Many applications, especially wearables, require electronics that are flexible, or that can even stretch. Sometimes, MDMs also want to retrofit electronic functions or connectivity into existing products, where the challenge is redesigning them without affecting patient familiarity with the current products or confusing the branding message.
As a result, an increasing number of MDMs outsource their EMS needs to contract manufacturers. EMS is a field that is not as familiar to MDM engineers as other aspects of device construction; they count on their EMS providers to be skilled in the latest EM technologies and have the right electrical solutions for their products, regardless of the challenges of miniaturization, unique geometries, and power needs. Highly complex electronic components often required for mission-critical tasks in medical applications may even require in-house research and development to create proprietary, one-of-a-kind solutions.
Device complexity is also complicating EMS supply chains. “We are seeing supply chain models evolve as electronics expand into smart device categories that were previously mechanical,” noted Walter Tarca, president of Forefront Medical Technology, a Singapore-based medical device contract manufacturer that makes diagnostic and monitoring devices and drug delivery systems. “For example, drug delivery systems that incorporate both fabricated parts and electronic components.”
Increased complexity of MDM designs and tight time-to-market requirements place intense design and production pressures on their EMS partners. In addition, governments and regulatory bodies around the world are establishing new rules to ensure safe and reliable equipment, including electronics, as well as the adoption of well-documented development processes.
“Electronic design and manufacturing services play an increasing role in helping medical device builders balance their time-to-market requirements and the investment in in-house design and manufacturing expertise/capabilities,” said Christian Fritz, director of sales for motion control and electronics for maxon group, a Switzerland-based provider of high-precision drive components, including motion control electronics and sensors.
Latest Trends in EMS
To stay competitive, EMS companies must be able to provide solutions that will meet increasingly complex OEM requirements for new devices, including the requests for miniaturization, mobility, wearability, connectivity, data collection, and more. They must be agile in providing solutions for rapidly evolving niche products, such as wearables and app-based devices. These product designs typically have unique requirements, such as being flexible and stretchable. Engineers are using more flexible and/or rigid flex circuits to meet these requirements. However, MDM designers often are not fully knowledgeable about flex/rigid flex material properties and may design circuits that have performance issues.
“There is a lack of highly skilled designers in the marketplace who truly understand these materials, their properties, and what can and cannot be done with these technically advanced circuits,” said Carey Burkett, vice president of business development for Flexible Circuit Technologies, a Minneapolis, Minn.-based provider of flexible circuits, membrane switches, and other electronic manufacturing services. “With the circuit being the heart of a given device, it is critical to get the design right while assuring it is cost-effective, manufacturable, and able to perform reliably within a given application.”
Wearable applications have unique requirements and unique challenges. “They usually involve flex or rigid flex and have very tight spacing requirements on the printed circuit board [PCB],” said Jered Stoehr, vice president of sales and marketing for Milwaukee Electronics, a Milwaukee, Wis.-based provider of EMS services that include design engineering and PCB layout. “We have witnessed companies that are inexperienced in this type of development present electronics designs to us that are almost un-manufacturable.”
As medical device manufacturers focus more on their core competencies, they are increasingly willing to leverage off-the-shelf components and subsystems for parts of their application. “This helps them quickly iterate on designs, especially during the early design phases, and create a product with an optimized and balanced cost structure,” said Fritz.
With advanced complexities in EMS design and functionality, more EMS providers are taking a leading role in supporting the needs of their MDM customers—not just providing the electronic components, but also advising on design, customer-specific modifications, and knowledge on regulatory rules and design practices. An increasing number of MDMs want EMS partners that can provide a complete build, from design and product development through manufacturing. EMS providers can have an especially big impact when they are brought in during the design for manufacturability stage.
Fortunately, materials market constraints have lessened over the last year, which reduces costs and improves supply chain performance for MDMs and their partners.
“This helps all our customers,” said Gary Fairhead, president and CEO of SigmaTron International , a multinational EMS provider with manufacturing facilities in the U.S., Mexico, China, and Vietnam.
“The China tariffs have been challenging, but our strong supply chain management team, tracking systems, and global network of facilities offer our customers tariff avoidance options in those areas.”
EMS companies are also using IoT to create a more automated, connected, and efficient manufacturing environment. These technologies include automation and implementation of smart devices that support asset tracking and data collection and monitor production processes in real time, including machine performance. “These advancements allow EMS companies to better understand their production processes, which improves yields and overall reduces costs,” said Burkett.
What OEMs Want
MDMs are eager to design and manufacture smaller and smarter medical devices that incorporate Internet of Things (IoT) features. The capabilities of new sensor technologies continue to push the limits of design and manufacturing processes for electronics-embedded devices and equipment. EMS companies are being approached by MDMs eager to leverage IoT technologies (communication interfaces, security, increased data collection and analytics, and more) to broaden their services offerings in hot fields such as wearables. Major concerns, however, continue to be security and data protection.
OEMs expect their medical EMS companies to deliver advanced medical manufacturing capabilities, including modified mechanical components, special communication interfaces, compliance with the regulatory requirements, and customized electronics functionality or modifications. “Today, a lot of the functionality of electronics systems is defined in firmware [software],” said Fritz. “This provides the flexibility needed to modify off-the-shelf hardware to meet customer specific requirements. The customization can range from proprietary communication interfaces all the way to custom control IP or application-specific state machines.”
Ultimately, OEMs are seeking products from their EMS partners that are cost-competitive, high quality, and delivered on time. “Customers are asking about the checks and balances in our systems, particularly our quality and inspection systems,” said Alexandra Topp, sales and marketing manager for Spectrum Assembly, a Carlsbad, Calif.-based full-service electronics manufacturing services provider. “They are under cost pressures and are looking for reduced cost. Product development timelines are also shrinking.”
These efforts to reduce manufacturing costs and streamline production are driving a more collaborative approach between MDMs and EM providers, with an emphasis on design for manufacturability, early identification of cost reduction opportunities, and strong inspection and data collection methodologies.
“There is strong focus on speed, cost reduction, supply chain integration, and elimination of unnecessary costs,” said Tarca. “Having a coordinated design effort for both fabricated parts and printed circuit board assemblies, for example, helps ensure a faster product development effort and a more manufacturable design.”
Tariff mitigation strategies are another way EMS companies and their MDM partners can save money, reduce risk, and shorten timelines. This is often accomplished by moving operations from China to a different low-cost country. “For example,” said Fairhead, “several of our U.S. medical customers are evaluating a move to our Mexican facilities.”
Regulatory requirements are also changing the relationships between MDMs, component suppliers, and service providers. This is yet another driver for OEMs to re-evaluate their sourcing strategies and supply chain structures, looking for vertically integrated EMS suppliers that can help them reduce costs and shorten and streamline the supply chain.
“This also allows for the development of a deeper partnership with suppliers that can take on more tasks, versus simple transactional business with an unending list of suppliers within the supply chain,” said Burkett. “With a more transparent relationship, the EMS supplier attains a deeper understanding of the customer’s needs and makes the investments and adjustments needed to ensure they are meeting the OEM requirements in a cost-competitive manner.”
New Technology Trends
There has been significant growth in the use of flexible circuits and substrates in response to OEM demands for miniaturization, mobility, and wearable applications. Flexible electronics is a segment of the market that is especially key for miniaturizing devices. They are essential for creating complex devices that can fit into small physical spaces, such as devices deployed into the human body. Many new flexible (and even stretchable) sensors are coming onto the market, which can measure parameters such as stretching, angle, and force, all of which are important for flexible devices. Other flexible sensors can measure touch, compression, and pressure, and detect variances in performance. Flexible electronics and conductive materials are also key components for wearable medical devices.
Products with flexible electronics are often IoT-enabled—especially wearables. IoT capabilities include networking, cloud computing, signal processing, data analytics, and real-time data analysis and decision making. There will be an increasing number of innovative EMS features in the future that will qualify as IoT capabilities. However, securing personal health information and thwarting cyberattacks is a top concern, which is why some MDMs are proceeding with caution in the IoT-enabled space.
“The medical device industry is very aware that any development needs to take security and data protection into consideration,” said Fritz. “Depending on the type and class of medical device, the adoption of IoT capabilities will vary greatly.”
More companies are investing in IoT technologies that support real-time data collection and analysis and improve communications with customers on issues related to material availability and product lifecycle planning. There is also a strong shift among EMS providers to use IoT to automate and streamline operations and connect manufacturing facilities. Because MDMs are highly regulated and tend to be naturally cautious about change, widespread adoption of IoT is proceeding at an overall slow rate of speed.
“From a product technology standpoint, we typically see new technologies adopted by our consumer or industrial customers much earlier than medical customers,” said Fairhead. “Because of the mission-critical nature of most medical products, medical customers tend to adopt new materials and technologies as they are proven out in other industries.”
Even though additive manufacturing (AM) has less of a role in EMS than IoT, it is starting to gain traction for certain applications. AM can be used in-house to make tooling, fixtures, and prototypes, especially in early-stage projects. In some cases, AM is used to print very low-volume parts, rather than making an expensive mold. Other companies use AM for quick turn tooling or to support unique test unit fixturing.
Electronic components can now be 3D-printed, which helps shorten the product development times for electronics—a key step toward reducing the bottleneck in product development and keeping electronic development in pace with mechanical development.
“3D printed circuits are most often utilized for more simplistic circuit designs and for prototyping exercises related to fit, form, and function,” said Burkett. “Other benefits of 3D-printed electronics include freedom of design, faster time to market given no need for complex tooling, and less waste. Presently, it seems the lack of economies of scale would make 3D-printed electronics not ready for prime-time large scale production.”
One of the biggest issues with the 3D printing of electronic circuits is the processing and effective combination of different materials. A research team from Chemnitz University of Technology and the Fraunhofer ENAS Institute in Chemnitz, Germany, has successfully combined inkjet and screen printing to develop electronic 3D-printed objects. Screen printing was used to print primary batteries and inkjet printing was used to make silver electrodes. “A major outcome of our research is that standard screen and inkjet printing technology can be exploited for the manufacturing of multi-material 3D objects with electronic functionalities,” said lead researcher Enrico Sowade.1 “Our study showcases the high potential of the manufacturing approach for many other, potentially more complex devices, such as microelectronics and printed circuit boards.”
Considerable research is also being conducted on developing stretchable electronics, especially for next-generation wearable devices. Many different stretchable electronic components are being developed. For example, low-cost stretchable conductors and electrodes are being made from silver nanowires and graphene. Non-flexible materials can be made stretchable using innovative design. “Brittle semiconductor materials like silicon can be grown on a pre-stretched surface and then allowed to compress, creating buckling waves,” stated the Science and Technology of Advanced Materials.2 “Another strategy involves linking ‘islands’ of rigid conductive materials together using flexible interconnections, such as soft or liquid metals. Origami-inspired folding techniques can be used to make foldable electronic devices. In the future, stretchable electronics may be enhanced with new capabilities, such as wireless communication, self-charging, or even self-healing.”
In other research, silver nanowires are integrated into polyurethane fibers to create completely flexible, conductive networks.3 These hybrid fibers present superior electrical conductivity, high elongation, wide response range, high gauge factor, fast response time, and excellent reliability and stability. “Such satisfactory stretchability and sensitivity are attributed to the combination of the highly stretchable polyurethane matrix and the embedded architecture of the silver nanowire conductive network,” explained lead researcher Guan-Jun Zhu. “Moreover, the polyurethane/silver nanowire fibers can be employed as wearable devices to detect various human motions and to drive light-emitting diodes at a lower voltage.”
Technology, Teamwork, and IoT
OEMs are constantly pushing for connectivity. EMS companies are being approached by medical device manufacturers eager to utilize IoT technologies such as communication interfaces, sensor networks, increased data collection and analytics, and security solutions in their products. As a result, more companies are investing in systems technologies that support real-time data collection and analysis and improve communications with customers on issues related to material availability and product lifecycle planning.
New developments in IoT, machine-to-machine communications, and the cloud (all of which depend on electronics and sensors) continue to emerge to solve complex manufacturing challenges—for example, advanced assembly methods and the greater use of flex circuitry and fluidics in smaller devices. A constant challenge in EMS is meeting customer demands for miniaturization, such as reducing the size of power supplies to fit into smaller packages, without sacrificing power.
There are still medical device manufacturers underestimating the true cost of custom electronics design and the flexibility of off-the-shelf solutions, noted Fritz. “Advancements in the electronics industry and the fact that a lot of functionality these days is defined on software provides a great deal of flexibility and enables customer-specific functionality on off-the-shelf hardware.”
“One of the biggest misperceptions MDMs have relates to perceived competency of our foreign operations,” said Fairhead. “Our teams in Mexico and Asia are capable of doing anything our U.S. teams can do. We virtually share engineering workload, so a test engineer in Asia may be helping address a test problem in the U.S. or Mexico. Our new product introduction processes, systems, and procedures are consistent throughout our facilities. The major driver of any variance would be differences in industry-related quality requirements or customer requirements. From a competency and commitment to superior quality standpoint, there is zero variance among our facilities. The other misperception we see is an assumption that turnover is often very high in foreign operations. We treat our employees well and have excellent staff longevity metrics in our foreign operations.”
Ultimately, the best way to build the best product is through well-established, trusted relationships with key suppliers involved in the design and development of the product.
“Benefits are gained when a vertically integrated contract manufacturer has early involvement in the design,” said Tarca. “We take a 360-degree approach that can encompass material selection, software development, optimum fabricated part processes, design for manufacturability, automation strategy, and post-manufacturing logistics. The earlier we are involved, the more flexibility we have to explore what options make the best sense for the customer’s goals.”
“OEMs are often unaware of how much we can bring to the table in terms of overall design strategy based on the expertise of our team,” he said. “We are often able to suggest changes to their initial strategy that reduce cost, improve material availability, or create a more manufacturable product. It is important for OEM teams to realize that their EMS partner isn’t simply a company that lays out their printed circuit board assemblies or builds their product. We are a collection of experts who have seen a broad range of products and challenges and understand the complexities of supply chain management and efficient production. When a strong partnership exists, a much greater level of value for price is delivered.”
Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders. He also writes a variety of feature articles for regional and national publications and is the author of five books.