Archives: Speakers

Michael C. Morton is Senior Director of Government Affairs and Policy at Medical Alley and a seasoned medical device regulatory consultant. He brings over 30 years of experience in quality, clinical, and regulatory affairs, including serving as Vice President of Corporate Regulatory Affairs at Medtronic, where he led public health policy advocacy and internal regulatory strategy.

Michael has held leadership roles at CarboMedics, W.L. Gore & Associates, Alcon Labs, and Sorin Group. He is a Fellow and Board member of the Regulatory Affairs Professionals Society (RAPS), and has played key roles in industry groups like AdvaMed, including chairing the PMA and Pediatric Devices Working Groups.

He has represented industry in global regulatory harmonization efforts through the Global Harmonization Task Force and the International Medical Device Regulators Forum. Focused primarily on U.S. regulation, Michael has contributed to FDA legislation, guidance documents, and regulatory policy development.

Recognized for his collaborative approach with the FDA, he has trained advisory committee members, participated in FDA workshops, and served as the industry representative on the FDA Circulatory System Devices Advisory Panel, for which he received an FDA service award.

Jeff is the CTO for Edinburgh HQ’ed tech consultancy CreateFuture, leading the AI strategy and enablement team. A lifelong technologist, having started coding at the age of six, Jeff has been in the industry for over 25 years. He has a love for CyberSecurity and AI, especially the human elements of both subjects. Working in the consultancy space, he’s seen the world change to be product and service-oriented, and bangs the drum for ensuring that everybody is involved in delivering secure and usable offerings

Offering years of industry success, Shirish has an extensive background in product development, market research and data analysis. Shirish continues to drive the development of our suite of NX products, identifying what our customers need and how we can best serve them. Shirish’s mission is to drive our SaaS transformation through industry leading products, such as our AI capabilities and our Immersive Engineering offerings

Jamie has a rich history in marketing, with over seven years of experience within software. He continues to drive the NX story, focusing on innovative marketing tactics, compelling content creation, and creating content to suit everyone’s needs. Jamie’s mission is to continue educating the market on Siemens Digital Industries Software solutions by looking at how product design will evolve in the future.

Isabel is a Market Solutions Specialist at Optum UK, specialising in clinical trials and real-world evidence with a focus on EMIS Web primary care data and systems. She supports the UK’s only clinical trial recruitment solution fully embedded within the GP clinical system, enabling faster, more accurate patient recruitment while reducing the burden on sites.

Alex French serves as VRG Project Oversight utilizing her out-of-the-box mindset to develop and provide the most efficient and effective strategy. She is a highly experienced project manager and decentralized clinical trials oversight director with considerable global CRO and site experience over the last 9 years. Alex has expertise in Phase I-IV clinical trials ranging from fully decentralized trials, pediatric nutrition and imaging to adult pulmonary, critical care, infectious, and rare diseases. She brings expertise from not only her CRO background, but site, pharmaceutical, and patient perspectives as well. Building on her experience, she seeks to add decentralized aspects where applicable to fully enhance the experience for the patient, CRO, and site.

Alex ensures detailed management and compliance with ICH-GCP, SOPs, and FDA/IRB regulations within each trial. She has been an integral part in the development of VRG at Premier, which has been a pivotal addition in patient recruitment, engagement, and decentralized elements. Alex earned her B.S. in biomedical sciences and neurobiology from the University of Cincinnati.