Consultant for Medical Device Design, Development and Testing
Technical Consultant #1411
- Medical device evaluation and testing.
- Skilled in mechanical laboratory testing and procedures for hard and soft tissue, joints and other devices such as artificial limb prosthetics and external fixation devices.
- Conduct medical device laboratory testing for product development, third party device evaluations, and testing for regulatory submissions.
- Testing of spinal implants and other orthopedic devices for FDA submission and other required pre-development testing for new devices.
- Biomechanical evaluation and fatigue analysis of silicone breast implants.
- Experienced applying mechanical engineering tools to biomechanical applications, including computer aided design, (CAD) and finite element modeling, (FEM) techniques.
- Over twenty years of experience of using FEA and CAD programs as well as manual drafting practices for the design, development, analysis and testing of medical devices.
- Presented and published papers on orthopedic problems and collaborated in development of patentable orthopedic devices.
Operates Medical Device Testing Laboratory, 2005 - Present
- Provide medical device evaluation testing including 510(k) and Premarket Approval Applications (PMA).
- Testing and design analysis for medical devices.
- Manage daily operations of company with averaging greater than 30 projects annually serving an international client base.
Harrington Arthritis Research Center, Phoenix, Arizona, Various Positions, 1984 - 2002
- As Director of Mechanical Testing Department, transformed under performing contract testing lab to a profitable and growing facility.
As CAD Engineer Specialist
- Research advisor for Orthopedic Medical Residents in their biomechanical research projects.
- Specialist in Finite Element Modeling using ANSYS.
- Specialist in Computer Aided Design (CAD) using Prime Medusa, Pro/Engineer, and SolidWork's.
- Collaborated with orthopedic companies including Biomed, ETEX Corp., Howmedica, Osteonics, Ortho Development, Zimmer, and others on projects in testing and developing of devices.
- Co Inventor of the OrthoFrame external fixator and Harrington's Composite Hip Implant.
Miller Institute, Phoenix, Arizona, CAD Instructor, 1984
- Instructor in the Design/CAD department for second and third term students.
- Instructed students on ANSI and military standards for the applications of printed circuit board design and manufacturing.
Honors & Publications
7 patents in the areas of:
- Apparatus for Delivering Cement
- Unilateral External Fixation
- Pin Clamp
- External Fixation Device
- Femoral Joint Prosthetic Device
- Beam Construction and Method
Seven Professional Publications
- CAD Design, Miller Institute, Phoenix, AZ
- B.S., Mechanical Engineering, Milwaukee School of Engineering