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Healthcare Robotics Engineering Forum

Dates:    December 9 – 10, 2019      

Booth #:    302  

Location:    Santa Clara Convention Center
                    Santa Clara, CA


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Healthcare Robotics - Mark Burchnall

Presentations and Papers

Taking Advantage of New FDA Guidelines for Healthcare Robotics System Development

by Mark Burchnall

Monday, December 9th | 3:00 – 3:45 PM

Traditional methods for healthcare robotics product development have historically relied on iterative cycles of prototyping and testing. This approach, both expensive and time consuming, especially as robotics systems have increased in complexity over time, can limit innovation and result in product development delays. Thankfully, the US Food and Drug Administration (FDA), along with industry representatives, has provided a pathway to address this problem. That pathway is ASME V&V 40, a guideline for computational modeling and simulation (CM&S) that allows medical device and robotics companies to prototype and validate devices and subsystems virtually, and increase the likelihood that those models can be instantiated in the physical world.  In this session, attendees will learn how ASME V&V 40 can be utilized for healthcare robotics. Emphasis will be place on demonstrating how developed models can live throughout the product lifecycle and provide digital twins for systems for new product development, manufacturing, sustaining activities and failure analysis.