Board Of Directors
Stacey Bonnell, MBA, RACPresident
Stacey was elected OSMA President in 2019; previously having served the Board in the capacity of VP and untitled Board member since 2014. Stacey is currently serving as Global Leader - Regulatory Affairs for Nuvasive, which boasts a broad portfolio of innovative orthopaedic solutions. Prior to joining Nuvasive she had a 20 year career with J&J DePuy Synthes where most recently she was responsible for directing RA activities supporting Trauma / CMF & Biomaterials New Product Development & Front End Innovation. She brings extensive medical device experience, working with all classifications of products and life cycles – acquired over the years managing complex orthopedic RA programs and high-performing teams, supporting regulatory compliance activities including outreach and remediation, and cultivating dynamic global programs.
In addition to her roles detailed above, FDA appointed Stacey as the non-voting Industry Representative serving the Orthopaedic & Rehabilitation Devices Medical Device Advisory Committee (MDAC). This appointed commenced in 2020 and is a 4 year term - concluding in 2024.
Stacey is a self-proclaimed Regulatory enthusiast who describes OSMA as a healthy blend of comradery, policy-shaping and advocacy.
Bradley HeilVice President
Bradley is a Director of Regulatory Affairs at Smith & Nephew, Inc., currently leading Smith & Nephew’s Regulatory Operations. He holds a Master of Science in Biomedical Engineering from the University of Kentucky and a MBA from the University of Memphis. Bradley has been actively involved with OSMA since 2016.
Angela Silvestri, RACSecretary
Angela currently works for Stryker Corporation as Director, Regulatory Affairs, Corporate. She has 30 years of experience in Orthopedic Device Regulatory Affairs, and has been an OSMA company representative between 1995-2004 and 2018 – present. Angela gained her experience in pre-market and post market regulatory affairs at Synthes, DePuy Synthes and Stryker. She is currently involved in advocacy initiatives through OSMA, Advamed, and MedTech Europe in the area of Orthopedics & UDI, and is actively involved in OSMA as the Co-Chair of the Meeting Planning Committee.
Ed Chin D.Ph., MBATreasurer
Ed is currently a Regulatory Affairs Director at Medtronic. He holds a BS Liberal Arts and a BS Pharmacy from the University of Tennessee, a MBA from the University of Memphis, a Tennessee Doctor of Pharmacy license, and is a graduate of the United States Army Command and General Staff College.
At Medtronic, he has held positions in Clinical, Quality, and Regulatory Affairs management and is experienced with FDA Medical Device/Pharma submissions, Quality System regulations, European Union Medical Device Directives and Medical Device Regulations, Notified Body applications and certifications, domestic and international inspections/audits, and acquisition/integration activities.
Ryan BelaneyBoard Member
Ryan Belaney, is the Vice President of Clinical & Regulatory Affairs for Active Implants, LLC. Ryan is a Biomedical Engineer, and Regulatory, Clinical, and Quality Leader with over 16 years of diverse medical device experience. His expertise includes an established rapport with FDA and CMS via clinical, regulatory, reimbursement, quality assurance interactions and full cycle product development. Previously, Ryan was Director of Applied Research with RTI Surgical, Sr. Director of Regulatory Affairs and Quality Assurance at AgNovos Healthcare, and held roles of increasing responsibility at Wright Medical Technology and Osteotech, Inc.
Ryan invests in the MedTech community as a mentor in the Zero-to-510 accelerator and as an Advisory Board member of Orthoworld, Inc. He earned his Bachelor’s degree in Biology and Chemistry from the University of Mount Union and his Master’s degree in Biomedical Engineering from the University of Toledo.
Ehab EsmailBoard Member
Ehab joined Orthofix in 2019 as the Senior Vice President of Quality, Regulatory and Clinical Affairs. A seasoned executive with more than 26 years of diverse experience in the orthopedic medical device and biologic industries, he most recently served as the Vice President of Global Regulatory Affairs and Regulatory Compliance for DJO where he supported all business units covering orthopedic surgical implants, bracing and supports, foot care, consumer products and recovery science. Prior to DJO, he held leadership positions of increasing responsibility with Zimmer Biomet, Biolase, Wright Medical and Smith & Nephew. Ehab earned his Bachelor’s degree in Mechanical Engineering from the University of Memphis.
Karen Mahoney, Esq.Board Member
Karen F. Mahoney, Esq. is the Worldwide Vice President, Regulatory Affairs DePuy Synthes. Karen leads the DePuy Synthes Regulatory organization with responsibility for driving regulatory strategy and execution for the Orthopaedics business worldwide. She has extensive knowledge of the DePuy Synthes business and is a proven leader who has worked at Johnson & Johnson in the DePuy Synthes companies for 22 years, and within the medical device industry for 24 years. Throughout her career, she has had the opportunity to work on all classifications of products in the Spine, Neurovascular, Sports Medicine, Trauma/CMF/Biomaterials, Joints, CMW, Powertools and Digital business units. Karen has held global roles in Regulatory, NPD Quality and Compliance.
Karen has been a member of RAPS, the Advamed Orthopedic Working Group, Orthopedic Surgical Manufacturers Association (OSMA), and has served as a Medical Device Committee Board Member of the Food and Drug Law Institute (FDLI).
Karen holds a B.S. in Biology from Fairfield University and received her Juris Doctor degree from Roger Williams University, School of Law. She is licensed to practice law in the states of Massachusetts and Rhode Island.
Marshall McCarty, RACBoard Member
Marshall is the Director of Quality Assurance and Regulatory Affairs at Innovasis, Inc. in Salt Lake City, UT. He has over 35 years experience in the Quality and Regulatory field with medical and In vitro diagnostic devices, and over 10 years with orthopedics. Marshall has a B.S. in Microbiology from Brigham Young University.
Stefan RuckBoard Member
Stefan is a Vice President of Quality Management and Regulatory Affairs at CeramTec GmbH. He is the strategic leader for Quality and Regulatory Affairs functions across CeramTec and he joined OSMA in 2011.