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 Expert  108013

Expert in Medical Products Packaging: FDA Package Validation, Development Standards, Test Methods, ISO 11607

Available for your Consulting and Expert Witness Needs

Minnesota (MN)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
Expert has expertise in the field of medical device packaging for both single use disposable devices and for long-term implantable medical devices. His primary involvement has been in the design, development, and qualification of device packaging.

His work takes into account all aspects of processing such as sterilization, handling, and package production. It also considers marketing product requirements such as effective labeling and FDA regulations. He has experience setting up and implementing new company packaging, sterilization, and parts cleaning operations. Expert is extremely knowledgeable in the fields of package sterilization science, FDA package validation, materials selection processes, package product environmental testing and evaluation, and controlled environment and limited access packaging and production. Additionally, Expert has co-authored "Package Guidance Document," being published by HIMA, which is a guide on how to and what to consider when designing, testing, and validating the building process of a sterile medical device package.


active packaging material


medical device packaging design


medical device packaging material


medical device packaging process


medical device sterilization


medical product packaging process


packaging engineering


sterile packaging process




bagging material


extended shelf-life packaging material


flexible packaging material


Food and Drug Administration drug packaging regulation


medical device package integrity


medical package


medical package strength


medical package testing


sterilization packaging technology

Expert is past Chair of the ASTM Subcommittee F2.6 on Medical Packaging. That subcommittee is responsible for developing standards and test methods for evaluating materials, assemblies, and other related areas involving packaging medical products. He is the Past Co-Chair of the ISO/ANSI/AAMI Technical Committee 198/WG7 Packaging of Terminally Sterilized Medical Products and co-authored the initial draft of ISO 11607. This group is active in writing ISO standard 11607 for medical packaging of sterile medical products. He is still active with the group, whose recommendations the FDA has adopted.

medical device packaging standard


package testing


medical device manufacturing quality control


American Society for Testing and Materials


American Society for Testing and Materials packaging standard


American Society for Testing and Materials standard


ASTM packaging test-method standard


integrity testing


international medical device packaging standard


medical device package testing


medical device process validation


medical packaging

Show Secondary and Basic Areas of Expertise
Expert may consult nationally and internationally, and is also local to the following cities: Minneapolis, Minnesota;  Saint Paul, Minnesota;  Rochester, Minnesota;  Burnsville, Minnesota;  Saint Cloud, Minnesota;  Eden Prairie, Minnesota;  and Minnetonka, Minnesota.

Often requested
with this expert:

Medical Technology
Package Development and Testing
Medical Packaging: Project Management, Design, Validation,...
Packaging Design, Development, and Testing

Year   Degree   Subject   Institution  
1967   B.S.   Packaging Technology   Michigan State University  

Work History:
Years   Employer   Department   Title   Responsibilities

1984 to







Has consulted for over 35 years in the medical device sterile barrier and protective packaging areas. He and his staff have over 70 years of experience in the medical device packaging field. He is a global leader in standards, design and testing.

1998 to 2008


DuPont Medical Packaging


Tyvek Medical Packaging




Expert was a global packaging consultant to medical device manufacturers.

1990 to 1998


Smith MD (SIMS Deltec, Inc.)



Principal Packaging Engineer


Expert was responsible for all products packaging materials, designs and manufacturing

1985 to 1990


Medtronic, Inc.



Principal Packaging Engineer


Pacing product package designs, testing and manufacturing.

1983 to 1985


Angiomedics Inc. (Schnider U.S.A./Boston Scientific)



Technical Services Manager


1982 to 1983


Medical, Inc.



Senior Packaging Engineer


Career Accomplishments:

Expert is a member of ASTM, where he is active on the D-10 Packaging Committee; He is on the board as a member-at-large and past Vice Chairman of Committee F2 Flexible Barriers; he was also a Past Chair of Subcommittee F2.6 on Medical Packaging. He is a member of the ADVAMED (old Health Industry Manufacturer's Association or HIMA), where he is on the QA and Sterilization/Packaging sub-committee. He is a member of the Association for the Advancement of Medical Instrumentation (AAMI) Sterilization Committee and a U.S. Delegate to ISO/Technical Committee 198/Working Group 7 where as cochair of the US WG 7, he coauthored the 1st draft of the present day EN/ISO11607-1:2006 and EN/ISO11607-2:2006. He is a professional member the Institute of Packaging Professionals. In addition, Expert is a member of the Packaging Alumni Association of Michigan State University, and a member of The School of Packaging Industrial Advisory Board. He is also a member of the University of Wisconsin - Stout Packaging Program Advisory Council.


CCP- Certified Packaging Professional, IoPP (Institute of Packaging Professionals; Technical Fellow - Institute of Packaging Professionals

Professional Appointments

Expert is Chair Emeritus of the IoPP Medical Device Packaging Technical Committee. He is a Senior Member at Large of ASTM Committee F2, Flexible Barrier Packaging.


In June, 2004, he was recognized as one of the "100 Notable People in the Medical Device Industry" by the Canon Communications Medical Device & Diagnostic Industry Magazine. He was chosen "Member of the Year" in 2006 and awarded a technical fellowship by the Institute of Packaging Professionals in 2007.

Publications and Patents Summary

Expert has 20 published articles on medical device sterile packaging and been quoted in numerous other articles. He has participated in 40 conferences or lectures on medical device packaging.

Selected Publications and Publishers  
 - Industry discussion, Pharmaceutical and Medical Packaging News  
 - Medical device packaging workshop. Michigan Medical Device Manufacturers and Suppliers Association  
 - Medical Device and Diagnostic Industry magazine  
 - Medical Device and Manufacturing. Conference and Exposition  
 - Annual Conference on Packaging of Healthcare Devices and Products  

Government Experience:
Years   Agency   Role   Description
2002 to 2002   FDA   Lecturer   Expert gave a presentation to the FDA Staff College on the ISO 11607 "Packaging for Terminally Sterilized Medical Devices" standard.

Consulting Services:
Selected Consulting Examples:
  • Expert has many examples of on-site consulting experiences and will discuss them with interested clients.
  • He is a global consultant in all areas of medical device packaging.....materials, designs, equipment, testing, compliance and know for being an expert in "fixing self inflicted wounds"!
  • Has done training in all aspects of medical device packaging throughout Canada, China, Costa Rica, Mexico, Puerto Rico and USA.
Recent Client Requests:
  • Medical packagin expert for consulting on Failure mode analysis with Mylar.
  • Expert in Primary packaging and syringes to consult on packaging development.
  • Terminally sterilized medical device packaging expert needed for consulting regarding Sterile Packaging for Medical Device.
  • Expert for consulting on Packaging design technology for the contact lens industry.
  • Flexible packaging expert for consulting on Medical device Flexible Packaging.
  • FDA sterile medical device regulatory expert for consulting on sterile package integrity validation.
  • Expert in packaging for consulting on a design for medical devise.
  • Expert for consulting on IVD Test Fluid Container Design.
  • Expert in Medical Devices Forum
  • Expert in medical product packaging for consulting on Flexible Medical Packaging.
  • FDA Expert needed to review packaging validation testing and provide assistance with FDA communications.
  • Fda skin care packaging expert for consulting on fda regulations for skin care products packaging.
  • Medical device packaging and clean room expert expert for consulting on Gap Analyses.
  • Medical packaging validation expert for consulting on visual inspection device validation development.
  • Expert in medical device packaging for consulting on Plastic serum vials for aseptic fill.
  • Expert for consulting on New Packaging Similar to Contact Lens.
  • Expert in sterile packaging for consulting on sterile packaging methods.
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:
Expert has been an expert witness through deposition stages for the Hartford Insurance Company and Venable LLP.
Recent Litigation Client Requests:
  • Expert in sterilization of medical instruments.
  • Expert for consulting on expert witness - sterile packaging issues.
  • Sterile packaging & expert for consulting on Medical Supply Damage Litigation.
  • FDA expert in medical devices for consulting on products liability litigation.
  • Expert in packaging for consulting on design flaws for medical devise.
  • Medical packaging expert for consulting on bottle design and sterility.
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
2002 to 2003   EC   Expert had an active role along with country members of the EC in harmonization of ISO 11607 with EN868 standards.
2008 to 2008   China   Traveled throughout China as a member of the Dupont Medical Device Packaging Team as the trainer in all aspects of sterile medical device packaging
2001 to 2008   Puerto Rico   Every Year for 8 years in January for a week......traveled throughout Puerto Rico as a member of the Dupont Medical Device Packaging Team as the trainer in all aspects of sterile medical device packaging
2001 to 2008   Canada   traveled throughout Canada as a member of the Dupont Medical Device Packaging Team as the trainer in all aspects of sterile medical device packaging

Market Research:
Expert has been an independent consultant in the medical device sterile and protective packaging field for over 35 years. He has had clients from small start up (virtual companies) to global multi-billion dollar corporate clients.

Expert was a consultant to the Dupont Tyvek Medical Packaging marketing team for nearly 10 years.

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:

Expert has made numerous presentations at ASQC, HIMA, AAMI, healthcare industry, and other conferences and workshops.

He has given webinars on ISO11607 in conjunction with AAMI, has done corporate training of standards conformance, testing aging and design requirements.

Supplier and Vendor Location and Selection

He has experience locating vendors of medical device packaging materials, equipment, and services, and contract manufacturing.

He has access to the following resources: personal contacts, printed materials, and databases.

Other Skills and Services

He has participated in 40 industry conferences and authored or coauthored publications on medical device packaging.


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