TCritical Feature Traceability

in the Medical Device Industry

The medical device industry provides highly effective therapies for orthopaedic problems that can radically improve a patient’s quality of life.  There are a myriad of features that define a device, but just a relative few that are critical to its success in service.  Failure to adequately control this set of features can undermine device performance and cause harm to recipients and even medical practitioners.

This presentation, in an entertaining way, discusses Critical Features, traceability to initial design requirements, and associated manufacturing controls.

 Slagle

Tom Slagle Bio

Thomas Slagle serves as Vice President of Quality and Facilities, as well as Compliance Officer for OrthoPediatrics. Mr. Slagle is a seasoned industry veteran with nearly 30 years of experience in medical device design, engineering and manufacturing.

Before joining OrthoPediatrics, Mr. Slagle served as the Senior Manager for Quality Engineering at Medtronic Spinal and Biologics, where he helped lead a major modernization of the design quality systems, resulting in the company's first FDA approval of a cervical disc.  Prior to Medtronic, Mr. Slagle spent nearly two decades at DePuy Orthopaedics in senior management capacities overseeing manufacturing engineering, plant management, manufacturing systems deployment, tooling services, distribution management, custom and special products, NDT, metrology, calibration and receiving inspection.

Mr. Slagle earned a bachelor’s degree in metallurgy and materials science and an MBA, both from Case Western Reserve University. He holds a certification for quality engineering from the American Society for Quality. Mr. Slagle also is a lead ISO 13485 auditor, a six-sigma black belt candidate, and an expert in lean manufacturing.