John Spitzley
Senior Consultant, Packaging Engineer

Professional Experience

John Spitzley is a consultant to the medical device industry, with more than 31 years of experience in the field of packaging.  Areas of expertise include package design, development and performance qualification, material selection and evaluation, manufacturing process development, equipment selection and validation, and package shelf life test protocols and testing.

• Prior to becoming a consultant, John spent 31 years working for Medtronic as a packaging manufacturing and design engineer in the Packaging Technology area.  His last position with Medtronic was as a Technical Fellow – Packaging.

1. He held the position of Manufacturing Packaging Engineer for over 10 years.
2. Responsible for implementation of the first double barrier thermoformed tray and lid configuration for an implantable device in the medical device industry in the early 1970’s.
3. Responsible for planning, development and installation of the sterile and final packaging areas for Medtronic’s first implantable pacemaker facility in Puerto Rico and Japan.
4. Responsible for planning and developing Medtronic’s first on-line, on demand computerized label printing line.
5. Developed and installed Medtronic’s first in-line, ionized air, tray cleaning system.

• John also has several years experience in other areas of packaging which he gained while working for Honeywell and Fingerhut Corporations.

John is actively involved in industry activities, task forces and working groups.

• He is co-Chair of the Association for the Advancement of Medical Instrumentation (AAMI) Packaging Working Group; co-author of the initial draft of ISO 11607 “Packaging for terminally sterilized medical devices”, and he was Chair of the Task Force that developed the Technical Information Report (TIR) #22 which is a guidance document for ISO 11607.
• He is a member of the American Society of Testing and Materials (ASTM) Board of Directors of Committee F02 Flexible Barriers and he is an active member of the ASTM F02.60 Medical Packaging Committee.

• He is the past chairman of the AdvaMed (Health Industry Manufacturers Association – HIMA) Sterilization / Packaging committee.  John was co-author, along with Curt Larsen, of the HIMA Sterile Packaging Guidance Document.

• He is a member of the Institute of Packaging Professionals (IoPP).

John holds a Bachelor of Science in Packaging from Michigan State University, and is a member of the Industrial Advisory Board for the University of Wisconsin – Stout Packaging Program.  John is recognized by the IoPP as a Certified Packaging Professional and he was selected by Canon Communications “Medical Device & Diagnostics Industry” magazine as one of the 100 Noteable People in the Medical Device Industry, June 2004.

John is the author and co-author of numerous articles on packaging and he has presented at various technical symposiums on the topic of medical packaging.