Flexible Product Innovation Cycles for Smart Medical Devices

Abstract

The development of medical devices currently faces several challenges, like the urgent need for new products in a pandemic situation and the release of a new regulatory framework for medical devices in the European Union, which shall ensure the safety and effectiveness of newly developed medical devices. At the same time, the desire for smart, user-friendly products is growing. These can be realized through agile and flexible process models. Based on agile values and the integration of customer feedback, this need can be achieved in iterative development cycles. What at first sight does not seem to be combinable, however, be well integrated into the regulated area of medical technology through the targeted use of agile processes and the adaptation of individual steps. This paper presents a framework for the integration of Scrum into the regulated design control process for medical devices. This framework facilitates flexible product development of smart medical devices.