Custom electronics are at the heart of innovation in the medical device industry—especially in the fields of surgical robotics, diagnostics, therapeutic energy systems, and patient monitoring. Contract manufacturers (CMs) and electronics manufacturing services (EMS) providers are often the leaders in propelling innovation forward. As medical device manufacturers (MDMs) push for smarter, smaller, and more integrated technologies, their CMs enable this shift by using the latest advanced manufacturing technologies and engineering value-add services, including proprietary processes developed in-house. 

“Whether it is managing the complexity of high-density interconnects in surgical visualization tools or ensuring test accuracy in patient-critical systems, we are not just building components to spec—we are partnering to solve,” said Sandra Hayes, vice president of the medical sector for Creation Technologies, a Boston, Mass.-based global specialty EMS provider, especially for innovative medical devices.

Also driving these advancements is the strong demand by MDMs for miniaturization, modular designs, and integrated sensing. “There is also a growing need for biocompatible electronics, flexible/stretchable printed circuit boards [PCBs], and wireless power and communication options, especially for wearable or implantable devices,” added Mark Morkos, an electrical design engineer for Brecksville, Ohio-based Lumitex, which designs, develops, and delivers lighting systems for several cutting-edge industries, including medical technologies. 

Other medical devices that depend heavily on custom electronic components include ultrasound devices, defibrillators, implantable pacemakers, portable medical monitors, and electro-surgical instruments. MDMs also want the “design freedom to customize a standard part, or build a component from scratch, based on their highly specific criteria,” said Joe Rosenblum, director of marketing for New Hyde Park, N.Y.-based Keystone Electronics, a manufacturer of precision electronic interconnect components that are specifically designed for the medical device industry. 

Current Trends

MDMs are seeking advances in functional miniaturization with manufacturability, lifecycle-centered sourcing, engineered materials, and customized features. For example, across surgical platforms and endovascular devices, MDMs are demanding ever-smaller electronics that will not compromise power integrity or reliability. “We are routinely supporting builds with 01005 component placement, ultra-fine pitch PCBs, and components capable of surviving sterilization or high-thermal loads,” said Hayes.

With so many devices incorporating optics, motion, or energy delivery (such as surgical lasers or therapeutic wearables), early involvement by EMS partners in the design for manufacturing (DFM) process is essential for streamlined, mistake-free production. This is also important for verifying the performance parameters for each device, which can require building tailored automated test solutions for production, ensuring precision calibration and compliance, even for six-axis motion applications. 

In sectors such as diagnostics and aesthetic lasers, where rapid technology evolution often collides with component obsolescence, “we have embedded bill of materials risk analysis and supplier alignment directly into our prototyping and ramp processes,” said Hayes. “That way, we are not just building a product—we are also proactively planning for its long-term sustainability.”

Surgical robotics, therapeutic lasers, pulsed field ablation systems, and energy-based devices increasingly require PCBs with thick copper (>3 oz/ft²) to support pulse-power delivery, thermal dissipation, and long-term reliability. “Our capabilities in heavy-copper manufacturing allow us to meet these needs while still maintaining compact form factors and strict regulatory compliance,” said Hayes.

In the connector area, MDMs are requesting smaller, lighter products—especially hybrid connectors that can accept more than one type of element, thereby combining multiple functionalities in a single connector. “In the medical world, a good example is containing power contacts and fiber optics into a single connector,” said Steven Lassen, senior customer application engineer for LEMO, a Swiss-based global company that designs and manufactures precision custom interconnection and cable solutions, with expertise in push-pull connectors. “This helps save space and weight as well as make it easier for end users, as they will only have to manipulate one connector rather than two or more separately.”

Light-emitting diode (LED) technology is rapidly advancing, both in size and performance. The speed at which companies are innovating LEDs is exponential, driven by ongoing demand for precision and versatility across a variety of medical applications. LEDs are getting incredibly small (micro and even sub-micro); when combined with the wide range of wavelengths available today, there are now design options that were not even possible five years ago. 

“This progress opens up new possibilities in treating disease states, enabling more targeted therapies,” said Joe Dombrowski, vice president of engineering for Lumitex. “There is also growing attention to system efficiency—for example, reducing water usage in dialysis machines—which ties directly into how custom electronics can support more sustainable and effective medical solutions.”

What MDMs Want

More MDMs are asking their EMS partners to engineer complete, integrated electronic systems—not just components. “This generally comes with constraints in the design [such as size, heat, cost, and efficiency] so we have to be creative with our solutions,” added Dombrowski.

For example, as the power requirements increase for a device design that is miniaturized, the space allotted on the PCB may not always be as accommodating. “This makes PCB real estate a premium, requiring more creative ways to connect a battery or power source for a medical device, specifically hand-held type units,” added Rosenblum.

Demand is on the rise for wireless technologies such as Bluetooth and Internet of Things (IoT)-enabled components for real-time data monitoring. Connectivity is a major priority, but rapid growth is also creating concerns regarding cybersecurity, electromagnetic interference, and overall system safety. Therefore, designing devices for secure, reliable performance is a top priority. 

Customization requests often revolve around form factor adaptation (such as ultra-thin, curved, or miniaturized boards), high reliability in extreme environments (heat, fluids, sterilization), and integration with optics. “There is also considerable interest in custom sensor arrays, LED lighting for imaging or therapy, and low-noise analog front ends for bio-signals,” said Morkos.

An increasing number of MDMs want “smart” connectors that make use of an EEPROM (electrically erasable programmable read-only memory) to store information such as serialization, or to act as a dongle (a small device that allows access to wireless broadband or protected software) that has an encrypted “token” which only works with their products. “This minimizes patient risk from using knockoff products,” said Lassen. “Smart connectors like these can also be programmed to count the number of times the connector has been cycled and perhaps disable a feature if the connection count goes over the pre-programmed amount.”

Lassen is also seeing more requests for higher-speed data to transmit 4K video (as well as power) over a single connector, rather than using the standard RJ-45 ethernet connectors. LEMO has ruggedized ethernet connectors for standard RJ-45 signals used in medical environments. This not only increases the number of mating cycles the connector can withstand but also protects signal integrity while combining additional connector elements such as power or fiber optics into a single, compact connector.

Tech and Tools

Artificial intelligence (AI) is always at the forefront of innovation. Tools such as AI-assisted PCB design, real-time signal simulation, and generative component placement/routing are speeding up prototyping. AI is also used for predictive reliability testing and automated defect detection during manufacturing. “For firmware, some teams use AI to suggest optimizations for power or response time in real time,” said Morkos.

Customizations for electronic components continue to get smaller. For example, custom application-specific integrated circuits (ASICs) are now being developed that are less than 1.0 mm², yet still provide fully tailored functionality for sensor arrays, neural implants, and smart contact lenses. 

“This allows engineers to embed highly specialized functionality into extremely compact footprints,” said Alan Greszler, chief technology advisor for Lumitex. “This level of miniaturization is especially valuable in next-generation medical applications such as neural implants, where space is limited and precision is critical, or in smart contact lenses that require unobtrusive, low-power electronics to monitor health metrics or deliver drug therapies discreetly.”

Micro-LEDS as small as 10 microns can be produced for transdermal applications and optogenetics. This size allows them to be integrated into flexible patches for transdermal phototherapy. In optogenetics, micro-LEDS can be implanted to precisely stimulate specific neurons using light, which opens possibilities for advanced brain research and new treatments for neurological disorders. Within light-guide systems, small light-guide bundles for direct light delivery and imaging in catheter systems as small as 0.3 mm are possible. “Delivering light in these spaces was previously not possible or accessible,” said Greszler. “Such miniaturized lighting solutions now allow for more minimally invasive procedures, deeper inside the body.”

New battery chemistries are constantly being developed, with a connective function that remains relatively unchanged: the need to solder a battery clip, contact, or holder to a circuit board to power the device. “Concerns with some new chemistries, however, include the possible incompatibility of the chemicals and the contacts in the event of leakage, which, in most cases, results in device failure, regardless of how it is designed,” said Rosenblum.

For push-pull type input/output (I/O) connectors, the use of edge-card technology is a relatively recent innovation. Normally used in board-to-board or daughter-card applications, utilizing edge cards on circularly cabled I/O connectors can greatly increase the number of contacts within a single connector. “Often the cost of termination of the connector can be as much, or more, than the connector itself, so assembly time and cost can be greatly reduced by automating the termination process,” said Lassen. “LEMO’s edge-card modules can be used in combination with other standard power, single-mode or multi-mode fiber, or pneumatic shutoff contact modules to custom-tailor a solution using a mix of standard components.”

Another recent development in the custom electronic component space is Texas Instruments’ eFuses. These integrated electronic fuses provide advanced circuit protection, including overvoltage, inrush current limiting, reverse current blocking, and even adjustable current limiting—all in a compact integrated circuit footprint. “They replace bulky discrete components like positive temperature coefficient, diodes, and field effect transistors with a single chip,” said Morkos. “They are ideal for space-constrained medical applications where power reliability and patient safety are critical.”

Top Challenges to Customization

MDMs are intent on finding new ways to use IoT technologies to customize their electronic components and add more functionality and durability. Finding the best solution depends on a number of factors, such as design complexity, size, end use, tolerances, and budget. Simply balancing these factors is often seen as the greatest challenge of all for medical electronics engineers. They must ensure compatibility with existing systems, maintain affordability, and address the rapid pace of technological advances. Increasingly strict regulatory guidance often requires extensive testing and documentation, which can be time-consuming, extend timelines, and delay time to market. MDMs can improve their legacy products (proven materials and performance, easier to approve) or design more innovative components that might require more testing and validation to satisfy the FDA—another balancing act. 

Miniaturization and flexibility/stretchability also come with several trade-offs. When components get smaller, power availability can become a limitation. There is only so much space for batteries or power delivery. Efficiency may also suffer, as it is more difficult to manage heat and signal integrity in tight spaces. “Flexibility and stretchability introduce additional challenges around material durability and long-term reliability,” said Dombrowski. “You might need to sacrifice some lifespan or performance to achieve the desired form factor.”

Next-Generation Thinking

AI applications that accelerate design and integrate technology more efficiently will drive the future of miniaturization. New medical device products/applications that rely on customized electronic components include:

• 3D-printed electronically sensitive materials that can be light-activated are being developed to allow for non-invasive cardiac support. “This will reduce patient risk while still delivering therapeutic benefits in real time,” said Dombrowski.
• Bioelectronic printed materials that are flexible and biocompatible will facilitate the development of implantable technologies that provide neural links via stretchable electrocardiogram sensors.
• Printed electronics—functional inks enable the printing of electronic components directly onto various surfaces, enabling the creation of ultra-thin, flexible, and conformable devices. Smart bandages, electronic skin patches for monitoring vital signs, and advanced drug delivery systems are currently using printed electronics.
• Integration of sophisticated test systems with manufacturing processes that do not just verify functionality, but also calibrate, log, and even provide predictive insights for the MDM using real-time data.
• “In energy-based surgical systems, for example, real-time monitoring of pulse delivery, waveform consistency, and thermal load during test is becoming standard practice,” said Pat Wilson, director of test development for Creation Technologies. “Combined with our heavy-copper board capability, we are now manufacturing boards that can support both high electrical demand and advanced thermal management within a compact footprint—blurring the lines between test lab performance and production execution.”
• Ingestible sensors that are designed to be swallowed to collect data from within the body. They are mostly used to monitor medication adherence and assess gastrointestinal conditions.
• Devices that once required multiple boards and connectors are now being built on single flex circuits with embedded intelligence—made possible by both component advances and refined manufacturing strategies.
• Improved user interface features, such as intuitive touchscreens, responsive controls, and clear displays, make medical devices easier to use, which improves patient compliance. 
• Custom electronics are essential for creating virtual reality simulations, which offer surgeons the opportunity to practice procedures before performing them on actual patients. These simulations also enhance their skills and knowledge, thereby improving patient satisfaction scores.

Perhaps the most innovative applications of miniature electronics are in the field of neurology. For example, “3D-printed scaffolds can be folded up and placed in the brain and then be manipulated to modulate brain activities to control movement disorders such as Parkinson’s and epilepsy,” said Greszler. “Stanford’s wireless vagus nerve stimulator for gut-brain modulation, which relies on microelectronics and ultrasound coupling to power the system, is truly mind-boggling as it provides full nerve stimulation without wires or an implantable generator.”

Moving Forward

As medical devices become smaller and more complex, so do their electronic components. In addition to shorter lead times for development, prototype availability, and product volume delivery, MDMs are asking their EMS providers for smaller form factors and higher power densities. These pressures are compounded by a drive toward flexibility in product design, smaller total footprint, and more sensitive circuitry—all of which contribute more time-to-market pressures and push custom electronic technology to its limits.

Collaboration between MDMs and their custom electronics vendors is essential for streamlining design and manufacturing procedures, including custom electronics needs. This starts with DFM, which will determine the best custom electronic package for a device by applying sophisticated design tools such as finite element analysis, digital twins, rapid prototyping, and generative design with AI, followed by rigorous testing. 

“Having an electronics manufacturing partner with a strong medical technology portfolio with some vertical integration can help support a faster time to market and offer product innovation for next-generation products,” said Ray Cottrell, executive vice president of Flexible Circuit Technologies, a Plymouth, Minn.-based provider of flexible circuit designs, including rigid and flat flexible circuits and heaters. “This portfolio could include PCB/flexible circuits, plastics, high-density interconnects, membrane switches, or cutting-edge substrate-like PCB materials that shorten possible supply chain issues, alleviate risk, and support OEM innovation.”¹

In addition, John Sheehan, president of Elk Grove Village, Ill.-based SigmaTron International, a provider of printed circuit board assemblies and electronic products, recommended an initial product lifecycle management (PLM) evaluation to identify obsolescence and availability risk in a timely enough manner that contingency planning can be done.¹

“It is important for EMS suppliers to have a PLM focus for continuity of supply and cost management,” he said. “We want a healthy bill of materials, which entails knowing when components are going end-of-life, ensuring we have replacements ready to drop in, and finding alternate components that are cost-competitive.”¹

The need for custom electronic components is driven by trends such as flexible electronics and the integration of AI and IoT technologies. Miniaturization in electronics and package sizes will also lead to advancements in materials, manufacturing techniques, and capital investment in equipment to support new medical products.

Ultimately, these innovations will lead to more sophisticated, personalized, and patient-friendly healthcare solutions. 

However, customization is not just about miniaturization or tweaking components—”it is also about aligning your manufacturing partner with your innovation strategy,” said Wilson. “For MDMs developing the next generation of surgical robotics, diagnostics, and therapeutic platforms, that means engaging their manufacturing partners early and often, particularly around test and supply chain architecture.”

Reference

¹ tinyurl.com/mpo250921

Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.