Background: The European Medical Devices Regulation (MDR) 2017/745 seeks to minimize clinical uncertainty – especially regarding the generation, dissemination, and quality of clinical evidence – across all phases of the medical device lifecycle: pre-market, market approval, post-market, and disinvestment. Although the MDR promotes using gold-standard methodologies, such as Randomized Controlled Trials to address clinical uncertainty, […]
The internal innovation activities of firms often encounter obstacles (i.e., factors hampering innovation activities) such as economic constraints and lack of skilled employees within enterprises, prompting them to adopt an Open Innovation (OI) approach as a means to overcome the obstacles and thus to achieve innovation performance, intended as Innovation Industrial Performance (IIP) and Innovation […]
A firm can improve its innovation processes by accessing useful external knowledge, profiting from the Open Innovation outside-in process. However, to benefit from the flow of knowledge from the firm’s outside boundary, the firm’s Absorptive Capacity – the ability to correctly acquire, assimilate, transform, and exploit external knowledge according to the innovation needs – plays […]
With the advent of the Digital Transformation, Healthcare Systems have switched from paper to electronic health records (EMR). However, there are few critical issues related to data governance (e.g., transparency of data, traceability, immutability, privacy and security) that need to be addressed in the upcoming years. Blockchain (BT) is a decentralized digital ledger and an […]