What to Expect from a Successful Medical Device Product Development Experience

Efficient and effective product development is a crucial step for commercializing new technologies. It sits between defining a minimum viable product and manufacturing, en route to being able to sell a desirable product to eager customers. This talk, led by experienced engineers from Triple Ring Technologies, will serve as an introduction to product development for entrepreneurs and innovators, with an emphasis on medical devices. Such technologies typically have high product complexity, tight budgets, and must ultimately operate in a regulated environment. The speakers will set the stage by establishing initial conditions for successful product development, and then review commonly encountered problems. They will compare and contrast several methodologies for product development and how they can be executed to support regulatory requirements, with an emphasis on the customer perspective. Case studies highlighting example product development timelines and outcomes will be included. Lastly, the speakers will also touch on transfer to manufacturing.

SPEAKERS:

Dr. David Shack: Vice President, Product Development, Triple Ring Technologies

Dr. David Shack is VP of Product Development at Triple Ring Technologies, where he focuses on delivering full-cycle development that optimizes transfer from technology development to product development and from product development into production. David has spent 30 years developing scientific measurement and analysis systems in a variety of fields including atomic force microscopy, X-Ray fluoroscopy, flow cytometry, genomic library preparation, and drugs of abuse testing among others. David’s technical experience is in the areas of algorithm development, embedded software development, fluidics, and optical measurement systems. David has held senior Engineering leadership positions at BD Biosciences and Agilent Technologies, and has also led product teams at start-ups. David received his PhD in Mechanical Engineering from Stanford University. He also holds an MSME from Stanford and a Bachelor’s of Applied Science from the University of Toronto.

Dr. Roger Tang: Senior Vice President, Science, Systems and Engineering, Triple Ring Technologies

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. 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.