Archives: Speakers

Esther has been part of PureCircle’s technical team for 2 and a half years working closely with global and regional accounts across EMEA. With a degree in Food and Nutrition, and a 12-month placement with a flavour house, Esther has experience in a range of product applications.

Romil has 12 years of regulatory experience in Class III combination products (Transcatheter Mitral/Aortic Valve Replacement Systems and Drug Eluting Stents) and Class II medical devices (Alpha-1 antitrypsin test, Software validation, Endoscope defogging device, Holter recorder, etc)

Romil has an in-depth understanding of regulatory, quality and clinical requirements, and he has a history of successfully managing regulatory submissions such as Premarket approval (PMA), Investigational Device Exemption (IDE), Early Feasibility Study (EFS-IDE), Premarket Notification [510(k)], Design Dossier (CE Mark), European Directorate for the Quality of Medicines & HealthCare (EDQM) Certification, Shonin Submission (Japan), Clinical Trial Applications (Europe & Japan), Global Regulatory Submissions, Amendments, Supplements and Annual Reports.

Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. She has extensive experience in leading data management activities for multiregional clinical trials in all phases and several therapeutic areas. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. In her role at Nevro, Frances is responsible for leading the data management team, driving the adoption of new technologies and innovative data management processes to bring new treatments to patients.

Tracy MacNeal is an engineer, healthcare entrepreneur, and MedTech investor.  She is CEO of Materna Medical, a Series B startup focused on transforming the standard of care in women’s pelvic health.  As an investor in Portfolia’s FirstStep fund, she supports the commercialization of high-growth segments typically undervalued and overlooked by traditional investing approaches.  Tracy serves as the national Chair of Advamed’s Women’s Executive Network, connecting and amplifying the top women leaders in the MedTech industry. She previously served as President of Diagnostics and Digital Health for Ximedica, held by SV Life Sciences, a private equity healthcare firm, after serving in Chief Strategy Officer and Chief Financial Officer roles at two successful medical devices companies.  Tracy received a Bachelor of Chemical Engineering with full scholarship at the Cooper Union in New York City and an MBA from Duke’s Fuqua School of Business, graduating summa cum laude as a Fuqua Scholar.