Mark Crawford, Contributing Writer02.07.22
Business is booming in the electronic manufacturing services (EMS) segment of the medical device industry. According to MarketWatch, EMS in the medical/healthcare field is expected to grow at a compound annual growth rate of over 4 percent through 2026, thanks largely to greater use of automation and advanced technologies such as the Internet of Things (IoT), wireless, and artificial intelligence (AI).1
This business surge also reflects that EMS companies have evolved from providing pure manufacturing capabilities to offering end-to-end services that support the entire lifecycle of products for medical device manufacturers (MDMs). “This includes handling all aspects of production, including high-quality complex product assembly, manufacturing processes, and testing,” said Gary Switzer, senior vice president of medical systems for Sanmina Corporation, a San Jose, Calif.-based contract provider of EMS services. “Other services are assisting with regulatory certifications and collaborating on design prototyping, new product introduction, documentation management, and supplier management, as well as maintenance, repair, and end-of-life services.”
“Medical device manufacturers are tasked with speeding up innovation and adopting new and unfamiliar technologies, without cutting corners or jeopardizing quality,” added Christian Fritz, head of business development for maxon (Taunton, Mass), a provider of high-precision micro drives, motors, and other controls. “Increasingly, technology innovations such as miniaturization, high-performance computing, and data analytics have led to the development of highly complex electronic components for mission-critical tasks in medical applications.”
However, the speed of innovation and technology adoption is still hampered by the persistent supply chain challenges that continue to limit EMS manufacturing and product development. “Although the ongoing global COVID-19 pandemic has actually increased the demand for novel treatments, it has also caused serious disruptions that impact delivery schedules, cost, logistics, and production planning,” said Fritz.
The pandemic continues to severely test the supply chain. All manufacturers are struggling with logistics costs and material lead times (wait times for some raw printed circuit boards, resistors, capacitors, and semiconductors have taken 52 weeks or longer, in some cases). Some EMS providers have resorted to the re-engineering or reverse engineering of product designs so they can work with materials and components that are readily available. It has never been more important for MDMs and their supply chain partners to collaborate creatively to minimize disruptions and shortages.
“This is a time when our people, systems, and processes are being severely tested,” said John Sammut, CEO of Grand Rapids, Mich.-based Firstronic, which provides advanced electronics manufacturing services, and optimized supply chain solutions and is part of LACROIX’s global network of EMS facilities. “Fortunately, Firstronic has been able to extend forecasting out two years and get the products we need via our global network and supply chain relationships to keep deliveries on time.”
“Proactive analysis and scenario planning around critical aspects of the supply chain, such as understanding the origin of every part that goes into a new product, also help MDMs avoid heavily centering supply chain operations around a single region, vendor, or material that might be compromised during times of crisis,” said Switzer.
What OEMs Want
OEMs are desperate for steadier supply shipments and shorter lead times, especially for semiconductors and electronic components, as well as raw materials for mechanical parts.
“Although semiconductors get most of the press, the issues are affecting everything from resistors to raw materials such as steel and aluminum,” said Thomas Allen, vice president of sales for Elgin, Ill.-based TRICOR Systems, an electronic contract manufacturer. “Manufacturers need to get creative in finding parts since the typical suppliers are providing dates that are over a year out on some parts. Brokers now hold all the cards, sometimes charging as high as 10 times the normal cost.”
Rapidly changing order status within the supply chain has been a vexing issue during the pandemic. The shortage of workers is also having a negative impact on lead times. Another troublesome factor is the lack of price continuity. “No longer is a quote good for 30 days,” added Allen. “Some are now as short as two days. The law of supply and demand is in full force in these pandemic times.”
COVID-19-related challenges in hiring and availability of engineering resources are forcing MDMs to focus their development efforts on their core competencies. Leveraging off-the-shelf components and subsystems for parts of their applications allows them to be more efficient, leaner, and truer to their timelines. This approach helps them quickly iterate prototypes on designs, especially during the early design phases, to create products with an optimized and balanced cost structure (development cost versus bill-of-materials)—a welcome relief to MDMs.
MDMs continue to experience massive swings in product demands, which makes it even harder for the EMS industry to deal with supply chain issues, component shortages, and prolonged lead times. “Addressing these challenges requires a close collaboration between EMS manufacturers, their customers, and critical component suppliers,” said Fritz.
“Our customers want us to navigate the materials/logistics issues for them,” Sammut added. “When OEMs come on board, we let them know the information and commitments that are needed regarding procurement and the supply chain.”
OEMs are asking for more capabilities such as electronics layout, specific architecture, firmware, and Bluetooth expertise to develop more advanced electronics based on their user requirements. Companies are also interested in board-level controller products that can be used for proof-of-concepts, prototypes, and smaller-quantity deployments. Further, MDMs want assurance the supply chains of their EMS vendors are as robust as possible, especially with global supply fluctuations. In addition, with the medical device landscape moving toward greater consumer personalization and data acquisition and digitalization, OEMs that make “disposable medical devices are adding sensors to obtain more data from the patients in order to customize specific treatments,” said Walter Tarca, president of Singapore-based Forefront Medical Technology, a global medical device contract manufacturer.
Another important trend is sustainability and reducing negative environmental impacts, ranging from carbon emissions and water consumption to recycling and disposal of material. “Impact on the environment should be considered in the early design concept, where materials, architecture, component, assembly, and operations are all defined,” said Jennifer Samproni, chief technology officer of health solutions for Flex, a contract design and manufacturing company.
Medical device OEMs are requesting environmentally-friendly materials be considered for new products. Demand for higher-quality products that have longer life spans is becoming a core part of environmental initiatives to reduce waste. This also supports consumer expectations and broadens brand recognition. During the repair of existing products, manufacturers also want more failure analysis data so they can improve reliability of new designs to reduce waste and product turnover. “An increasing number of OEMs are starting to prioritize sustainable operations over always achieving the lowest possible cost,” said Switzer.
New Technology Trends
New product designs are largely aimed at using electronics, automation, and sensors to minimize the potential for human error and enhance ease of use—therefore, these devices tend to be more sensor-driven and wireless. For example, “we manufacture a smart baby monitor product that measures heart rate, EKG [electrical activity of the heart], and blood oxygen,” said Sammut. “Parents can take it home from the hospital.”
The development of wearables and non-invasive monitoring devices continues to generate high interest within the medical device community. These products use sensors, flexible electronics, and wireless technologies that allow people to monitor their health status at any time. “Sensorization is becoming a reality in the future of patient care that will also free up hospital capacity,” said Tarca.
Wearables can now monitor an increasing number of health measurements on a daily basis, enabling at-home care and real-time communication with medical professionals. “For example, non-invasive remote monitoring devices such as those used for dental care allow patients to scan their teeth in the comfort of their home and wirelessly transmit that data to the dentist for review,” continued Tarca.
The 3D printing of electronics is being seriously evaluated as a way to make simple circuits, where the operating frequencies and power requirements are low—for example, radio-frequency identification tags or simple electronic labels. In these cases, “a cheap plastic substrate can be the foundation to build small logic gates, printed batteries, and simple segmented displays,” said Samproni. “Some proof-of-concept designs have already been developed, but are still challenged by a long shelf life and high-reliability targets.”
The medical device industry has been adopting key IoT technologies such as networking, cloud computing, signal processing, and data analytics for many years. This trend will continue at an accelerating rate as more IoT capabilities are built into new and upcoming devices. However, “the industry is also 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.”
Security measures often cannot keep up with the steady release of new EMS-based devices into the marketplace. One of the needs evolving from the rapid growth of telemedicine and wireless devices is the integration of connectivity and cybersecurity. This trend impacts medical devices, mobile applications, cloud and data analytics, as well as manufacturing. “Manufacturers must ensure the configurability of devices as well as the protection of data being configured during primary installation and assembly in the manufacturing line,” said Samproni. “As a result, new measures such as encryption, data security and protection, firewall, compliance to HIPAA [Health Insurance Portability and Accountability Act], GDPR [General Data Protection Regulation], ISO 27001, and other regulatory standards have been implemented within the manufacturing process.”
One example is the wireless transmission of firmware upgrades—the firmware should be cryptographically signed and encoded to guarantee that only genuine updates are installed within medical devices already on the market. This feature not only implies a new set of capabilities for the medical device (for example, crypto algorithms), but also new requirements for the other parts of that medical device ecosystem. “The firmware images are protected when they are temporarily stored in the cloud or on a mobile phone,” said Samproni. “The encryption keys should be securely generated and installed during device manufacturing and configuration and not be exposed to third parties. R&D, manufacturing, cloud services, mobile app developers, and the customers should closely collaborate to design a secure solution for the entire ecosystem.”
The global pandemic has compelled many MDMs to adopt IoT technologies to improve manufacturing and supply chain efficiencies and help management make faster and better-informed decisions about their operations. Being able to remotely monitor operations and automate basic tasks through IoT became essential during lockdowns to ensure safety and productivity. A combination of AI and machine learning helps predict quality issues and equipment failures before they happen, which minimizes downtime and increases efficiency on the factory floor. “As these platforms become smarter with more data, the accuracy of their predictions improves and can be used to proactively schedule machine maintenance,” said Switzer.
In addition to embracing IoT technologies to optimize manufacturing operations, many quality and regulatory processes such as audits and document reviews moved online during the pandemic to mitigate travel restrictions and physical distancing rules. Cloud-based IT tools such as collaboration software, video conferencing, and digital solutions for managing contract reviews quickly became the norm to facilitate important quality activities.
All these operations will be up to 100 times faster with the near-future deployment of 5G technology, which allows data to be transferred almost instantaneously because of the ultra-high speeds and low latencies involved.
“The emergence of 5G will enable faster computing, data sharing, and testing response times between cloud-based MES [manufacturing execution systems] platforms and intelligent factory machines,” said Switzer. “When you consider a manufacturing line that is producing 40 million medical devices and tracking serial numbers at a rate of one per second, along with possibly 100 different assembly steps and the associated equipment, it’s a huge amount of data to process. Comprehensive data analytics from these communications will improve production quality and efficiency, alerting workers in real time to any developing situations for faster mitigation.”
Manufacturing is one of the industries where 5G is expected to have the biggest economic impact in the next five to 10 years. Forward-thinking companies are already hard at work learning about 5G and how it can help optimize their overall operations, especially processes on the shop floor. For example, Flex is part of the 5G-ACIA (Alliance for Connected Industries and Automation) that focuses on promoting the utilization of 5G technology in manufacturing. “We are deploying a 5G testbed in one of our factories and developing our own 5G interface so we can connect our machines,” said Samproni. “It is a learning process that has just started and we will evolve along with the 5G technology as it matures.”
Regulatory Challenges
From a regulatory standpoint, OEMs increasingly seek out EMS companies that have strong regulatory and quality programs. “Over the past few years, EMS providers have helped OEMs navigate recent changes to RoHS [Restriction of Hazardous Substances], REACH [Registration, Evaluation, Authorization and Restriction of Chemicals], and MDR [Medical Device Regulation] standards that required them to update product designs and rework parts of the supply chain to ensure that prohibited materials were removed from their products and processes,” said Switzer.
OEMs also expect expert guidance from their EMS partners regarding data integrity and software validation, which are being more scrutinized by the FDA. “Basically, the data attained by a device must be tamper-proof and no one should be able to change the data,” said Tarca. “The repeatability and reproducibility of the results attained by the device should be validated.”
Regulatory and registration activities have always represented a challenge for MDMs. However, the evolving regulatory requirements and time-to-market challenges are generating more complexity, such as:
Although there are good practices and procedures in place for all of these challenges, “a common pitfall is to keep the focus on the specific solution to each challenge, instead of adopting a holistic approach,” advised Samproni. “The opportunity for medical device manufacturers resides in the concept of integration.” For example:
Moving Forward
With the increasing complexity of EMS-based devices, evolving regulations, and the constant push for more speed, partnerships are essential to be efficient and competitive. Some MDMs may not be aware they can leverage EMS companies across the complete lifecycle of their products, from the initial design to end-of-life services. Proactive companies that get the best value from their EMS partners integrate them as if they were a part of their own business and involve them during product development, especially design-for-manufacturing activities.
Many contract manufacturers are ideal partners because they have comprehensive design and development teams that work across a range of medical products and are exposed to new and innovative technologies, some of which come from other fields. “This unique exposure creates a vast amount of knowledge and deep experience that a team working on similar products, day in and day out, may not have an opportunity to see,” said Samproni. “New materials, methods, and processes from one market/product can be leveraged and applied to a client’s unique challenges. This applies across the full design and development through manufacturing ecosystem to provide a true holistic benefit for OEMs.”
This deep experience also saves MDMs considerable money and time.
“We still see a lot of OEMs reinventing the wheel when more cost-effective off-the-shelf solutions are available to them, at a lower risk and without the prolonged development time of a tailored solution,” said Fritz. “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 testing, and sustaining engineering are often overlooked.”
The most effective adjustments MDMs and their EMS partners made during the pandemic will likely be integrated into their business and manufacturing operations as standard operating procedures. For example, virtual practices and telework at EMS companies have proven to be very effective during the pandemic and many of these approaches are here to stay. This also applies to the manufacturing and quality programs that embraced technology and automation to streamline processes and reduce errors.
As medical devices get smaller and more complex, it takes strong, multi-disciplinary design, engineering, and advanced manufacturing teams (both MDMs and contract manufacturers) to integrate highly sensitive materials and components to make creative (and affordable) products that meet all performance and regulatory standards. Such creative, “out of the box” thinking was maximized in dealing with COVID-19, which showed MDMs that flexibility and innovation are huge competitive advantages. Electronics has traditionally been the main core of an EMS-based device; now, however, a variety of advanced technologies are being combined in ways that force the EMS industry to provide a wider range of solutions for a growing number of applications.
A good example of multi-technology advancement is incorporating optics in EMS devices, either as simple sensors or for image analysis, supported by smart algorithms, allowing miniaturization and accurate analysis. “This new trend encourages EMS providers to become more expert in several fields,” said Samproni. “They must be able to design custom-made smart tools, train technicians and engineers, and adopt the know-how needed to support the process. Combining new disciplines and technologies requires strong collaboration between design entities and manufacturing groups. Such projects are both exciting and challenging and demand an expanded vision that will take the production of cutting-edge products to a higher level.”
Reference
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.
This business surge also reflects that EMS companies have evolved from providing pure manufacturing capabilities to offering end-to-end services that support the entire lifecycle of products for medical device manufacturers (MDMs). “This includes handling all aspects of production, including high-quality complex product assembly, manufacturing processes, and testing,” said Gary Switzer, senior vice president of medical systems for Sanmina Corporation, a San Jose, Calif.-based contract provider of EMS services. “Other services are assisting with regulatory certifications and collaborating on design prototyping, new product introduction, documentation management, and supplier management, as well as maintenance, repair, and end-of-life services.”
“Medical device manufacturers are tasked with speeding up innovation and adopting new and unfamiliar technologies, without cutting corners or jeopardizing quality,” added Christian Fritz, head of business development for maxon (Taunton, Mass), a provider of high-precision micro drives, motors, and other controls. “Increasingly, technology innovations such as miniaturization, high-performance computing, and data analytics have led to the development of highly complex electronic components for mission-critical tasks in medical applications.”
However, the speed of innovation and technology adoption is still hampered by the persistent supply chain challenges that continue to limit EMS manufacturing and product development. “Although the ongoing global COVID-19 pandemic has actually increased the demand for novel treatments, it has also caused serious disruptions that impact delivery schedules, cost, logistics, and production planning,” said Fritz.
The pandemic continues to severely test the supply chain. All manufacturers are struggling with logistics costs and material lead times (wait times for some raw printed circuit boards, resistors, capacitors, and semiconductors have taken 52 weeks or longer, in some cases). Some EMS providers have resorted to the re-engineering or reverse engineering of product designs so they can work with materials and components that are readily available. It has never been more important for MDMs and their supply chain partners to collaborate creatively to minimize disruptions and shortages.
“This is a time when our people, systems, and processes are being severely tested,” said John Sammut, CEO of Grand Rapids, Mich.-based Firstronic, which provides advanced electronics manufacturing services, and optimized supply chain solutions and is part of LACROIX’s global network of EMS facilities. “Fortunately, Firstronic has been able to extend forecasting out two years and get the products we need via our global network and supply chain relationships to keep deliveries on time.”
“Proactive analysis and scenario planning around critical aspects of the supply chain, such as understanding the origin of every part that goes into a new product, also help MDMs avoid heavily centering supply chain operations around a single region, vendor, or material that might be compromised during times of crisis,” said Switzer.
What OEMs Want
OEMs are desperate for steadier supply shipments and shorter lead times, especially for semiconductors and electronic components, as well as raw materials for mechanical parts.
“Although semiconductors get most of the press, the issues are affecting everything from resistors to raw materials such as steel and aluminum,” said Thomas Allen, vice president of sales for Elgin, Ill.-based TRICOR Systems, an electronic contract manufacturer. “Manufacturers need to get creative in finding parts since the typical suppliers are providing dates that are over a year out on some parts. Brokers now hold all the cards, sometimes charging as high as 10 times the normal cost.”
Rapidly changing order status within the supply chain has been a vexing issue during the pandemic. The shortage of workers is also having a negative impact on lead times. Another troublesome factor is the lack of price continuity. “No longer is a quote good for 30 days,” added Allen. “Some are now as short as two days. The law of supply and demand is in full force in these pandemic times.”
COVID-19-related challenges in hiring and availability of engineering resources are forcing MDMs to focus their development efforts on their core competencies. Leveraging off-the-shelf components and subsystems for parts of their applications allows them to be more efficient, leaner, and truer to their timelines. This approach helps them quickly iterate prototypes on designs, especially during the early design phases, to create products with an optimized and balanced cost structure (development cost versus bill-of-materials)—a welcome relief to MDMs.
MDMs continue to experience massive swings in product demands, which makes it even harder for the EMS industry to deal with supply chain issues, component shortages, and prolonged lead times. “Addressing these challenges requires a close collaboration between EMS manufacturers, their customers, and critical component suppliers,” said Fritz.
“Our customers want us to navigate the materials/logistics issues for them,” Sammut added. “When OEMs come on board, we let them know the information and commitments that are needed regarding procurement and the supply chain.”
OEMs are asking for more capabilities such as electronics layout, specific architecture, firmware, and Bluetooth expertise to develop more advanced electronics based on their user requirements. Companies are also interested in board-level controller products that can be used for proof-of-concepts, prototypes, and smaller-quantity deployments. Further, MDMs want assurance the supply chains of their EMS vendors are as robust as possible, especially with global supply fluctuations. In addition, with the medical device landscape moving toward greater consumer personalization and data acquisition and digitalization, OEMs that make “disposable medical devices are adding sensors to obtain more data from the patients in order to customize specific treatments,” said Walter Tarca, president of Singapore-based Forefront Medical Technology, a global medical device contract manufacturer.
Another important trend is sustainability and reducing negative environmental impacts, ranging from carbon emissions and water consumption to recycling and disposal of material. “Impact on the environment should be considered in the early design concept, where materials, architecture, component, assembly, and operations are all defined,” said Jennifer Samproni, chief technology officer of health solutions for Flex, a contract design and manufacturing company.
Medical device OEMs are requesting environmentally-friendly materials be considered for new products. Demand for higher-quality products that have longer life spans is becoming a core part of environmental initiatives to reduce waste. This also supports consumer expectations and broadens brand recognition. During the repair of existing products, manufacturers also want more failure analysis data so they can improve reliability of new designs to reduce waste and product turnover. “An increasing number of OEMs are starting to prioritize sustainable operations over always achieving the lowest possible cost,” said Switzer.
New Technology Trends
New product designs are largely aimed at using electronics, automation, and sensors to minimize the potential for human error and enhance ease of use—therefore, these devices tend to be more sensor-driven and wireless. For example, “we manufacture a smart baby monitor product that measures heart rate, EKG [electrical activity of the heart], and blood oxygen,” said Sammut. “Parents can take it home from the hospital.”
The development of wearables and non-invasive monitoring devices continues to generate high interest within the medical device community. These products use sensors, flexible electronics, and wireless technologies that allow people to monitor their health status at any time. “Sensorization is becoming a reality in the future of patient care that will also free up hospital capacity,” said Tarca.
Wearables can now monitor an increasing number of health measurements on a daily basis, enabling at-home care and real-time communication with medical professionals. “For example, non-invasive remote monitoring devices such as those used for dental care allow patients to scan their teeth in the comfort of their home and wirelessly transmit that data to the dentist for review,” continued Tarca.
The 3D printing of electronics is being seriously evaluated as a way to make simple circuits, where the operating frequencies and power requirements are low—for example, radio-frequency identification tags or simple electronic labels. In these cases, “a cheap plastic substrate can be the foundation to build small logic gates, printed batteries, and simple segmented displays,” said Samproni. “Some proof-of-concept designs have already been developed, but are still challenged by a long shelf life and high-reliability targets.”
The medical device industry has been adopting key IoT technologies such as networking, cloud computing, signal processing, and data analytics for many years. This trend will continue at an accelerating rate as more IoT capabilities are built into new and upcoming devices. However, “the industry is also 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.”
Security measures often cannot keep up with the steady release of new EMS-based devices into the marketplace. One of the needs evolving from the rapid growth of telemedicine and wireless devices is the integration of connectivity and cybersecurity. This trend impacts medical devices, mobile applications, cloud and data analytics, as well as manufacturing. “Manufacturers must ensure the configurability of devices as well as the protection of data being configured during primary installation and assembly in the manufacturing line,” said Samproni. “As a result, new measures such as encryption, data security and protection, firewall, compliance to HIPAA [Health Insurance Portability and Accountability Act], GDPR [General Data Protection Regulation], ISO 27001, and other regulatory standards have been implemented within the manufacturing process.”
One example is the wireless transmission of firmware upgrades—the firmware should be cryptographically signed and encoded to guarantee that only genuine updates are installed within medical devices already on the market. This feature not only implies a new set of capabilities for the medical device (for example, crypto algorithms), but also new requirements for the other parts of that medical device ecosystem. “The firmware images are protected when they are temporarily stored in the cloud or on a mobile phone,” said Samproni. “The encryption keys should be securely generated and installed during device manufacturing and configuration and not be exposed to third parties. R&D, manufacturing, cloud services, mobile app developers, and the customers should closely collaborate to design a secure solution for the entire ecosystem.”
The global pandemic has compelled many MDMs to adopt IoT technologies to improve manufacturing and supply chain efficiencies and help management make faster and better-informed decisions about their operations. Being able to remotely monitor operations and automate basic tasks through IoT became essential during lockdowns to ensure safety and productivity. A combination of AI and machine learning helps predict quality issues and equipment failures before they happen, which minimizes downtime and increases efficiency on the factory floor. “As these platforms become smarter with more data, the accuracy of their predictions improves and can be used to proactively schedule machine maintenance,” said Switzer.
In addition to embracing IoT technologies to optimize manufacturing operations, many quality and regulatory processes such as audits and document reviews moved online during the pandemic to mitigate travel restrictions and physical distancing rules. Cloud-based IT tools such as collaboration software, video conferencing, and digital solutions for managing contract reviews quickly became the norm to facilitate important quality activities.
All these operations will be up to 100 times faster with the near-future deployment of 5G technology, which allows data to be transferred almost instantaneously because of the ultra-high speeds and low latencies involved.
“The emergence of 5G will enable faster computing, data sharing, and testing response times between cloud-based MES [manufacturing execution systems] platforms and intelligent factory machines,” said Switzer. “When you consider a manufacturing line that is producing 40 million medical devices and tracking serial numbers at a rate of one per second, along with possibly 100 different assembly steps and the associated equipment, it’s a huge amount of data to process. Comprehensive data analytics from these communications will improve production quality and efficiency, alerting workers in real time to any developing situations for faster mitigation.”
Manufacturing is one of the industries where 5G is expected to have the biggest economic impact in the next five to 10 years. Forward-thinking companies are already hard at work learning about 5G and how it can help optimize their overall operations, especially processes on the shop floor. For example, Flex is part of the 5G-ACIA (Alliance for Connected Industries and Automation) that focuses on promoting the utilization of 5G technology in manufacturing. “We are deploying a 5G testbed in one of our factories and developing our own 5G interface so we can connect our machines,” said Samproni. “It is a learning process that has just started and we will evolve along with the 5G technology as it matures.”
Regulatory Challenges
From a regulatory standpoint, OEMs increasingly seek out EMS companies that have strong regulatory and quality programs. “Over the past few years, EMS providers have helped OEMs navigate recent changes to RoHS [Restriction of Hazardous Substances], REACH [Registration, Evaluation, Authorization and Restriction of Chemicals], and MDR [Medical Device Regulation] standards that required them to update product designs and rework parts of the supply chain to ensure that prohibited materials were removed from their products and processes,” said Switzer.
OEMs also expect expert guidance from their EMS partners regarding data integrity and software validation, which are being more scrutinized by the FDA. “Basically, the data attained by a device must be tamper-proof and no one should be able to change the data,” said Tarca. “The repeatability and reproducibility of the results attained by the device should be validated.”
Regulatory and registration activities have always represented a challenge for MDMs. However, the evolving regulatory requirements and time-to-market challenges are generating more complexity, such as:
- Increased focus on usability engineering/human factor (UE/HF) analysis
- Early clinical trials during planned intermediate phases of the product development while requiring IEC and ISO safety compliance
- Increased expectations about information security management systems and cybersecurity requirements
- The transition from a “simple” environmental compliance to “design for environment” approach
- Management of the changes to product standards and regulations during design and development
Although there are good practices and procedures in place for all of these challenges, “a common pitfall is to keep the focus on the specific solution to each challenge, instead of adopting a holistic approach,” advised Samproni. “The opportunity for medical device manufacturers resides in the concept of integration.” For example:
- Adopt a product development lifecycle that integrates the UE/HF lifecycle and clinical activities within an iterative and evolutionary approach
- Establish an ISMS (information security management system) tailored to the product development environment and not necessarily applied to the whole organization and systems
- Integrate the cybersecurity analysis with product risk management, product testing, and post-market surveillance processes
- Integrate design for the environment (DfE) considerations with the product architectural design phase
- Establish a center of competencies to support the product requirements analysis with the standards and regulatory competencies—“for example, said Samproni, “the Flex Standards and Regulatory Committee”
- Establish a comprehensive project plan that integrates the different deliverables and dependencies; avoid having independent project plans
Moving Forward
With the increasing complexity of EMS-based devices, evolving regulations, and the constant push for more speed, partnerships are essential to be efficient and competitive. Some MDMs may not be aware they can leverage EMS companies across the complete lifecycle of their products, from the initial design to end-of-life services. Proactive companies that get the best value from their EMS partners integrate them as if they were a part of their own business and involve them during product development, especially design-for-manufacturing activities.
Many contract manufacturers are ideal partners because they have comprehensive design and development teams that work across a range of medical products and are exposed to new and innovative technologies, some of which come from other fields. “This unique exposure creates a vast amount of knowledge and deep experience that a team working on similar products, day in and day out, may not have an opportunity to see,” said Samproni. “New materials, methods, and processes from one market/product can be leveraged and applied to a client’s unique challenges. This applies across the full design and development through manufacturing ecosystem to provide a true holistic benefit for OEMs.”
This deep experience also saves MDMs considerable money and time.
“We still see a lot of OEMs reinventing the wheel when more cost-effective off-the-shelf solutions are available to them, at a lower risk and without the prolonged development time of a tailored solution,” said Fritz. “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 testing, and sustaining engineering are often overlooked.”
The most effective adjustments MDMs and their EMS partners made during the pandemic will likely be integrated into their business and manufacturing operations as standard operating procedures. For example, virtual practices and telework at EMS companies have proven to be very effective during the pandemic and many of these approaches are here to stay. This also applies to the manufacturing and quality programs that embraced technology and automation to streamline processes and reduce errors.
As medical devices get smaller and more complex, it takes strong, multi-disciplinary design, engineering, and advanced manufacturing teams (both MDMs and contract manufacturers) to integrate highly sensitive materials and components to make creative (and affordable) products that meet all performance and regulatory standards. Such creative, “out of the box” thinking was maximized in dealing with COVID-19, which showed MDMs that flexibility and innovation are huge competitive advantages. Electronics has traditionally been the main core of an EMS-based device; now, however, a variety of advanced technologies are being combined in ways that force the EMS industry to provide a wider range of solutions for a growing number of applications.
A good example of multi-technology advancement is incorporating optics in EMS devices, either as simple sensors or for image analysis, supported by smart algorithms, allowing miniaturization and accurate analysis. “This new trend encourages EMS providers to become more expert in several fields,” said Samproni. “They must be able to design custom-made smart tools, train technicians and engineers, and adopt the know-how needed to support the process. Combining new disciplines and technologies requires strong collaboration between design entities and manufacturing groups. Such projects are both exciting and challenging and demand an expanded vision that will take the production of cutting-edge products to a higher level.”
Reference
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.
