| Wednesday, May 24 | |
| Location: Juan Vasquez de Coronado Ballroom, Costa Rica Marriott Hotel Hacienda Belen | |
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| 7:30-10:10 a.m. | Registration & Continental Breakfast Sponsored by:  |
| 10:10-10:15 a.m. | Welcome Address Speakers:
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| 10:15-11:00 a.m. | Welcome to Costa Rica An introduction to the medical device manufacturing community within Costa Rica. A look at the region as well as business within the Trade Zones will be highlighted. Speakers:
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| 11:00 a.m.-12:00 p.m. | Supply Chain Challenges: Addressing Risk and Resiliency The pandemic revealed just how delicate the medical device supply chain can be. As OEMs reduced the number of suppliers with which they worked, they unknowingly added risk to their formula as the chance of relying too heavily on a few suppliers increased. This panel will discuss the medtech supply chain today and what actions are taking place to help reduce risk while also addressing the need for resiliency. Moderator: Barry Schnur, President & CEO, David Schnur Associates Panelists:
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| 12:00-1:15 p.m. | Networking Lunch Sponsored by:  |
| 1:15-2:00 p.m. | Value-Add Auditing—A Paradigm Shift to Drive Value The announcement is made and you’re filled with fear—you have an audit coming. Immediately, you are dreading the notification and trying to figure out how to get out of it. The intent of this presentation is to provide the paradigm shift that audits can add value through a specific approach. Further, the approach is applicable not only with your suppliers, but also for internal audits as well. Find out how you can add value through the audit process. Speaker: James Shore, Chief Quality Officer, Quality Lean Solutions |
| 2:00-2:45 p.m. | Regulatory Revisions and Their Real-World Impact on You While the title may be boring, the discussion will not. The regulatory requirements for legal and contract manufacturers continue to shift and increase across different countries; thus, increasing expectations mean increased workloads. In this session, we will review the MDR changes that seem to be “taking it up a notch” on tech file/dossier preparation, supplier quality, and other key issues requiring more planning or testing for the legal and contract manufacturers. We will discuss recent updates to certain FDA guidances, EUA transitions, and the ISO 13485 potential. Lastly, some lessons learned and take home pointers will be given on how to be more prepared for MDSAP audits. Speaker: Dawn N. Norman, MS, Partner, MRC Global LLC |
| 2:45-4:00 p.m. | Networking Break Sponsored by:  |
| 4:00-5:00 p.m. | Moving Manufacturing: Nearshoring, Transfer Concerns, and What to Expect Logistics troubles and rising costs have medical device manufacturers reevaluating from where they are sourcing supplies and how far they are shipping them. Further, changes in labor availability and behavior adds to the equation. In this panel, OEMs and suppliers will discuss the challenges and considerations associated with nearshoring. Also involved will be a conversation regarding the transfer of manufacturing and the associated revalidation process. Moderator: Ronald Lachner, Senior Partner, BLP Legal Panelists:
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| 5:00-7:00 p.m. | 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: |
| * All session times, speakers, and content are subject to change. | |
| Thursday, May 25 | |
| Location: Juan Vasquez de Coronado Ballroom, Costa Rica Marriott Hotel Hacienda Belen | |
| 7:30-9:00 a.m. | Registration & Continental Breakfast
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9:00-9:45 a.m. | Creating Flow and Empowering Employees to Achieve Medtech Manufacturing Efficiency Creating flow in complex customer delivery systems with a high complexity of products, demand, and shared resources can be challenging. In this session, Maxon will show attendees how to apply advanced lean principles to create a value stream of multiple product flows at the pull of the customer with a step-by-step process. He will cover determining true product families in complex manufacturing environments; calculating takt time and takt capability for a mix of products with different volumes; determining the interval at the pacemaker for a mix of products; and understanding new concepts on sequencing, such as FIFO lanes and offset scheduling. Real-world case studies of complex manufacturing operations that have gone beyond basic value stream mapping to create a future state that supports mixed model production will help illustrate the points. The result is a process that will right size inventory, increase on-time delivery, and improve quality to yield a competitive advantage and increased market share. Speaker: Michael Maxon, Senior Associate, Duggan Associates |
| 9:45-10:30 a.m. | Logistics Challenges & Opportunities for the Medical Devices Sector The pandemic and subsequent supply chain restart and stoppage has led to a significant disruption in the flow of product from source to manufacturing facilities. Exacerbating the situation is challenges within the logistics space, from a shortage of labor to handle ports to shipping delays. This session will provide insight into these challenges within the logistics industry and set realistic expectations of what medtech manufacturers can expect. In addition, the trends, what the current happenings are, and how to prepare for any changes will be covered. Speaker:
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| 10:30-11:30 a.m. | Networking Break Sponsored by:  |
| 11:30 a.m.-12:30 p.m. | Ask the Experts: Revealing Sourcing Strategies and Best Practices Sourcing supplies, raw materials, and components for medical device manufacturing seems to have become more of a challenge than ever before. Questions swirl around dual-sourcing, nearshoring, expanding/shrinking preferred vendor lists, outsourcing, insourcing, and more. Hearing from those who have been doing this for some time can help provide best practices. This session will assemble a panel of those with experience in sourcing to share some tips and expertise. Moderator: Lucia Gross, Life Sciences Sectoral Consultant Panelists:
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| 12:30 p.m. | End of Conference |
| * All session times, speakers, and content are subject to change. | |
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