Specialist in Medical Devices, Post-Market Surveillance & Scientific Due Diligence

Dr Harry Hothi, BEng, MSc, PhD

Experienced clinical-engineering professional with over 15 years of expertise at the intersection of orthopaedic R&D, post-market surveillance, and regulatory science. I have worked closely with surgeons, NHS/European clinical R&D teams, industry innovators (e.g. DePuy, Stryker, Globus Medical/NuVasive, MatOrtho, JRI), and regulatory bodies (e.g. MHRA, Notified Bodies) to drive device performance and patient safety. My roles have involved leading multidisciplinary teams to manage clinical studies, device evaluations, and product development projects.

I have a proven track record of high-impact achievements: authoring 89+ peer-reviewed publications and delivering 160+ scientific presentations globally, and securing significant industry funding for an MHRA-endorsed post-market clinical follow-up (PMCF) study involving orthopaedic implants.

In consultancy, I provide expert witness reports, technical analyses of implants, scientific advice and evidence-based recommendations that help clients improve design, meet compliance, and satisfy due diligence requirements.

My skill set bridges engineering, medicine, and business. I offer expertise in UK/EU/US device regulations (EU MDR, ISO 13485/14155/14971) and clinical evaluation, underpinned by extensive experience in evidence generation (clinical trials, research studies, retrieval analysis). I excel at scientific communication (from technical reports and regulatory documents to stakeholder presentations and educational summaries), and at building strategic partnerships with Key Opinion Leaders (KOLS) and cross-functional teams.

I am passionate about advancing health-tech innovation. I bring a unique perspective informed by both NHS/European clinical research and global industry collaborations, with an interest in supporting product development, ongoing safety/performance assessment and investment decisions in the MedTech sector.