by Sean Fenske, Editor-in-Chief, Orthopedic Design and Technology
Hopefully by now, you’ve seen the ads, received the emails, or heard the buzz—but in case you haven’t, the ODT Forum is returning. In addition, it’s going back to where it started—Memphis, Tennessee. On April 11, this one-day event will feature six educational conference sessions supported by an array of suppliers who service orthopedic device manufacturers. These sponsors will be available to speak during multiple networking breaks at their tabletop locations.
The ODT Forum first debuted in 2009 in Memphis at the FedEx Institute of Technology—the same place it will be this year. As Memphis is such a vital location for orthopedic device manufacturing, it only makes sense to return to such an influential region for the event.
While we greatly appreciate the support of the sponsoring companies who are involved, we also get a tremendous amount of support from more regionally-based organizations. At this year’s ODT Forum, we have gotten fantastic cooperation from The Greater Memphis Medical Device Council (GMMDC). The non-profit was established in 2014 to increase career opportunities and job growth for the Memphis-area biotech and medical device industries. Leading the council’s impressive board, which boasts representatives from both orthopedic device manufacturers and the suppliers and contract manufacturers who partner with them is Roy Smith, GMMDC’s president and executive director. Smith will get the ODT Forum started this year with a brief overview of the Memphis region and why it is an attractive location for orthopedic device companies.
Following up this local look will be Bryan Hughes, director of P&M Corporate Finance, who will offer a greater overview of the marketplace in his State of the Orthopedic Industry address. This session will provide a comprehensive analysis of the latest trends within the orthopedic device industry, including M&A activity among both the medical device manufacturing firms and their supply chain partners.
In the session, Perfect Storm: Addressing the Changing Face of Regulations in the U.S. and Globally, Christine Scifert, co-founder of MRC-X LLC will tackle many regulatory challenges that currently need to be addressed as well as those on the horizon. Most notably, the EU’s new MDR 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. These topics will be covered along with insight on changes with ISO and notified bodies.
Dawn A. Lissy, president and founder of Empirical, will lead a “Tech Talk” type of discussion where she invites several other members of industry to join her in discussing the growing role of new technologies impacting orthopedics. If you’re interested in figuring out how to best implement additive manufacturing into your portfolio of capabilities, but are uncertain of how to best go about it or want clarity on the challenges involved with materials or testing, this session will be for you.
Following our break for lunch, Lisa Ferrara, Ph.D., owner and president of OrthoKinetic Technologies/OrthoKinetic Testing Technologies, and Dan Sands, CEO and director at AMB Surgical, will offer a deep dive into Smart Implants: Data and Analytics in Orthopedics. “Intelligence” via the incorporation of data and analytics into development offers the promise to change the relatively static advancements in implant design. This session is intended to provide a closer look at this emerging segment, highlighting the trends and technologies that have come to the forefront.
Every business that makes products or sells services—and wants to be successful—must evaluate and optimize design and human factors. 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. Dr. Bryce Rutter, founder and CEO of the Metaphase Design Group Inc. will offer his insights on design innovation for the orthopedic sector.
Rounding out our day in Memphis will be a panel discussion among OEM executives. 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 cover a variety of critical issues and how these executives and their companies are handling them. Led by moderator David C. Kelman, president of Kelman & Company Consulting LLC, the panel will consist of Ken Birdsong of Paxeon Life Science, Dean Hughes, M.S., P.E. of Smith and Nephew, Scott Shankle of MicroPort Orthopedics, and Chris West of ZeroTo510 Medical Device Accelerator.
Hope to see you there!
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within standards development organization ASTM International and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the U.S. Food and Drug Administration’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.