Development of Medical devices in the COVID-19 era

From the global pandemic situation caused by the COVID-19 virus, there has been a shortage of medical tools to treat critically ill patients and to protect medical personnel. The cause stems from various factors, particularly the infection rates in countries that are concerned with the global supply chain. This has resulted in the limited availability of medical equipment, which is insufficient to meet the rapidly increasing and severe rates of critically ill patients. In Thailand, both the public and private sectors have recognized the importance of self-reliance and supported innovative medical tool platforms to promote research and new business development for maximum benefit in post-COVID-19 era. To drive ongoing operations, it is necessary to have a regulatory framework and testing certification to ensure the safety of new medical innovations, protect consumers and prevent potential risks. This article presents the background of medical tool production, laws, medical device regulations, and examples of medical tool development in the COVID-19 era. It also discusses research and innovation in new medical tools within the sandbox innovation framework under a quality certification and safety standard, from the perspective of experts and consumer protection for medical product manufacturing.