January 23, 2018 — The Promise and Peril of Agile for Medical Devices
Date(s) - 01/23/18
8:30 am - 10:45 am
Sunnyvale City Council Chambers- 456 West Olive Ave., Sunnyvale,
Event Speaker Title:
Sr. Medical Devices Consultant
Event Speaker Company:
Event Speaker Bio:
Aaron has 20 years of experience in medical device development over a wide range of products: surgical robotics system, digital x-ray fluoroscopy system, heart-lung bypass machine, robotic catheter system, drug inhaler devices, x-ray catheter for brachytherapy, laser eye surgery system, and endoscopy instrument with RF ablation. 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.
Agile methods promise faster development of medical devices but at the peril of jeopardizing regulatory compliance. Learn about the four key rules to follow to ensure you don’t sacrifice compliance in order to take advantage of agile methods. This presentation will describe how agile methods can lower risks, improve quality, and shorten time to market for medical device development. The presentation will cover the basic principles behind agile and lean methods and important adaptations needed for the particular needs of medical device companies. We will illustrate the methods with a comparison of two product development teams—one following a traditional approach and the other following an agile-lean approach. The presentation will conclude with a discussion of how to modify design controls, risk management, and other quality system procedures to support agile-lean product development.