MD&M Minneapolis, an MD&M Event

October 16-17, 2024
Minneapolis Convention Center
www.advancedmanufacturingminneapolis.com

MD&M Minneapolis is the sourcing home for hundreds of different types of suppliers. From medical device components to medical packaging, it has everything, and more, under one roof. Medtech moves fast… especially in a healthcare hub like Minnesota. Keep 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.

KEYNOTES:

Wednesday, October 16 10:15-11 AM • Engineering Theater

Pat Baird, Senior Regulatory Specialist, Philips

The Next Iteration of AI in Medical Devices

Artificial intelligence is an impressively fast-moving technology in all fields, and especially for medical devices. It is already improving patient lives with innovative healthcare, lower healthcare costs, and better patient outcomes, but as with all advances, if not properly regulated, these benefits could possibly open risks to safety and security. In this keynote, Baird will address new and emerging regulations and standards (both national and international), differences between predictive AI and generative AI, and where this technology will take us in the next few years.

Wednesday, October 16 1:15-2:00 PM • Engineering Theater

Rahul Garg, Vice President of Industrial Machinery, Siemens Digital Industries Software

Digitalization: The Key to Accelerating the Future of Manufacturing

Digitalization can take companies to new levels of manufacturing efficiencies on the way to becoming an automated, data-driven organization. Digital threads form the backbone that enables digitalization, and companies can leverage AI to mature the adoption curve and expand their foundational capabilities.

In this keynote, Garg helps attendees learn how digitalization is transforming organizations, from product design through manufacturing and into service delivery. Tools such as AI, XR, and digital twins are driving the future of manufacturing, allowing companies to harness the enormous quantities of data generated by industrial IoT that power the new insights and opportunities required to stay ahead of the competition.

Thursday, October 17 1:15-2:00 PM • Engineering Theater

Jonathan Arenberg, Chief Mission Architect, Science & Robotic Missions, Civil & Commercial Space, Northrup Grumman Space

Sensors in Space: Learnings from Designing NASA’s James Webb Telescope

The James Webb Space Telescope (JWST) is the largest, most complex and powerful space telescope ever built. It is also the world’s first space deployable telescope and includes 10 new technologies. The construction took over 100 million man hours by hundreds of companies spread over the globe. JWST contains the largest mirror ever launched into space and two different types of extraordinarily sensitive detectors. The JWST just passed its second year in space and is performing twice as well as required. Jon Arenburg, chief mission architect for the JWST at Northrop Grumman Space, oversaw the integrated design performance for the project. In this keynote, Arenberg will review the mission and then delve into the sensors and other devices developed for the project. And, of course, he will share some of the jaw-dropping images the JWST has sent back.

Thursday, October 17 10:15-11:00 AM • Engineering Theater

Amy Alexander, Unit Head - Mechanical Development & Applied Computational Engineering, Division of Engineering, Mayo Clinic

Printing a Healthier Tomorrow: How 3D Technology Is Shaping the Future of Medicine

The future of healthcare delivery is more precise, personalized, and accessible. This view into the future explores the transformative potential of 3D printing/additive manufacturing (AM), 3D scanning, extended reality (XR), and artificial intelligence (AI) in revolutionizing how we deliver medical care. In this keynote, Alexander will delve into these four key growth areas. 3D printing will enable the creation of customized implants, prosthetics, and even bioprinted tissues, tailored to each patient’s unique needs. 3D scanning will ensure the accuracy of these medical devices, leading to improved outcomes.

XR technologies will offer immersive training for surgeons, such as real-time data overlays during procedures, and interactive patient education, fostering a more informed and empowered patient experience and facilitating remote collaboration, potentially improving access to specialists in underserved areas. Finally, AI will change the game of healthcare delivery when it comes to automation, education and training, patient interaction, and digital healthcare applications. By exploring the future directions of these technologies, this view highlights their potential to significantly improve patient outcomes, reduce healthcare costs, and personalize medical care. This glimpse into a “printed” future paints a picture of a more efficient, effective, and accessible healthcare system, paving the way for a healthier tomorrow.

MUST-SEE SESSIONS

Automating Excellence: How LLMs and Generative AI Transform Medical Device Design

The development of medical devices system is highly complex and dynamic, requiring systems engineers to understand and apply a vast amount of domain knowledge from multiple engineering disciplines to meet design requirements. However, it is challenging for individual human engineers to fully and deeply process and apply all this domain knowledge. It’s time-consuming, error-prone and requires proper training, which leads to high development costs and projects delays. In this presentation, we will share an AI-driven Intelligent Design solution to demonstrate how it addresses the above challenges by automating the manual process of analyzing the requirements as well as generating the comprehensive design testing scenarios considering interoperability of various design entities. To be specific, the intelligent solution will be applied to the following areas: 1) Design requirements: industry standards, FDA guidance, product requirements, 2) lower-level requirements across software, hardware, mechanical, and electrical. 3) design entities including but not limited to hardware, human behaviors, environmental elements, and cybersecurity. Xiaofan Mai, CEO and founder at IntelliU, will share case studies that demonstrate the solution’s capabilities and benefits. It empowers engineers to transform product development to the next level, saving business much development cost by preventing failures early on and expediting the development cycle with quality excellence.

Biodegradable and Implantable Elastomers

Biodegradable and implantable elastomers are highly desirable for medical products in which materials interface with soft tissues subjected to large and dynamic strains. They exhibit elastomeric properties in both dry and wet environments and stretched specimens can completely recover after force is removed. These elastomers are degradable in vitro and in vivo, and both the polymers and their degradation products show high cytocompatibility in vitro. Specimens implanted in the gluteal muscle of rats trigger similar tissue responses as compared with poly(glycerol sebacate) (PGS) and PCL controls, two widely accepted implantable polymers. PCL-PβMαVL-PCL can be readily processed by printing, extrusion, or hot-pressing at 60 °C, and lysozyme can be incorporated during processing without losing its bioactivity. The elastomeric, biodegradable, biocompatible, and thermoplastic properties collectively make these materials highly valuable for biomedical applications. This session is presented by Wei Shen, associate professor in the department of biomedical engineering at the University of Minnesota.

De-Risking the Valley of Death: The Total Product Life Cycle Advisory Program

This panel will provide participants with an overview of the FDA’s innovative Total Product Life Cycle Program (TAP). That program is intended to help ensure that participating device developers receive earlier and more frequent interactions, more strategic input from stakeholders, and proactive, strategic advice from CDRH to spur more investment in and rapid development of high-quality, safe, effective, and innovative medical devices that are critical to public health. Panel organizer Michael Morton has more than 30 years of experience in the medical device industry and has served on the Regulatory Affairs Professionals Society (RAPS) board of directors. He is currently an independent regulatory consultant and a senior policy advisor for Medical Alley. As part of the discussion, Morton will draw upon current FDA resources supporting the TAP program and will share industry insights with the Breakthrough Devices program. Panelists: Ben Wagner, director of communications, Medical Alley; Nikita Basandra, director of regulatory affairs, CVRx; and Kai Kadoich, TAP advisor, FDA CDRH.

Microscale 3D Printing: Implications and Applications for Healthcare

Microscale 3D printing is rapidly transforming the landscape of medical device design, offering unprecedented precision and versatility in creating intricate structures from various materials. This session will explore some of the benefits and applications of microscale 3D printing, particularly its ability to produce components at a scale and complexity that conventional additive manufacturing and microfabrication techniques cannot achieve.

Attendees will gain insights into the various printing technologies available, specific considerations for medical applications, and the unique requirements for printing biological materials. In the session, Seth Hara, manager of the Microfabrication Laboratory at the Mayo Clinic, will also highlight applications at Mayo Clinic, showcasing how microscale 3D printing is driving innovation for the advancement of patient care.