Registration & Continental Breakfast

Opening Remarks

Howard Revitch

Sean Fenske

Welcome to Colorado

An introduction of the region serving as the host of the 2024 MPO Summit—Colorado—and an overview of why the area is important to the medical device manufacturing industry.

Elyse Blazevich

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.

Ben Dunn

A Deep Dive into the Medtech Industry Consolidation Trends

This panel will expand upon the main points revealed during the State of the Industry session to determine what the findings mean for both medical device OEMs and their service provider partners. Discussion among the panel will help position the key takeaways from the previous session through the lens of actual industry representatives.

Moderated by Daniel S. Wittenberg

Tasha Bond

Frank Chan

Perry DeFazio

Nick Traggis

Daniel S. Wittenberg

Networking Break

Sponsored by:

Extending Your Global Reach and Minimizing Your Compliance Exposure at Home

MDSAP (the Medical Device Single Audit Program) helps medical device manufacturers cast a broader net into global markets with minimum effort. It is a highly structured program that has gained traction since 2016 and is now building momentum with greater recognition. Building on the framework and success of the MDSAP program, the U.S. FDA has adopted ISO 13485 as the recognized framework for design and manufacturing compliance for medical devices with recent announcements of the Quality System Management Regulations (QMSR), replacing the Quality System Regulation promulgated in 1996. This session will highlight history, background, summaries of current and historical activities, and personal insights from conversations with regulatory leaders on what manufacturers should be doing now and what to expect from FDA and the most current perspectives. It will also cover how participation in the MDSAP program will not only build strength in your system for improvement but will prevent scheduled visits from FDA as long as you are participating—a clear and measurable benefit.

Tim Gooch

Networking Luncheon

Sponsored by:

EY’s Pulse of the Industry—Presentation and Panel Discussion

A comprehensive look at the EY report’s findings with a focus on the trends driving change within the industry. From digital healthcare to regulatory shifts, this overview of the happenings within medtech will help shape expectations of what’s ahead for the sector. Following the presentation, a panel will focus on the points highlighted during the presentation and discuss their impact on the medtech sector. Using the report’s findings as the conversation pathway, this group of industry representatives will reflect on how factors such as digital health and regulatory changes, along with numerous other variables, will play a role in shaping healthcare technology.

Presented and moderated by Mark Ginestro.

Mark Ginestro

Amy Beckley, Ph.D.

Anthony S. Freeman

Kimberly Muller, M.Sc., J.D.

Dalip Sethi, Ph.D., MBA, MSc

Session 6

Networking Break

Sponsored by:

The Digital Transformation of Medtech

As more of the healthcare landscape shifts to a digitally supported industry, the medical device sector needs to assist this movement with the latest connected technologies. Unfortunately, this path is filled with many challenges, including cybersecurity, privacy concerns, data collection and management, interoperability, and more. Hear from industry experts closely involved in this transformation on their thoughts of what’s happening now and where the industry’s headed.

Moderated by Christopher Lueken 

Dr. Nicholas Pachuda

Jodi Scott

Christopher Lueken

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