7:30 AM - 8:30 AM | 2nd Floor, Lobby

Networking Breakfast

Continental Breakfast + Networking Opportunity + Exhibitors and Sponsors

General Session | 8:30 AM - 9:30 AM | General Session Room

WElcome and Opening Remarks

Stephen Rapundalo, PhD, CEO, MichBio
Hon. Hillary Scholten, U.s. Representative (MI-3) 

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.

General Session | 9:35 AM - 10:30 AM | General Session Room

Navigating the New Normal: Medical Device Product Development in a Digitally
Driven Regulatory World

In an era where innovation in medical devices is rapidly accelerating—driven by AI, robotics, wearables and digital health platforms—the product development lifecycle faces unprecedented regulatory complexity and scrutiny. This session explores how companies are reshaping their development strategies to meet evolving global regulatory demands while accelerating time to market. It will delve into how regulatory expectations for software as a medical device, cybersecurity, real-world evidence, and digital traceability are influencing engineering and R&D choices from concept to commercialization. 

10:30 AM - 11:00 AM | 2nd Floor, Lobby

Networking Break

Coffee + Networking + Exhibitors and Sponsors

General Session | 11:00 AM - 11:55 AM | General Session Room

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, and include considerations around early clinical evaluations, including FIH studies. 

General Session | 12:00 PM - 1:15 PM | General Session Room and 2nd Floor, Lobby

Lunch Program Featuring Innovator Hot Pitches

Lunch + Innovator Hot Pitches + Networking + Exhibitors and Sponsors

Innovator Hot Pitches: Get a front-row seat to the future of medical technology at the Innovator Hot Pitches session. This dynamic showcase features early-stage medtech startups from Michigan presenting their cutting-edge products, breakthrough technologies, and disruptive innovations. Each company will deliver a rapid-fire pitch designed to capture attention, spark dialogue, and highlight their potential to transform healthcare delivery and patient outcomes. Don’t miss this opportunity to discover the next wave of medical device trailblazers and engage with the visionary entrepreneurs behind them.

Dual Track Sessions | 1:15 PM - 1:55 PM | Session Rooms 1 & 2

TRack 1 - Innovation
Translating Innovation to Market: From Bench to Business

Bringing breakthrough medical technologies from the research lab to the hands of clinicians and patients is a complex journey - one marked by high potential and high risk. This panel will explore the critical challenges and pivotal opportunities in translating scientific innovation into viable commercial products. Panelists will delve into key factors that shape success, including early-stage venture formation, navigating regulatory and reimbursement pathways, building effective business models, and scaling medtech startups in a competitive marketplace. 

Track 2 -Medtech Product Development
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.

Dual Track Sessions | 2:00 PM - 2:40 PM | Session Rooms 1 & 2

Track 1 - Innovation
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. 

Track 2: Medtech Product Development
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 explore how medical device companies are proactively mitigating risk, enhancing responsiveness, and building greater 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 | 2nd Floor, Lobby

Networking Break

Coffee + Networking + Exhibitors and Sponsors

General Session | 3:15 PM - 4:00 PM | General Session Room

Smart Manufacturing in Medtech: Harnessing Industry 4.0 for Precision 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, artificial intelligence, data analytics, and the Internet of Things (IoT) are driving next-generation manufacturing processes in the medtech sector. 

General Session | 4:00 PM - 5:00 PM | General Session Room

Closing Plenary: Medtech on the Edge — A candid Fireside Chat with Mark Leahey

As the medical technology industry confronts a perfect storm of disruption — from supply chain fractures and policy whiplash to the race for innovation supremacy — what's really at stake? In this unfiltered fireside chat, Mark Leahey, President & CEO of the Medical Device Manufacturer Association (MDMA), pulls back the curtain on the forces reshaping the medtech landscape. We'll tackle tough questions about U.S.  competitiveness, the future of advanced manufacturing, shifting global power dynamics, and how innovators and manufacturers can survive — and thrive — in a volatile new era. Expect candor and clarity as we close the summit with a call to action. 

Moderator: Stephen Rapundalo, PhD, CEO, MichBio

Speaker: Mark Leahey, President and CEO, Medical Device Manufacturers Association

Summit Summary and Closing Remarks

Stephen Rapundalo, PhD, CEO, MichBio

5:00 PM - 6:30 PM | 2nd Floor, Lobby

Networking Reception

Appetizers + Networking + Exhibitors and Sponsors