Electronic manufacturing services (EMS) are a robust segment of the medical device industry. According to MarketsandMarkets, global EMS in the medical/healthcare field is expected to grow at a compound annual growth rate of over 6.9% through 2026, thanks largely to the demand for portable medical devices and wearable electronics.¹ Other drivers are advances in sensors and digital technologies, especially the use of artificial intelligence (AI). This surge in production also reflects that an increasing number of EMS firms are evolving from providing just manufacturing capabilities to offering end-to-end services through vertical integration, which supports the entire lifecycle of products and shortens the supply chain (and adds relief) for their medical device clients.

Innovation is on the rise, with medical device manufacturers (MDMs) presenting highly complex designs for medical devices and diagnostics to their contract EMS providers. These include wide-ranging electromechanical devices, sensors, video, analysis, and energy solutions. “OEMs seek differentiating connectivity and capabilities for device diagnostics, upgrades, pay for use, artificial intelligence, and complex integration with other devices,” said Ronald Reinhart, software/firmware/electrical senior manager for Jabil, a St. Petersburg, Fla.-based contract manufacturer that provides services from design and manufacturing through supply chain and logistics.

Telehealth also requires more connected medical devices to advance its capabilities and reach more people. In addition, remote and mobile applications push the envelope on design requirements for improved and remote connectivity, reduced form factors, and improved power management without performance degradation.

“Technology innovations such as miniaturization, high-performance computing, and data analytics have led to the adoption of highly complex electronic components for mission-critical tasks in medical applications,” said Biren Patel, business development manager for maxon, a provider of high-precision micro drives, motors, and electronics. “Medical device manufacturers are tasked with speeding up innovation and adopting new and unfamiliar technologies without cutting corners or jeopardizing quality.”

Many design projects coming to EMS providers are focused on complete turnkey services, research innovation, and development. “Recently, many of our projects are supply chain-related to refresh current designs to address inventory availability or end-of-life of components,” said Reinhart. “Jabil is well-positioned to help customers refresh designs with complex changes because of our expertise in design for test, manufacturing and assembly, electrical and mechanical computer aided design, and component engineering.”

With this trend toward EMS innovation, medical devices are evolving into niche markets segregated according to device end-use, production volumes, functionality, and EMS provider expertise. “While we’ve done a range of products that include in-hospital diagnostics and assistive devices, we currently focus mostly on medical devices designed for consumer use that are handheld or in-home diagnostics, because these leverage our expertise in the Internet of Things and our manufacturing capabilities,” said Gary Fairhead, chairman and CEO for SigmaTron International, a global provider of EMS product development, assembly and test, fulfillment, and depot repair services to the medical device industry.

Speed of innovation and technology adoption, however, are still hampered by the persistent supply chain challenges that hinder EMS manufacturing and product development. Major disruptions still impact delivery schedules, costs, logistics, and production planning. For example, a serious shortage of semiconductors for medical devices still exists, which is being prolonged by the war in Ukraine.

Major supply chain issues are not exclusive to semiconductors. Although semiconductors get much of the attention, supply chain disruptions are affecting everything from resistors to raw materials such as steel and aluminum. “We have had to get creative in finding parts since the typical suppliers are providing dates that are over a year out on some parts,” said Thomas Allen, vice president of sales for TRICOR Systems, an Elgin, Ill.-based electronic contract manufacturer of medical, aerospace, and industrial products. “Brokers sometimes charge as much as 10 times the normal cost. Fortunately, we are starting to see some parts coming in with more reasonable lead times.”

An Evolving EMS Market

Trends in EMS are highly dependent upon the type of medical device sub-market being served. “There are a set of macrotrends that are common across numerous domains and business segments, but there are some that receive different weighting regarding importance to the industry and the need to address them,” said Reinhart. “The factors driving these trends include remote care, connectivity, sustainability, as well as demographic shifts with chronic disease and an aging population. We are also involved in creating R&D platforms to take on cost and complexity.”

EMS R&D investments include genetic diagnostic equipment for detecting COVID-19, flu, and other diseases that, until recently, could not be detected with in-home testing equipment; as a result, there is now significant growth potential for Internet of Things (IoT)-enabled medical devices for home care and monitoring. Not only does this equipment provide speed and convenience for quick (and hopefully early) diagnosis, it also reduces the total cost of medical service delivery.

Supply chain frustrations, shipping delays, and labor shortages are compelling more OEMs to consider reshoring options. “The reshoring of product manufacturing continues post-pandemic due to the lack of control over foreign shutdowns, either self-imposed or governmentally,” said Allen. “Shipping cost has come down, but to nowhere near 2019 prices, adding to the reasons to move manufacturing to the U.S.”

Finding, hiring, and maintaining engineering staff are other reasons medical device OEMs are outsourcing their EMS needs, which also allows them to focus more on developing their core competencies. In addition, leveraging off-the-shelf components and subsystems whenever possible makes their projects more efficient, leaner, and faster. “This approach helps OEMs to quickly iterate on designs, especially during the early design phases, and create a product with an optimized and balanced cost structure,” said Patel. “A growing number of electronics providers, often focused on special application tasks, are supporting the device manufacturers not only with technology, but often valuable design expertise, customer-specific modifications, and knowledge on regulatory rules and design practices.”

What OEMs Want

The shortage of critical components across multiple industries continues to be a problem for MDMs. They are always on the hunt for partners that can manage supply chains and create some reliability.
“Companies are asking for stable supply chains and full-service solutions,” said Alicen Pittenger, director of sales for Conductive Technologies, a York, Pa.-based contract manufacturer of advanced printed electronics, ablated circuitry, and electrochemical sensors. “They want a partner as much as they want a manufacturer.”

“To help our customers, we’ve been able to leverage our extensive footprint across a range of industries from medical to industrial, automotive, and consumer products,” added Patrick Kostraba, senior vice president of health solutions for Flex, a contract design and manufacturing company. “With this reach and buying power, we collaborate with customers and suppliers to reduce risk, source alternative components, and future-proof designs with a modular approach that includes component options.”

Top expectations by OEMs are high product quality, streamlined production, and faster speed to market. They want a high-quality product that can be manufactured at the lowest competitive price. This is where design for manufacturability (DFM) becomes especially important. Sustainability is another top concern by OEMs—nearly every MDM today has varying degrees of sustainability goals and they look to their supply chain partners to help them make their products more sustainable.

“Flex has been investing in circular economy solutions and tools to help customers take strides toward goals such as zero-waste,” continued Kostraba. “With intelligent reporting capabilities and second life value calculators, we help customers determine the optimal repair, refurbishment, parts harvesting, or recycling solutions to help reduce emissions, waste, energy, and water, and quantify value recovery activities.”

Top Trends, Technologies, and Techniques

As industries look for ways to improve efficiency and effectiveness, they leverage emerging technologies from IoT, artificial intelligence, big data, and cloud computing to shape their digital transformation strategies. Accompanying this are the demands to decrease product development and operational expenses while also accelerating time to market. To try to meet these challenges, more MDMs are relying on digital twins to improve performance and reduce costs. A digital twin is a digital representation of a physical product or system, whose variables can be digitally manipulated to identify the most beneficial configurations for the physical model/application.

“Digital twins promise utility across the entire product lifecycle, from early-stage design through validation and verification, manufacturing and Industry 4.0, and finally, sustaining engineering,” said Jennifer Samproni, chief technology officer of health solutions for Flex. “The technology may drive improved outcome prediction based on digital simulations and output modeling, which in turn should aid in developing better products and manufacturing processes to achieve stakeholder goals.”

For example, to optimize manufacturing a new Class II diabetes product, Flex used advanced simulation to create a digital twin of the factory floor. Design engineers then digitally simulated processes without expending money on equipment or materials, thereby iterating hundreds of thousands of “what-if” scenarios. The result was highly optimized production and improved yields, helping the customer get to market faster.

Another challenge that can be resolved with digital twins is the cost and lead time required to produce physical prototypes. With some component lead times, particularly considering recent supply chain disruptions, there is an opportunity to reduce the reliance on physical prototypes by using digital twin technology. Further, rather than needing a statistically significant number of prototypes with which to do testing, “a limited number of physical prototypes could be augmented using digital twin technology,” added Samproni. “This approach also allows product development to proceed faster as multiple concurrent variables can be input into the simulation tool, rather than needing to reduce each to practice and repeat the complete set of test protocols.”

More manufacturing facilities are implementing Industry 4.0-enabled production lines, where inspection technologies can adjust process parameters based on the data received and analyzed in real time. Technologies can be as sophisticated as CT scanning, which measures dimensions, geometries, and features as small as just a few microns, both on the surface and within the walls of a solid structure.

With current supply chain issues, MDMs are considering new or alternative materials for their parts and projects. For example, material science boundaries are being pushed for the types of substrates that can be utilized for flexible electronics. Historically, rigid polyethylene terephthalate (PET) had always been the material of choice, “but with the increase of wearable/patient monitoring devices, there is much more need for conformable, comfortable substrates for the patient/end user,” said Pittenger. “This pushes the limits for some of the printing technologies as well, but in a good way.”

AM can be helpful in EMS, where it is often used to create tooling. Advancements in AM printing of metals and other materials have expanded the usefulness of this technology for EMS, especially for prototyping during product development. It also provides a viable alternative for low-volume manufacturing that cannot support high tooling cost—such as personalized medicine solutions in which customized implants are 3D-printed and equipped with electronics and sensors that monitor performance and alert the patient and care team about wear and tear and other performance metrics.

P1 Technologies uses additive manufacturing for end-product simulation and assembly support. As a contract manufacturer, the company performs considerable small-scale hand-assembly operations on a large variety of products. With additive manufacturing, “we are able to rapidly design custom assembly fixtures to support our operators,” said Darren Goff, manufacturing engineer for P1 Technologies, a Roanoke, Va.-based contract manufacturer of complex medical cables. “We also can 3D-print prototypes to assist in our DFM review and developing the manufacturing process before production tooling is ready.”

Researchers at the University of Hamburg and Deutsches Elektronen-Synchrotron (DESY) have developed a 3D-printing process that produces transparent and mechanically flexible electronic circuits. “Typically, 3D printing is associated with mechanical structures as the additive manufacturing process,” said physics professor Michael Rübhausen from the Center for Free-Electron Laser Science at the University of Hamburg. “Our intention is to integrate structure with electronic capabilities, which could be useful for many different applications related to sensing, energy storage, and computing.” The electrical capabilities of the polymer material are created by embedded silver nanowires that form an internal conductive mesh.²

Additive manufacturing technologies, as well as roll-to-roll capabilities, and solution transfer methodologies have enabled flexible electronics to scale. In combination with functional inks, “high-speed processes are driving down costs in producing printed flexible electronics for sensors, displays, and consumer applications,” said Samproni.

Specialized materials are increasingly used to create miniaturized, flexible batteries for wearables. Printed electronics technology enables conductive materials such as copper and silver, as well as emerging materials like graphene, metal nanoparticles, and organic semiconductors, to be printed directly onto flexible circuits on a wide variety of substrates. These include plastic, polyurethane, textile, paper, and glass. Manufacturers utilize multiple printing methods to accomplish this, including screen printing, inkjet printing, gravure, and flexography. “Furthermore,” said Girish Wable, senior engineering services manager for Jabil, “it is now already possible to print more advanced components—such as capacitors, transistors, antennae, and batteries—all on the same flexible substrate as traditional electronics.”

P1 Technologies has developed methods of overmolding for a vast array of off-the-shelf pins, connectors, and other electrical components for clients, as well as maintaining its own custom contacts. “Overmolded connectors tend to be more rugged and durable, which is a difference that you can feel when you hold the part,” said Goff. “Additionally, the appearance of the part can be customized for the client. This can be as simple as a custom color or an inserted logo, but we also have the capability to design a fully custom overmolded connector or cable bend-relief to our clients’ specifications.”

Supply chain availability challenges will likely continue through 2023. Some contract manufacturers are experiencing shortages in small-diameter thin-walled PET shrink tubing. “We have been quoted 50-week lead times on items that used to be stocked, and others have been obsoleted by our suppliers,” said Goff. “It affects a relatively small percentage of our current business but is notable for both the magnitude of the lead time and the lack of viable alternatives.”

Although lead times are stabilizing for certain materials and components in medical device manufacturing, “we are still asking our customers for 24-month forecasts,” said Fairhead. “The big challenge everyone in EMS faces in this type of environment is balancing material on hand with improvements in availability. Excess inventory can be as bad as shortages, so we are watching this closely.”

The Push to Be ‘Smart’

Trends in medical device design continue to emphasize miniaturization and electronic/data capabilities. With the push toward decentralized diagnostics, functions such as monitoring, IoT, big data, and sensor technology all play a critical role. Creating a digitally connected health ecosystem, including cybersecurity and regulatory needs, is a global challenge and technology—especially EMS—is a big part of the solution. Healthcare is increasingly engaged with IoT and connected devices. For example, in 2022, about 50% of Jabil’s finished medical device production included digital, connected, and/or sensor elements. “Many of our customers want LAN, Bluetooth, Wi-Fi, and 5G in order to integrate with more complex devices, offer phone/tablet applications, or to enable remote monitoring, AI deep learning, pay for use, service, and diagnostics,” said Reinhart. “Jabil understands the challenges associated with connected devices, including complete cybersecurity design and test support.”

As today’s smart devices get smarter, they need more sensors, memory, power, processing, and communication capabilities. Integrating flexible circuits with a wider range of substrate materials (for example, plastic, paper, or textile) greatly expands the range of possible EMS applications, such as wearable heart rate monitors. The explosion of IoT applications and sensor technologies render most wired solutions archaic and enable faster and more effective technology solutions, such as AI-enabled machine learning.

It is easy to get excited with all the new advancements in the electronics industry and the increased functionality that results from advanced software solutions. It can be good to remember, however, that existing EMS solutions are still highly effective and can save time and money, depending on the application.

“We still see a lot of OEMs reinventing the wheel when more cost-effective, off-the-shelf solutions are available to them at lower risk and without the prolonged development time of a tailored solution,” said Patel. “Leveraging these well-tested and readily available devices not only allows for faster time to market, but also greatly simplifies the bill of material and reduces investment in non-differentiating features and capabilities. The costs for validation, production test, and sustaining engineering are often overlooked. Additionally, much of the investment required for a fully custom design is incurred early in the design process, when market potential and acceptance are only vaguely outlined.”

COVID-19-related shutdowns, unpredictable demand spikes, and supply-demand imbalances in materials kept EMS innovation subdued during the pandemic.

However, “finding effective ways to address those challenges has increased the expertise of our team and driven a focus on more responsive systems and processes,” said Fairhead. “As the market normalizes, our internal response to the two-year stress test will pay dividends in terms of innovation and more efficient operations.” 

References

1. bit.ly/mpo230161
2. bit.ly/mpo230162

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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 over 15 years and is the author of five books.