Keynote Presentation: Wisdom for the R&D Engineer
Wednesday, June 20th 9:00-9:55 AM
John P. Collier, Ph.D.
Dartmouth College, Thayer School of Engineering
Myron Tribus Professor of Engineering Innovation and Senior Lecturer

In the 1970s, Dartmouth began to collect failed, "explanted" artificial joints from around the world to study the reasons for their failure. Also, Dartmouth's Dr. Michael Mayor, an orthopaedic surgeon, and John Collier, a biomedical engineer, began to develop and clinically test one of the earliest porous-coated hip implants.

From a lessons learned perspective—drawing upon his review and analysis of more than 8,000 explanted joints amassed at Dartmouth (the world's largest such collection)—Dr. Collier will arm the device engineer with practical considerations regarding the new product development process relative to idea generation, product design, and detail engineering.

John P. Collier, Myron Tribus Professor of Engineering, received his A.B. from Dartmouth College and his B.E., M.E., and D.E. degrees from Thayer School of Engineering. He is a member of the Society for Biomaterials, the Orthopaedic Research Society, the American Academy of Orthopaedic Surgeons, and the Hip Society. Collier has been a research consultant for Canadian Oxygen, Ltd., DuPont Inc., and for DePuy, a Johnson and Johnson company.

He has authored over 30 technical articles and delivered more than 50 conference presentations on aspects of orthopedic implant design and engineering. He also holds three patents for design or processes relating to orthopedic prostheses. At Thayer School he teaches the School's signature course, ENGS 21, Introduction to Engineering, as well as other courses in design methodology and biomaterials.

John Collier has engaged in the development and testing of hip and knee prostheses for the last two decades. He is now co-director, with orthopedic surgeon Michael Mayor, of the largest implant retrieval program of its type in the country. Their laboratory has analyzed more than 8,000 retrieved hip and knee prostheses, supplied by more than 750 surgeons from around the world; the knowledge gained has a significant impact on the choices and techniques of the practicing orthopedist and leads to improved implant designs with longer service life.

Professor Collier has traveled around the country and abroad educating surgeons about the factors which influence the performance of joint prostheses as learned from the examination of a wide variety of retrievals and from cutting edge research in bearing materials and implant design.

• How to select outsourcing partners compatible with your standards and integrity
• When and how the FDA must be notified about your suppliers
• Common pitfalls in outsourcing — and how to avoid them
• What activities can be outsourced and which should not
• The correct language to include in all contracts and service level agreements (SLAs) to protect yourself and satisfy the FDA
• How to establish a supplier monitoring program with teeth
• What to do when faced with off-spec products, recalls or complaints
• The outlook for increased FDA regulatory scrutiny of suppliers

Mr. Browning is the President and co-founder of EduQuest. He left the Food and Drug Administration in 1995 after 22 years as a local, national, and international expert Investigator and then as a Special Assistant to the Associate Commissioner for Regulatory Affairs.

While with FDA, Martin served as Vice Chair of the Electronic Record and Signature Working Group, which drafted the 21 CFR Part 11 regulations. He also served as Chair of the U.S. Government ISO-9000 committee; on the Global Harmonization Task Force; and on the committee that developed the new medical device good manufacturing practice regulations, otherwise known as the Quality System Regulation (QSR). He participated in the EduQuest Computer System Validation training courses presented to FDA.

Mr. Browning has an undergraduate degree in Aerospace Engineering and Political Science and a Masters Degree in Computer Science.