SMT007 Magazine

SMT-Jan2016

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44 SMT Magazine • January 2016 Wimer: CGMPs, Current Good Manufacturing Practices, which lead to ISO certifications 9001 and 13485. Las Marias: From your perspective, what are the biggest challenges when it comes to medical elec- tronics manufacturing? Wimer: The major challenge we face today is cost, from an internal standpoint, and from a customer standpoint, it depends on what they are willing to pay for. ObamaCare's presence in the market has led to medical companies being more cost-conscious than ever. Las Marias: What about reliability, complexity and sophistication challenges, while meeting the regulatory requirements especially in the medical electronics sector? What strategies do you have in place to address these issues? Wimer: Our first strategy is to place subject mat- ter experts in each area of our organization to meet regulatory requirements in our manufac- turing practices. From a regulatory standpoint, we supply engineers in quality, manufacturing and project management. Our focus is to com- ply with regulatory bodies and find solutions for our customers' issues. Las Marias: What are the biggest requirements for your medical electronics customers? Wimer: Our requirements are specific to custom- ers' needs for quality products with established compliance and the main driver of on-time de- livery. We must comply with quality standards, and in every process, time is key from quote de- livery to product delivery. Las Marias: What are the top opportunities in the medical electronics sectors? Which are growing markets? Wimer: From our standpoint, what we are see- ing is an influx in products focused on neuro- stimulation. Biorobotics is a current trend that is continuously building on new innovations and technology. In addition, the Internet of Things is quite the topic today, bringing real-time data from the patient direct to the caregiver or doc- tor with the use of a medical device. Las Marias: What do you see as the biggest driver of medical electronics innovation? Wimer: The biggest driver of medical electron- ics innovation is cost constraints that drive the reduction of medical devices, the continued age increase in the millennial generation who are more apt to utilizing various technologies, the increase of biomedical graduate students and the simple fact that we have a need for medical electronics from a healthcare standpoint. Las Marias: how do you ensure the reliability of the components in your supply chain? do you have traceability systems in place? Wimer: By utilizing DFMEA analysis and our supplier qualification requirements, we are able to ensure reliability. We also have an ERP sys- tem in place, which provides serialization and upward/downward traceability. Las Marias: Where do you see the medical elec- tronics market headed in the next five years? Wimer: Medical electronics and devices will be- come more complex, smaller—depending on the package size—lighter, and faster, with great- er functionality. Las Marias: thank you very much, Jay. Wimer: Thank you. SMT FEATurE inTErViEw Valtronic Highlights Vital Components in Medical Electronics Manufacturing " our focus is to comply with regulatory bodies and find solutions for our customers' issues. "

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