Medical Design & Manufacturing (MD&M) West has announced a slate of educational sessions as part of its annual North American conference, including an AAMI-sponsored track with participation from AAMI staff, committees, and volunteers.

MD&M West is an exhibition and networking event for engineers, business leaders, disruptive companies, and innovative thinkers who create powerful solutions and life-changing medical devices.

Organized by Informa Markets – Engineering, the event is being held at the Anaheim Convention Center April 12-14, 2022. According to Informa, the 2022 conference will focus on powerful solutions that have been developed as a result of the global pandemic.

“Even amid unprecedented challenges, we’re continuing to see new life-saving innovations and exciting partnerships arise that are fueling the multi-hundred-billion-dollar industry,” says Adrienne Zepeda, group event director, MD&M West.. “We are so proud to announce our conference partners that are slated to take the stage and share valuable insights and arm our attendees with sought-after solutions to improve product speed-to-market, infuse new materials and technologies into devices, and further industry connections and accelerate trade.”

The 2022 conference features four content partners:  AAMI, the Chemical Angel Network (CAN), MedtechWomen, and the Society of Plastics Engineers – Medical Plastics Division.

These partners are “offering the unmissable opportunity to learn from highly technical experts in medtech product development, medical plastics, quality and regulatory, to investors and startups bringing product innovation to market, as a part of this year’s nine-track conference held over two days,” Informa announced.

AAMI is sponsoring a track on engineering quality assurance, featuring speakers hailing from standards development working groups and industry thought leaders.

Sessions include:

  • Opening remarks from Chair Ovidiu Munteanu, Senior Director of Standards, AAMI
  • Moving from CFR 820 to ANSI/AAMI/ISO 13485:2016 –
    How will the FDA pivot to ANSI/AAMI/ISO 13485:2016 impact quality and risk management practices across industry? This talk with have a special focus on risk management and the different ways that it is used throughout the Quality Management System.
  • Culture of Quality –
    Featuring a special look at the Leadership Engagement Playbook, a resource of leading practices and tools that provide concrete goals and actions to help medical device leadership move from a reactive to a proactive approach to quality.
  • The Rise of AI in MedTech: Innovation & Regulation of Artificial Intelligence – Featuring insights from a study of medtech executives and thought leaders on the current state of innovation and regulation of AI/ML and further establishes benchmarks on time and resources required to attain regulatory approval for novel AI/ML-enabled medical devices.
  • Evolving Combination Products International Standards –
    This presentation will review the dynamic combination product global regulatory landscape, and review harmonization efforts underway, discuss additional standards work that may contribute to harmonization activities, including: AAMI TIR 105:2020, AAMI TIR 48 ISPE Module 2 Harmonization.
  • Debate: Maintaining a Validated State for Connected Medical Devices, SaMD & DTx in an Era of Chaotic Innovation –
    Developing AI and cloud computing in medical devices is often not compatible with medtech’s traditional approaches to regulated change management. Two thought leaders will explore this “uncomfortable truth” in the pursuit of solutions and best practices for the industry.
  • Industrial Sterilization of Medical Devices—Overview and Update –
    A detailed overview of the primary methods for industrial sterilization of medical devices and detail the considerations when choosing the best method for use with a particular product. This session will also cover standards updates and regulatory issues impacting industrial sterilization.
  • Building Consensus Solutions to Wicked Problems in Medical Device Packaging –
    Learn from leaders from the AAMI Packaging working group about the latest developments in international standards for medical device packaging, including the recently published new edition of ISO/TS 16775 and amendments under development for the ISO 11607 series.

Visit www.mdmwest.com for more information about the event.