SMT007 Magazine

SMT-Jan2016

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48 SMT Magazine • January 2016 the overall risk and opportunities for error for electronics manufacturers. As a result, require- ments 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 elec- tronics 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 con- trols 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 com- plex products and assemblies require more capable and intelligent equipment and test strategies. Manufacturers have been focusing on more real-time feedback through integra- tion and by implementing higher coverage test strategies through advanced test methods to provide a more complete end-to-end vali- dation solution. We have seen the electronics industry em- brace the challenges presented by the medical market through a higher level of design collab- oration than previously seen, better and more capable assembly tools and traceability capa- bilities 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 in- dustry 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, nano- technologies and an increased use of leading edge technologies which, for reliability rea- sons, were not commonly found in medical electronics. This shift has placed requirements on man- ufacturers and designers alike to have a better understanding of the capabilities and limita- tions of both the design itself and the manu- facturing 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. Las Marias: From an ems standpoint, what are the biggest challenges when it comes to medical electronics manufacturing? Morrison: The biggest challenge in medical electronics manufacturing is in the develop- ment of the risk management plan and the subsequent controls and traceability to sup- port that plan. Commonly, the manufacturer is engaged after the design is complete and the EMS is tasked to develop control plans to address risk as a result of non-optimal compo- nent selection, assembly requirements and test strategy coverage gaps which can result in an overly complex and costly plan which may be avoidable. In cases where critical components or as- pects of the design are sub-contracted the EMS MEDICaL ELECTrOnICS: rISkS anD OPPOrTunITIES FOr ELECTrOnICS ManuFaCTurErS FEATurE inTErViEw

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