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26 The PCB Design Magazine • January 2016 lence. This begins with laying a sol- id foundation where every project receives a detailed review that in- cludes recommendations for manu- facturability, design integrity and material requirements. From there, we use highly trained technicians that guide each design through a fully traceable fabrication process. Multiple inspection points are also used during this procedure to ensure design adherence at all stages. Once completed, each board undergoes a thorough final inspection and testing process before being shipped. Shaughnessy: i know you all do quite a bit of flex. Are the boards for medical devices primarily flex, rigid, or rigid-flex? Davoud: We see an equal amount of each type, though there has been growth in the flex and rigid-flex segments over the past few years. This can be attributed to the increase in robotics and devices that have repetitive movement re- quirements. In 2016, I anticipate that we will see flexible circuitry requirements surpass rigid needs for medical devices. Shaughnessy: the medical electronics field is so heavily regulated. What sort of "hoops" do you have to jump through, such as certifications and standards, to fabricate medical pcBs? Davoud: This industry may present the biggest challenges out of any we work in. FDA regula- tions place logical limits on materials that can be used in implanted devices as well as requir- ing strict adherence to approved builds overall. This places great importance for us to work on the design in its infancy as we often see some advanced projects with little wriggle room and repeatability concerns. The standards for devic- es vary. However, as we regularly build to IPC 6012, 6013 and 6018 Class 2/3, we qualify for most projects we see. There are some additional standards which may assist in qualifying includ- ing ISO 13485 certification, which compliments ISO 9001:2008, and is specifically for medical devices. In the end, the most critical require- ment is having a fully traceable process that will ensure repeatability while allowing detailed tracking analysis in case of failures. That means we maintain rigorous records for every step start- ing with material allocation. Shaughnessy: What trends are you seeing in medical pcBs? Davoud: In my opinion, the medi- cal world is mirroring the electronics world. Devices are being made smaller, more portable, equipped with multifunctional capabilities and perhaps most importantly interoperability. That requires PCBs to have increased RF/microwave capabilities, fine-line technology, and high- density interconnects. The biggest challenge for board houses is to stay on pace or ahead of the technology requirements of the day. We man- age this by reinvesting on average 10-15% of our annual revenue on technology advances. Over the past year, we purchased equipment that allows us to reduce space/trace, enhance our conductive via fill operations and virtually eliminate contamination. These trends also add "hoops" as discussed above; for example, RF ca- pabilities also come with their own FDA guide- lines which need to be met. Shaughnessy: people seem to be living longer and longer. do you think the medical segment will con- tinue to grow? Davoud: That's a great question, and I think one is a derivative of the other. Advances in tech- nology and treatment have directly impacted the length and quality of our lives. Over the past 150 years we have doubled life expectancy from 38 years to 76 years. Living beyond 100 years of age will become the norm for children born within the next generation. We will look to technology even more to sustain the health of our aging bodies and manufacturing will be called upon to support the increased heath care needs of a rapidly increasing population. Shaughnessy: thank you, Amir. Davoud: Thanks for the opportunity, Andy. PCBDESIgN INNovATIvE CIRCuITS SEES HEALTHY MEDICAL MARkET feature interview