A clinical engineer with 15 years of expertise in the post-market surveillance of medical devices.

Dr Harry Hothi, BEng, MSc, PhD

With 15 years of expertise in implant research, development, and regulation, I specialise in the post-market surveillance of medical devices. I am experienced in building collaborative relationships with key opinion leaders (KOLs), including spine, hip, and knee surgeons, as well as hospital R&D teams across the NHS and Europe. My experience extends to healthcare regulators, notified bodies, academic researchers, engineers, scientists, and medical devices manufacturers.

I have authored 89 peer-reviewed journal articles on post-market surveillance of medical implants and delivered over 160 presentations at international conferences worldwide.

I have 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. I am experienced in designing and writing clinical study documents, including for approval by Research Ethics Committees (study protocols, consent forms, etc.).

My expertise includes grant writing, UK/EU medical device regulations (ISO 13485, ISO 14971, ISO 12891, ISO 14155 and ASTM F561), technical report writing for the MHRA, and having served as an explant alliance advisor for the Beyond Compliance initiative.

Additionally, I provide expert engineering advice for medico-legal cases and operate an independent medical implant analysis consultancy service.