|Thursday, April 11|
|Location: FedEx Institute of Technology at The University of Memphis|
|7:00-8:40 a.m.||Registration & Continental Breakfast
|8:40-8:45 a.m.||Opening Address
|8:45-9:00 a.m.||Welcome to Memphis
An introduction of the region serving as the host of the 2019 ODT Forum—Memphis, Tenn.—and an overview of why the area is so important to the orthopedic device manufacturing industry.
Speaker: Roy Smith, Executive Director, Greater Memphis Medical Device Council (GMMDC)
|9:00-9:45 a.m.||State of the Orthopedic Industry
A comprehensive analysis of the latest trends within the orthopedic device industry. M&A activity among both the medical device manufacturing firms and their supply chain partners will be a focal point. Also, concerns and considerations relevant to the OEM and supplier relationship will be discussed.
Speaker: Bryan Hughes, Director, P&M Corporate Finance
|9:45-10:30 a.m.||Perfect Storm: Addressing the Changing Face of Regulations in the U.S. and Globally
The medical device industry’s regulatory landscape is changing and it’s leading to a “perfect storm” of deadlines and headaches for an array of companies in the industry. Most notable, the EU is replacing its MDD with the new MDR, which will require review of most devices to be sold in the region, whether already on the market or not. Within the same time frame, the medical device single audit program, or MDSAP, has been implemented and is required to market devices in Canada. The FDA is enforcing stricter biocompatibility documentation per the 2016 guidance. Further, ISO 13485:2016 transition audits are coming into play. All the while, notified bodies in the EU are going to be overwhelmed with the sheer amount of work coming their way. This session will help you prioritize and ensure your focus is on the right tasks for your company.
Speaker: Christine Scifert, Co-Founder, MRC-X LLC
|10:30-11:15 a.m.||Networking Break
|11:15 a.m.-12:15 p.m.||Tech Talk: An Overview of the Growing Role of Additive Manufacturing and Robotic Surgery|
Thinking about being part of the next wave of technology advancements emerging in orthopedics? Contemplating adding instrument sets compatible with one of the robotic systems available for use on the market or considering developing your own robotic system? Exploring the use of additive manufacturing for one or more of your products? This panel of experts will offer attendees the opportunity to hear from and ask questions of those already involved in the space. The participants will provide the rules of thumb as well as offer critical considerations for those interested in these technology segments. Get insight on additive manufacturing and robotic systems within orthopedics, with a specific focus on development, testing, and regulatory aspects.
Moderator: Dawn A. Lissy, President & Founder, Empirical
|12:15-1:45 p.m.||Networking Luncheon
|1:45-2:30 p.m.||Smart Implants: Data and Analytics in Orthopedics
Traditional implants have gone through several revisions but generally, have remained static in terms of true innovation in the space. Smart implants and the incorporation of data and analytics bring the promise to change that paradigm. As such, there are many unfamiliar with the technology. This session is intended to provide a closer look at this emerging segment, highlighting the trends and technologies that have come to the forefront. Further, since it is a relatively new field, regulatory hurdles exist that need to be addressed.
|2:30-3:15 p.m.||Design Innovation: How Human Factors & Industrial Design are Reshaping Orthopedic Design
Every business that makes products or sells services—and wants to be successful—must evaluate and optimize design and human factors. Your product or service design directly impacts utility, usability, comfort and performance, which, in turn, define your brand experience, and ultimately sales. Good design is holistic. It considers all user touch points, from product to packaging and instructions for use to digital footprint on the web and mobile apps. Join Dr. Bryce Rutter to learn about techniques and tactics that inject design thinking and product/service innovation into your company to grow your market share and revenues. Three decades of experience creating innovative designs for global brands, including Sony, Motorola, Microsoft, Smith & Nephew, Medtronic, Stryker, Intuitive Surgical, Bausch & Lomb, Ab-InBev, Purina, Caterpillar, Bayer, McDonald’s, Bristol-Myers Squibb, PepsiCo, Kraft and J&J, will provide a proven roadmap for growing businesses with design innovation.
Speaker: Bryce G. Rutter Ph.D., Founder and CEO, Metaphase Design Group Inc.
|3:15-4:00 p.m.||Networking Break
|4:00-5:00 p.m.||Executive Viewpoint: A Panel Discussion
Gaining insights on how peers are dealing with challenging factors across the industry, from helping to address the shift to value-based healthcare and bundled payments to the influx of new technologies, can be invaluable. This session will present a panel of executives from a variety of orthopedic OEMs to discuss critical issues and how they are handling them. Gain a better understanding of how different firms are adjusting to shifting trends and regulations within the ecosystem.
Moderator: David C. Kelman, President, Kelman & Company Consulting LLC
|5:00 p.m.||End of Conference|
|Wifi provided courtesy of|
|* All session times, speakers, and content are subject to change.|