Expert in Medical Device Manufacturing & Biocompatible Material: Orthopaedic Devices, Cardiology, Review, etc.
Expert ID: 724952 Israel
Expert has been a key player in a number of device design reviews during his career. He is experienced as both a developer of design history files, a participant as a presenter at design review sessions and has been a senior member of design review boards with approval authority and responsibilities.
Expert has been responsible for all manufacturing, logistics and operational activities at several different organizations during his career. From primary vendor selection for orthopaedic implant castings to being Managing Director of a European production center and having an in-depth knowledge of device packaging, microbiological testing and sterilization methods he has always been associated with device manufacturing, the quality systems required to maintain compliance and has been consulting for several years with a number of different start-up companies to share this expertise
Expert has had numerous opportunities to work with external end users and internal design teams to bring a number of different orthopaedic, cardiac and urological products to commercialization. The key to success has always been a full understanding of what the customer would like to have and the realities of the regulatory, manufacturing and production processes required to bring the concept to reality.
Expert been associated with implantable Class III devices for many years in several different organizations. He has an excellent understanding of what is required in the design, development, testing, manufacturing, packaging and sterilization of implantable devices fabricated from different materials.
Expert has experience leading efforts to establish ISO 9001 compliance in a number of different organizations from the start-up level to more firmly established groups. He has been involved with efforts with several different Notified Bodies and understands the dynamics involved in maintaining that relationship.
He is a Certified Crosby Quality System Instructor, he has taught Kepner-Tregoe courses and has been Director of Quality Assurance at several different organizations during his career. He is fully familiar with all aspects of quality control, quality engineering, test methodologies and microbiology for the production of biomedical devices and implants.
He is currently working with a number of start-up medical devices companies in the US and overseas, guiding manufacturing operations and research activities.He was instrumental in clarifying the design and manufacturing processes for a critical care device being developed by a US based start-up company.By clearly establishing design requirements for a novel Surface Acoustic Wave technology based device clinical trial parts were available on schedule.Identified critical flaws in fixture designs that lead to premature failure of a heart valve.He has performed QSIT audits in advance of FDA inspections and has done international auditing for manufacturers of devices containing tissue of animal origin.
|Year: 1974||Degree: Ph.D.||Subject: Mechanical Engineering||Institution: University of Vermont|
|Year: 1972||Degree: MS||Subject: Mechanical Engineering||Institution: University of Vermont|
|Year: 1970||Degree: BSME||Subject: Mechanical Engineering||Institution: University of Vermont|
|Years: 1993 to 2003||Employer: (Undisclosed)||Title: VP Operations||Department: Collegen Products||Responsibilities: He was VP of Operations responsible for all aspects of manufacturing in both the European Production facility and one in the United States.|
|Years: 1991 to 1993||Employer: Osteonics, Division of Stryker||Title: Director, Quality Assurance||Department:||Responsibilities: He was responsible for the Quality Assurance System for this major Orthopaedic Device Manufacturer. Duties included Quality Assurance and Quality Control.|
|Years: 1989 to 1991||Employer: Orthomet||Title: VP Manufacturing||Department:||Responsibilities: He was responsible for manufacturing operations at this orthopaedic device manufacturer.|
|Years: 1983 to 1989||Employer: Zimmer||Title:||Department: Director, Special Materials Projects||Responsibilities: He worked on novel processing technologies for orthopaedic implant materials and lead a commercialization project for Ion Implantation of Titanium alloy Implants.|
|Years: 1983 to 1989||Employer: Zimmer||Title: Director, Quality Assurance||Department:||Responsibilities: He was responsible for all aspects of Quality Assurance, Quality Control and Microbiology.|
|Years: 1983 to 1989||Employer: Zimmer||Title: Director, Research Laboratories||Department:||Responsibilities: He was responsible for all mechanical testing activities done in conjunction with Research and Development at Zimmer.|
|Years: 1980 to 1983||Employer: Howmedica||Title: Group Leader||Department: Central Research Facility||Responsibilities: He directed the mechanical testing laboratory at this research facility.|
|Years: 1974 to 1980||Employer: Georgia Institute of Technology||Title: Assistant Professor||Department: School of Mechanical Engineering||Responsibilities: He was involved in academic research and teaching material science and processing classes at the undergraduate and graduate level.|
|Years||Country / Region||Summary|
|Years: 1993 to 2003||Country / Region: The Netherlands||Summary: He was the Managing Director and VP of Operations for (Undisclosed)'s Collagen Manufacturing Facility in Vaals.|
|Years: 2003 to Present||Country / Region: Israel||Summary: He has been associated with several start-up medical device development companies located in Israel.|
|Years: to Present||Country / Region: Germany||Summary: He worked with a number of German-based vendors and suppliers during his tenure at the (Undisclosed) facility in the Netherlands|
|Years: to Present||Country / Region: France||Summary: He assisted with a due diligence audit for a possible acquisition in France.|
|Expert Witness Experience|
|In his various capacities at Zimmer he did deposition work relative to litigation the company was involved with. Additionally while at Georgia Tech he had the opportunity to testify in Federal court in a product liability suit. More recently he acted as an expert witness in an Intellectual Property suit dealing with surgical devices.|
|Training / Seminars|
|He is certified Phil Crosby Quality System Instructor and Kepner-Tregoe Trained|
Fields of Expertise
biocompatible material, bioimplantable material, biomedical device, irradiation sterilization, biomedical device design review, biomedical device manufacturing, medical device manufacturing, biomedical product development, CE Marking, Current Good Manufacturing Practice, ISO 9000 quality system documentation, implantable device, ISO 9001, quality, orthopedic product, joint replacement, urology device, first article inspection, hip replacement, polymer biocompatibility, biocompatibility testing, fatigue failure, artificial joint, plastic medical device, biomechanical engineering, biocompatible coating material, 510(k) document, in-service materials failure analysis, metal quality, governmental registration process, foreign medical device regulation, forensic materials failure analysis, disposable medical device, forensic engineering, biocompatibility, bioengineering, wound healing, surgical instrument, metal failure analysis, medical device, failure analysis, biomedical engineering, biocompatible polymer, biocompatible metal, artificial limb