The scene rightfully belongs within the realm of human imagination, unfolding among the pages of a classic science-fiction novel. Set on Earth (or any planet, really) far into the future, the scene would unfold with the protagonist (most likely young, handsome, and male) overcoming a life-altering crisis—paralysis, perhaps—through extraordinary technology. An explanation for the technology might sound something like this:

“When I want to move using the exoskeleton, I do exactly the same as you. That is, when you think about walking, you think about moving your legs one in front of the other. I do exactly the same, except that when my brain lights up, the command doesn’t work. My spinal cord is damaged, so my muscles can’t move, but my brain is trying to do the same as you do when you walk. For me, it’s the implants that receive the information and make the exoskeleton work for me.”

Those implants would likely be part of a sophisticated computer network that could harness brain signals to help tetraplegics walk again. Using sensors inserted on either side of the head (under the skin), the network would record and decode electrical activity within the sensorimotor cortex, an area of the brain that controls sensation and motor function.

In other words, mind over matter.

More like mind controlling matter: In the sci-fi universe, paraplegics can walk again by merely thinking about it. Such matters, however, are considerably harder to manage in the non-fiction world.

Incredibly, there are several existing solutions that use the brain’s electrical signals to overcome spinal cord-induced paralysis, but those innovations are not without challenges. Despite their fantastical designs in the sci-fi universe, most current brain-computer interfaces capture cerebral electrical signals using implantable, hard-wired ultra-thin electrodes that lack long-term efficacy and can increase infection risk.

French researchers, however, have resolved those issues by developing electrodes that rest on the brain’s tough outer membrane. “Previous brain-computer studies have used more invasive recording devices implanted beneath the outermost membrane of the brain, where they eventually stop working,” neurosurgeon Alim Louis Benabid, Professor Emeritus at Université Grenoble Alpes (France), said last fall. He and his colleagues at Grenoble released two-year study results of a mind-controlled exoskeleton suit that helped a tetraplegic patient move all four paralyzed limbs.

“[These recording devices] have also been connected to wires, limited to creating movement in just one limb, or have focused on restoring movement to patients’ own muscles,” he continued. “Ours is the first semi-invasive wireless brain-computer system designed for long-term use to activate all four limbs.”

That wireless system consists of an implantable medical device called Wimagine, which records the motor cortex’s electrical activity (a.k.a., ElectroCorticoGrams, or EcoG) using 64 electrodes connected to the dura mater. Wimagine incorporates integrated circuits (for measuring electrical activity), a wireless transmission module, and antennas; the EcoG signals recorded by Wimagine are decoded in real time by algorithms designed to process very large data volumes, according to Université Grenoble. The algorithms predict a subject’s intentionally imagined movement used to control complex functional substitution devices (like exoskeletons).

“Our findings could move us a step closer to helping tetraplegic patients drive computers using brain signals alone, perhaps starting with driving wheelchairs using brain activity instead of joysticks and progressing to developing an exoskeleton for increased mobility,” Stephan Chabardes, a Centre Hospitalier Universitaire de Grenoble neurosurgeon, told Popular Mechanics.

Though the mind-controlled exoskeleton is not yet ready for clinical application (it requires a ceiling-mounted support for balance and movement), the technology nonetheless represents a pivotal step forward in helping tetraplegics regain their ability to walk. Further improvements in this innovation are practically guaranteed as the Internet of Medical Things (IoMT) and connected healthcare drive advancements in medical electronics.

The deployment of fully connected health devices in recent decades has prompted the development of smaller, smarter, and more sophisticated medical electronics. While COVID-19 has boosted demand for semiconductors (fundamental in ventilators and patient monitoring/multi-parametric systems), the pandemic has not curtailed the need for electronic designs that increase both power density and device longevity. Modern systems must be highly versatile yet reliable, addressing market requisites for wireless communication, wearability, and portability. Most importantly, however, medical electronics must be able to properly analyze, manage, and secure health data transmitted to/from patient devices, transmission equipment, and the Cloud.

To better determine the requisites for custom medical electronics design, Medical Product Outsourcing spoke with numerous industry professionals over the last few weeks. Those who provided input included:

Carey Burkett, vice president at Flexible Circuit Technologies, a global supplier of flexible circuits, rigid flex, flexible heaters, sub-assemblies, and related value-added services.

Steve Heckman, engineer; David Gallick, senior vice president; and Joe Ogle, vice president; at P1 Technologies, a high-tech medical component manufacturer based in Roanoke, Va.

Anthony Kalaijakis, strategic medical marketing manager at Molex, a worldwide electronic components and solutions provider.

Bob Kish, sales manager at Faulhaber Micromo LLC, a global provider of high-performance, high-precision micro motion technologies (coreless dc motors, brushless dc motors, stepper motors, piezo motors, linear servo dc motors, precision gearheads, encoders, and advanced drive systems).

Steven Lassen, senior customer application engineer at LEMO USA Inc. The firm’s Swiss parent, founded in 1946, designs and manufactures precision custom connection and cable solutions.

Angel Lasso, senior director, engineering services, at Jabil, a global solutions provider of design, manufacturing, supply chain and product management services.

Don Minnick, sales and marketing manager at Gowanda Electronics, a Gowanda, N.Y.-based designer and manufacturer of high-performance standard and custom inductor components for medical, military, aerospace and other applications.

Michael Barbella: What factors must be taken into consideration when designing critical electronic components for medical devices?
Carey Burkett: Flexible circuits are used in such a wide variety of medical applications, it is important to define the requirements unique to the application prior to starting the design. For example, if the flex will be used in a static, room temperature environment (like an interconnect in a piece of medical diagnostic equipment), the requirements will be much different than a dynamic flex used in a surgical probe, or a wearable activity tracker. Considering that the flex or rigid flex is the component on which all other components are mounted, it is imperative that the flex is designed properly to ensure a successful and reliable finished product. A good starting point is to first determine if your application will require a static or dynamic flex, and if dynamic, how many cycles it will it be subjected to in service.

A good rule of thumb (per IPC-2223D) is for one- or two-layer flex circuits, your bend ratio (bend radius to circuit thickness) should at least 10:1. For three to eight layers, it is recommended that you increase this ratio to 20:1. Keep in mind these are minimum suggestions and a larger bend radius will almost never be detrimental. It also important to note these suggested bend ratios assume a bend of 90 degrees or less. A bend of more than 90 degrees will require a more liberal bend radius to ensure the flex will perform reliably. One the flip side, a bend angle of less than 90 degrees can typically be bent reliably to a smaller bend ratio.

Steve Heckman, David Gallick, and Joe Ogle: For most of the products we design and manufacture at P1 Technologies, we must meet U.S. and international standards for quality systems and specific product standards depending on the intended use of the end device. The number of requirements and the complexity of the requirements continue to grow year over year and present increasingly complex challenges. The medical device market has been a core focus for us for 30-plus years, and we have built and adapted our quality and regulatory systems over time to manage existing regulatory processes and adapt to new requirements as they arise.

Anthony Kalaijakis: Medical devices cover a massive scope of modalities and applications that require a matrix of considerations for electronic solutions. There are distinct considerations and challenges with several subsets, which include unique requirements and risks with each modality. Even the applications within the same modality can be dramatically different. For example, in imaging, a magnetic resonance imaging (MRI) system requires electronic components to be non-ferrous with very low magnetic permeability. With computed tomography (CT), the spinning gantry puts significant centrifugal force on the flexible circuits, connectors, and other electronics of which must be considered. In therapeutics, there are additional levels of complexity from the proximal end of the device through the therapy applied at the distal end as interventional applications require contact on or in the body. Key areas like biocompatibility in material selection, user interface type and materials, impact of sterilization, interaction of mating services including plating and mating cycles must be considered.

It is very helpful to engage with the device manufacturer to set the expectations and needs for the program. This would include the timelines and the regulatory, standards, and safety and compliance requirements (e.g. IEC60601) that programable medical devices safety standard must meet. Once the framework is established, there is the flexibility to decide on whether the electronic solution can be obtained commercial-off-the shelf, modified-off-the-shelf, or to custom specifications.

Bob Kish: Motor drive circuits must be “designed to fail” in a safe manner to protect both patients and physicians alike. For example, a runaway motor on an infusion pump could result in a patient receiving a lethal dose. This same situation, in a surgical power tool, for example, could cause damage to a patient’s internal organs or injure the physician’s hand if excessive torque is produced instantaneously. Fail-safe motor drive designs are particularly important for Class II and III medical devices like these.

Steven Lassen: When selecting connectors there are options such as internal board-to-board or external I/O, re-usable or disposable, metal or plastic housings, latching or non-latching as well as current and voltage ratings. LEMO’s designs incorporate scoop-proof and touch proof standards in most configurations. Between electrical contacts or contacts and housings there may be creepage and clearance considerations for a given application. There is also the new IEC 60601-1-2 4th Edition, which increases the ESD test voltage to 15kV. Connectors can be made quite small; however, in applications where elderly patients may directly manipulate the connectors, considerations must be given to an appropriate connector size and low connection forces.

Angel Lasso: Jabil conducts a survey on digital health trends each year and we’re seeing a marked increase in development of products with electronics and other technologies. In 2020, 44 percent of companies reported having digital products in production, versus just 21 percent in 2018. This is driven by customer demand, adoption of remote care, value-base care (VBC), and calls for better clinical trials. It’s a new era for healthcare and we’re seeing that both in new tech-focused companies entering healthcare and the continuing integration of electronics and technologies into existing products.

Healthcare can look to other industries, such as consumer tech and transportation, for guidance and verification of winning strategies for meeting market requirements while still proactively addressing potential hazards and harms. Design that leverages modular product architecture provides the best course for an original equipment manufacturer (OEM) to ensure their products are keeping pace with evolving technology. The entire product management strategy must have supply chain impacts and issues at the forefront, or risk losing traction against faster, more agile competitors.

Don Minnick: Part performance, size, operating temperature, manufacturability, and reliability are key factors when designing components for medical devices. In some applications, solvent-resistance or the need for non-magnetic materials can be an additional requirement.

Barbella: Please discuss some of the challenges in designing and manufacturing electronic components for medical devices. How has your company overcome these challenges?
Heckman, Gallick, Ogle: The current challenge for P1 Technologies and other companies in the medical device industry is COVID-19. Some companies are seeing significant increases in business, but many are seeing decreases in business. We have seen a downturn in some product lines, but we have been able to bring in new business to replace the losses. We are fortunate that our manufacturing is in the U.S. and most of our raw materials are sourced in the U.S., so many of the challenges that other companies with complex Asian supply chains face have not affected us. Another benefit of U.S.-based manufacturing and engineering is our ability to work closely with our customer’s engineers. Our projects are managed by engineers and they are always available to our customers through the development phases and throughout the product’s life.

Kalaijakis: There are several challenges that manufacturers face when designing and manufacturing electronic components for medical devices. The following is a sampling of trends and challenges manufacturers are keeping pace with to try and ensure safe, quality, and reliable components. Molex overcomes these challenges by working closely with its customers to understand their needs and customize components to meet their device design requirements.

• Safety: Safety for the patient and staff is of upmost importance. For example, from an electronic components supplier to the medtech industry, the ISO14971 standard is just one of the safety standards that provides a framework for mitigating risk in conjunction with the end customer’s compliance roadmap. The standard provides a methodical process for managing risk related to medical devices by identifying hazards, estimating the risk, evaluating acceptability and establishing risk control measures.
• Connected Health: A significant external market force disrupting medtech is the convergence of mobile devices and on-patient wearable monitoring/therapies otherwise known as connected health. This disruptive trend is part evolution and part revolution where everyday devices, like a smart phone, are quickly integrating with medical devices further increasing the number of use cases and areas of operation. Thus, risk assessment becomes more critical. Components must meet standards and have the ability to power up and connect devices for safe and secure information sharing.
• Patient-Provider Dynamic: More recently, the current COVID19 pandemic highlighted the need for options outside the clinic setting and tele-health services have come to the forefront – likely to change the patient-provider-payer ecosystem. Figuring prominently in this space is the interaction of the personal device, wireless body area networks, cloud services and population health records while regulators try to figure out how to keep the security of patient privacy.

Kish: Medical device applications typically have many design constraints which are in some cases conflicting. Creating system-level performance and thermal models allows us to optimize critical parameters and see the effects of our optimization efforts. These models help us customize motor windings and gearhead ratios in order to match performance to the customer’s precise design parameters. Our ability to offer a wide range of system-level solutions based on coreless DC, brushless, stepper and piezo motor technologies allows us to propose multiple solution scenarios, each with different trade-offs to assist device manufacturers with their design optimization and selection process.

Lassen: The demands of the medical market for enhanced video and data communication rates are pushing the limits of electronics. Copper-based connections may not be fast enough to handle the increased data speeds and bandwidth. Similar to the change that happened in the commercial broadcast industry over the last two decades when moving from standard definition to high-definition television, a move from copper-based connections to fiber optic-based connections is inevitable. With this transition there are learning curves which end-users must adopt to keep the fiber end-faces clean, especially for single-mode applications. Copper-based connection rarely needs cleaning, whereas optical fiber needs to be periodically cleaned. Depending on the application that may mean keeping a cleaning device near the unit, or carrying one on-person. End-face technology such as expanded beam can help minimize cleaning time, however, they still need to be cleaned periodically.

Lasso: Medical products will always have unique challenges with regulatory requirements, factory certifications, and validation standards. These are the concerns that have always been native to healthcare. The market’s shift embracing innovations in technology and connectivity have just added another layer. It’s also upped the ante on getting to market quicker and heightened the importance of being mindful of obsolescence risks for outdated components and electronics parts. Today, 41 percent of companies say their development and launch cycle for digital health solutions are less than 18 months, whereas only 29 percent said the same in 2018.

There are essentially two interlinked dynamics which must be navigated in tandem: Accelerated time-to-market requirements and the expertise and insights for addressing the increased pace of innovation.

Historically, very long product cycles combined with relatively slow evolutions in therapy and regulatory concerns have established a ‘status quo’ market environment for medical device manufacturers. Meanwhile, pushing back on this hesitancy to change is the “digitalization of everything.” In fact, there are really no industries immune to the hyper-fast evolutions in technology. So, healthcare, as has been the case with automotive and consumer tech, now must adopt shorter product cycles in order to keep pace with the speed of technology.

Comprehensive product lifecycle management now requires being proactive, but perhaps more importantly, predictive to avoid interruptions in the production process. In today’s environment, design and engineering-focused product teams require strategic insights for managing risks in their supply chain, with an eye towards components or parts scheduled for end-of-life. At the same time, predictive analysis helps to identify the technology changes that are on the horizon so that necessary modular redesigns get traction early enough to help the OEM maintain leadership and competitiveness in their market. In our survey, just over half of companies say they’ve built new teams with technology expertise and 44 percent have put in organizational structures to ensure better coordination across departments. Outsourcing areas that don’t traditionally fall in medical OEMs’ strengths will be a strategy on the rise as demand for more sophisticated electronics and technology grows.

Minnick: The need for non-magnetic inductors for applications where magnetic materials must be avoided (as in magnetic resonance imaging) is particularly challenging. As a passive component, the inductor’s purpose is to store energy in a magnetic field when electric current passes through it, thereby protecting the device’s circuitry. Traditional inductors consist of a magnetic core (iron or ferrite) and a wirewound coil. To address the need for a non-magnetic inductor, Gowanda developed a proprietary material that is truly non-magnetic but yet provides inductance qualities. The company utilizes a magnetoscope to test its material and to confirm the lack of magnetism, thereby giving customers documented evidence to support the non-magnetic distinction, unlike other manufacturers whose claims are unsupported. In fact, Gowanda’s non-magnetic components provide relative permeability of ≤ 1.00003. For design flexibility they are available in surface mount and through-hole configurations.

Barbella: What are customers demanding or expecting in their electronic components?
Heckman, Gallick, Ogle: Customers have always wanted zero defects, low price and on-time delivery; our customers now take it for granted that they will receive these items and they are now looking for innovative custom solutions, miniaturize and ways to get to market faster. One of the key items we offer is a comprehensive solution package that walks customers through a process from conception to product realization including regulatory requirements and validation.

Kalaijakis: The customers’ demand and expectation is that their electronic components be smaller, sleeker, and connected. Medical devices are transforming from the clinical setting to the internet of things (IoT) of connected health with wireless body area networks (WBAN) and mainframe capital equipment applications that are connected via the picture archival and communications systems (PACS) digitizing images and data. The medtech ecosystem is requiring Molex to adapt to the digital transformation that is happening today.

Overall, the medtech market is expecting more than just electronic components but a total solution. There is a need to handle the increased bandwidth, high speed interconnects inclusive of fiber optic interconnects and high signal integrity and speed from data communications which are pushing innovation—and customer expectations for a total solution.

The advantage of being an integrated supplier is seeing that both the market and customer requests are for the assembly of the electronic components and sub-assemblies to be wrapped into a total device solution. For the customer, further integration and the need for a one-stop supply chain is preferred. As such, Molex has brought in contract design and manufacturing (CDMO) into the fold with the Phillips-Medisize acquisition. In addition, the market is asking for upfront design, human factors considerations and regulatory assessment to decide on either a CDMO or medical product outsourcing (MPO) where the emphasis is fulfillment (and improvement) of scale production.

Kish: Device manufacturers are looking for motion component suppliers that are capable of providing fully-integrated, system-level motion solutions that incorporate additional components,  such as machined parts, precision lead screws, gears, pulleys, bearings, drive electronics, sensors, and interconnect PCBs.  This approach simplifies the supply chain, reduces inventory, and improves quality for the customer.

Lassen: Connectors must be of the highest reliability and handle multiple elements, such as electrical contacts, fiber contacts, thermocouple or even fluidic/pneumatic with shut-off. The reliability of the connector must meet or exceed the design intent of the end product.

Lasso: There is no denying the market demand for products with the latest electronics and connectivity features—across all industries. Consumers today have real-time data on their sleep, steps, heart rate, and more—so they expect more from their medical devices, too. Take note of the tech giants moving into the healthcare space in the last few years as proof of the opportunity: Apple has been acquiring health startups and companies since 2015 to elevate their health tracking capabilities. Amazon acquired Health Navigator in October 2019 and launched Amazon Care to its employees. A week after the Amazon acquisition, Google acquired Fitbit in November 2019 to make its mark within healthcare wearables.

Customers expect their contract manufacturers (CMs) to keep production going, but this can be challenging and costly to OEMs. Today’s market requires CMs to be strategic, with a predictive eye on both technology trends and any potential supply chain risks, while ensuring their customers’ production stays on track. Take as an example the coordination required to migrate a product from technology A to technology B (e.g. BLE to Wi-Fi), without significant regulatory impact or any product demand shortages. To do this migration or change seamlessly, a strategy must be defined and started at design.

As healthcare continues its shift to a market addressing patients, acting like consumers, with increased demands for what’s “current,” expectations are changing. In Jabil’s survey, 92 percent of respondents said consumer demand is increasingly pushing for innovation in digital health devices.

Minnick: Customers are demanding high performance inductors to have tight inductance tolerance, as low as ±1 percent, compared to other less stringent applications where that tolerance might be as high as ±20 percent. This tolerance tightening requires Gowanda to pursue innovative approaches to inductor design, often resulting in application-specific solutions.

Barbella: How is IoT (Internet of Things) influencing electronic component development?
Heckman, Gallick, Ogle: Being a U.S. manufacturer in a cost competitive industry, P1 Technologies has taken advantage of the Industry 4.0 technology advances to lower costs and improve quality. Advanced automation, IoT, automated communication systems, and machine self-monitoring have been key items that have helped us stay cost competitive.

Kalaijakis: The medical device ecosystem is moving from clinic bedside to mobile devices. At Molex, we have a long-standing pedigree in connected commercial devices that allows for these design concepts for commercial applications to be adapted to medtech. There has been more innovation in the IoT in home automation, infotainment, automobile networks, and other industries. 

The vast number of applications and crossover opportunities make this a compelling segment for which Molex is well aligned. By listening to our customers and providing unique and differentiated solutions, we are more focused on medtech solutions that can be agile to adapt to changes.

Lasso: Technology is evolving at an exponential rate and impacting industries across the board. In fact, some people are now referring to the trend as simply, the Internet of Everything. The design and production of new medical devices is one of the most exciting spaces for IoT innovation. Patients are and will continue to push medical device companies to deliver products that support their connected lifestyles. We’ve seen that seamless technology integration and interoperability are key to delivering the type of predictive and preventative healthcare experiences which are increasingly becoming key to the patients’ journeys to increased health and wellness. The path to this future relies on emerging technologies, like artificial intelligence (AI), communication enhancements from 5G, patient care and disease state platforms built with cloud technology, and a growing roster of Internet of Medical Things (IoMT) devices.

Medical devices that serve within the IoMT require cross-industry collaboration and input to keep progress moving. Most importantly, these devices need to be designed so that they are interoperable within broader platforms. Without it, the potential of digital health cannot be unlocked. This effort will be a big change—and a great opportunity—if the industry is willing to adapt and accept the new challenges.

Barbella: How is the trend toward miniaturization of medical devices driving the design of electronic components? Please explain.
Heckman, Gallick, Ogle: A significant proportion of P1 Technology’s business is focused on interconnects and cables for wearable medical devices. This market requires miniaturization to achieve lightweight and comfortable devices that can be worn for extended periods of time. P1 also manufactures infusion cannulas and electrode systems for neuroscience research that are designed with tight tolerances and miniaturization in mind.

Kalaijakis: Smaller devices mean designers must consider space optimization for even smaller components for power delivery, design flexibility to allow for the incorporation of various enabling technologies and more communication circuits within a tighter footprint. In addition, medical device designers will look to low-profile micro-connectors and wire-to-board and flex-to-board options to help transmit signals and data and power up all while staying within the constrained space given.

Kish: We’re definitely seeing a trend in the need for higher torque and power densities in order to push the performance envelope or to shrink the size and weight of devices—particularly with handheld and ambulatory devices. Demand for IoT devices is growing rapidly and many of these are hand-held devices used in a point-of-care environment, so battery life, weight and size become more important design considerations. Fully embedded and integrated motion solutions can also help reduce component count while also reducing the overall size of the end product.

Lassen: Electronic connectors that are manipulated by hand have a limit to the degree of miniaturization. Although the internals of the connector can be miniaturized to a great degree, the overall external portion of the connector that will be manipulated by an end-user has a size limit. Some designs require a deviation from solder bucket contacts which are terminated by hand, to an automated process of termination directly to a printed circuit board for extremely small conductor sizes.

Lasso: The growth in RPM, wearable and “point of need” (not just point-of-care) devices is significantly influencing design options and requirements for new medical devices. These markets are being driven by desire for more functionality with increased portability and mobility. Miniaturization is one of the key solutions for product designers and engineers answering the market’s call. As they push their capabilities into next generation devices, reducing form factor size and optimizing power consumption, the challenge then shifts downstream. Remember, miniaturization is a trend felt across all industries, so the impact is also significant for supply chain, sourcing, and component availability.

Here’s an exciting example of the potential for smaller form factors to improve patient experiences. A dialysis device traditionally intended for in-center use, can now be reduced in size with enhancements to both power consumption and connectivity requirements so that it performs exceptionally well in a home environment. Miniaturizations allows for better patient care at a lower overall cost.

Miniaturization is also a major catalyst in the highly rigorous clinical trials market. Smaller form factor, unobtrusive wearables with innovative sensor and connectivity enhanced designs are improving data collection and supporting much higher adherence in clinical trials. That’s a lot of technology to fit on a wristband, or connected injector, and that requires sophisticated design, component integration, and assembly.

Minnick: Miniaturization of devices continues to impact the design of electronic components. There are some practical limits to the size of an inductor due to the electrical performance characteristics required, but novel approaches have enabled development of very small conical inductors which are barely 2.6mm in size versus traditional inductors which can be up to 15mm in size.