Board Of Directors 2023 - 2026
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.
Ryan BelaneyVice President
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.
Angela Silvestri, RACTreasurer
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.
Lisa Boyle is the Director of Regulatory Affairs at Tyber Medical with 38 years of experience in the medical device industry. She began her career in Quality in 1985 before transitioning to Regulatory Affairs in 2001. Her role entails managing RA, ensuring compliance with post-market obligations, supporting MDD and MDR registrations across various regions, and navigating product classifications through the 510(k), IDE, and PMA processes. Lisa has also been an active member of OSMA throughout her career, serving as both Secretary (2016-2018) and Vice President (2019) on its board. Currently, Lisa co-chairs the OSMA Planning Committee and serves as Secretary on the board. She earned her bachelor's degree from Cedar Crest College.
Karen AriemmaBoard Member
Karen Ariemma is the Regulatory Strategy Director at Stryker Orthopaedics with responsibility to provide strategic input and technical guidance on global regulatory requirements to support new product development and sustaining regulatory. She has over thirty-five years experience in the orthopaedic industry. She started her career as a research engineer at Stryker. Karen has diverse experience in various roles within pre and post market regulatory. She has supported global submission over a wide breadth of product and technologies including robotics; total joint, trauma, and spinal devices; 3D printed devices and patient specific implants and instrumentation.
In addition to her roles detailed above, the FDA appointed Stacey as the non-voting Industry Representative serving the Orthopaedic & Rehabilitation Devices Medical Device Advisory Committee. This appointment commenced in 2020 and is a four-year term concluding in 2024.
Karen has a BS in Materials Engineer from Rensselaer Polytechnic Institute.
Patty BeresBoard Member
Patty’s career started at Tulane University Medical School after receiving a degree in Biomedical Engineering from Tulane University. Her industry career started over 35 years ago at Biomet, experiencing the growth of Biomet from a small company to a larger company, and has remained with the company following the merger which created Zimmer Biomet. During her tenure she worked her way from a Research Manger to the Director of Regulatory, Clinical and Compliance. Currently she works as a Regulatory Principal with a focus on upper extremities.
Patty has extensive submission experience with over 150 510(k)s cleared. She has also authored original IDEs, an original PMA, supported numerous international registrations including MDD dossiers and MDR Technical Files.
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.
Gabriela ParanaBoard Member
Gabriela (Gabby) Parana is the Regulatory Affairs Director for the Surgical Intelligence portfolio at NuVasive (now Globus Medical). Gabby comes with over 18 years of experience in global medical device regulatory affairs. Her prior roles have included Piramal Critical Care (supporting anesthetic drugs requiring ANDA/ANADA approvals); Medtronic (responsible for leading complex regulatory initiatives involving combination devices and expanded indications for neurosurgical implants and ENT devices); and Abbott Neuromodulation in directorship roles whereby she oversaw the regulatory aspects of Abbotts’ active implantable portfolio. This recent role required Gabriela and team to navigate the regulatory strategy of Abbotts’s digital health portfolio, and to develop complex strategies involving interaction of software applications and implantable components across different therapies.
Gabriela earned her Bachelors of Science in Chemical Engineering from the University of Notre Dame; and her Masters of Science in Regulatory Affairs from San Diego State University.
Michael Thomas, RACBoard Member
Michael is currently serving as the Director of Regulatory Affairs at Innovasis, Inc. which manufactures over two dozen product systems for the lumbar, thoracic, cervical, and cranial regions. He has been the author or co-author of numerous 510(k)s and other market authorization submissions, bringing new products to market through collaboration with regulators. Michael’s experience is primarily focused on the US market but has also supported CE certification and withdrawal processes in response to the EU MDR and helped transition his company's QMS for multiple significant changes including but not limited to ISO 13485:2016 and the MDSAP audit model. He has also supported post-market surveillance processes for multiple product lines in the US, Australia, Brazil, and Canada. Innovasis also proudly supports a humanitarian program in Peru, which treats spinal pathologies in underprivileged communities.
Michael has a B.S. in Sociology from the University of Utah, holds the RAPS RAC credential for Medical Devices, and holds multiple certifications for medical device manufacturing.
Stacey Bonnell, MBA, RACPast President
Stacey served as OSMA President 2019-2022; 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.