Katzis, Konstantinos

The Artificial Pancreas is a medical device, currently in development, that aims to provide automatic regulation of blood glucose (BG) levels in ambulatory type 1 diabetes mellitus sufferers. The most popular approach utilises subcutaneous (SC) continuous glucose monitoring (CGM) combined with SC insulin injection controlled by a Model Predictive Control (MPC) algorithm. From a safety risk perspective problematic elements include the performance robustness of the CGM and the need for a pre-meal insulin bolus to provide satisfactory post prandial BG regulation. This contribution presents preliminary in silico studies which indicate that the use of an alternative approach to insulin delivery - intra-peritoneal (IP) infusion - could provide a similar level of BG regulation (as obtained with SC delivery), without the need for the pre-meal bolus. This simplified control architecture would remove the patient safety risk related to the administration (or not) of pre-meal bolus.

5G wireless is the next step in the evolution of mobile communications with the aim being to provide connectivity for any kind of device and any kind of application. Wireless Body Area Networks (WBANs) constitute just one component of connected healthcare utilising small intelligent physiological sensors either on or implanted in the human body. This contribution examines the 5G technologies that will make a significant contribution to providing secure healthcare-orientated WBANs with improved energy efficiency, interference mitigation and wireless power transfer capability.

Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.