Áine Duffy has been a medical device consultant for over 5 years, gaining experience in several therapeutic areas, including vascular, cardiovascular and gastrointestinal. She has aided clients with the transition of clinical evaluations to the Medical Device Regulation (MDR) and helped address non-conformities issued by Notified Bodies. She has also worked with physicians to develop manuscripts for publication in peer-reviewed journals.

Following a career in academia, which included an adjunct professor role at New York University, Áine joined NAMSA’s Syntactx in 2017 to apply her research and problem-solving skills in medical writing. Áine has a broad scientific background, with post-graduate experience in basic research and a PhD in neuroscience.

CORE COMPETENCIES

• Managing project timelines and resourcing for regulatory and medical writing projects
• Providing mentorship and leadership to the regulatory and medical writing team
• Developing Clinical Evaluation Plans and Reports (MEDDEV 2.7.1/rev. 4 and EU MDR)
• Performing systematic literature reviews and analysis of data extracted from the literature for regulatory submissions
• Preparing manuscripts, protocols, study reports and other deliverables in conjunction with clinical teams
• Working with the internal regulatory strategy team and Sponsors on submissions to the U.S. Food and Drug Administration (FDA)
• Assisting Sponsors with responses to queries from regulatory bodies
• Development of post-market documentation (PSUR, PMCF Reports, PMS and PMCF plans

RECENT PROJECTS

• Worked with several Sponsors on transitioning Clinical Evaluations to meet MDR
• Successfully assisted Sponsors with responses to Notified Bodies
• Drafted a clinical manuscript that has been recently published in a peer-reviewed journal

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