Personalised medical devices, regulation and challenges
Personalised medical devices are medical devices that are specifically designed and manufactured, or adapted/modified, to meet the needs of an individual. There are 3 specific terms to describe personalised medical devices: Patient-matched medical devices; Adaptable medical devices; and Custom-made medical devices. It is a new but fast growing sector within the MedTech industry. It is essential for Biomedical/Clinica engineers to familiarize themselves with this new sector and regulation involved while learning from experts who have been players in this sector.
About the Speaker
Senior Rehabilitation Engineer , University of Queensland
A rehabilitation engineer with 13 years of experience in Public Health, primarily in personalised assistive technologies. His role includes design and manufacture of patient-matched medical devices which has required him to delve deeply into the regulatory reforms covering this space. Being a biomedical engineering within the hospital setting has given him a deeper appreciation of the importance of the professional engineer within the multidisciplinary healthcare team. Iain is currently the chairperson of the National Committee on Rehabilitation Engineering, a committee within the Biomedical College. In this role, he is actively advocating for a better awareness of professional engineering practice within Health and Disability sectors.
