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.
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.
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.
11:15 a.m.-12:15 p.m.
Make vs. Buy: An OEM/CM Supply Chain Discussion
How do you best determine what to do yourself versus employing the expertise of an outside service provider? Many factors go into this decision, hence the challenge with making the determination. And a wrong decision can lead to time delays and increased costs. This session will feature a panel discussion among industry representatives who have had to answer this question. They will share the best practices they use and their own recommendations for an effective evaluation.
Moderated by Barry Schnur.
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.
2:30 a.m.-3:15 p.m.
Lean Isn’t Dead—It’s Digital: Rethinking Inventory in the Age of Smart Manufacturing
Lean principles are evolving. This session will explore how digital tools are enabling leaner, more responsive inventory systems in medical device manufacturing, balancing efficiency with the need for resilience in a volatile global market.
4:00-5:00 p.m.
Face to Face: Industry Execs Address Medtech’s Most Pressing Issues
Where are the pain points for today’s medical device manufacturers? How are others addressing these problems? What are the best practices taking place around the industry? This session will offer a candid discussion among industry peers who represent various aspects of the industry. A multitude of discussion topics will be touched upon, including supply chain, labor, regulatory, cost controls, among others. Further, attendees are encouraged to pose their own questions to the group or ask about a topic that concerns them.
Moderated by Julie Schulte.
5:30-7:00
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.
9:45-10:30 a.m
Scientific AI for the Medical Device Industry
AI is transforming every industry—and the medical device sector is no exception. NobleAI’s Science-Based AI platform offers a unique, scientifically grounded approach to Practical AI that may align well with the evolving needs of medtech companies. This session features an open conversation between NobleAI and Paul Orlando, an industry leader with deep experience across OEM operations, engineering, procurement, and partnerships with CMs and CDMs. Together, they will define what Science-Based AI is and discuss how medical device organizations can harness it to deliver greater value to customers and patients, while building a sustainable competitive advantage.
11:15 a.m.-12:15 p.m.
The Sterilization Road Less Traveled: A Look at Alternatives
Medtech has a significant concern. A closer eye is being given to sterilization methods used for medical devices. As such, new practices are being explored and evolving methods are being investigated for their feasibility for certain types of products. This session brings representatives offering more modern options to share insights about their respective technologies. They will then join a moderator to discuss challenges, trends, and future outlooks.
Moderated by Darci Diage.
12:15
End of Conference