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This module focuses on the challenges of bringing innovative medical devices to market, especially those that include artificial intelligence and machine learning, and that are 鈥渃onnected鈥� directly to apps, databases and/or hospital computer systems.

This includes effective communication with all stakeholders (including patients and medical staff), so they can make informed choices and trust the medical technology they use.

Rapid technological change, including in artificial intelligence, connected devices, and very compact microelectronics, provide opportunities for new types of medical devices that could transform the way patients are assessed and their treatments personalized.

This technological change is accompanied by a rapidly evolving regulatory environment for innovative medical devices. The regulatory framework that applies isn鈥檛 just the medical device regulations, but also regulations around privacy, data protection and emerging regulations on the use of Artificial Intelligence. New risks therefore need to be taken into account in the medical device product lifecycle, including in requirements, specifications, verification, validation and vigilance.

Communication to stakeholders about medical devices, called 鈥渓abelling鈥�, needs to cover more issues and be more digestible. 听In particular, it is important to effectively describe the benefit versus risk profile of these innovative devices.

To enable biomedical engineering students to:

• have critical awareness of the evolving regulatory landscape for innovative medical devices, in particular in the areas of artificial intelligence and cybersecurity.
• understand how risks are assessed and managed in the entire lifecycle of medical device development and marketing.
• effectively communicate to clinicians, patients and the wider public, the benefit versus risk balance of innovative medical devices.