Companies in multiple industries have found that lean and agile methods speed up their product development while simultaneously improving quality and cutting costs. In spite of these proven advantages, these methods have not been widely adopted in the highly regulated medical device industry. Regulations and standards do not prevent the adoption of lean and agile methods but many companies’ quality systems do. Understanding these barriers and how to modify quality system procedures is key to more efficient medical device development and improved compliance.
This will be an interactive presentation and attendees are encouraged to raise issues and ask questions regarding their specific experiences in new product development. We will cover the basic principles behind lean and agile methods and then illustrate them in more detail with a side-by-side comparison of two example projects—one utilizing lean and agile methods and the other utilizing a traditional approach. The presentation will conclude with a discussion of how to modify design controls, risk management, and other quality system procedures to support lean and agile product development.
Speaker: Aaron Joseph, Lean & Compliant Medical Device Development Consultant
Aaron Joseph has 20 years of experience in medical device development over a wide range of products: surgical robotics system, digital x-ray fluoroscopy system, drug inhaler devices, robotic catheter system, x-ray catheter for brachytherapy, laser eye surgery system, heart-lung bypass machine, and endoscopy instruments with RF ablation.
Aaron is an avid promoter of lean and agile methods and helps clients to efficiently comply with regulatory requirements for software and hardware development. He works closely with product development teams in performing risk analyses, designing test plans, managing product requirements, refining design control procedures, making efficient use of SW tools, 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 a MS in Bioengineering from University of Washington.