Áine Duffy serves as Associate Director of Clinical Strategy at NAMSA, where she leads a team of clinical and regulatory consultants dedicated to guiding medical device manufacturers through the complex global regulatory landscape. Her team partners with Sponsors to develop and execute strategies that ensure compliance, streamline submissions, and accelerate the path from concept to commercialization.
Áine began her career in academia after earning a PhD in Neuroscience from University College Dublin. She completed a postdoctoral fellowship at Weill Cornell Medical Center and later served as an Assistant Research Scientist at the Nathan Kline Institute of Psychiatric Research and taught students in the Master of Psychology Program at New York University. In 2017, she transitioned into the medical device industry by joining the Contract Research Organization Syntactx, where she applied her research and analytical expertise to regulatory and clinical documentation. Since then, Áine has built a strong track record of delivering strategic solutions for regulatory submissions and clinical evidence development.
CORE COMPETENCIES
- Leadership and strategic planning for the clinical and regulatory strategy teams
- Managing project, resources, and cross-functional collaboration
- Authoring and reviewing clinical documentation, including protocols, study reports, and manuscripts
- Preparing and reviewing regulatory submissions to the U.S. FDA and international authorities
- Conducting systematic literature reviews and data analysis for regulatory compliance
- Developing Clinical Evaluation Plans and Reports (MEDDEV 2.7.1/rev. 4 and EU MDR)
- Drafting post-market documentation (PSUR, PMCF Reports, PMS, and PMCF plans)
RECENT PROJECTS
- Assisted clients in publishing manuscripts in peer-reviewed journals
- Transitioned multiple Clinical Evaluations to meet EU MDR requirements
- Successfully supported Sponsors in responding to Notified Body and FDA queries
PUBLICATIONS
- Silver MJ, Giri J, Duffy Á, et al. Incidence of Mortality and Complications in High-Risk Pulmonary Embolism: A Systematic Review and Meta-Analysis. Journal of the Society for Cardiovascular Angiography & Interventions. 2023;2(1)doi:10.1016/j.jscai.2022.100548
- Acknowledged in Gray WA, Cardenas J, Teigen CL. Evaluation of safety and efficacy of the S.M.A.R.T.® Flex Vascular Stent System (OPEN study). Catheter Cardiovasc Interv. 2022;100(6):1078-1087. doi:10.1002/ccd.30414
- Acknowledged in Torsello G, Bertoglio L, Kellersmann R, et al. One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms. J Vasc Surg. 2022;75(6):1904-1911.e3. doi:10.1016/j.jvs.2021.12.066
- Acknowledged in Parikh PJ, Lee P, Low DA, et al. A Multi-Institutional Phase 2 Trial of Ablative 5-Fraction Stereotactic Magnetic Resonance-Guided On-Table Adaptive Radiation Therapy for Borderline Resectable and Locally Advanced Pancreatic Cancer. Int J Radiat Oncol Biol Phys. 2023;117(4):799-808. doi:10.1016/j.ijrobp.2023.05.023
- Acknowledged in Holden A, Krauss M, O’Hara R, Jones J, Smith DK. A First-in-Human Trial of a New Aqueous Ionic Liquid Embolic Material in Distal Embolization Applications. J Vasc Interv Radiol. Published online November 4, 2023. doi:10.1016/j.jvir.2023.10.029
- Acknowledged in Torsello G, Bertoglio L, Kellersmann R, Wever JJ, van Overhagen H, Stavroulakis K. Three-Year Safety and Efficacy of the INCRAFT Endograft for Treatment of Abdominal Aortic Aneurysms: Results of the INSIGHT Study. J Endovasc Ther. Published online November 30, 2023. doi:10.1177/15266028231214162
- Acknowledged in Holden A, Krauss M, O’Hara R, Jones J, Smith DK. A First-in-Human Trial of a New Aqueous Ionic Liquid Embolic Material in Distal Embolization Applications. J Vasc Interv Radiol. Published online November 4, 2023. doi:10.1016/j.jvir.2023.10.029
