers today make decisions using a risk-based approach to meet these challenging needs.

Matteri: There have been rapid changes in the medical market over the last few years. The adoption of pulsed field ablation technology to treat atrial fibrillation and other heart arrhythmias is a great example where regulatory requirements are lagging. The 3rd Edition of IEC 60601-1 is over 20 years old and designers must balance the needs of this new technology with guidelines that don’t fit well. As standards continue to evolve, they will give designers greater flexibility to fully leverage what PFA technology can offer patients while maintaining safety and compliance.

Stein: Regulatory requirements influence virtually every aspect of medical electronics development. They are not something addressed at the end of the process; they must be considered from the earliest design stages.

Component selection often extends beyond performance specifications to include traceability, supplier quality history, documentation availability, and long-term lifecycle support. Design architectures must support risk mitigation, verification testing, cybersecurity requirements, and reliability expectations. Manufacturing processes must be validated and closely controlled to ensure repeatability and consistency.

Regulatory expectations also drive documentation and change management practices. Even relatively minor modifications to components or manufacturing processes may require detailed evaluation and validation before implementation. This is especially important in today’s electronics environment, where component availability can change rapidly.

Organizations that integrate regulatory, design, supply chain, and manufacturing expertise early in development are often better positioned to accelerate commercialization while maintaining compliance. The most successful programs treat regulatory requirements not as constraints, but as design inputs that help create safer and more reliable products.

Thornhill: Regulatory frameworks like ISO 13485 and FDA guidelines dictate every phase of the manufacturing layout, from initial design-for-manufacturability (DFM) through final shipment. Compliance requires comprehensive process control, environmental segregation in ISO Class 7 and 8 cleanrooms, and absolute, lot-level component traceability to mitigate risk for the OEM. For contract manufacturers, this means that validation protocols, testing criteria (such as In-Circuit and functional validation), and risk management documentation are integrated directly into the actual manufacturing cell architecture. Regulatory mandates ensure a manufacturing process isn’t just precise, but completely repeatable and auditable at every step.

Tucci: The best organizations don’t view regulatory requirements as constraints; they view them as engineering discipline. Every design decision should assume it eventually must be verified, validated, documented, and reproduced consistently over years of production. That philosophy influences everything from component selection and supplier qualification to software architecture, manufacturing validation, traceability, inspection strategies, and change management. Here too, we see a fundamental shift required in the regulatory approach away from mechanical reliability to one of hardware/software interdependence as the hardware device is becoming more of a delivery platform than the therapy. 

Increasingly, we’re also seeing AI become a valuable engineering tool. Activities such as manufacturability assessments, documentation reviews, tolerance analysis, and process risk identification that once required weeks of engineering effort can now be completed in hours—or even minutes—allowing teams to identify issues much earlier in development while improving overall product quality.

Tuers: Regulatory requirements must be treated as design inputs from the beginning, rather than testing performed at the end. For a medical power supply, IEC/ES 60601-1 and the applicable EMC and product-specific standards affect isolation, creepage and clearance, touch and leakage current, dielectric strength, materials, thermal protection, and documentation.

These requirements also shape manufacturing through traceability, controlled processes, and disciplined change management. Even when a certified medical-grade power supply is used, the finished device must still be evaluated as a complete system. Designing with adequate margin and working closely with the OEM throughout integration and testing are therefore essential.

Brusco: Can you recall a project where custom electronics enabled a function or clinical outcome that otherwise wouldn’t have been possible?

Clark, Gavin, Rossberg: In addition to support of catheter applications, custom flex circuits can support applications requiring heat. By using resistive conductor material, flex circuits can deliver very precise heating to medical applications. These applications range from diagnostic equipment to heated surgical tools to skin warming devices to increase circulation. Most of these applications would be difficult or impossible without flex circuits.

Matteri: Rather than a single project, we’ve seen custom electronics become an enabling technology across numerous medical applications. Many of the therapeutic and diagnostic procedures currently in use wouldn’t have been possible 30 years ago. Computing power has massively changed what is possible, from advanced 3D mapping of the heart at a very high resolution to cameras small enough to look inside a shoulder or knee.

Rosenblum: Our only real benchmark for success on these custom medical projects is repeat ordering—as a component supplier working through an authorized distribution network, we’re often not told the end application and have no visibility into a program’s clinical trial status or outcome. That said, we’ve supplied custom battery contacts used in defibrillators, patient monitoring devices, and handheld medical monitoring equipment operated by both clinicians and consumers. One clear example: our complete line of locking coin cell battery retainers—engineered with a locking flange to secure the battery under shock and vibration—began as a custom request from the medical marketplace and is now a standard catalog offering. We’ve also developed contacts specifically for small, plastic-enclosure designs, giving OEMs more design flexibility and easier battery replacement in the field.

Stein: One common example involves next-generation connected medical devices that combine advanced sensing, embedded processing, and wireless communications to create entirely new models of patient monitoring and care.

Historically, many healthcare interactions occurred only during scheduled clinical visits. Today, custom electronics can enable devices to continuously collect physiological data, process information locally, and securely transmit meaningful insights to healthcare providers in near real time. This capability can support earlier interventions, reduce unnecessary hospital visits, and improve overall patient engagement.

Enabling these outcomes requires more than simply integrating electronics. It demands custom architectures that balance performance, power consumption, data integrity, reliability, and user experience within a highly regulated environment. The combination of miniaturized electronics, intelligent sensors, connectivity, and scalable manufacturing has helped transform many categories of medical devices from standalone products into connected healthcare platforms that deliver value throughout the patient’s care journey.

This type of innovation highlights why custom electronics have become such a critical component of modern medical device development and why collaboration between device innovators, engineering teams, and manufacturing partners is increasingly important.

Thornhill: We recently finalized a complex, next-generation spinal harness assembly for one of our customers, a project that required nearly two years of close collaboration among several of our specialized design and manufacturing engineers. The surgical instrumentation space demands absolute signal integrity and environmental protection under rigorous operating conditions, which off-the-shelf electronic components cannot reliably support. By developing a power-level harness configured to highly customized specifications, our team successfully balanced tight-tolerance mechanical ruggedization with flawless signal transmission. This intricate, multi-layer integration provides the continuous diagnostic feedback and system reliability that surgeons rely on during complex, high-stakes spinal procedures.

Tucci: One example involves a next-generation therapeutic device currently under development. While I can’t discuss the customer or product specifically, the challenge wasn’t designing sophisticated electronics—it was integrating relatively simple electronics, multiple sensing pads, and electrical interconnects into a complex silicone overmold while preserving the flexibility, durability, and mechanical performance required for repeated clinical use. That integration enabled an entirely new therapeutic approach by allowing the device to safely operate within the body while maintaining the intuitive feel physicians expect. In this case, the application engineering was significantly more challenging than the electronics themselves.

Just as importantly, the product couldn’t achieve the required quality, consistency, or commercial economics through manual assembly. It had to be designed from the outset for highly automated manufacturing, where precision over-molding, electronics integration, inspection, and functional testing become part of one integrated process.

Having previously experienced the automotive industry’s transition from predominantly mechanical products to intelligent, electronically controlled systems, we’ve seen how transformative these shifts can be. Success wasn’t driven simply by better electronics—it came from rethinking how products were designed and manufactured as fully integrated systems. We believe medical devices are entering that phase.