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Regulatory, Market, Packaging, and Thermal Design for Wearable and Implantable Medical Electronics
Keywords: Medical regulatory, Medical implantable/wearable/ingestible, Package and thermal design
The market for medical devices intended to be worn externally, implanted in the body, or consumed orally is expected to be over $50 billion worldwide over the next three years and growing rapidly. This presents opportunities for product design, material selection, and problem solving in order to achieve practical and beneficial electronic products. These devices must be developed, designed, and marketed within a complex range of regulatory requirements and meet consumer expectations for sports and health monitoring capabilities with the opportunity to impact clinical performance. These devices also potentially raise new questions at a societal level regarding privacy of data generated, data storage, and how "big data" rules and requirements may need to change to accommodate societal and privacy expectations. This presentation will outline current regulatory landscape and impact on device design and functionality, how electronic systems must be designed within those requirements, as well as the functional packaging, thermal, and materials requirements for energy storage and for power, RF, and integrated circuit components. Discussion will follow this outline: 1. Regulatory environment and impact of regulation: a. Regulations – U. S. and abroad b. Monitoring and tracking devices. c. Medical implantable and ingested electronic devices; 2. Product concepts: a. Needs analysis – fit, form, function b. Current wearable and implantable electronic devices and packaging and design: Sports and activity tracking and monitoring; implantable medical devices; ingested electronics; c. Future wearable and implantable electronic devices and packaging and design and thermal issues. 3. Societal expectations and potential issues for data generation, monitoring, storage, and use as “big data” for medical research and other uses.Semiconductor and hardware design in a medical regulatory environment. 4. Packaging and thermal requirements within wearable/implantable devices in a medical regulatory environment. 5. Needs for materials and thermal solution developments for miniaturized wearable/implantable devices.
Dave Saums, Principal
Amesbury, MA

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