A clinical engineer with 15 years of expertise in the post-market surveillance of medical devices.
Dr Harry Hothi, BEng, MSc, PhD
Experienced clinical-engineering professional with over 15 years of expertise at the intersection of medical device R&D, post-market surveillance, and regulatory strategy. Demonstrated success in developing strong partnerships with surgeon key opinion leaders (KOLs), regulatory bodies (MHRA, Beyond Compliance), industry R&D teams, and academic stakeholders. Proven ability to lead clinical research, support regulatory submissions, and provide scientific input across the product lifecycle, including clinical evaluations and post-market clinical follow-up (PMCF).
Authored 89 peer-reviewed journal articles and delivered 160+ presentations globally. Strong background in clinical study design, scientific writing, and evidence generation, including direct contributions to engineering case studies and regulatory dossiers. Deep working knowledge of UK/EU/US medical device regulations, ISO standards (13485, 14155, 14971), and medical-scientific communications.
Successfully led multidisciplinary teams of academics, engineers, and clinicians to manage research projects and post-market clinical studies funded by leading manufacturers such as DePuy, Stryker, and NuVasive/Globus Medical.
Provides expert engineering advice for medico-legal cases and operates an independent medical implant analysis consultancy service.