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Introduction and Logisitcs Thomas Kroc, PhD Midwest Medical Device Sterilization Workshop 18 September 2019 Fire/Tornado Safety Fire Parking Lot Tornado Bathrooms 2 18 Sep 2019 Kroc | Introduction & Logistics Fermi

  1. Introduction and Logisitcs Thomas Kroc, PhD Midwest Medical Device Sterilization Workshop 18 September 2019

  2. Fire/Tornado Safety Fire – Parking Lot • Tornado – Bathrooms 2 18 Sep 2019 Kroc | Introduction & Logistics

  3. Fermi National Accelerator Laboratory • National Laboratory: Funded by the Department of Energy (OHEP) • Mission: High Energy Physics Research (Discovery Science) • To carry out that mission Fermilab designs, builds, & operates: High Energy, High Power (MW) Accelerators that must have very high reliability • 6800 acre site, ~$360M/yr budget, Staff of 1700, > 2200 users • 350 Accelerator scientists and engineers + 300 technical staff (+ANL) • Largest collection of accelerator experts in the world • Broad skills in accelerator design, simulation, fabrication, integration & test • Also well versed in industry, university, and international partnerships 3 Kroc | Introduction & Logistics 18 Sep 2019

  4. Illinois Accelerator Research Center (IARC) • The opportunity for Fermilab: We build accelerators for a living…. • IARC = opportunity to use our staff and capabilities to have a large impact on future industrial accelerators and applications Mission Partner with industry to exploit technology developed in the pursuit of science to create the next generation of industrial accelerators, products, and new applications. IARC is a joint DOE and State of Illinois DCEO funded project $ 70 M complex on the Fermilab site 4 18 Sep 2019 Kroc | Introduction & Logistics

  5. What is IARC’s role in the development process ? The Technology Continuum Fermilab IARC Government Partners Industry Commercialization/ Proof of Demonstration/ Development Underlying Deployment Concept Verification Research 5 Kroc | Introduction & Logistics 18 Sep 2019

  6. What can IARC do for Industry? • Utilize one of Fermilab’s strengths/core capability – Accelerators – Accelerator Technology • Vacuum • Cryogenics (low temperatures) • RF • Etc. – Detector Technology – Computing, particularly big data • Fermilab must have a unique capability that is not available elsewhere in industry – Or is only available from a competitor 6 Kroc | Introduction & Logistics 18 Sep 2019

  7. Why is IARC (Fermilab) interested in Medical Device Sterilization? • Conversation and presentation at IMRP – 2016 (Vancouver) – Mention of in-line sterilization • Presentation attended by NNSA – Accelerator-driven Medical Sterilization to Replace Co-60 Sources • lss.fnal.gov/archive/2017/pub/fermilab-pub-17-314-di.pdf • Subject Matter Expert for upcoming White Paper – Non-Radioisotopic Alternative Technologies 18 Sep 2019 7 Kroc | Introduction & Logistics

  8. Simple Assumptions Concept • Regulation is the problem – Reducing or modifying will accelerate Design switching of modalities Manufacture • Devices are simple – A syringe Sterilization • Each device stands on its own – Syringe, clamp, suture Regulatory • A single person or group has a Approval comprehensive view from conception to sale Sale/Distribution • Choice of sterilization modality is a discrete point in decision making 8 Kroc | Introduction & Logistics 18 Sep 2019

  9. Sterilization Gamma, X-ray Modality E-beam Device Response to Cost Radiation Design Gamma, X-ray, e-beam Functional  X X Performance Functional Is Item Performance Part of Larger Product Family ? (Is it the Material master product?) Validation Where Choice Process Marketed Africa Mexico ? Regulator Brazil US China Knowledge EU Argentina & Familiarity Japan Regulatory Canada UK Quarterly Approval Verification 9 Kroc | Introduction & Logistics 18 Sep 2019

  10. Facilitator • Made a connection with Baxter, international headquarters nearby • What can we do? • Provide a neutral environment to see if we can help develop collaborations on a non-competitive topic – i.e. Safety – specifically, the sterilization of medical products using ionizing radiation using accelerators – Develop more resiliency in the system • Focus of this workshop is on radiation sterilization – But we won’t completely ignore EO – It is part of the sterilization environment 10 18 Sep Kroc | Introduction & Logistics 2019

  11. Feedback • We want to hear what you are thinking – Pre and post surveys – Questions during panels • Use note cards, pass to ends • Mics for interactive questions – Topical discussions during lunch – Breakout sessions – Sticky notes • Use at any time, place on easels during breaks • Final report – NNSA & FDA participation  Intend to report on the essence of conversations and discussions  Not our intention to put anyone on record 11 18 Sep 2019 Kroc | Introduction & Logistics

  12. Format • Four Themes 1. You Are Here: Current Paradigms and Drivers in Medical Device Sterilization 2. The Right Tool for the Right Job: Considerations for choosing your Sterilization Method 3. Flipping the Switch: Moving from Planning to Implementation 4. Accelerating the Path Forward: Prioritizing Needs, Opportunities, and Points for Collaboration 12 18 Sep 2019 Kroc | Introduction & Logistics

  13. Format • Each theme is led by 1 or two presentations • Followed by moderated panel discussion – Questions during panels • Use note cards, pass to ends • Mics for interactive questions • Sticky notes – Use at any time, place on easels during breaks 13 18 Sep 2019 Kroc | Introduction & Logistics

  14. Thank you • Attendees • Presenters and Panelists • Moderators – Kyrstan Polaski – Jodi Lieberman • Organizing committee – Mark Pasmore – Debbie Cotton – John Williams – Cherri Schmidt – Thomas Kroc • Fermilab and DOE site office 14 18 Sep 2019 Kroc | Introduction & Logistics

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