Addressing Peak Issues in Medtech

The MPO Summit has carved a niche for itself within the industry by mirroring the targeted focus presented within this magazine. That is, a critical examination of medical device outsourcing, as well as the multiple factors that impact it, such as regulatory issues, quality considerations, supply chain relationships, testing concerns, and more. The event, taking place for more than 10 years, is presented as a highly informative, educational conference coupled with high-value networking opportunities with sponsors, speakers, and other attendees. This year, the event is hosted by the Omni Interlocken Resort in Colorado. Following provides the session highlights attendees can look forward to.

Kicking off the first day will be what has become a much-anticipated presentation. The annual “State of the Industry” (SOTI) session consistently provides a comprehensive diagnosis of the latest trends within the medical device manufacturing industry. This year’s SOTI speaker, Anthony S. Freeman, president of A.S. Freeman Advisors LLC, will focus on M&A activity among both the medical device manufacturing firms and their supply chain partners. Also, concerns and considerations relevant to that OEM and supplier relationship will be discussed.

With impending changes across the globe increasing the difficulty of navigating the regulatory landscape, it’s difficult for companies to know when they should start preparing. “Regulatory Transitions—Navigating the EU MDR, Brexit, and More” by Kim Trautman, executive vice president of Medical Device International Services at NSF International, will lay out major changes and a timeline of global regulatory changes so senior management can appropriately develop their regulatory strategies to keep facilities in compliance and products on the market.

In a group presentation, several medical device original equipment manufacturers tell the story of how and why they set out to discover a more efficient part process development and validation process for injection molding that could be transferable. They executed a real-world “proof of concept” event and formally documented their results. The session “Part Process Development and Validation for Multiple Machines” (which is coupled to an article of the same name that appeared in the July/August 2017 issue of MPO) will enlighten attendees on the findings of this effort.

A supply chain best practices session offers valuable insights to device manufacturers. Kenneth L. Ward, president and founder of TeraSTRAT Consulting, will discuss the importance of having the agility to meet the ever-flexing customer demand, without excessive inventory. Having that agility requires superior end-to-end supply chain management processes. This session touches upon best practices for a robust and agile SCM process. Topics will include developing the sales, inventory, and operations (SIOP) process; selecting and aligning the right KPIs; using tools such as 4DX and A-3 Thinking in a medical device world to improve supplier quality; implementing Lean and the Toyota Production System; and more.

The changes to ISO 13485:2016 have placed additional emphasis on supplier controls. As companies outsource more of their processes or become virtual, the expectation is that controls need to be implemented. “ISO 13485:2016 Supplier Controls—Best Practices that Make Sustainable Change” will seek to discover the big problems found during ISO audits and reveal best practices. Further, speaker James Shore, chief quality officer at Quality Lean Solutions, will review the ISO requirements and some of the best practices that are being used in industry.

In a panel discussion helmed by Maria Shepherd, president and CEO of Medi-Vantage, executives from both sides of the aisle—OEM and supplier—will discuss the next steps in a follow-up to 2017’s Make vs. Buy presentation. The participants will debate today’s trends revolving around the medical device manufacturer/supplier arrangement. Topics of conversation will include determining how medical device manufacturers recognize service providers who can truly become partners and how the supplier moves their status into that direction.

Opening the second day, a panel discussion will offer a look “behind the curtain” at oversights made by OEM customers when working with a supply partner. David C. Robson, principal at Robson Advisors will lead the session that includes topics such as the RFQ process, contract negotiations, monitoring work progress and invoicing, managing conflict, and more. Attendees will learn how to get the best results from outsource providers, while at the same time reducing the risk to the success of a project.

Developers of medical devices are finding the testing needed to meet the requirements of design verification and validation becoming increasingly challenging. As companies employ more sophisticated materials and designs, the testing to ensure safety and effectiveness often becomes significantly more complex. Additionally, the technical challenges of testing must be addressed within an ever-changing regulatory landscape where international standards are continually revised and government agency expectations are elevated.

Successfully compiling the necessary test data to support a Design History File requires much more than in-depth knowledge of the product being developed to ensure market approval. Christopher Scott, vice president of Eurofins Medical Device Testing, will discuss these concerns in “Verification and Validation: How Technology and Regulatory Trends Have Raised the Bar for Testing Medical Devices.”

As manufacturers of medtech innovations, many Summit attendees have been responsible for the next great product for a company and have spent a significant amount of time laying out milestones, creating relationships, and investing in tools, time, and resources. What if the plan path is not aligning with the created goals? How do you recognize when plans aren’t working and what are critical steps for correcting and/or changing the plan? Dawn A. Lissy, president and founder of Empirical will lead a panel who will discuss this critical juncture in a development lifecycle during her session “When Rain Is All You Find at the End of the Rainbow—Moving on from a Project and onto the Pot of Gold.”

On behalf of the MPO Summit team, I hope to see you there! 

Get further details on the speakers, panelists, and other conference sessions, as well as the networking opportunities and sponsors for the 2018 MPO Summit at www.mposummit.com.