With the increased development and utilization of custom electronic components in expanding medical markets such as near-patient testing, remote patient monitoring, and wearables (for example, continuous glucose monitoring), the demand for custom electronics for these and other applications has never been higher. Trends such as advanced capabilities in the Internet of Things (IoT), wearables, miniaturization, and non-invasive procedures continue to drive medical product engineers to develop customized electronic components and interconnect solutions.

Medical device manufacturers (MDMs) are seeing an increased need for specialty interconnects within their devices, including “flexible circuits, rigid flex, and flexible heaters,” said Carey Burkett, vice president of Plymouth, Minn.-based Flexible Circuit Technologies (FCT), which designs and produces custom specialty interconnect solutions and provides value-added assembly services. “Trends such as miniaturization, mobility, and wearable technologies are driving product designers to use specialty interconnects because of their ability to fit into compact or irregularly shaped products and still maintain high performance and durability.”

Another reason for the surge in custom interconnects over the past few years is the increased use of pulsed field ablation for electrophysiology applications. This has created the need for interconnect solutions that combine high voltage and low voltage signals in the same connector. “Each system has different voltages and a different number of contacts, so standard catalog solutions are not practical,” said Gary Reed, director of product management for ODU-USA, a Camarillo, Calif.-based provider of interconnect solutions, including integration for cable assembly in various markets, including medical devices. “We are also seeing increased demand for fluid or gas contacts in the same connector as the logic signals. The combination of the connections in a single interconnect elevates the user experience and cuts the cost of the system.”

Miniaturized intelligent modules that drive motors and collect performance data are becoming increasingly sophisticated, “combining power amplification, analog signal processing, and microcontroller-based data processing,” said Chuck Lewin, CEO for Performance Motion Devices (PMD), a Boxborough, Mass.-based designer and manufacturer of advanced motion control electronics used in medical devices, laboratory automation, mobile robotics, and other automation industries.

Custom electronic modules typically consist of one or more printed circuit board assemblies (PCBA) inside a housing, which often has single sole-sourced components. In these limited sourcing situations, “these critical components need to be monitored for obsolescence or availability risk,” cautioned John Sheehan, president of SigmaTron International, a global electronic manufacturing services (EMS) provider with operations in the U.S., Mexico, China, and Vietnam. “To address this need, our new product introduction process includes a product lifecycle management analysis/review.”

Sheehan also noted that more MDMs are looking for alternate sources for custom modules and components to replace those coming out of China, not only for greater supply chain stability but to also avoid the tariffs that apply to China-sourced products. “Currently, manufacturing in Mexico can eliminate the tariffs associated with China-built modules, but we don’t know how long that policy will remain,” he added.

Current Trends

MDMs are intent on finding new ways to use IoT technologies to customize electronic components and add more functionality and durability. Sometimes the customization is easy—in other instances, it requires innovative thinking, creative design, and proprietary equipment. Finding the best solution depends on the design, size end use, tolerances, and budget.

“A primary trend we see in custom electronic components in the field of motor control for mission-critical medical or robotic devices is the application of artificial intelligence [AI] to not just control the motor, but to also analyze the performance feedback the motor provides,” said Lewin. “This feedback comes from position encoders, current sensors, heat sensors, and vibration sensors that are already present in the normal function of controlling the motor. Analyzing this data allows for a future prediction of that device’s ability to carry out its function.”

One of the fastest-growing trends in custom electronic components is the development of flexible substrates and conductive inks with greater elasticity. “The wearables category of medical devices is a strong contributor to this trend,” said Alicen Pittenger, director of sales for Conductive Technologies, a York, Pa.-based contract manufacturer (CM) for the medical device and industrial markets. “Medical device manufacturers are looking for components that will move and flex with the end user, without compromising the electronic component.”

As the overall size of medical devices becomes smaller, so does the available space into which subcomponents can be fitted. MDMs often challenge their CMs to incorporate more electronic capabilities into smaller spaces or challenging form factors, which requires a design team with deep, multi-discipline experience. “Design engineers must understand the design rules,” said Burkett. “They must know when or when not to push the rules to get to designs that will satisfy the customers’ requirements and still produce a cost-effective product.”

These designs can often be customized by increasing the device’s electronic capabilities or its mechanical performance. “Motor speeds can sometimes be slightly increased to hit performance points, while also offering the ability to monitor temperatures, should things heat up with less breathing room,” said Dave Howard, business development manager at KNF Neuberger, a Trenton, N.J.-based designer, manufacturer, and distributor of diaphragm pumps and systems for handling gases and liquids.¹

What OEMs Want

OEMs are always on the hunt for quality, functionality, smaller designs, faster speed to market, and product differentiation in the marketplace—all at a good price.

The best way to accomplish these goals is through the deployment of IoT technologies—which also enhance the multifunctionality, complexity, and customization of electronic components.

With new technology and software developments, component designs have had to shift to support the vast array of new technology. “For example, many years ago, cables and connectors were very simplistic and just a means to connect items,” said Drew Bratton, director of business development at P1 Technologies, a Roanoke, Va.-based manufacturer of injection molded products and interconnect cables for the medical industry.

“Many of our clients now look to combine multiple cables, electrodes, and circuitry into one complete system, whereas in the past, it may have been multiple items working in tangent. Some of these new components include electronic identification and limited-use chips, making our cables and connectors intelligent.”¹

Customers are demanding more complex solutions than ever before—especially wearables and devices that interface with the body and transmit data to a cell phone app. “Medical device companies are requesting custom components that are much more complex than before, such as sensor designs that require the use of fine-line silk screening and laser ablation,” said Pittenger.

Many MDM product designs involve some degree of miniaturization—from individual electronic components to the entire device. Smaller medical device dimensions and footprints that enable mobility, convenience, and lower costs can be huge differentiators in the marketplace. For example, “a PMD client has developed a mobile dialysis machine that patients will be able to carry around and use in their homes,” said Carlos Bielicki, vice president of sales and marketing at Performance Motion Devices. “Think of the benefits to kidney failure patients! Miniaturization and affordability [including electronic components] were key design goals for this product. The current system is going through approval processes and the customer is already planning the next generation, which will be even smaller and lighter.”

Miniaturization itself is a custom solution—whether it is customizing biosensors down to the level of microns or making a wearable device more functional by reducing its size by half. Miniaturization of legacy components can also require creative design solutions and knowledgeable material choices to maintain product performance in a smaller size. “The goal of miniaturization, in many cases, is to make more devices portable or wearable,” said Jan Moehler, sales manager at P1 Technologies. “As a result, our engineering and design team must give more critical consideration to material choices, design for manufacturability, and performance than in the past.”¹

Ultimately, IoT is only as good as the quality of the data being provided.

MDMs are keen on finding experienced engineering support, especially for the design of specialty interconnect solutions. “Unfortunately,” said Burkett, “there is a lack of true expertise in the marketplace for designers who truly understand the materials, material properties, and what can and cannot be done to design cost-effective solutions that will perform in the challenging applications where these technologies are most often deployed.”

The best way to concentrate the multi-disciplinary talent required for customizing electronic components is through vertical integration. Design for manufacturability, quick-turn prototyping, machining for proof of concept, and modifying legacy products can all be accomplished, quickly, under one roof.

“A high degree of vertical integration as a component supplier is essential in order to be responsive and ensure quality through the manufacturing chain,” said Reed. “Having in-house expertise and the ability to propose alternatives is an advantage to the design process, but also improves responsiveness and ultimately will influence lead time.”

Customized Applications

Customizing electronic components requires adaptability and innovative thinking. The first question is how to integrate different technologies and components into smaller areas without sacrificing functionality or performance. Sometimes it is a simple solution—only an adjustment or two. With more complex architectures, “the contract manufacturer may have to introduce new manufacturing technologies/techniques to a medical device manufacturer that will allow the items to be mass-produced, while still maintaining the ability to achieve the outcomes the medical device manufacturer intended,” said Pittenger.

Not only is miniaturization at the top of the customization list, but so are engineered mechanical or material properties, such as stretchability.

“Conductive Technologies is frequently tasked with creating small electronic components or components that are more flexible or stretchable,” said Pittenger. “These adaptations bring challenges to maintaining tolerances, conductivity, and even structural integrity.”

Fiber optics are being used more frequently as a way to transmit data. For medical devices, fiber can reduce electromagnetic interference and electromagnetic compatibility concerns, minimize latency, and improve transmission quality over distance. MDMs are eager to integrate functionality, such as combining signal, high-speed data transmission, high density, high voltage, or even fluid and air, through fiber optics. “The customization happens mostly with the fiber termination and assembly, which can be complicated,” said Reed. “The fiber interfaces require significant investment, but also have several offsetting advantages. The connector becomes more complicated but the end product becomes less complicated, as it is a single point of connection and is quicker and easier for the operator.”

PMD continues to see an expansion of capabilities in FPGAs (field programmable gate arrays), allowing in-field modifications if needed. Device functionality that was previously hard-wired in an application-specific integrated circuit (ASIC) is now feasible to implement in an FPGA.

For example, a module drive unit built by PMD that had been successfully deployed for years in the field by an OEM customer, then found itself operating in a high ESD (electrostatic discharge) environment that exceeded the specifications for which the original unit was designed.

“Via a change in an internal interboard communications protocol, the unit was successfully upgraded without the requirement of a new PCB to operate in this more extreme environment,” said Lewin. “This was only possible because the original protocol processing function was implemented in an FPGA.”

Customizing an electronic component does not have to be a complicated process. Overall, for MDMs, it is much easier to take an existing product series and make small modifications. For example, in the case of connectors, a supplier might have a mixed-signal, high-voltage connector developed for a standard 1,000V, but the customer has a requirement for 1,200V due to differences in waveforms and signal propagation. “We would take 20 of the existing components and combine with a new insert for the customer requirement,” said Reed. “We model and evaluate per the standards and then move to a low-volume tool or tool up to high volume. Again, vertical integration for core competencies plays a key role in making modifications quickly.”

Sometimes customization brings out additional functionality at a lower cost. For example,  a connector that is in use today can sometimes be customized to accommodate more stringent requirements for IEC 60601-1 as a drop-in replacement. “We can add an extra level of operator and patient safety without a large change from the customer, who may not even be aware of the possibility. With this modification, another more expensive means of protection can be reduced elsewhere and the total costs reduced,” added Reed.

Keeping Up with Technology

Consumer devices have led the way in miniaturization—MDMs and their CMs and suppliers must keep up with technological advances or risk becoming obsolete. Miniaturization requires precise process control and Industry 4.0-capable equipment, which helps control processes at speeds and precision levels that far exceed what a human operator can achieve alone.

“Over the last several years, we have been upgrading our surface mount technology [SMT] placement equipment to place smaller components,” said Sheehan. “While doing that, we have also embraced Industry 4.0 communications technology. This allows our SMT inspection equipment to monitor quality and adjust parameters in our SMT line, or call a technician if defects trend up. As with design software, machine learning requires a database that enables machines to make good decisions and our Lean Six Sigma team has built the databases needed for this to be an effective tool. As an example, we can detect tooling wear that is creating a small variation before it creates the variations that drive defects.”

Wearables continue to be a hot market—MDMs want the electronics to be as durable and robust as possible, which means ensuring conductors remain flexible and/or stretchable to protect components and solder joints from flexing. Design considerations for wearables include where the product will be worn and for how long, what stresses the product will experience, and the bend cycle requirements that must be met.

“Working with a specialty interconnect supplier that offerseep experience in the design of wearable technologies can be invaluable in shortening time to market while also getting to a solution that will perform in what can be very challenging applications,” said Burkett.

AI will be a game changer in terms of improving equipment optimization, equipment programming, and designing custom components. “That said, AI is not plug and play,” cautioned Sheehan. “It requires a team to develop underlying databases and test whether machine learning decisions are good decisions.”

Medical device design teams tend to be less experienced in dealing with electronic components—knowing what they can do and how they can be integrated into the design—compared to material properties or manufacturing processes. Therefore, it is essential for MDMs to listen to their electronic component providers and get them involved early in the design for manufacturing process. Simply having the ability to pack more electronics into a smaller, more complex space within a device can be a big differentiator among competitor products. 

Be Ready

Custom electronic advancements typically target reducing time to market. 

Key design questions are how long the project will take, what is the customer’s schedule, and what is the best way to reduce the timeline from concept to prototype to customer trials to production. “This really depends on communication,” said Reed. “The market and customers tell us what we need to do. Our job is to package these requirements to reduce future development cycles. Communication, design, and production are typically faster through vertical integration, with the ability to control the internal supply chain, design, tooling, manufacturing, and quality.”

“When meeting with MDMs and design engineering firms,” added Burkett, “we often will review specialty interconnect capabilities and uses, while reviewing a broad range of samples. We often get feedback from the engineers that they had no idea of what can be done with these types of specialty interconnects. One engineer stated that if he had known what he could do with a flexible circuit, it would have saved him nine months on a product and would have been a far better solution. Improved understanding for what is possible will lead to improved solutions, where one can leverage these technologies in innovative ways.”

As medical devices get smaller and more complex, so do their electronic components. MDMs are increasingly asking their CMs for smaller form factors and higher power densities. MDMs are demanding shorter lead times for development, prototype availability, and product volume delivery. These pressures are compounded by a drive toward flexibility in product design, higher density, smaller total footprint, and more sensitive circuitry—all of which push technology to its limits.

Because medical device manufacturing is advancing so quickly, component suppliers must stay knowledgeable about the requirements for these next-generation products. Forward-thinking suppliers will invest the time needed to develop product roadmaps that do their best to follow/react to the larger-scale technology and market roadmaps.

“When companies develop roadmaps,” said Reed, “there is a tendency to evaluate current product extensions and current technologies. The market, however, will have separate roadmaps that incorporate technology adoptions or technology improvements that require more R&D. Suppliers must understand what the customer roadmaps look like, how they reflect trends in the industry, and then position themselves to be ready to respond to those trends, whenever they come, in a proactive fashion.” 

Reference

1. tinyurl.com/mpo240991

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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.