The Two Mindsets of Successful Medical Device Development
Modern product development teams face increasing challenges in bringing new medical devices to market: greater product complexity, tighter budgets, and more regulatory scrutiny. Agile and Lean practices, properly implemented, can enable medical device companies to accelerate product development, improve product quality, and lower manufacturing costs while still maintaining regulatory compliance. In this presentation we will describe the core principles of Agile and Lean product development practices and how they are often misunderstood and poorly implemented: It is not one practice or the other, but rather two “mindsets” that need to be applied at the right time in the product development process. Topics covered include:
- Overcoming the systematic shortcomings of traditional “waterfall” or stage-gate linear approaches
- Improving risk management, usability, and manufacturability for medical devices
- Strategies for implementing agile and lean strategies to save money, time and be compliant with regulatory requirements
About the Speakers
Aaron Joseph, Principal at Sunstone Pilot, Inc.
Aaron Joseph has over 20 years of experience in medical device development over a wide range of products: surgical robotics systems, digital x-ray fluoroscopy system, heart-lung bypass machine, robotic catheter system, drug inhaler devices, x-ray catheter for brachytherapy, laser eye surgery system, endoscopy instrument with RF ablation, and multiple IOT products.
Aaron is an avid promoter of lean and agile methods for medical device development and helps clients efficiently implement design controls. He works closely with product development teams in performing risk analysis, requirements management, and software and hardware testing as well as refining design control procedures and training R&D staff.
Aaron is an expert at medical device design verification and validation, including software, hardware, and system testing. He is able to apply design controls efficiently and rigorously to a broad range of products and adapt them to small and large organizations. Aaron has a BS in Electrical Engineering from Rice University and an MS in Bioengineering from the University of Washington.
Roger Tang, Senior Vice President, Science, Systems and Engineering at Triple Ring Technologies, Inc.
Dr. Roger Tang has spent his entire career bridging the disciplines of biology and engineering in both industrial and academic environments. Currently, he leads science, systems, and engineering functions at Triple Ring Technologies, an innovative research and development company that, in collaboration with clients and partners, develops technical solutions to critical, typically complex, challenges.
Triple Ring’s team of over 100 scientists and engineers provides leading edge, integrated science, design, engineering, innovation, regulatory strategy, and business services. Previously, Roger managed the Research Group and Ideation activities at Molecular Devices, LLC. His industrial career started in 2001 at a biotechnology startup, Signature Bioscience, Inc., which developed some of the first label-free assay technologies based on bioimpedance. Signature’s technologies were eventually commercialized as the CellKey™ System. Before his industrial career, he was an Assistant Adjunct Professor in Radiology at the University of California, San Francisco, where his research focused on cancer imaging (primarily using X-Ray CT, and molecular imaging). Roger received his PhD in Bioengineering from the Joint Graduate Group in Bioengineering at the University of California, Berkeley and San Francisco. He also holds an MS in Optical Sciences from the University of Arizona and a BS in Applied Physics from the California Institute of Technology.