Metrology Strategies for use as an Evidence Base in Device Evaluations

Metrology is “the science of measurement, embracing both experimental and theoretical determinations at any level of uncertainty in any field of science and technology.” defined by Bureau International des Poids et Mesures [1]. Some areas of the engineering are well developed over the years with the help of advanced metrology, for instance, surface texture or topography measurement. Scientists and engineers continuously develop new measuring tools and methods in order to evaluate products and manufacturing procedures which drives the qualities up. In medical devices development, however, it lacks of methods or standardised procedures to evaluate the effects to patients, typically skin, and also in general the effectiveness. The Centre of Precision Technologies and the Institute of Skin Integrity and Infection Prevention at the University of Huddersfield preformed various experiments and evaluations on medical devices including static and dynamic mattresses, mattress’ covers, bandage and etc. Most of those experiments and evaluations were performed with some tailor-made procedures because those are not standard engineering evaluations and without any guidance from British Standards Institution (BSI) standard or International Standard Organisation (ISO) standard. Standardisations and development of robust evaluation tools were deemed to be the needs of the medical device field, thus, computational skin model was developed in 2017 at the University of Huddersfield. The computational model focused on the effects of medical devices to skin and cutaneous blood vessels in relation to the formation of pressure ulcer. This novel computational model is a first step towards a comprehensive evaluation method in medical device development. The Centre of Precision Technologies and the Institute of Skin Integrity and Infection Prevention at the University of Huddersfield will continuously focus on 3 key aspects in device development including standardisation of measurement, better understanding of the effects of devices to human body and the application of engineering measuring tools.

This lecture is presented by: Isaac Leung