Continuing from the activity and goals set out in P1, P2, and P3, solid progress has been achieved in P4 for this SAFE-Infusion project.
In a systematic review of the unmet need for the ReAL technologies, professionals from the healthcare sector indicated issues with the state-of-the-art, determining the need for innovative solutions to the problem areas as set out in this project proposal.
As this project has progressed, each technology has been matured with clinical input informing design thinking, usability, risk analysis, clinical scenarios, human factors, integration into healthcare settings. Through the advancement of the project and maturing of the technical offering, and as each device approaches a market-ready state, the feedback from clinicians and targeted customers has continued to indicate that the unmet needs identified at the outset of the project will be adequately met by the developed technologies and will have a measurable impact on patient treatments.
To ensure a complete design and risk analysis, stakeholders from across the clinical value chain and multiple health institutes across a spread of countries were asked to give an opinion on the product and problem. It also assessed technologies that can act as competitors and/or conduits for ReAL technology. This in-depth market assessment has two benefits, 1) to ensure accurate and suitable products are offered for commercialisation, and 2) to build a network of potential pilot sites as early adopters and champions of the devices. The industry partners expanded this search well beyond just the academic hospital partners of SAFE-Infusion project. Polling of various clinical end-users, supported by direct engagement throughout P3 and P4, has indicated a desire among frontline workers, further supported by senior management and procurement officers, to integrate ReAL devices into daily work. This can have several impacts. Firstly, it reveals strong market pull and potential for commercial success, which is vital for each company and the SWIRL consortium to reach its impact goals of 91 jobs created, €114m revenue and global markets reached by 2029. It also gives reassurance that the proposed devices are suitable solutions, which will result in achieving the impact goals of €3.3bn reduction in costs related to adverse events. Finally, the methods employed by the SAFE-Infusion industry and academic partners in designing the clinical study protocols and endpoints that underpin the regulatory approval have been robust, which will act as a strong catalyst for dissemination of anticipated good results, a key determinant of reaching a broad audience and achieving the planned goals of successful market entry.
