Meet Our Leadership Team
Elizabeth Weathers, PhD, RN, RGN, FAAN, Founder & CEO of ECNE Research
Dr. Elizabeth Weathers is a clinician, researcher, and clinical regulatory strategist with almost 20 years of experience spanning patient care, academia, and the pharmaceutical and medical technology industries. As Founder and CEO of ECNE Research, she leads an expert team that helps companies define the clinical value of their products, develop evidence strategies, and navigate regulatory requirements in the US, Europe, and Asia.
Elizabeth’s work spans clinical research, protocol development, regulatory strategy, clinical evaluation, and postmarket evidence generation. She has led clinical and regulatory programs for pharmaceutical products and a broad range of medical technologies, including advanced radiotherapy and imaging systems, software as a medical device, blood and cell technologies, cardiovascular implantable devices, neurostimulation devices, wound care therapies, and digital health products. Her experience across Europe, Asia, and the US allows her to connect clinical needs with the evidence and regulatory decisions that shape product development and market access.
Formerly an associate professor at University College Dublin, Elizabeth has authored more than 50 peer reviewed publications. She holds a PhD in Medicine and Health, is a registered nurse in Ireland and the US, and is a Fellow of the American Academy of Nursing.
ECNE Senior Advisors
Dr. Carole Chrvala
Robert Steele BA Eng. CEng. Mi Mech E. MCQI. MASQ
Robert Steele BA Eng. CEng. Mi Mech E. MCQI. MASQ
Dr. Carole is an accomplished epidemiologist and medical strategist with more than 30 years of experience supporting biotech, pharmaceutical and medical device organisations. Her expertise spans health economics and outcomes research, competitive intelligence and strategic medical communications across therapeutic areas.
Robert Steele BA Eng. CEng. Mi Mech E. MCQI. MASQ
Robert Steele BA Eng. CEng. Mi Mech E. MCQI. MASQ
Robert Steele BA Eng. CEng. Mi Mech E. MCQI. MASQ
Robert is a Chartered Engineer and RAQA professional with extensive experience in medical device design, quality and regulatory affairs across US, European and Asian markets. He has supported the approval of numerous medical technologies through EU MDR CE marking, FDA 510(k) submissions, and PMA applications.
Dr. Joanna McCarthy
Dr. Sheela Devi, PhD, PMP
Dr. Sheela Devi, PhD, PMP
Dr. Joanna is a clinical and regulatory specialist experienced in developing regulatory strategies and accelerating market access for medical technologies. Her expertise includes Class III and combination devices, trial design, notified body interactions and post-market clinical follow-up. She held senior roles at Stryker Instruments and Lilly and now supports Irish MedTech companies as an independent consultant.
Dr. Sheela Devi, PhD, PMP
Dr. Sheela Devi, PhD, PMP
Dr. Sheela Devi, PhD, PMP
Dr. Sheela Devi is a scientific and medical affairs leader with nearly 20 years’ experience across the Asia-Pacific region. Her expertise spans clinical research, medical affairs strategy, commercialisation and operational excellence. She advises healthcare and life sciences organisations on market expansion, digital transformation and the integration of AI into clinical settings. She holds a PhD and PMP certification and is completing an MBA.
Be the first to know
Sign up to our mailing list to receive regular updates on medical writing and clinical research topics.