Medical Packaging Consultants 

Curt Larsen | CPPL, Fellow - Package Engineer

 

Curt brings more than 45 years of packaging design and consultation experience to Spartan Design Group.

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Education

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Curt is a 1967 graduate of Michigan State University with a B.S. degree in Packaging. He is a member of their Alumni Association and a past member of the Industry Advisory Committee of the MSU School of Packaging.

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Experience

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Curt was active in medical device packaging very early in his carrier and early in the industry (1972) on the Sterile Disposable Devices Committee (SDDC) of AdvaMed, formerly HIMA in drafting the original FDA device industry GMP's.

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Curt is a member of the Institute of Packaging Professionals (IoPP) and has served as a co chair of the IoPP Medical Device Packaging Technical Committee. He is a Certified Packaging Professional (CPP) by the IoPP. In 2007, he was inducted into the IoPP College of Fellows and received the prestigious Member of the Year Award. He is a member of AdvaMed (Health Industry Manufacturers Association) - Sterilization / Packaging Committee. He is currently an active member of the ASTM F04 Medical and Surgical Materials and Devices Committee, D20 Plastics Committee, D10 Packaging Committee and the F02 Flexible Barrier Packaging Committee. He has served as chairman of Subcommittee F02.60, Medical Packaging and has recently completed 12 years of various positions on the Board of Directors of Committee F02.

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Curt is a member of the Association for the Advancement of Medical Instrumentation (AAMI) committee that developed ISO 11607, a Sterile Medical Device Packaging standard for the International Standards Organization (ANSI/ISO). Curt is a past co-chair of the U.S. Delegation of ISO TC (Technical Committee) 198 / WG (Working Group) 7 on Packaging for medical devices. He was co-author of the initial draft of ISO 11607 and is a member of the ISO / EN harmonization revision task group.

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In addition to his Spartan Design Group experience, Curt has worked in the medical device field for Zimmer, Medtronic, Angiomedics (Schneider / SciMed Life Systems / Boston Scientific), Medical CV (Medical Incorporated) and Smith MD (Deltec, Inc.). He was a packaging engineering consultant for DuPont™ Tyvek® Medical Packaging serving the industry in education and problem solutions for nearly 10 years. He also has several years experience in consumer products with The Pillsbury Company and Tonka Toys.

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Curt has given numerous technical presentations and lectures on Medical Device Packaging at various technical symposiums, the FDA CDRH staff college, Health Canada and universities. He is an instructor for AAMI and teaches a sterile medical device packaging segment in their industrial Sterilization course. He has published over 20 articles on medical packaging and is member of the UBM Canon Pharmaceutical & Medical Packaging News (P&MP) Editorial Advisory Board.

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Professional Associations

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• Institute of Packaging Professionals (IoPP), Member

• Michigan State University School of Packaging Industry Advisory Committee, Past Member

• IoPP Medical Device Packaging Technical Committee, Past Co-Chair, Member

• University of Wisconsin - Stout Packaging Program Industrial Advisory Board, Past Member

• ASTM International Committee F02 Flexible Barrier Packaging, Member

• ASTM International Committee F02, Board of Directors

• ASTM International Committee F04 Medical and Surgical, Member

• ASTM International Committee D10 Packaging, Member

• Association for the Advancement of Medical Instrumentation (AAMI) Technical Committee (TC) 198, Sterilization, Working Group (WG) 7, Packaging, Past Co-Chair and present Member

• AdvaMed Sterilization/Packaging Committee, Member

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Awards and Recognition

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• 100 Notable People in the Medical Device Industry, Canon Communications Medical Device and Diagnostics Industry, June 2004

• Institute of Packaging Professional (IoPP) Member of the Year Award, May 2007

• IoPP College of Fellows, May 2007

• IoPP Certified Packaging Professional (CPP) Lifetime Certification, July 2010

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John Spitzley | CPPL, Fellow - Package Engineer

 

John brings more than 45 years of medical packaging engineering experience to Spartan Design Group.

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Education

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John is a 1968 graduate of Michigan State University with a B.S. degree in Packaging. He is currently a member of their Alumni Association and the Industry Advisory Committee of the MSU School of Packaging.

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Experience

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Before co-founding Spartan Design Group, John worked for Medtronic Inc. for 32 years as a packaging manufacturing and design engineer and in the Packaging Technology area. He held the title of Technical Fellow - Packaging until his retirement in May of 2005. He also has several years of experience in other Areas of Packaging, having been employed by Honeywell and Fingerhut Corporations. John was the past chairman of the AdvaMed (Health Industry Manufacturers Association - HIMA) Sterilization/Packaging Committee. John was co-author, along with Mr. Larsen, of the HIMA Sterile Packaging Guidance Document.

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John was chair of the AAMI committee that published and revised the Technical Information Report (AAMI TIR 22), a companion guidance document for ISO 11607 and along with Mr. Larsen has been involved with all the revisions to that document. He is a past member of the AAMI (Association for the Advancement of Medical Instrumentation) committee that developed the International Standard "AAMI, ANSI, ISO 11607" Packaging of terminally sterilized medical devices. He was also the co-chair of the US delegation of (working group) WG7 of that committee and was co-author of ISO11607 with Curt Larsen. John was chair of the AAMI committee that published and revised the Technical Information Report (AAMI TIR 22), a companion guidance document for ISO 11607, and along with Curt has been involved with all the revisions to that document.

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John has had many articles published in Medical Device and Diagnostics, Health Care Providers Pharmaceutical and Medical Packaging News and other magazines and has given numerous technical presentations to the Medical Device Industry. He is a member of the editorial advisory board of the Canon Communications publication "Pharmaceutical and Medical Packaging News". In June 2004 John was selected by Canon Communication's "Medical Device and Diagnostics Industry" magazine as one of the 100 Notable People in the Medical Device Industry.

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Professional Associations

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• Institute of Packaging Professionals (IoPP), Certified Packaging Professional (CPP) and Fellow

• ASTM Committee  F04 Medical Products

• ASTM Committee F02 Primary Barrier Packaging

• ASTM Committee D10 on Packaging

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Awards and Recognition

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• Medtronic Technical Fellow

• 100 Notable People in the Medical Device Industry, Canon Communications Medical Device and Diagnostics Industry, June 2004