This page includes materials related to MGMC conferences and other events where MGMC partners have made presentations related to the MGMC initiative to develop harmonized standards for medical-grade materials.
2024
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2024 MGMC Mini-Conference and Material Fair
Ethicon Surgeons’ Dining Room and Ethicon Gym, Cincinnati
13–14 August 2024
The MGMC Mini-Conference for 2024 focused on a review of the consortium’s most recent publication—a ‘soft guideline’ that encompasses key topics discussed in previous white papers by the Association of German Engineers (Verein Deutscher Ingenieure; VDI) and the North America Medical-Grade Materials Consortium (MGMC). The goal of those publications was to develop a consolidated guideline for defining what constitutes a medical-grade material, with sections covering terms and definitions; regulatory requirements; consistency of formulations; manufacturing processes; security of supply; change management; packaging, storage, and logistics; end-user cleaning, disinfection, and sterilization; supplier-client relationships; and quality management systems. Day two of the conference centered on the theme of sustainability for materials used in medical technologies, and featured a panel discussion involving experts from Johnson & Johnson as well as materials suppliers.
- Agenda – Download PDF
- 12-Point Checklist for Medical Grade Material – Download PDF
- Guidelines for the Classification of Medical-Grade Polymers Used in Nonimplantable Applications Cincinnati: North America Medical-Grade Materials Consortium, 2024. Available Here.
- Richtlinien für die Klassifikation von “medical-grade” Polymeren, die bei nicht-implantierbaren Anwendungen zum Einsatz kommen. Cincinnati: North America Medical-Grade Materials Consortium, 2024. German Translation Available Here.
- Newsletter Available Here.
2023
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Day 1
Day 2
2023 MGMC Mini-Conference
Ethicon Medical Research Institute, Cincinnati
23–24 August 2023
The MGMC Mini-Conference for 2023 focused on a review of key points from the group’s two white papers, including breakout sessions on regulatory compliance, shipping and logistics, end-user disinfection, and customer expectations. Attendees also had opportunities to review and comment on the harmonized Medtech Material Application Questionnaire/Design Form and OneMD Material e-Cert Form, now available here. Day two of the conference opened a new topic for the medical plastics community, with sessions focused on strategies for sustainability. Presentations discussed packaging, design, and pricing for sustainability.
- Agenda – Download PDF
- Anim J, Posgai M. 2023 Medical-Grade Material Definition Mini-Conference Summary. Cincinnati: Ethicon, 2023. Available Here.
- Guidelines for Medical Grade Definition, Part 2: Regulatory Compliance, Shipping and Logistics, End-User Disinfection, and Customer Expectations. Cincinnati: North America Medical-Grade Materials Consortium, 2023. Available Here.
- Richtlinien für die Definition von „medical-grade Material,“ Teil 2: Einhaltung gesetzlicher Vorschriften, Versand und Logistik, Endnutzer-Desinfektion und Kundenerwartungen. Cincinnati: North America Medical-Grade Materials Consortium, 2023. German Translation Available Here.
MD&M West SPE MPD MiniTec Conference
Anaheim Convention Center
6–7 February 2023
- Anim J, Klein R. Establishing and Maintaining Biological Safety of Medical Devices per ISO 10993-1:2018: A Long and Tortured Process. Presentation at MD&M West SPE MPD MiniTec Conference, Anaheim, CA, 6–7 February 2023. Available Here.
2022
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2022 MGMC Mini-Conference
Ethicon Medical Research Institute, Cincinnati
17 August 2022
Recognizing that current guidelines for polymers are driven predominantly by the automotive, aerospace, and oil and gas industries—offering little or no basis for considering issues that might affect patient safety—one of the key objectives of the MGMC Mini-Conference for 2022 was to establish a seat for the medtech industry within the portfolio of North American polymer producers. The conference continued work toward creating the first harmonized standard for defining materials suitable for use in medical devices; introduced the concept of vendor-led material prescreening (initial biocompatibility testing, chemical compliance certification, sustainable chemistries), and discussed the need to expand the timing for notification of change and opportunities for last-time buys.
- Agenda – Download PDF
- Anim J, Torain S. Medical-Grade Material Definition Mini-Conference Summary. Cincinnati: Ethicon, 2022. Available Here.
2019
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2019 MGMC Mini-Conference
Ethicon Medical Research Institute, Cincinnati
8 August 2019
After an initial call to action presented at the 2017 Medical Design & Manufacturing Conference and Exposition in New York City, Ethicon convened the first MGMC Mini-Conference on 8 August 2019, in Cincinnati. The conference established that the scope and ultimate goal of the MGMC initiative would focus on defining the basic requirements for medical-grade, locked-down grade, pharmaceutical packaging, and skin-contact grade materials. It was determined that nonmedical and implant-grade materials would not be included within the scope of the initiative. A summary of the conference was published in the form of a white paper in November 2019.
- Agenda – Download PDF
- Anim J, Torain S. Medical-Grade Resin Mini-Conference & Material Fair Summary. Cincinnati: Ethicon, 2019. Available Here.
- Guidelines for Defining Medical-Grade Materials; Part 1: What Is a Medical-Grade Material? (rev ed). Cincinnati: Ethicon, 2024. Available Here.
- Richtlinien für die Definition von medical-grade Materialien; Teil 1: Was ist ein medical-grade Material? (rev Ausg). Cincinnati: Ethicon, 2024. German Translation Available Here.