How do we manage upgrades to a new medical device after product launch? If you don’t expect to ever make changes to the product then this may not be a concern at all. However, if you’re developing software-intensive, connected devices or capital equipment, then this IS a big concern!
These types of medical devices need to be upgraded throughout their lifetimes. Therefore, the majority of development projects will likely be product upgrades, not new product development - and your quality system should be designed with this in mind.
Aaron Joseph is a biomedical engineer and Principal Consultant at Sunstone Pilot, Inc. where he helps medical device companies implement modern processes for development of complex, software-intensive medical devices.
Aaron has over 20 years of experience in medical device development over a wide range of products, including surgical robotics systems, wearables, x-ray imaging system, and catheters.
He is an avid promoter of lean and agile methods for medical device development, and is always looking for new ways to make it faster and cheaper to bring new medical devices to market.
Aaron has a BS in Electrical Engineering from Rice University, and an MS in Bioengineering from the University of Washington.
Please join Voler Systems for this insightful session on July 25, 2024.