|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.
|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|
|3:15-5:30 p.m.||Facility Tours
All in attendance will have the opportunity to visit two of the following three locations for guided tours. Sign-ups will be available on the day of the event.
Tour Option #1: Mary Free Bed is the 5th largest rehabilitation hospital in the nation. Highlights of this tour include the Orthotics & Prosthetics Rehab Technology Center, Motion Analysis Center (gait analysis lab), ZeroG Gait & Balance System, specialized therapy gyms, and the LokomatPro.
Tour Option #2: The Michigan State University Grand Rapids Research Center is a 162,800-square-foot facility that accommodates 33 principal investigators and their research teams. The Center will eventually house 44 research teams. Areas of scientific study include Alzheimer’s and Parkinson’s diseases, cancer, women’s health and infertility, as well as autism and pediatric cancers.
Tour Option #3: Spectrum Health is a not-for-profit health system offering a full continuum of care through the Spectrum Health Hospital Group, which is comprised of 12 hospitals, including Helen DeVos Children’s Hospital. Spectrum Health was named one of the nation’s 15 Top Health Systems and is ranked among the top five among the largest health systems in 2017 by Truven Health Analytics. This tour will include the Advanced Technology Laboratories, the iHub at Helen DeVos Children’s Hospital (lean manufacturing practices modified for pediatric medicine to improve quality and patient experience), and the Cardiovascular Simulation Center.
Join attendees, speakers, and exhibitors at the MSU College of Human Medicine 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.|