Midwest Medical Device Sterilization Workshop

US/Central
IARC Building (Fermi National Accelerator Laboratory)

IARC Building

Fermi National Accelerator Laboratory

Batavia, IL
Cherri Schmidt (Fermilab), Debbie Cotton (Baxter), John Williams (Medtronic), Mark Pasmore (Baxter), Thomas Kroc (FNAL)
Description

On September 18 – 19, the Illinois Accelerator Research Center (IARC) at Fermi National Accelerator Laboratory will host a regional workshop for stakeholders exploring accelerator-based sterilization alternatives. Fermilab has been tapped as a key partner to the federal government and industry in advancing the feasibility of particle accelerator-driven sterilization approaches. This work builds on our 50-year history of building and innovating these technologies for industry applications.

The workshop will focus on the current state of medical device sterilization, educate participants on the fundamental principles, address what information is needed to ease regulatory approval, and how scientists and industry can work together toward a new industry standard. The schedule will alternate between presentations and moderated panel discussions in order to give all participants an opportunity to be involved in the discussion.

 

Confirmed Speakers and Panelists

  • Peter Baker (Quantum EBX)
  • Jeremy Brison (IBA)
  • Tim Carlson (BD Medical)
  • John Conrad (iBIO)
  • Debbie Cotton (Baxter)
  • Emily Craven (Mevex)
  • Arved Deecke (Benebion)
  • Tony Faucette (BD)
  • Lance Garrison (NNSA)
  • Pamela Goldberg (MDIC)
  • Betty Howard (Steris)
  • Thomas Kroc (Fermilab)
  • Byron Lambert (Abbott)
  • Christophe Malice (IBA)
  • Josef Mittendorfer (High Tech Consulting)
  • Mark Murphy (Pacific Northwest National Laboratory)
  • Clarence Murray (FDA)
  • Larry Nichols (Steri-Tek)
  • Kim Patton (BD)
  • John Schlecht (Sterigenics)

 

Who should attend: Recent events in the medical device sterilization community reinforce that sterility assurance is not specific to any particular company or vendor. All stakeholders need to work together to define and build the future of this industry. Participants from technical, business, and regulatory functions from the following organization types will benefit from workshop participation:

  • Medical device manufacturers
  • Accelerator manufacturers
  • Contract sterilization vendors
  • Medical device regulators

 

Attendees should expect to:

  • Understand and contribute to conversation on the key drivers for choosing and implementing a sterilization approach:
    • The science of radiation sterilization technologies (X-ray, gamma, & E-beam)
    • The economics of sterilization technologies
    • The potential paths and obstacles to registration of a sterilization method for medical device sterilization
  • Network within the community supporting the sterilization of medical devices including industry, research, and regulatory organizations
  • Connect with Fermilab technology experts and tour Lab facilities
  • Influence discussion on the direction of medical device sterilization and potential collaboration opportunities and mechanisms to help realize that future

 

Registration open until September 14. Walkup registration will not be available for this workshop.

 

Cancellations and refunds accomodated until September 11, minus applicable credit card processing fees. - Registration is now closed.

Participants
  • Andrew Porteous
  • Anoosha Murella
  • Arved Deecke
  • Barry Sanders
  • Betty Betty
  • Bob Stringham
  • Brian Rembialkowski
  • Bryan Carrigan
  • Byron Lambert
  • Candice Nagel
  • Charlie Cooper
  • Cherri Schmidt
  • Christophe Malice
  • Clarence Murray, III
  • Daniel Wojtczak
  • David Ullmar
  • Debbie Cotton
  • Elizabeth Claverie
  • Emily Craven
  • Eric Beers
  • FERNANDO LUNA ARENA
  • Jeff Cook
  • Jeff Sauter
  • Jeffrey Margolis
  • Jeremy Brison
  • Jodi Lieberman
  • John Conrad
  • John Schlecht
  • John Williams
  • Jose Mijares
  • Josef Mittendorfer
  • Joseph Adduci
  • Joseph Wolinski
  • Kate Davenport
  • Kenneth Kohler
  • Kim Patton
  • Kyrstan Polaski
  • Lance Garrison
  • Lara Simmons
  • Larry Nichols
  • Leo Fifield
  • Marco Cardenas-Carmona
  • MARIA GARMENDIA-HARO
  • Mark Murphy
  • Mark Pasmore Pasmore
  • Matthew McCoy
  • Mattt Baitinger
  • Michael Clark
  • Michael Lioudis
  • Mike Rust
  • Nicole McLees
  • Pamela Goldberg
  • Pete Noverini
  • Peter Baker
  • Rafael Rodriguez
  • Rick Galloway
  • Rishabh Jain
  • Roger Dimitrov
  • Shelly (Michelle) Luebke
  • Thomas Kroc
  • Tim Carlson
  • Tim Zimmerman
  • Tony Faucette
  • Trisha Pankratz
  • Vanessa Vargas
  • William Jeschke
  • Winston Cockburn
  • Ying Zhang
Event Organizer: Tom Kroc
  • Wednesday, 18 September
    • 08:15
      Breakfast & Registration IARC Lobby

      IARC Lobby

    • Fermilab Welcome IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Convener: Nigel Lockyer (Fermilab)
    • Department of Energy Welcome IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Convener: Mark Bollinger (DOE)
    • Baxter Welcome IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Convener: Mark Pasmore (Baxter)
    • Introduction & Logistics IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Convener: Thomas Kroc (Fermilab)
      slides
    • Radiological Security through Alternative Technology: the DOE/NNSA Approach IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Convener: Lance Garrison
      slides
    • Keynote: “Gamma to e-beam/x-ray: fundamentals to practice” IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Convener: Byron Lambert
      slides
    • 10:35
      Networking Break IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
    • Panel 1: Current Landscape: Internal and External Factors Driving Sterilization Decisions IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Conveners: Jeremy Brison (IBA), John Schlecht (Sterigenics), John Williams (Medtronic), Kim Patton (BD)
    • 11:50
      Lunch The Big Room

      The Big Room

      Fermi National Accelerator Laboratory

      Batavia, IL

      Lunch and Activity #1

    • Transitioning from Cobalt-60 to e-beam or X-ray for Sterilization - A Model for Collaboration IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Convener: Mark Murphy (PNNL)
      slides
    • e, X, γ - The Good, the Bad, and the Promising IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Convener: Thomas Kroc (Fermilab)
      slides
    • Panel 2: Tales from the Trenches IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Conveners: Clarence Murray III (FDA), Debbie Cotton (Baxter), Jodi Lieberman (Sandia), Larry Nichol (Steri-Tek), Peter Baker (Quantum EBX), Tim Carlson (BD)
    • 15:00
      Networking Break IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
    • Tour #1: Leveraging Fermilab for Medical Device Sterilization Innovation IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL

      Tour of Illinois Accelerator Research Center

    • Breakout Activity IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
    • Day 1 Readout IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
    • No-Host Reception: Two Brothers Roundhouse IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
  • Thursday, 19 September
    • 08:15
      Breakfast & Networking IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
    • Day 1 Recap & Day 2 Reset IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
    • Opportunity Case Study 1: The choice of sterilization modality - technical and normative aspects IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Convener: Josef Mittendorfer (High Tech Consulting)
      slides
    • Opportunity Case Study 2: Machine source Irradiation vs. Gamma. Shifting decision criteria in a changing industry IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Convener: Arved Deecke (Benebion)
      slides
    • 10:00
      Networking Break IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
    • Panel 3: The Business of Switching: Economics and Logistics IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Conveners: Betty Howard (Steris), Christophe Malice (IBA), Emily Craven (Mevex), Kyrstan Polaski (Baxter), Tony Faucette (BD)
    • Models for Collaboration: E-beam and X-ray: Why? What? How? IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Conveners: Christophe Malice (IBA), Emily Craven (Mevex)
      slides
    • 11:55
      Lunch The Big Room

      The Big Room

      Lunch and Activity #3

    • Panel 4: Identifying the Shared Path Forward IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
      Conveners: Byron Lambert (Abbott), Clarence Murray III (FDA), John Conrad (iBIO), Mark Pasmore (Baxter), Pamela Goldberg (MDIC)
    • Breakout Activity IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
    • Workshop Readout and Recommendations IARC Building

      IARC Building

      Fermi National Accelerator Laboratory

      Batavia, IL
    • Tour #2: Behind the Scenes at Fermilab (Optional): Pre-Registration Required Fermilab site (various locations)

      Fermilab site (various locations)

      Fermi National Accelerator Laboratory

      Batavia, IL