|Tuesday, May 22|
|Location: Michigan State University—College of Human Medicine|
|7:30-8:55 a.m.||Registration & Continental Breakfast
|8:55-9:00 a.m.||Opening Remarks
|9:00-9:15 a.m.||Welcome Address
An overview of the life sciences and industrial sectors in Grand Rapids, Michigan—the state’s second largest city and the urban center of a growing region of more than 1 million people.
Speaker: Birgit M. Klohs, President & CEO, The Right Place Inc.
|9:15-10:00 a.m.||State of the Industry
An insider’s update on the issues and factors in Washington that are impacting the medical device manufacturing industry. Coverage topics to include device tax, President Trump’s impact on healthcare, Obamacare’s effect, Congressional measures, CMS/reimbursement, FDA oversight, and more.
Speaker: Clayton Hall, Vice President, Government Affairs, Medical Device Manufacturers Association (MDMA)
|10:00-10:30 a.m.||Networking Break
|10:30-11:15 a.m.||Demystifying the FDA’s Human Factors Guidance
In 2016, the FDA finalized its human factors guidance for medical devices. Due to the wide diversity of medical devices manufactured today (auto-injector vs. infusion pump vs. robotic surgical system, etc.), manufacturers often struggle to understand how the guidelines apply to their own specific device(s). This session will describe proven strategies that will help manufacturers: (1) improve their time to market and overall design through early implementation of human factors, and (2) pass their human factors validation test for FDA clearance.
Speaker: Dr. Russell J. Branaghan, Founder/Chief Scientist, Research Collective
|11:15 a.m.-12:00 p.m.||Impact of Digital Health Technologies
An overview of the digital health technology landscape and its impact on more traditional medical equipment manufacturers. Coupling apps with physical devices will be explored as well as the trend toward Software as a Medical Device. This session will provide considerations for those with a more traditional device manufacturing background or those with more experience in the digital environment.
Speaker: Nada Hanafi, Chief of Strategy Officer, Experien Group LLC
|12:00-1:30 p.m.||Networking Luncheon
|1:30-2:30 p.m.||Panel: Pathway to Innovation—Academia’s Role in Device Development
Universities and medical device manufacturers seem to be broadening their agreements to enable the academic institution to serve as an R&D facility for new product development and idea generation. Is this a view of the future of innovation development for the medtech industry or just one tool in the OEM’s toolkit? Hear from individuals currently involved in this process to hear how they view the arrangement, benefits, and what’s ahead.
Moderator: Brent M. Nowak, Ph.D., Executive Director, applied Medical Device Institute
|2:30-3:15 p.m.||Networking Break/Tour Preparation
|3:15-3:30 p.m.||Transit to Tour 1|
|3:30-4:15 p.m.||Tour of Michigan State University Research Center or Mary Free Bed|
|4:15-4:30 p.m.||Transit to Tour 2|
|4:30-5:15 p.m.||Tour of Michigan State University Research Center or Mary Free Bed|
|5:15-5:30 p.m.||Transit to MSU College of Human Medicine|
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.
|* All session times, speakers, and content are subject to change.|