Tyrpak will be a featured speaker and panelist as part of the UMass M2D2 “Key Considerations & Best Practices” session on June 15.
BUFFALO, N.Y., June 11, 2021 –Stephen Tyrpak, director of clinical & regulatory affairs at Garwood Medical Devices, LLC, will be a featured speaker and panelist at a June 15 virtual event being coordinated by the Massachusetts Medical Device Center (M2D2) at UMass Lowell and sponsored by Johnson & Johnson Innovation – JLABS.
Tyrpak will share his expertise and insights regarding key considerations and best practices related to regulatory strategy in and out of the U.S., the importance of reimbursement considerations early on, and clinical study design and management for early-stage companies seeking regulatory approval. He is one of five participants in the third and final program in the M2D2 Clinical Trial Series.
“Clinical trials are required to gain FDA approval and show us what works, and what doesn’t work in health care,” said Brennan Fournier, program manager at UMass M2D2. “The goal of this program is to provide start-up companies, shareholders, and others with expert insight and knowledge into the clinical trial process and to help them better understand best practices in conducting a successful study. We welcome Stephen’s participation and know our participants will benefit from him sharing his expertise and experience.”
“At Johnson & Johnson Innovation – JLABS, we are proud to partner with M2D2 on this series. Through our global network of JLABS sites, we work with innovators focused on some of the most complex health care challenges,” explains Stephen Pitt, head of JLABS US North East. “Educational series like this one are an important opportunity to network and learn from others who have overcome similar hurdles.”
Tyrpak served as a consultant for Garwood Medical before officially joining the company in May 2018. In his role with the organization, he oversees the quality, regulatory, clinical, and reimbursement teams. His primary role involves shepherding Garwood Medical’s BioPrax™ device through the FDA approval process, ensuring the device can eventually be distributed throughout U.S. and global markets.
Garwood Medical’s BioPrax™ device is currently under investigation to study the elimination of biofilm infections on prosthetic knee implants during early intervention procedures and used alongside the current standard of care.
Stephen Tyrpak, Garwood Medical Devices
Tyrpak began his career working on products and therapies within the hospital sector and eventually branched off to help small companies get their proof-of-concept device or pharmaceutical to the clinical setting. He learned early on in his career that small companies face unique obstacles that many are ill prepared for. He has spent years learning and helping companies develop strategies not only to achieve market notification but post-market reimbursement, out of U.S. clearance and Breakthrough Device Designation.
Tyrpak was recently honored by Buffalo Business First as a “30 Under 30” honoree and is an advocate for mental health issues and actively supports numerous LGBTQA+ services and activities. He was also recently elected to the Board of Directors of Mental Health Advocates of Western New York.
About Garwood Medical Devices
Garwood Medical is an emerging Buffalo-based company developing groundbreaking BioPrax™ technology to prevent and treat antibiotic-resistant bacterial biofilm infections associated with metallic orthopedic implants
BioPrax™ was accepted into the FDA’s Breakthrough Device Program in October 2019, an important milestone on the path to market acceptance and widespread usage among orthopedic surgeons and hospitals as soon as 2025.
Garwood Medical recently completed its move to the historic “Red Shed” building in the Northland Corridor on Buffalo’s East Side.
For more information, visit garwoodmedicaldevices.com.
The Massachusetts Medical Device Development Center (M2D2) is a lifeline for smaller medical device companies, offering inventors and executives easy, affordable, and coordinated access to world-class researchers and resources at the UMass Lowell and UMass Medical School campuses of the University of Massachusetts.
M2D2 is a Johnson and Johnson Innovation – JLABS site and the medical device and pharmaceutical company was M2D2’s first founding sponsor. UMass M2D2 has 3 incubator locations in Massachusetts and conducts an annual start-up competition called the $200K Challenge in which the winner gets lab space in the M2D2 Center for free for one year, along with access to Johnson & Johnson mentoring.
For more information, visit https://www.uml.edu/research/m2d2/.