JULY 20228Celestina Bianco, Director of Quality and Regulatory Affairs, Clinical Software, WerfenByAmedical 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, CAN YOUR MEDICAL DEVICE LEARN WHILE WORKING?Celestina BiancoIn My Opinionand 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. The approach is, as in many other fields, based on risk reduction. The risks with a device must be reduced as much as possible and/or to a level where the benefits outweigh the risks to the patients. This is traditionally assured by a thorough validation and clinical evaluation. The challenge for AI devices is to assure safety is maintained when the device changes according to the experience and learning that it gets during use. The FDA is studying a model that lowers the scrutiny on the products once the maturity and quality level of the manufacturer is certified. In the following section, I will describe the concept of the model, without entering into any detail that might change before going live.The maturity of the processes of the manufacturer, its capability to build devices safe (and secure) by design, is certified initially and re-evaluated constantly through analysis of performance data and inspections.A certified manufacturer will still submit its products for approval, for the Intended Use and capability that it will have
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