Discover how OSMA is advancing orthopaedic surgical solutions and fostering collaboration within the industry.
President
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 orthopaedic 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 orthopaedic 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.
Vice President
Driving innovation in medical devices for over 20 years, Ryan Belaney, President & CEO of Phoenix Kinetics, leverages his deep expertise in the full product life cycle to bring innovative technologies to market and improve patient outcomes. Ryan's journey began as a biomedical engineer at Osteotech Inc. and Wright Medical Technology, where he honed his skills in device development and regulatory. He then built upon his expertise to lead research, regulatory, quality, and clinical efforts at RTI Surgical, AgNovos Biosciences, and Active Implants, ultimately culminating in his current role at Phoenix Kinetics.
Beyond his leadership role, Ryan invests his time and expertise in the MedTech community, mentoring entrepreneurs in the Zero-to-510 accelerator and offering guidance to Orthoworld, Inc. as an Advisory Board member. This unwavering dedication to both innovation and community leadership reflects Ryan's commitment to shaping a brighter future for healthcare.
A graduate of the University of Mount Union, Ryan holds a BS in Biology with additional expertise in Chemistry and Psychology, alongside a master's degree in biomedical engineering from the University of Toledo.
Treasurer
Angela currently works for Stryker Corporation as Director of Regulatory Affairs – Corporate. She has 30 years of experience in orthopaedic device regulatory affairs and has been an OSMA company representative from 1995 to 2004 and from 2018 to the present. Angela gained her experience in pre-market and post-market regulatory affairs at DePuy Synthes and Stryker. She is currently involved in advocacy initiatives through OSMA, Advamed, and MedTech Europe in the area of orthopaedics and UDI, and is actively involved in OSMA as the co-chair of the meeting planning committee.
Secretary
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.
Board 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 its merger, which created Zimmer Biomet. During her tenure at the company, she worked her way from a Research Manager 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 and an original PMA, and supported numerous international registrations including MDD dossiers and MDR Technical Files.
Board Member
Karen is the Worldwide Vice President, Regulatory Affairs of DePuy Synthes. She leads the DePuy Synthes regulatory organization and is responsible for driving regulatory strategy and execution for their orthopaedics business worldwide. She has extensive knowledge of the DePuy Synthes business and is a proven leader who has worked at Johnson & Johnson 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, from those that deal with sports medicine to trauma/CMF/biomaterials to joints to various infections. Karen has held global roles in regulatory, NPD quality, and compliance.
She has been a member of RAPS, the Advamed Orthopaedic Working Group, Orthopaedic Surgical Manufacturers Association (OSMA), and has served as a Medical Device Committee Board Member of the Food and Drug Law Institute.
Karen holds a Bachelor of Science 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.
Board 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.
Board 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.
Karen has a BS in Materials Engineer from Rensselaer Polytechnic Institute.
Board Member
Gabriela (Gabby) Parana is the Regulatory Affairs Senior Director for Globus Medical overseeing the spine, orthopaedic, trauma and enabling technologies portfolio. Gabby comes with over 18 years of experience in global medical device regulatory affairs. Her prior roles have included NuVasive (managing the Surgical Intelligence portfolio); 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.
Past President
Stacey served as OSMA President from 2019 to 2022, previously having served the Board in the capacity of Vice President 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 Johnson & Johnson DePuy Synthes, where most recently she was responsible for directing RA activities supporting the new product development and front-end innovation of trauma/CMF and biomaterials.
She brings extensive medical device experience, working with all classifications of products and life cycles, acquired over the years managing complex orthopaedic 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, 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.
Stacey is a self-proclaimed regulatory enthusiast who describes OSMA as a healthy blend of comradery, policy-shaping, and advocacy.
