Wearable Medical Devices: Intersection of Technology, Regulation and Hype
Date(s) - 09/20/16
8:30 am - 10:30 am
Sunnyvale City Council Chambers- 456 West Olive Ave., Sunnyvale,
Event Speaker Title:
Event Speaker Company:
Event Speaker Bio:
Dr. Ochoa is currently Principal Engineer for the Biomedical Engineering practice at Exponent, Inc., a leading engineering and scientific consulting firm providing solutions to complex technical problems. Before becoming a consultant, Dr. Ochoa was Chief Technology Officer of Archus Orthopedics, Inc., a privately held development stage medical device company developing novel surgical devices for patients suffering from degenerative spine disease. Before that, Dr. Ochoa was Vice President, Research and Development, at DePuy Orthopaedics, a Johnson & Johnson Company where he was responsible for R&D in the joint reconstruction business. Dr. Ochoa was raised in Guadalajara, Mexico, , and holds a B.S. in Mechanical Engineering (Cum Laude) from the University of Missouri-Rolla, and an M.S. and Ph.D. in Mechanical Engineering from Purdue University. He has co-authored over 75 peerrefereed journal articles and conference abstracts and has 13 U.S. patents to his name. He is a member of various professional societies and also serves on advisory boards for various engineering schools. He is proud of the fact that all of his engineering contributions are directly related to the betterment of the human condition, the implicit goal for all engineers. Throughout his career, Dr. Ochoa has endeavored to work on research projects related to biomedical technology. He hopes to be able to inspire engineers around him to always be concerned not just about engineering, but also about people, and to do whatever they can to support their profession. The fact that Biomedical Engineering requires a unique combination of technical excellence and respect for the human element of engineering was crucial to his decision to dedicate his career to helping people afflicted with debilitating conditions.
The current regulatory environment and technology advances in the United States have created an environment in which safety and efficacy issues of medical devices are at a unique crossroads. FDA is taking a more definitive and proactive stance on postmarketing surveillance, quality, and innovation, which may impact device effectiveness and patient safety. At the same time, introduction and adoption of novel technologies is not only facilitating the development of totally new medical device treatment modalities, but these new technologies are rapidly transforming established medical device domains such as orthopaedics and cardiovascular. Also, the blurring of the line between health-related consumer products and medical devices have created an environment where device safety and effectiveness can be at risk. This may stem from potential confusion and overlap of technical and regulatory requirements, development processes, and associated device performance and post market surveillance requirements of device manufacturers. This is especially challenging for companies whose base is in consumer products and have ventured into the medical device space. We will review the latest trends in new technological and regulatory areas of emphasis such as additive manufacturing, cybersecurity, “wearables,” FDA’s case for quality (e.g. Voluntary Compliance Improvement Program (VCIP)), postmarketing surveillance, and Human Factors and Usability Engineering. How well a company manages these new technological trends and regulatory approaches, can affect not only the future viability of their current and future product lines, but can also affect the company’s liability, and financial loss. Most importantly, hiccups in a company’s ability to maintain compliance with updated regulations and effectively verify and validate new technologies in their products can also impact a company’s good will, reputation, and "brand equity."