SHOW PREVIEW

MD&M Minneapolis
October 10–11, 2023
Minneapolis Convention Center, Minneapolis, MN
www.mdmminn.com

Medtech moves fast … especially in a healthcare hub like Minnesota. Keep the pace with the latest innovations and immerse yourself in a community of visionaries and industry leaders. It’s all waiting at the region’s most comprehensive medical design and manufacturing event — MD&M Minneapolis — part of Advanced Manufacturing Minneapolis.

KEYNOTE: Meeting the Unmet Clinical Need: A Story of Loss, Drive & Innovation

Dr. Brad S. Sutton will address how advances in medical devices are transforming the lives of patients around the world. The innovative medical devices available today improve and extend people’s lives, and the careful design of those devices enable patients to manage their own care more easily and effectively than ever before. In his keynote, Dr. Sutton will discuss the evolution of the world’s first left atrial appendage closure device and his personal connection to unmet clinical need.

Dr. Sutton joined Boston Scientific in 2019 and is currently chief medical officer, AF Solutions. In this role he oversees the Electrophysiology and Watchman clinical enterprises. Dr. Sutton completed his medical training at the Johns Hopkins School of Medicine and Johns Hopkins Hospital, and received an MBA in Medical Services Management at the Johns Hopkins Carey School of Business. Dr. Sutton is board certified in cardiovascular medicine and clinical cardiac electrophysiology. Prior to joining Boston Scientific, he served as associate professor of medicine and clinical vice-chair of the department of medicine, as well as assistant dean for health strategy and innovation at the University of Louisville.

This keynote is presented in partnership with Minnesota ASQ.

KEYNOTE: Navigating the Path to Packaging Sustainability

David Chmura will explore how packaging plays a critical role in preserving the safety, nutrition, and quality of the food General Mills makes. In his keynote, he will also present challenges both in terms of raw materials and waste generated when improper disposal occurs and is a top sustainability issue with consumers. He will further discuss how General Mills works to reduce the environmental impact of packaging through five key strategies: Reduce, re-use and recycle, material innovation, education, infrastructure, and external collaboration.

Chmura leads packaging strategy and development for General Mills Snacks Operating Unit. In that role, he sponsors GMI packaging sustainability efforts and leads the technology team. Chmura has 23 years of experience in packaging across the plastics industry and food consumer packaged good, with 18 years at General Mills in packaging and rrocessing R&D, operations, and supply chain. He currently resides in Minnesota.

This keynote is presented in partnership with the Minnesota Chapter of The Institute of Packaging Professionals (IoPP).

TECH TOURS

These hour-long tours start at the IME Media Lounge, Booth #1835.

Cardiovascular

Tuesday, October 10

11:00 AM–12:00 PM Central Time

3D Printing & Additive Manufacturing

Wednesday, October 11

10:15–11:15 AM Central Time

Food & Beverage Packaging

Wednesday, October 11

2:15–3:15 PM Central Time

COFFEE TALK

Tuesday, October 10

10:30–11:15 AM Central Time

Bridging the Gap: Navigating the Transition from Medical Prototyping to Production with Ease

Navigating the new product development journey in the medical space can be an arduous process. As initial prototyping moves through FDA submittals, clinicals, and into commercialization, the requirements of data and testing change — as does what is required of a manufacturer. In this special session, attendees will learn about:

• Prototyping vs. production requirements in the medical space and how they are accommodated for in the manufacturing process.

• Digital manufacturing and how it can be used to supplement/augment existing supply chains.

• The value of vendor consolidation in supporting the different requirements of prototyping and production.

• Examples of this supply chain strategy in practice.

TECH THEATER HIGHLIGHTS

Tuesday, October 10

11:00–11:45 AM Central Time

U.S. FDA Adoption of the Quality Management System Regulation — How Should You Prepare?

On February 23, 2022, the United States Food and Drug Administration proposed an amendment to 21 CFR 4 and 820. The purpose of the proposed change is to better align the agency’s medical device quality management system requirements with the international consensus standard for devices, ISO 13485: 2016 (the Standard), used by other regulatory authorities.

This will affect quality management system (QMS) requirements for both medical devices and combination products involving both medical devices and drugs. This presentation will include information directly from key individual within the agency on what expectations will be for current activities for the greatest impact toward compliance with the new requirements.

Speaker: Tim Gooch, BSEE, technical director, life sciences management systems and supply chain at SGS North America. Tim has 40 years experience in the medical device industry including design and development for head and neck implant design, active implantable medical devices, manufacturing for orthopedics and spine, quality systems consulting, third-party audits, and business development as well as testing, inspection, and certification.

Tuesday, October 10

1:00–1:45 PM Central Time

The Impacts of Updated Standards on IFU Validations for Reusable Medical Devices

As reusable medical devices continue to advance, the validations used to evaluate the reprocessing (cleaning, disinfection, and/or sterilization) procedures have had to advance as well. These advancements have resulted in numerous standards and guidance documents being either updated or created to ensure that reusable medical devices can be safely reprocessed. This presentation will discuss these changes as found in documents such as AAMI ST98, AAMI TIR12, and ISO 17664, as well as others. Additionally, this presentation will discuss how these changes impact new and already completed reprocessing validations for reusable medical devices and will address what is next for these validations.

Speaker: Alpa Patel, director of scientific improvement at Nelson Laboratories. He is a certified microbiologist and has been part of the medical device industry for 20 years specializing in cleaning/disinfection and sterilization of reusable medical devices and endoscopes and validation of tissue disinfection or sterilization processes. Her current role as a director of scientific improvement at Nelson involves overseeing test method validations for reprocessing, writing standard test protocols (STP) and standard operating procedures (SOP) for reprocessing and other internal and globally related documents, providing technical consulting for the reprocessing sections at Nelson Laboratories in Salt Lake City and globally. Patel presents at Nelson Laboratories’ seminars, trade shows, FDA, AAMI, and client facilities across the United States and international sites.

As a member and collaborator with the American Standard Test Methods (ASTM), American Association of Tissue Banks (AATB) and American Association of Medical Instrumentation (AAMI), and International Organization for Standardization (ISO), she plays an active role, in concert with the FDA and regulatory committees, in developing standards and discussing and voting on changes to those standards.

Patel is one of a select group of experts in the industry, and her participation on these committees offers insight on industry trends and helps prepare Nelson Laboratories and its clients for the most up-to-date medical device validation requirements.

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