Temperature control optimization has become increasingly important in today's climate scenario. Thermal comfort is a crucial human factor during the performance of tasks, often insofar as user safety and the prevention of errors and accidents are concerned. It is a variable that depends on many physical parameters, including the temperature of the air and the regulation of body temperature, as well as sex, age, clothing and other general and local body characteristics.
In order to detect differences in heat maps due to pathologies, skin conditions or joint injuries, the Instituto de Biomecánica (IBV) has created a methodology that analyses the body's thermoregulatory response and measures surface temperatures and their evolution. Using a huge infrared database (>300,000 images), models have been trained to estimate such parameters as the user’s sex, age, thermotype and identification all of which facilitate the prediction of thermal discomfort by means of a thermal image. Using contactless technology and artificial intelligence, applications have been implemented in the field of Health and Well-being to help professionals (clinicians, physicians, etc.) to diagnose certain diseases, such as circulatory and vascular problems, the effect of therapies or cosmetic products, or to prevent such risks as heat stroke.
The implementation of the new European Medical Devices Regulation (MDR) has caused a minor revolution in the sector that has required a major effort on the part of companies to adapt to this new framework. The Instituto de Biomecánica (IBV) provides advice on the development, evaluation and certification of medical devices to companies in the HEALTHCARE sector that are committed to the quality and safety of their medical devices as elements of brand identification. One such company is ECOPOSTURAL, a leading company in the field of healthcare furniture, which was granted a manufacturing license by the AEMPS (Spanish Agency for Medicines and Medical Devices) in 2001.
In collaboration with the Galician Health Service (SERGAS) and VECMEDICAL SPAIN S.L., the Instituto de Biomecánica (IBV) has developed an innovative multichannel device for flexible or rigid intrarectal endoscopy and rigid instrument-assisted removal of rectal lesions that cannot be treated using conventional flexible endoscopy techniques. The starting point was a conceptual idea defined by the clinical group, led by Dr. José Noguera, and all the stages of the development were carried out jointly, beginning with the conceptual design and including risk assessment, in vitro functionality tests, redesign, animal experimentation, design for manufacturing and the generation of the necessary documentation for CE marking and to begin clinical trials in humans.
The period of transition for Class I medical devices to the new regulatory framework established by EU Regulation 2017/745 on medical devices, also known as MDR, will come to an end on 25 May 2021. As of this date, if they wish to continue marketing these products, all manufacturers and their respective products must adapt to the MDR.
This article will address the main changes introduced by the new regulatory framework and will provide the keys to a successful transition for class I medical device manufacturers.