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2025 Medical Device Summit

Thursday, September 25, 2025

Grand Valley State University | L.V. Eberhard Center

301 Fulton Street West
Grand Rapids, MI 49504-6431
United States
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Thursday, September 25, 2025
Grand Valley State University | Grand Rapids

Join Michigan's premier Medical Device Summit to explore cutting-edge technologies, regulations, and industry insights. Network with top medtech professionals, researchers, investors, and government officials. Discover Michigan's thriving medtech ecosystem and its impact on innovation and economic growth.

Who Should Attend?

Join us if you are:

  • Industry Executives and Thought Leaders in the MedTech sector
  • MedTech Research and Development Experts
  • Professionals in Contract Manufacturing, Prototyping, or related services
  • Academic Professionals engaged in MedTech education
  • Clinical Research Organization Specialists

Be part of the conversation driving Michigan's medical device technology, regulatory updates, and intra-state B2B investments.

Venue:

Address:
Grand Valley State University
L.V. Eberhard Center
301 Fulton St W, Grand Rapids, MI 49504

Presented By: 
         

Agenda

September 25
7:30 AM - 8:30 AM Networking Breakfast Continental Breakfast + Networking Opportunity + Exhibitors and Sponsors
8:30 AM - 8:40 AM Welcome and Opening Remarks Stephen Rapundalo, PhD, CEO, MichBio
Hon. Hillary Scholten, U.S. Representative (MI-3) 
8:40 AM - 9:30 AM C-Suite Unplugged: Building a Durable Medtech Enterprise in a Changing World In this unfiltered conversation with top executives from Michigan's medical device industry, hear firsthand how today's C-suite is navigating unprecedented disruption—from regulatory shifts and global supply chain volatility to talent shortages, digital transformation, and capital market uncertainty.
9:35 AM - 10:30 AM Designing for Impact: Engineering Strategies Throughout the Product Development Lifecycles Developing innovative medical devices requires a balance of technical rigor against market realities. From early-stage design and prototyping through verification, validation, and scale-up, panelists will share best practices for optimizing development workflows, integrating digital requirements, and rethinking end-to-end product development lifecycles. The discussion will also consider how engineering choices impact business outcomes while positioning products for long-term commercial success.
10:30 AM - 11:00 AM Networking Break Coffee + Networking + Exhibitors and Sponsors
11:00 AM - 11:55 AM Regulatory Strategies and Risk Road Mapping for Medtech Success This expert panel will explore the latest developments in domestic and international regulatory frameworks and how medtech innovators can build effective, risk-informed development roadmaps. Panelists will discuss designing pathways that identify and mitigate clinical and regulatory risks. The emphasis will be on holistic, cross-jurisdictional strategies that support efficient product development and timely market access.
12:00 PM - 1:15 PM Lunch Program Featuring Innovator Hot Pitches Lunch + Innovator Hot Pitches + Networking + Exhibitors and Sponsors
1:15 PM - 1:55 PM T1—Translating Innovation to Market: From Bench to Business Bringing breakthrough medical technologies from the lab to clinicians and patients is a complex journey marked by high potential and risk. This panel explores challenges and opportunities in translating innovation into viable products. Panelists will discuss early-stage venture formation, regulatory and reimbursement pathways, business models, and strategies for scaling medtech startups in a competitive marketplace.
1:15 PM - 1:55 PM T2—Cybersecurity & Data Privacy in Medical Devices Ensuring cybersecurity and data privacy is critical, especially as artificial intelligence (AI) becomes increasingly embedded in medical technologies. This session will examine the growing threat landscape for connected devices, recent FDA guidance on cybersecurity requirements, strategies to ensure compliance and product effectiveness, as well as risk management best practices for securing devices throughout their lifecycle.
2:00 PM - 2:40 PM T1—Evidence Development Challenges Posed by FDA and Payers Most regulatory strategies focus on achieving approval or clearance. But too often, lack of concordance between sponsors and FDA in the Q-submission process can complicate, extend, and imperil regulatory reviews. Subsequently, widespread payer coverage routinely lags product approval - often for years. This presentation will show you how to tailor a comprehensive evidence plan to address the needs of both stakeholders to help shorten the gap. 
2:00 PM - 2:40 PM T2—Strategies for Building Resilient Global Supply Chains As global disruptions continue to challenge the medtech industry, resilient supply chain design has become more critical than ever. This panel will examine how medical device companies are proactively mitigating risk, enhancing responsiveness, and increasing agility in their global operations. Hear from supply chain leaders on best practices in nearshoring, dual-sourcing, and redundancy planning to reduce dependencies and ensure continuity. 
2:45 PM - 3:15 PM Networking Break Coffee + Networking + Exhibitors and Sponsors
3:15 PM - 4:00 PM Smart Manufacturing in Medtech: Harnessing Industry 4.0 for Prescision and Efficiency Smart manufacturing, guided by Industry 4.0 principles, is redefining how medical devices are designed, produced, and delivered. This session will explore how cutting-edge technologies such as automation and robotics, additive manufacturing, artificial intelligence and machine learning, digitization, and data analytics, are helping to create "smart factories" for medical devices faster.
4:00 PM - 5:00 PM Closing Plenary—Medtech on the Edge: A Candid Fireside Chat with Mark Leahey The medtech industry faces a perfect storm of disruption—from supply chain fractures and policy shifts to the race for innovation. In this fireside chat, Mark Leahey, President & CEO of MDMA, reveals the forces reshaping the landscape. We’ll explore U.S. competitiveness, advanced manufacturing, global power dynamics, and how innovators and manufacturers can survive and thrive in this volatile new era.
5:00 PM - 6:30 PM Networking Reception Appetizers + Networking + Exhibitors and Sponsors
Mark Leahey
President & CEO, Medical Device Manufacturers Association (MDMA)

Mark Leahey is the President & CEO for the Medical Device Manufacturers Association (MDMA), the leading national trade association representing hundreds of innovative and entrepreneurial medical technology companies in Washington, DC. His responsibilities include advocating on behalf of the medical device industry to Congress, the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and other federal and state agencies.
C-Suite Unplugged: Building a Durable Medtech Enterprise in A Changing World
  • John Kennedy, IV, Chief Technology Officer, Autocam Medical
  • Gene Parunak, Managing Director, in2being, LLC
  • Stuart Shulman, CEO, Medical Devices Inc.

Designing for Impact: Engineering Strategies Throughout the Product Development Lifecycles
  • Aaron Kehrer, Vice President, Product Development, in2being, LLC
  • Jim Medsker, President & CEO, Keystone Solutions Group

Regulatory Strategies and Risk Road Mapping for Medtech Success

Innovator Hot Pitches

Translating Innovation to Market: From Bench to Business

Cybersecurity & Data Privacy in Medical Devices

Evidence Development Challenges Posed by FDA and Payers
  • Mark Duval, CEO, DuVal & Associates, P.A.
  • Chris Lyle, MS, Vice President, Evidence Strategy, DuVal & Associates, P.A.

Strategies for Building Resilient Global Supply Chains
  • Matt Noorman, Senior Manufacturing Engineer, SafeHeal
  • Alexis Smith, Chief Strategy Officer, Everis Medical
  • Ryan Wasson, Director, Global Procurement, Oliver Healthcare Packaging

Smart Manufacturing in Medtech: Harnessing Industry 4.0 for Precision and Efficiency
  • Ryan Eggleston, President, UTP Solutions
  • Eric Guice, Quality Systems/Compliance Assurance Professional, Becker Orthopedic
  • Steven Lopez, Director for Manufacturing Solutions, The Right Place

Keynote Session:
Medtech on the Edge—A Candid Fireside Chat with Mark Leahey
  • Mark Leahey, President and CEO, Medical Device Manufacturers Association (MDMA)

Credits Price
Academic - Nonmember - Early Bird
Registration Ended 8/29/25 at 11:59 PM EDT
$129.00
Industry - Nonmember - Early Bird
Registration Ended 8/29/25 at 11:59 PM EDT
$299.00
Student - Nonmember - Early Bird
Student tickets are for full-time students not otherwise employed. Registration Ended 8/29/25 at 11:59 PM EDT
$39.00
Academic - Nonmember - Regular Registration
Registration Ends 9/22/25 at 11:59 PM EDT
$149.00
Industry - Nonmember - Regular Registration
Registration Ends 9/22/25 at 11:59 PM EDT
$349.00
Student - Nonmember - Regular Registration
Student tickets are for full-time students not otherwise employed. Registration Ends 9/22/25 at 11:59 PM EDT
$49.00
Academic - Nonmember - Late Registration
Registration Opens 9/23/25 at 12:00 AM EDT
$179.00
Industry - Nonmember - Late Registration
Registration Opens 9/23/25 at 12:00 AM EDT
$399.00
Student - Nonmember - Late Registration
Student tickets are for full-time students not otherwise employed. Registration Opens 9/23/25 at 12:00 AM EDT
$59.00

MichBio has not arranged official room blocks for the 2025 Michigan Medical Device Summit. Below are accommodations near the venue.

Holiday Inn Grand Rapids Downtown

310 Pearl Street NW, Grand Rapids, MI 49504
(616) 235-7611 | Visit Hotel Website

Courtyard by Marriott Downtown Grand Rapids

11 Monroe Avenue NW, Grand Rapids, MI 49503
(616) 242-6000 | Visit Hotel Website

Residence Inn Grand Rapids Downtown

40 Louis Street NW, Grand Rapids, MI 49503
(616) 776-5900 | Visit Hotel Website

Unlock Opportunities for your Brand

Sponsor | Exhibit | Advertise

The Michigan Medical Device Summit will be taking place on Thurs., Sept. 25 in Grand Rapids. This is the ultimate gathering for the state’s medtech innovators. Attendees will explore cutting-edge medical device technologies, navigate evolving regulations, and uncover market trends that position Michigan as a leader in medical innovation. This is your chance to elevate your company’s presence in the ever-evolving healthcare technology landscape.

Expand Your Network, Elevate Your Impact

Engage with a vibrant mix of professionals, including:

  • Medtech industry experts
  • Academic researchers
  • Healthcare providers
  • Suppliers and contract manufacturers
  • Investors and business leaders
  • Government officials

Forge meaningful connections that can drive your business forward.

Prospectus
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For questions, don't hesitate to reach out. 

3600 Green Court, Suite 780
Ann Arbor, MI 48105
events@michbio.org
Sponsors: