Registration & Networking Breakfast

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Opening Remarks

Howard Revitch

Welcome to Costa Rica

An introduction of the region serving as the host of the 2025 MPO Medtech Forum—Costa Rica—and an overview of why the area is important to the medical device manufacturing industry.

Laura López Salazar

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.

Anthony S. Freeman

Proactive Operational Risk Assessments: Finding Risks Before They Find You

A strong operational risk assessment process is essential to preventing supply disruptions, such as those experienced during and following the pandemic, as well as those that may result from U.S. tariffs. This session will provide a structured approach to identifying risk conditions early, distinguishing show-stopper risks, and understanding supplier-specific versus industry-wide challenges. We’ll discuss why subjective scoring models can dilute real risks and how to prioritize based on impact, likelihood, and recovery time. Using real-world examples, such as the Evonik plant explosion, we’ll illustrate how deep-dive assessments and mitigation mapping can uncover hidden vulnerabilities. Attendees will gain practical strategies for conducting thorough risk assessments, collaborating with quality teams, and proactively managing supply risks. If you’re ready to move beyond surface-level risk scoring and build a more resilient supply chain, this session is for you.

Patrick Lynch

Networking Break

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Solving the Make vs. Buy Puzzle: Strategies for Medical Device OEMs

While the outsourcing of many manufacturing capabilities continues to grow, some medtech makers choose to keep a process or component fabrication in-house. What factors should be considered when making this decision? How can one decide the best course of action? 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 Jim McCormack

Dave Mabie

Johnny Chinchilla

Jim McCormack

Nicolas Medrano

Cecilia Monge

Esteban Corrales

Networking Lunch

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Navigating Evolving FDA Priorities: Hot Topics & Global Insights

As the U.S. Food and Drug Administration (FDA) priorities continue to evolve, this session will explore key focus areas during pre-market reviews, including biocompatibility, data requirements for studies outside of the U.S., real world evidence, MRI safety, statistics, and digital health. Additionally, this session will provide insights on changes seen within the agency under the new administration and the potential impact to manufacturers. The session will also offer a high-level overview of similar regulatory trends being raised in the EU under the transition to MDR/IVDR.

Hannah Irwin

Navigating the U.S. Products Liability Landscape

Doing business in the United States can be challenging for those unfamiliar with operating in a litigious environment. As such, it’s important for suppliers, especially those based outside the country, know what can be involved. This session will look at products liability in the U.S.──the quirks of a litigious society. It will also compare and contrast the U.S. and Costa Rican legal systems. In addition, essential provisions in supply chain agreements that can mitigate legal liability will be shared as well as how insurance can help a company respond to litigation threats.

Sara E. Dyson, Esq. CPCU

Networking Break

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A Look at Labor: Assessing Human Resources in Costa Rica

Medical device manufacturers are constantly seeking to address concerns and issues involving labor. Securing the best people for the right positions is an ongoing challenge. Companies are competing for many of the same types of candidates for roles they need to fill. This panel will look at the current situation with labor and what they are doing to help resolve problems they face. Panelists will share best practices and offer their own insights and experience in tackling this task.

Networking Reception

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