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 Expert  723158

Expert in Medical Device: Design, Development, Manufacturing and Quality Assurance


Available for your Consulting and Expert Witness Needs

New York (NY)
USA
Education Work HistoryPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
He has been involved in Good Manufacturing Practices (GMP) for over twenty seven years in Class II and III product environment. Set up and maintained Class 100,000 clean rooms and manufactured Class II Critical and Class III devices in this environment. He has designed, implemented, qualified and validated numerous Class II and Class III pilot plants and production lines for blood oxygenators, autotransfusers and dialyzers. Refurbished and implemented a parallel plate dialyzer line. Produced more than 10,000 units on contract. Validated product and process for this product line. Validated a dry powder (sorbent) dispensing production line. Set up and operated an FDA registered manufacturing facility.
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Current Good Manufacturing Practice

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manufacturing documentation system

He has R&D medical device experience in Cardiovascular, Vascular, Nephrology and Liver Detoxification. He has managed many projects from product concept through full manufacturing, such as a home based sorbent dialysis system with a team representing mechanical, electrical, software engineering and industrial design, as well as the contract manufacturing for both the machine and the sterile disposables. He has been responsible for the creation, audit and remediation of Design History Files (DHF) on products such as dialysis systems, patient monitors, electronic thermometers and single use blood pressure cuffs. He has created & implemented Design Control systems utilizing electronic documentation viewing and revision control for an entire team based in multiple locations around the world.
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design process

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medical device design

He has served as a Primary Product and Therapy engineer responsible for development and technical revisions of System and Design requirements, design of complex Graphical User Interface (GUI) and custom disposable blood pump, blood leak detector, blood oxygenator, autotransfuser and ammonium sensor. He has extensive knowledge of the plastics used in the medical products industry, including sterilization validation and biocompatibility, for disposable design. He has presented nationally at the Medical Device & Diagnostics show regarding World Class Design and Design for Manufacturing.
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disposable medical device

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medical device

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medical device testing

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medical device manufacturing

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medical device hazard analysis

He is nationally known for his design, manufacturing .and quality acumen in this field. He is a senior level professional with over twenty seven years of experience in the medical device industry including electromechanical and sterile disposable product design, manufacturing and quality assurance. He has exhibited strong leadership, consensus building and team development in the design, manufacturing and quality environments for Class II and III medical devices. He has a proven record of multi-disciplinary project completion in conjunction with successful implementation through manufacturing line start up. He has consulted with a numerous firms in the areas of Design Controls; including Verification & Validation experimentation, Process Validation and Risk Management. He has the unique ability to view design from product concept though post market surveillance and all the feedback, so critical to excellent design, in between.
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medical device product development

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device product development

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manufacturing quality assurance


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Buffalo, New York;  Rochester, New York;  Syracuse, New York;  and Niagara Falls, New York.

Often requested
with this expert:

Mold, Industrial Hygiene, Indoor Air Quality, Toxins,...
Microbial Contamination Issues
Parenteral/ Sterile Product Formulation Development;...
Medical Device Design and Manufacturing, Measurement...

Education:
Year   Degree   Subject   Institution   Honors
1985   MBA   Business   University of Phoenix  
1974   BS   Mechanical Engineering   Clarkson University   w/Distinction

Work History:
Years   Employer   Title   Responsibilities

1998 to

 

(Undisclosed)

 

President

 

He has created Polcy and Procedure for Quality systems (ISO 13485:2003), review and remediation of Design History Files, performed Risk Management (ISO 14971) and managed Master Validation Plans for Class III manufacturing.

2001 to 2003

 

Renal Solutions, Inc

 

Vice President, Product Development

 

He was the Primary Product and Therapy engineer responsible for development and technical revisions of System and Design requirements and design of Graphical User Interface (GUI) for a home based hemodialysis machine. Also created & implemented Design Control system utilizing electronic documentation viewing, and revision control for entire team based in multiple locations around the world.

1999 to 2001

 

HemoCleanse, Inc

 

Vice President & General Manager

 

He set up an entire FDA registered facility including a startup production & kitting operation for sterile and nonsterile Liver dialysis disposables in a clean room environment.

1992 to 1998

 

WellPort, Inc

 

President

 

He co-founded, started and managed all aspects of a medical device contract design and manufacturing organization. Negotiated capital purchase of clean room and office equipment including lease contract for 11,000 sq. ft facility. Set up and maintained Class 100,000 clean rooms and manufactured Class II Critical and Class III devices in this environment.

1990 to 1992

 

Porterfield Enterprises

 

Director, Technical Services

 

He was responsible for technical, regulatory and business consulting to medical device companies. Presented “Design for Manufacturing” at Medical Device and Diagnostics (MD&DI) Show, Presented “World Class Manufacturing” at MD&DI Show.

1987 to 1990

 

BioSurge, Inc

 

Vice President of Technology

 

He was responsible for a sterile disposable intraoperative autotransfuser design, noted as R&D Magazine “Top 100”Products for 1990, from concept to market.

1980 to 1986

 

COBE Laboratories Inc

 

Cardiovascular R&D Engineering Manager

 

He lead a team (30 people) that completed the membrane lung (CML2) product and production line design. This team designed the product, semi-automated production line and ran the pilot plant for start up.

1974 to 1990

 

Eastman Kodak Company

 

Sr. Development Engineer

 

He designed movie camera and instant camera transport mechanisms and plastic parts.


Publications:
Publications and Patents Summary

He holds one US and one Japanese patent in membrane oxygenation.


Consulting Services:
Selected Consulting Examples:
  • He has developed Quality System SOPs, specifically Complaint handling, Incoming Inspection and Nonconforming material for a Class III manufacturing company in alignment with ISO 13485.
  • He has developed and implemented Master Validation plans for process validation in compliance with the Global Harmonization Task Force (GHTF/SG3/N99-10:2004).
  • He has participated and facilitiated Design Reviews and Risk analysis for Class II developers of medical devices.
  • He has participated in an FDA inspection of a Class III device manufacturer.
  • He has developed the materials and trained technical & production personnel in Failure Investigation and ISO 13485:2003.
Recent Client Requests:
  • Expert for consulting on Trends for audio functionality in medical devices.
  • Expert in PFMEA applied to chemical processes.
  • Expert for consulting on Evaluation of contract medical device manufacturer.
  • Expert in Clean Room -Aseptic Packaging of Beer.
  • Expert medical manufacturing for consulting on starting a medical manufacturing facility.
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:
Recent Litigation Client Requests:
  • Contract manufacturing expert witness pharmaceuticals for consulting on Trial on pharmaceutical contract manufacturing.
  • Clean room testing expert for consulting on contamination issue.
  • 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
1984 to 1984   Japan   He was part of a three member team in Tokyo negotiating with Asahi to manufacture microporous membrane for oxygenators.

Market Research:
He has developed and placed ads, created product name and identity, developed brochures and created web sites.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Presented “Design for Manufacturing” at Medical Device and Diagnostics (MD&DI) Show, Presented “World Class Manufacturing” at MD&DI Show. Developed and presented Failure Investigation and ISO 13485 training presentation.

Supplier and Vendor Location and Selection

He has sourced and qualified over 100 suppliers of medical device components and services, including sterilization, biocompatibility, injection molding and electromechanical components

Other Skills and Services

He has owned and operated a medical device design and manufacturing business. He understands the legal and financial aspects of this business.


 

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