Medical Electronics: Risks and Opportunities for Electronics Manufacturers

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Brian Morrison is the director for Value Engineering & Technology at SMTC Corp. and has direct responsibility for process, test and development focusing on new customer and new product introduction. In an interview with I-Connect007, he discusses the manufacturing challenges facing electronics manufacturing service (EMS) providers when it comes to medical electronics, and the increasing need for risk management, design control and traceability.

Stephen Las Marias: What can you say about the impact that the medical market has on the electronics manufacturing industry?

Brian Morrison: The medical market for the electronic manufacturing services (EMS) industry is a branch of electronics that deals with design, implementation and use of electrical devices and equipment for medical purposes such as research, examination, diagnosis, treatment, assistance and care.

We are seeing a number of portable and wearable medical electronic devices that are used both in a hospital and home environment. Conventional medical devices have evolved over time with the advent of handheld smart phone-sized systems, which are now becoming available for monitoring patients at home or in the field and can send data to a doctor in a connected environment.

The medical market’s drive for smaller, complex and advanced electronics has increased the overall risk and opportunities for error for electronics manufacturers. As a result, requirements for risk management, design control and traceability has driven manufacturers to evolve from traditional new product introduction (NPI) practices, procedures and manufacturing methodologies typically employed in the electronics industry to meet the challenge.

Medical component level traceability has driven the need for enhancements to both business systems and manufacturing execution systems, including how we communicate and integrate production equipment to facilitate data sharing and collection. Improvements in data exchange standards and adoption from equipment and software providers have helped provide a more seamless traceability system and less reliance on paper driven data collection.

The criticality of risk assessment and controls requires the electronics industry to look at medical products with a more holistic approach to analyzing not just the assembly but also the design, components and processes. As a result, tighter collaboration between the designer and the manufacturer are required for success.

Similarly, control plans for highly complex products and assemblies require more capable and intelligent equipment and test strategies. Manufacturers have been focusing on more real-time feedback through integration and by implementing higher coverage test strategies through advanced test methods to provide a more complete end-to-end validation solution.

We have seen the electronics industry embrace the challenges presented by the medical market through a higher level of design collaboration than previously seen, better and more capable assembly tools and traceability capabilities and tighter closed loop controls. All in all, providing a more complete and robust risk management plan in step with advances in medical technology.

Las Marias: How has the medical electronics industry evolved over the past five to 10 years, and what major changes have you witnessed?

Morrison: Over the past number of years, we have seen a higher focus on wearables, nanotechnologies and an increased use of leading edge technologies which, for reliability reasons, were not commonly found in medical electronics.

This shift has placed requirements on manufacturers and designers alike to have a better understanding of the capabilities and limitations of both the design itself and the manufacturing process to ensure both the design and production are capable of achieving a reliable product.

Supplier collaboration has shifted from a best practice to a mandatory requirement and is a key differentiator for new OEMs seeking an EMS partner.

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Editor's Note: This article originally appeared in the January 2016 issue of SMT Magazine.


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