Aerospace and automotive companies are looking for longterm growth strategies following significant impact from the COVID-19 pandemic and the resulting economic downturn. With manufacturing synergies to the medical device industry, automotive and aerospace executives are looking to expand their offerings and enter into the medical device field. Evolving to MedDev 2021 , the only event of its kind, provides the perfect opportunity for building connections across industries needed to meet short-term demand and create long-term business opportunities. (Register for MedDev 2021 .)

In a recent research study conducted by Tech Briefs Media Group (now SAE Media Group ), one-third of the auto and aero companies surveyed said they were planning to expand into the medical market. Thus, the inaugural Evolving To MedDev 2021 digital event will provide automotive and aerospace suppliers and manufacturers with practical information about how they can enter into the medical device supply chain, while also teaching them how to get certified and how to implement medical device standards.

SESSIONS

Welcome and Market Overview

Bill Bihlman, Founder and President, Aerolytics; Connie Conboy, Director, MedAccred; Sherrie Trigg, Editor, Medical Design Briefs; and Matt Wasowski, SAE International

Join SAE, P-R-I/MedAccred, and Medical Design Briefs staff to preview the event’s sessions, speakers, networking, and sponsors.

Case Study: DarwinAI’s Shift from Automotive AI to Healthcare

Sheldon Fernandez, CEO, and Fineas Tatar, Senior Growth Associate, DarwinAI

This case study reviews the company’s successful shift from automotive AI to its COVID-Net solution, an open source system to diagnose COVID-19 via chest x-rays, for hospitals and healthcare facilities.

Introduction to MedAccred

Connie Conboy, Director, MedAccred

MedAccred is an industry managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain. Audits are conducted on behalf of its subscribing OEM members using collaboratively created audit criteria. The accreditation is granted and accepted by the program’s subscribing OEM members.

Case Study: University of Minnesota’s Collaboration with Ford to Make Air Filtration Devices

Dr. Jiarong Hong, Associate Professor, Mechanical Engineering, University of Minnesota

Learn how Ford and the University of Minnesota teamed up to develop air filtration kits that people can make at home or in school to help reduce COVID-19 virus particle concentrations in a room.

Bridging the Gap from Aerospace Manufacturing to Medical Device Compliance

Paul Kunder, President, Amera-Veritas; Jason Lee, Adaptive Quality Systems; John Kirkpatrick, retired, General Electric Aircraft Engines; Shawn Findlater, Consultant, QE Coach and ASQ Author; Maura Callahan, SAE International

Transitioning from aviation, space, or defense to medical device manufacturing? Learn how to begin your journey to FDA medical device compliance and approval. The speakers will explore the current and future environmental conditions and market changes, talk about similarities in regulation and compliance across the aerospace and medical device industry, and review what opportunities might exist.

Panel: Pivoting to MedDev

Martin Petrak, CEO, and Andy Christensen, Board Member, Precision ADM; and Robert Carter and Kirk Rogers, Barnes Global Advisors

Experts discuss practical considerations necessary for a transition to medical devices from other industries.

Additive Manufacturing for Aerospace

Bill Bihlman, Founder and President, Aerolytics

Learn how additive manufacturing lends itself to replacing conventionally manufactured parts and assemblies with lightweight components for aircrafts and engines.

Why Get into Medical Devices and How Might You Do It

Dr. Michael Hawkins, Technical Affairs Consultant, AcceLinx

A primer about the medical device industry, covering expansion possibilities, regulations, certifications, and the best places to enter into the market.

America Makes: Its Pivot to Medical and Rules of Engagement to Transition

John Wilczynski, Executive Director, and Brandon Ribic, Technology Director, America Makes, National Center for Defense Manufacturing & Machining (NCDMM)

America Makes discusses its shift from aero to medical to support the U.S. COVID mitigation plan and the rules of engagement for AM that apply to many sectors.

How Additive Manufacturing Can Help Businesses Make the Technical Pivot from Aerospace to Medical

Eliana Fu, Industry Manager, Aerospace, & Medical, TRUMPF North America

Learn why AM may allow businesses to rapidly pivot from aerospace to medical, given similarities in material, processing, and stringent qualification processes.

Panel: The Similarities and Differences of AM within Aerospace and Medical Devices — Powered by Boston Micro Fabrication

John Kawola, CEO, Boston Micro Fabrication; Bill Bihlman, Founder and President, Aerolytics; Eliana Fu, Industry Manager, Aerospace & Medical, TRUMPF North America; John Wilczynski, Executive Director, and Brandon Ribic, Technology Director, America Makes, National Center for Defense Manufacturing & Machining (NCDMM); Dr. Michael Hawkins, Technical Affairs Consultant, AcceLinx

Additive manufacturing (AM) has proven to be highly disruptive in design and development for industrial products. This new paradigm creates opportunities from optimized lightweight components in aerospace to custom bio-conformed hardware for medical applications. This panel will explore the similarities and differences of these end markets — and others — in the context of this exciting technology.

Medical Device Quality Management System Requirements and the Value of ISO 13485 Certification

Kim Trautman, Executive Vice President, Medical Device International Services, NSF Medical Devices

Understand the value of ISO 13485 certification, “commercial” and “regulatory” certification, and differences between Quality Management System (QMS) sector-specific requirements. The medical device sector as a globally regulated industry has very specific QMS requirements. This presentation will explore:

  • The value of ISO 13485 certification.

  • The need and difference between “commercial” and “regulatory” ISO 13485 certification.

  • General differences between QMS sector-specific requirements such as ISO 13485 for medical devices, IATF 16949 for automotive, and AS9100 for aerospace.

Using MedMMAP for MedAccred® Certification

Bill Donohue, President and Executive Director, and Scott Schein Director, National Network & Supply Chain Programs, A.L. Philpott Manufacturing Extension Partnership, Genedge

Learn how the Medical Manufacturers MedAccred® Accreditation Pathway (MedMMAP) program can assist businesses to evaluate and begin their MedAccred certification.

Panel: MedAccred Subscribers

Dannette Crooms, Sr. Director of Quality, Edwards Lifesciences; Elizabeth Gaipa, Vice President Quality Management – Supplier Quality, BD

Learn how MedAccred subscribers benefit from being part of the certification program, including oversight of suppliers to address vital issues in all the critical manufacturing processes.

Improve Public Health by Utilizing Existing Expertise in the Aerospace Industry

Steven Niedelman, Lead Quality Systems & Compliance Consultant to the FDA and Life Sciences Practice, King & Spalding

Uncover opportunities to improve public health by utilizing expertise in the aerospace industry, which is surprisingly aligned with the medical devices industry.

Breakout Discussion: MedAccred® Criteria for Electronics — Powered by Interpower

Ralph Bright, VP, Marketing, Interpower Group of Companies; Julia Markardt, Master Instructor and Staff Engineer, MedAccred; Michael Lau, Senior Designer, Stryker

An interactive breakout discussion allowing attendees to ask questions to better understand what MedAccred looks for in the electronics area.

DISTINGUISHED SPEAKERS

Kim Trautman, Executive Vice President Medical Device International Services, NSF Medical Devices

Kimberly A. Trautman, MS, is a medical devices and In vitro diagnostics expert with over 30 years of experience. She worked at the US FDA for over 24 years and with other regulatory agencies around the globe, giving her both industry and regulatory agency experience. She has a demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Trautman executes several medical device, IVD, and combination product regulatory consulting services and has developed a formal education/ training business.

She is an Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/ MDR Designation. She is an expert in global medical device regulations, has written and harmonized the current 1996 US FDA Quality System Regulation, and was on the international authoring group of ISO 13485 since inception in 1994.

Trautman is an expert in combination products and was on the FDA authoring committee for 21 CFR Part 4. She conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. She is a 20-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). She is also a recognized international medical device expert with a master's degree in biomedical engineering.

Steven Niedelman, Lead, Quality Systems & Compliance Consultant to the FDA and Life Sciences Practice, King & Spalding

Steve Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement, and policy matters. He provides strategic advice, insight, and guidance to the medical device, pharmaceutical, biologics, and food industries to ensure FDA compliance. Niedelman retired from FDA in 2006 after a 34-year distinguished career, serving as the deputy associate commissioner for regulatory affairs and as chief operating officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of ORA, including the Office of Regional Operations, Office of Enforcement, and Office of Criminal Investigations. Additionally, Niedelman assisted in the day-to-day management of the FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. While at ORA, he served as the principle liaison to CDRH and was a member of the GHTF Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee, and the CDRH Post Market Initiative Steering Committee. He also served on the steering committee to the pharmaceutical cGMP for the 21st Century Initiative as well the Counterfeit Drug Task Force.


Medical Design Briefs Magazine

This article first appeared in the April, 2021 issue of Medical Design Briefs Magazine.

Read more articles from this issue here.

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