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 Expert  724952

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


Available for your Consulting and Expert Witness Needs

NJ
Israel
Education Work History Career Accomplishments Consulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
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.
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biocompatible material

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bioimplantable material

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biomedical device

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irradiation sterilization

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.
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biomedical device design review

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
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biomedical device manufacturing

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medical device manufacturing

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.
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biomedical product development

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CE Marking

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Current Good Manufacturing Practice

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ISO 9000 quality system documentation

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.
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implantable device

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.
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ISO 9001

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.
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quality

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orthopedic product


Show Secondary and Basic Areas of Expertise

Often requested
with this expert:

Skeletal Biomechanics, Design and Evaluation of Orthopaedic...
Medical Device Quick Prototyping/ CAD Design/ Concepting
Medical Device Marketing, Market Research, Competitive...
Pharmaceutical and Biomedical Business Development,...

Education:
Year   Degree   Subject   Institution  
1974   Ph.D.   Mechanical Engineering   University of Vermont  
1972   MS   Mechanical Engineering   University of Vermont  
1970   BSME   Mechanical Engineering   University of Vermont  

Work History:
Years   Employer   Department   Title   Responsibilities

1993 to 2003

 

(Undisclosed)

 

Collegen Products

 

VP Operations

 

He was VP of Operations responsible for all aspects of manufacturing in both the European Production facility and one in the United States.

1991 to 1993

 

Osteonics, Division of Stryker

 


 

Director, Quality Assurance

 

He was responsible for the Quality Assurance System for this major Orthopaedic Device Manufacturer. Duties included Quality Assurance and Quality Control.

1989 to 1991

 

Orthomet

 


 

VP Manufacturing

 

He was responsible for manufacturing operations at this orthopaedic device manufacturer.

1983 to 1989

 

Zimmer

 

Director, Special Materials Projects

 


 

He worked on novel processing technologies for orthopaedic implant materials and lead a commercialization project for Ion Implantation of Titanium alloy Implants.

1983 to 1989

 

Zimmer

 


 

Director, Quality Assurance

 

He was responsible for all aspects of Quality Assurance, Quality Control and Microbiology.

1983 to 1989

 

Zimmer

 


 

Director, Research Laboratories

 

He was responsible for all mechanical testing activities done in conjunction with Research and Development at Zimmer.

1980 to 1983

 

Howmedica

 

Central Research Facility

 

Group Leader

 

He directed the mechanical testing laboratory at this research facility.

1974 to 1980

 

Georgia Institute of Technology

 

School of Mechanical Engineering

 

Assistant Professor

 

He was involved in academic research and teaching material science and processing classes at the undergraduate and graduate level.


Career Accomplishments:
Licenses/Certifications

He is certified Phil Crosby Quality System Instructor


Consulting Services:
Selected Consulting Examples:
  • 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.
Recent Client Requests:
  • Expert medical manufacturing for consulting on starting a medical manufacturing facility.
  • Expert in orthopedic devices for consulting to sell intellectual property patent.
  • Data Encryption Standard Expert for consulting on new DES clinical and marketing perspectives.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
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.
Recent Litigation Client Requests:
  • Medical device expert needed for consulting regarding a shoulder pain pump.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
1993 to 2003   The Netherlands   He was the Managing Director and VP of Operations for (Undisclosed)'s Collagen Manufacturing Facility in Vaals.
2003 to   Israel   He has been associated with several start-up medical device development companies located in Israel.
to   Germany   He worked with a number of German-based vendors and suppliers during his tenure at the (Undisclosed) facility in the Netherlands
to   France   He assisted with a due diligence audit for a possible acquisition in France.

Additional Skills and Services:
Training/Seminars

He is certified Phil Crosby Quality System Instructor and Kepner-Tregoe Trained


 

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