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Instrument Testing and Validation

Predicting an instrument's performance over time is essential to the design phase. This session will cover reliability testing and performance deterioration, including recommendations for tests that should be performed to ensure that an instrument will function through a lifetime of use, and ways to collect measurable outputs of the instrument from initial use to the end of its lifecycle.

Session speaker and topics include 

Disposable Instruments 
Presenter: James Schultz, Executive Vice President of ECA Medical Instruments

Mr. Schultz will address the design, development, testing and validation process to commercialize disposable (single-procedure) ortho/spine surgical instruments and procedural kits. It will include PD process and stages, design inputs/outputs, test criteria and methodologies, key validations and commercial readiness.

Jim Schultz webJames Schultz is Executive Vice President of ECA Medical Instruments, leading the global marketing, sales and program management operations. He has over 40 years of experience in medical, bio-pharma, enterprise software and high-tech product companies and government agencies serving in executive, technical, sales, marketing, investor relations, M&A and operations roles and at firms ranging from start-up to Fortune 500. 

Prior to working at ECA, Mr. Schultz served in executive roles at PBS Biotech, Jabil Circuit Inc., Red Rocket, Inc., MSC Software (NYSE), and EOS Corporation. He started his career in the US Air Force as a AC-130 flight engineer and later as a DOD civilian in our nation’s military space & ICBM programs serving in senior staff, intelligence and operations roles.

Clinical Reprocessing
Presenter: David M. Blakemore, President of BoneSim Laboratories

Mr. Blakemore will cover clinical reprocessing cycles and the importance of validating instruments to ensure they withstand repetitive cleaning & autoclaving cycles.

david blakemore webDavid M. Blakemore has served as President of BoneSim Laboratories since 2009. The firm provides medical device lifecycle testing for re-usable medical devices. Prior to joining BoneSim, Mr. Blakemore served as Vice President of Research & Development and CSO of Valpo Orthopedic Solutions and Principal Engineer—Biomechanics at Zimmer. Prior to joining orthopaedics, he was a space shuttle orbiter engineer at NASA Rockwell International. 

Mr. Blakemore is a published author who holds more than a dozen patents related to orthopaedics.

Mechanical Testing
Presenter: Kevin Knight, Cofounder and President of Knight Mechanical Testing

Mr. Knight will speak on test strategies and performance considerations in the absence of validation guidance from FDA, ISO and ASTM.

kevin knight webKevin Knight is Cofounder and President of Knight Mechanical Testing, a leader in medical device testing, consulting, and prototype machining. Mr. Knight started KMT in 2006, growing the company from a small test lab to a full service research and development operation with clients spanning the globe. He currently manages the company along with a team of experienced engineers and technicians, providing testing services to clients ranging from surgeon inventor start-ups to Fortune 500 orthopaedic manufacturers. Prior to starting KMT, Mr. Knight held positions in engineering and finance at Navistar International, with primary responsibility for heavy truck suspension components.