Traditional approaches to medical device development focus on tightly controlling a final product design. In the modern healthcare environment of software-intensive, connected medical devices, there is no final design and companies must become adept at frequently updating their products. Only by embracing change can companies address the modern challenges of connecting to complex, evolving software and rapidly changing cybersecurity risks. This presentation will describe how to structure medical device development for rapid design iterations to speed up product development and to ensure devices remain safe and secure after product launch. Learn how to configure design control processes to support efficient software patches to address interoperability, cybersecurity, OS upgrades, and bug fixes. We will discuss techniques medical device companies can leverage to minimize the cost of change during product development and throughout the product life cycle.
About the speaker
Aaron 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 implement requirements management tools for streamlined compliance. He works closely with product development teams in performing risk analyses, managing testing for software and hardware, managing product requirements, 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.
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