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    Features

    Power Trip: A Discussion of Custom Medical Electronics

    Nearly a dozen electronics manufacturers weigh in on the medical device industry trends and challenges impacting their businesses.

    Power Trip: A Discussion of Custom Medical Electronics
    3GHz contact that can be used in various insulator types. Image courtesy of LEMO.
    Power Trip: A Discussion of Custom Medical Electronics
    A rigid flexible circuit able to fold and install into an application. Image courtesy of Flexible Circuit Technologies.
    Power Trip: A Discussion of Custom Medical Electronics
    REDEL SP connectors are plastic Push-Pull connectors with an ergonomic grip and a variety of colors. Image courtesy of LEMO.
    Power Trip: A Discussion of Custom Medical Electronics
    B Series connectors provide a modular, ergonomic, rugged, and reliable circular multipole connector for applications needing quick and secure Push-Pull latching. Image courtesy of LEMO.
    Sam Brusco, Associate Editor09.06.23
    Thanks to the advancement and integration of technologies like the Internet of Things (IoT), big data, and artificial intelligence (AI), the medical industry has moved toward a digital transformation, driving creation of a networked, intelligent, and personalized Internet of Medical Things (IoMT) ecosystem and applications.

    The COVID-19 pandemic accelerated progress of telehealth/telemedicine with no-contact health monitoring devices as well as online consultations. In addition to medical devices to remotely, continuously monitor health and treatment conditions, biometric and wearable devices are growing more popular for use outside hospitals and at home, creating a new wave of medical electronics business opportunities.

    Diabetes management systems, cardiovascular health systems, respiratory and sleep therapy, and remote medical examinations are rapidly emerging as a result. Compared to traditional devices that have simple functions and can be bulky, the next generation of digital medical devices is smaller in size and can be combined with smartphone apps to offer faster data access, remote health monitoring, and automation.

    For example, insulin injection patches can be activated to automatically deliver bolus when low blood sugar is detected. Or, a heart monitoring patch can record heart rate data and transmit to a smartphone app and centralized server to be observed and evaluated by a primary care physician.

    Advanced electronics manufacturing capabilities and technologies like automation and robotics, digitization, simulation, and additive manufacturing are also offering better efficiency, quality, and sustainability for electronics manufacturing. Given these factors, the demand for custom, precision medical electronics manufacturing is stronger than ever.

    To further examine the medical electronics industry and custom manufacturing services for medical device makers, MPO spoke with nearly a dozen manufacturers over the past few weeks:

    Andrew Aurand, national sales manager at Clippard, a Cincinnati, Ohio-based designer and manufacturer of miniature fluid control solutions.
    Peter van Beek, business development manager for medical at maxon, a Taunton, Mass.-based provider of precision drive systems.
    Carey Burkett, vice president at Flexible Circuit Technologies, a Plymouth, Minn.-based supplier of flexible circuits, rigid flex, flexible heaters, and membrane switches.
    Ernie Doering, chief operating officer at Clippard.
    Tim Hemphill, sales manager at ATL Technology, a Springville, Utah-based custom interconnect solutions provider.
    Jamie Holley, president at Backer Hotwatt, a Danvers, Mass.-based manufacturer of electric heating elements.
    Richard Johannes, director of engineering at LEMO USA, a Rohnert Park, Calif.-based designer and manufacturer of precision custom interconnect solutions.
    Bob Kish, sales product manager at FAULHABER MICROMO, a Clearwater, Fla.-based supplier of high-precision micro motion technologies.
    Jan Moehler, sales manager at P1 Technologies, a Roanoke, Va.-based full-service contract manufacturer of complex medical cables.
    Biren Patel, business development manager for mobility and motion control at maxon .
    Doug Paynter, proportional valves product manager at Clippard.

    Sam Brusco: What are customers commonly demanding or expecting from their electronic components?

    Andrew Aurand: Electronic components are such a large category. For electronic valves, some of the demands differ, depending on the valve technology. However, they all must be reliable and high quality. Consistency in the manufacturing process is required to ensure the customer doesn’t have issues between batches. For electronic controls, the demands are much more complex—not only must the product be reliable and high quality, it also needs to be easy to troubleshoot, have flexibility in configurations, and be able to pass quality certifications.

    Carey Burkett: Our view is the specialty interconnect (flexible circuit, rigid flex, flexible heater) may be the most important component of all, especially when considering the challenging applications where these solutions are often deployed. Trends including miniaturization, mobility, connectivity, IoT, and challenging form factors are driving product development engineers toward these solutions. There are limited design experts offering significant expertise related to materials, material properties, and capabilities in designing a specialty interconnect that will perform as required.

    These specialty interconnects are often at the heart of the product solution and must be able to perform flawlessly in medical applications. Customers often demand and expect the supplier can provide expertise and guidance that will lead to a cost-effective design that will perform flawlessly. Customers also expect responsive service, support, and on-time delivery during prototyping and further throughout production.

    Tim Hemphill: Shorter lead times, alternative equivalents, assurance of supply, and the absolute best quality.

    Jamie Holley: Our customers are increasingly asking for smaller form factors and higher power density, so we are continually looking for ways to reduce the footprint of our heaters, while at the same time, increasing the power. This involves researching new raw materials that were previously too expensive to use in our applications or that were not readily available in the marketplace. We are now looking at designing heaters with materials such as carbon nano tubes with high electrical conductivity, or high dielectric strength materials like aluminum nitride or barium titanate to solve customers’ design challenges.

    Richard Johannes: Customers commonly demand short lead times for development, prototype availability, and product volume delivery. This is compounded by a drive toward flexibility in product design, higher density, smaller total footprint, and more sensitive circuitry.

    Bob Kish: First and foremost, a stable supply chain, availability of stock, and stable pricing. Supply chain issues for electronic components continue to be a challenge, driving up cost. Equally important, compliance to industry norms such as REACH and RoHS. Many customers today look for complete motion system solutions from a single supplier (motor, gearhead, encoder, and drive electronics). These system solutions must be able to communicate via CAN Open, USB, and EtherCAT.

    Jan Moehler: Customers consistently demand high performance, traceability, reliability, and dimensional consistency from their electronic components. Superior quality cables, connectors, and molded parts are a must for end-users and the patients they serve. There’s also a trend toward more turn-key projects that include labeling, IFUs, and final packaging.

    Biren Patel & Peter van Beek: Customers are expecting robust solutions that can stand up to harsh environments like cleaning, as well as occasional splashing of fluids.

    Brusco: How is the miniaturization trend in medtech affecting electronic component manufacturing?

    Burkett: Specialty interconnect solutions can address a broad range of needs where miniaturization is a driving force for the application. When compared to standard rigid PCBs flexible circuits, rigid flex, and flexible heaters can be offered in a smaller footprint, space, and in challenging form factors. Any component you can place on a standard rigid board can be placed on a flexible circuit, including fine pitch BGAs and 01005 components.

    For a medical device we produce, we have a small plastic housing into which the circuit must fit. There were many components required, given the need to pack significant electronic capability in a very small space. The solution we designed was a rigid flex with two rigid areas—components in the front and back with flex in between. This solution allowed folding the circuit over onto itself and inserting it into the small housing.

    Ernie Doering: Miniaturization in medtech is having a profound effect on electronic component manufacturing. Smaller devices require smaller electronic components, which in turn must be mounted on smaller printed circuit boards. Maintaining robust PCB behavior in a smaller package requires great design creativity. As medical devices get smaller, thermal management grows more important. Components must become more efficient, driving development of more advanced materials and technologies.

    Hemphill: Medtech manufacturers must make new investments to keep up or outsource some of their manufacturing process, i.e., chip scale packaging and direct attach die bonding. Typical medical device manufacturers have not invested in these advanced processes yet.

    Holley: It’s forcing us to push boundaries for what we believed possible, and creating new possibilities. We have made significant steps in improving the power densities of our heaters in small form factors. As we find new materials that make these improvements possible, we must define design envelopes, assembly processes, and reliability tests to prove out the technologies. This requires keeping our ears to the ground to find new materials and ideas that will help solve our customers’ problems.

    Johannes: The miniaturization trend in medtech requires use of ultra-fine 44 AWG and smaller wires, making assembly/termination of a large number of conductors the primary cost driver for medical device systems. In addition, the signals are either extremely low energy (and easily corrupted), or high-voltage, high-density signals requiring new techniques to prevent insulator breakdown and arcing. These high voltage circuits are also typically pulsed voltage, making crosstalk a major issue.

    Kish: For motor and motion control components, miniaturization leads to revolutionary mechatronic designs, where cabling and electromagnetic interferences (EMI) are greatly minimized. While there is a trend toward smaller solutions with more features and functions, many times customers simply want to get the primary job done at the lowest total cost and/or lowest risk.

    Moehler: Miniaturization of legacy components or new innovative technologies requires creative design solutions and knowledgeable material choices to maintain product performance in a smaller body. The goal of miniaturization, in many cases, is to make more devices portable or wearable. 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.

    Patel & van Beek: We must be more creative and start to consider offering controllers not based on traditional PCB concepts. There are efforts toward integrating the controller into the same housing as the motor and gearbox—the big challenge is heat management. As an example, our IDX platform incorporates gearbox, motor, encoder, brake, and drive electronics into one housing. The user can customize a solution (the complete drive assembly) all online via a configure-to-order tool.

    Brusco: How is IoT (Internet of Things) and the trend toward connected medical devices affecting electronic component manufacturing?

    Burkett: IoT and connected devices lead to added design considerations, including connectivity method, data speed, data integrity, miniaturization, wearability, mobility, and challenging uses. All are a part of IoT-related considerations impacting design and manufacturability in getting to a solution that will perform as desired for a given application. Flexible circuits allow incorporation of embedded, custom precision Bluetooth antennae and EMI shielding for the most effective processing of sensitive signals. These features can be added with little increase to the flex’s overall thickness.

    IoT’s impact on component manufacturing will continue to push manufacturers to miniaturization, mobility, and added IoT-related features to meet the requirements for these growing applications. Customer-driven technical roadmaps will continue to push manufacturers to their limits, given the desire to pack more electronic capability into smaller spaces and packages.

    Hemphill: Being connected to the internet is being pushed more and more and for capital equipment, and is very common now. For single-use, disposable medical devices, the overhead cost is usually prohibitive. But costs are coming down and it’s likely the trend will cause more adoption.

    Holley: We’re constantly assessing ways to improve our yields and reduce waste. We can now capture scrap data and perform process testing in real time with networked testing equipment. As test data comes in from the shop floor, we can see if there’s a problem before any more value is added to the parts. We are also gathering an abundance of valuable data that will help us solve problems by looking at inter-relationships that may not be obvious. For example, hi-pot failures are quite common in our industry—our raw materials tend to absorb moisture during storage and the manufacturing process. We now have data to trace these failures back to the supplier material/manufacturing process/storage time/operator and look for dependencies.

    Johannes: The IoT is forcing two main requirements in electronic component manufacturing: a reduction in wired interfaces with an increased reliance on wireless connections, and in cases where wired interfaces are used, the connections must be more rugged and much smaller in footprint (often with integrated active content).

    Kish: The trend in warehouse automation toward IoT has driven development of a new set of firmware features (Rev M) in our latest generation of intelligent motion control components. Key IoT features added allow the user to specify preprocessed statistics like Min, Max, and Standard Deviation on selected application objects via configurable antialiasing filters. This component level preprocessing of statistics enables low-frequency sampling of user-specified objects over the internet.

    Moehler: The IoT is only as good as the quality of the data being provided. As the world gets more connected, the need for high-quality, reliable, diagnostic devices is increasing. Customers are coming to us for unique solutions for cost-effective, yet high-performing materials and designs to fit into this new and expanding landscape.

    Patel & van Beek: The effect we see is mainly with communication protocols and the addition of wireless communication. Security of communication will start to become important as there are more and more IoT devices.

    Brusco: What trends in the medical device industry as they pertain to electronic component manufacturing do you anticipate having to address soon?

    Burkett: It is our belief the trends listed prior will continue to be the drivers related to the medical device industry, which will impact electronic component manufacturing. Product developers will continue to push limits as they seek to develop new and improved solutions. Electronic component manufacturers must respond with investments needed to attain improvements in technical capabilities that will allow them to meet these needs. At the same time, there’s a balancing act between desired capabilities pushing the limits, when compared to attaining cost effective solutions that are manufacturable at high yields, that will perform as desired.

    Holley: Recently, we’ve seen many high-profile recalls of various medical devices. As globalization has forced a downward pressure on prices, some companies have had to take shortcuts with respect to new supplier evaluations and reliability testing of their materials. The hope is these shortcomings will drive the industry to have better methods to evaluate suppliers and their solutions. More time spent up front leads to less headaches down the road.

    Johannes: The key trends will be to increase the focus on automation, especially automation of quality inspection and verification cells. This will force the development of more sophisticated flexible inspection equipment and possibly its augmentation using machine-learning based artificial intelligence.

    Kish: There is a growing trend to select “one-stop shop” suppliers offering complete motion system solutions. In the past, medical device customers typically selected one supplier for the motor-encoder-gearhead solution and another for the drive electronics. There are sometimes challenges related to device regulations that require special safety features or redundancy but thankfully there are often multiple ways to address these challenges.

    Moehler: Trends toward home healthcare and drug-free solutions are moving the focus to disposable diagnostic tools with reusable systems. Also, within the medical device industry throughout the world, there is a trend for more traceability and regulation. Our ISO 13485 registration enables us to best serve medical customers. We understand standards for material composition, traceability, compliance, and labeling are constantly being updated and we have already begun adapting our capabilities to meet these requirements.

    Patel & van Beek: As devices get smaller and more integrated, and demand for customized solutions increases, we see ourselves offering more than just components. We’ve started to offer engineering services with our know-how and experience in markets. We’re seeing closer collaborations and partnerships formed than in the past.

    Doug Paynter: As the industry becomes more familiar with 3D bioprinting, genomic mapping, and other molecular-level processes, providing the finite control necessary to deliver and assist with the highest quality results is paramount to proportional control products. All the same key words like accuracy, repeatability, resolution, communication, etc. are used when picking the right components, but those words are now prefaced with "better." Suppliers must bring "better" to the table with pressure and flow controls, proportional media isolation valves, and an ever-growing list of components that provide better results for the evolving industry. 
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