James Coburn Email & Phone Number

Temporary Assignment, on Detail (Sabbatical) from FDA, leading initiatives targeting medical product supply chain issues, especially shortages of generic drugs.

Silver Spring, Md

Senior Advisor in the Office of the Chief Scientist / OCET focused on cross-cutting Advanced Manufacturing projects including Additive Manufacturing (3D printing), continuous manufacturing, and modular manufacturing. I identify internal and external experts, connect them, then ensure the Agency is able to use and grow the available knowledge, research, and resources to effectively regulate emerging technologies. Consultant to the FDA Additive Manufacturing Core research facility

Sivler Spring, Md

Led the FDA's Additive Manufacturing of Medical Products (AMMP) Lab and developed regulatory policies and standards for 3D printing of medical devices.

Capitalized on diverse experience to perform computational and bench research on medical devices, their uses, and their manufacturing processes. Initiated 3D printing research a program at FDA.

Silver Spring, Md

Research Fellowship with the Division of Chemistry and Material Science in the Center for Device and Radiological Health (CDRH) at the FDA.

This independent, non-profit research foundation focuses on evaluating patients with orthopedic ailments and implantable devices. I managed the gait analysis and fluoroscopy laboratory. We analyzed athletes with and without injuries, orthopedic patients with hip or knee ailments, and children with neuromuscular disorders. The masses of information that we collected from optical motion capture, EMG, force measurements, and fluoroscopy were distilled down to the fundamental changes between our subject groups and either a normal population or another study population. I also negotiated commercial contracts with orthopedic device manufactures and clinicians for research projects. Finally, I maintained the Windows 2000 SBS network and trained personnel on new software and hardware.

As a research fellow, I studied the mechanical properties of soft tissues and engaged in teaching several classes to undergraduates. This position integrated techniques from mechanical engineering, molecular biology, histology, and biochemistry. Finite element models were also made of the material and its proposed implant sites were developed to allow better optimization of the material and minimization of experimental repetition. I developed a protocol for testing abdominal wall properties during various breathing maneuvers to obtain some of these properties. Several experimental devices and protocols had to be developed and built to facilitate the project. Additionally, I gave lectures and demonstrated for computer lab classes in subjects from biomaterials to solid mechanics computer simulation.

My primary project was the characterization of the movement of wrist bones to more accurately describe and understand normal and injured states to improve medical treatments. I developed spatial splining and averaging methods for use with 3D kinematic data. This data was taken at specific data points and we were unable to fill in the entire 3D motion envelope until the implementation of my interpolation algorithm, adapted from several different disciplines. I developed several corollary measures between three-dimensional data and clinical measures to make the information we discovered accessible to health professionals and more relevant to the patients. Other projects I contributed to involved pelvic reconstruction after fracture, knee kinematics, and shoulder tendon movement.

Scm, Mechanical Engineering

Scb, Mechanical Engineering

Education record