AGENDA Information of Event Schedule

Focusing on the design and manufacture of medical devices alongside factors affecting that industry (e.g., regulatory, M&A, quality, legislative), coupled with a keen awareness of challenges associated with the space, the MPO Summit presents a comprehensive agenda that targets many of today's most important issues impacting stakeholders.

7:00-8:40 a.m.

Registration & Continental Breakfast

Sponsored by:

8:40-8:45 a.m.

Opening Remarks

speaker-1

Howard Revitch

speaker-2

Sean Fenske

8:45-9:00 a.m.

Welcome to Silicon Valley

An introduction of the region serving as the host of the 2025 MPO Summit—Silicon Valley—and an overview of why the area is important to the medical device manufacturing industry.

9:00-9:45 p.m.

State of the Industry

With an emphasis on M&A activity within the industry among OEMs and the supporting supply chain, this session will highlight the current state of affairs within the medical device manufacturing sector. Key data points and trends will be featured in this opening session, enabling predictions for future activity within the industry.

speaker-1

Bryan Hughes

9:45-10:30 a.m.

Beyond Reshoring: What Companies Are Doing Now

Join us for a journey through the history of offshoring, reshoring, and into the future of manufacturing. Consider the current and future strategies of global manufacturing companies, including where in the world to source and manufacture based on your product profile and the ever-changing geopolitical landscape. Learn what factors are most important to consider in making strategic location decisions and why reshoring may not be the best approach for your products. Rosemary Coates has been at the forefront of the reshoring movement for a decade. She will challenge you to rethink your global manufacturing strategy.

speaker-1

Rosemary Coates

10:30-11:15 a.m.

Networking Break

Sponsored by:

11:15 a.m.-12:15 p.m.

Make vs. Buy: An OEM/CM Supply Chain Discussion

Description to come.

speaker-1

Brent Hahn

speaker-2

Jim Fitzgerald

speaker-3

John Schneider

speaker-4

Barry Schnur

12:15-1:45 p.m.

Networking Luncheon

Sponsored by:

1:45-2:30 p.m.

Washington Update

With the rapid influx of changes happening in the nation’s capital, it’s vital to stay abreast of what’s happening at various levels of government, as well as where agencies such as the FDA and CMS are heading. As a new Congress and administration continue to implement and work on their respective legislative agendas, learn about the latest federal landscape and how it could impact the medical technology ecosystem.

speaker-1

Brendan Benner

2:30 a.m.-3:15 p.m.

Session 6

Description to come.

3:15-4:00 p.m.

Networking Break

Sponsored by:

4:00-5:00 p.m.

Face to Face: Industry Execs Address Medtech’s Most Pressing Issues

This session will feature a panel discussion among industry representatives who have had to address challenges including supply chain, labor, regulatory, cost controls, and other topics.

speaker-1

Julie Schulte, MBA

speaker-2

Nora Crivello

5:30-7:00

Networking Reception

Join attendees, speakers, and exhibitors for drinks and hors d’oeuvres during an evening reception. Take advantage of the setting for networking and conversation with peers within the medtech manufacturing industry.

Sponsored by:

Wifi/Social Media Sponsor

7:30-9:00 a.m.

Registration & Continental Breakfast

Sponsored by:

9:00-9:45 a.m.

FDA's New QMSR Is on the Horizon—Will Your Company Be Ready?

On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.” Considering 21 CFR 820 has been the agency’s standard for multiple decades, what is the impact of this alignment with ISO 13485:2016 and how will FDA implement and enforce compliance? The drop-dead date for compliance has been slated for February 2, 2026; and medtech companies (globally) will be expected to comply with the changes. This presentation will dive into: (a) the nuances of the FDA’s changes; (b) edits made to 21 CFR, Part 4 (clarification for combination products); (c) FDA’s development of a new inspection process that better aligns with ISO 13485 requirements; (d) requirements/expectations for compliance; and (e) future changes made to ISO 13485.

speaker-1

Christopher Joseph Devine

9:45-10:30 a.m

Session 9

Description to come.

10:30-11:15 a.m.

Networking Break

Sponsored by:

11:15 a.m.-12:15 p.m.

Session 10

Description to come.

speaker-1

Michelle Kennedy Scott

speaker-2

Derek Prince, Ph.D.

speaker-3

Megan C. Frost, Ph.D.

speaker-4

Darci Diage

12:15

End of Conference

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