Expert Details

Expert in Medical Device Manufacturing & Biocompatible Material: Orthopaedic Devices, Cardiology, Review, etc.

Expert ID: 724952 Israel

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Expert has been actively involved in orthopaedic, cardiology and urology development projects for a number of years. All of these projects have relied upon and require biocompatible materials. As such he has developed an excellent understanding of the interrelationships between biocompatibilty of materials, the manufacturing processes needed to produce and sterilize them and the testing to ensure that the desired properties are still present at the end of the process.

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.

Array

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.

Education

Year Degree Subject Institution
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

Work History

Years Employer Title Department Responsibilities
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.

International Experience

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.

Additional Experience

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

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