February - 20208Celestina Bianco, Director of Quality & Regulatory Affairs, Clinical Software, WerfenByA medical device must be effective and most importantly not cause harm. That is why regulators request that medical devices are fully validated before put into use.Recently, we have seen the evolution of software applications that learn whilst operating, the so called adaptative devices--artificial intelligence (AI)-based machines.These machines are highly promising both from a clinical and a business perspective, as well as being perceived as a risk by both stakeholders. Physician concerns relate to the quality of data and algorithms. Manufacturer concerns relate to obtaining approval from the authorities once the product is ready. An adaptative machine cannot be fully validated, and there is not an alternative regulatory framework available to manufacturers.On the other hand, regulators realize the potential of the new technologies and the benefits for public health, and are working on different proposals, at the national and international level. FDA, EU, China, Japan, Korea and national authorities are studying new ways to assure and certify device safety, taking into account work of international organizations such as IMDRF.CAN YOUR MEDICAL DEVICE LEARN WHILE WORKING?Many of the AI companies are small and composed of engineers with a mentality and experience which is far from regulation and interpretations. Have they the skills and can they afford to define the process expected?In My Opinion
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