Periodic Reporting for period 2 - SAFE-Infusion (Stop Adverse Fluid Events in Infusion: weak-link tube connection and air removal devices for safer, more accurate and cost-effective IV therapy in hospital and at home.)
Reporting period: 2022-04-01 to 2023-03-31
Intravenous (IV) therapy is the most performed invasive treatment with 3.8 bn disposables tubes used annually. This procedure is not safe, neither for healthcare personnel nor patients, with serious consequences generating additional healthcare costs of €43b every year. In addition, there is a growing trend to administer IV infusion at home presenting social and economic benefits to patients with chronic diseases, cancer and, being especially important, to the current ageing European population.
In view of the situation, there is an urgent need for IV therapy risk reduction by preventing accidental IV dislodgement and Vascular Air Embolism (VAE) while simultaneously supporting the ‘bringing care home initiative’.
In response, SAFE-Infusion is developing ReAL devices, both a novel weak-link tube connection and closed system air aspirator, to make IV therapy more accurate and safer for healthcare personnel and patients. ReAL helps patients to receive a more accurate dose with faster recovery, while healthcare providers save money. Providing IV therapy at home has a 90% potential cost saving compared to corresponding care provided in the hospital.
This SAFE-Infusion project aims to disrupt the IV tube market by maturing, testing, and launching next-generation IV therapy safety devices. Estimated total accident-related cost-savings of €3.3bn for healthcare (i.e. €28 for each €1 spent in ReAL), 57 tonnes of plastic waste saved, €114m in accumulated revenues and €44m in accumulated operating profit for the industry partners within the first five years post SAFE-Infusion project.
In view of the situation, there is an urgent need for IV therapy risk reduction by preventing accidental IV dislodgement and Vascular Air Embolism (VAE) while simultaneously supporting the ‘bringing care home initiative’.
In response, SAFE-Infusion is developing ReAL devices, both a novel weak-link tube connection and closed system air aspirator, to make IV therapy more accurate and safer for healthcare personnel and patients. ReAL helps patients to receive a more accurate dose with faster recovery, while healthcare providers save money. Providing IV therapy at home has a 90% potential cost saving compared to corresponding care provided in the hospital.
This SAFE-Infusion project aims to disrupt the IV tube market by maturing, testing, and launching next-generation IV therapy safety devices. Estimated total accident-related cost-savings of €3.3bn for healthcare (i.e. €28 for each €1 spent in ReAL), 57 tonnes of plastic waste saved, €114m in accumulated revenues and €44m in accumulated operating profit for the industry partners within the first five years post SAFE-Infusion project.
The SAFE-Infusion project has set out a goal to improve the landscape of IV infusion by improving the state-of-the-art technology. Since the beginning, each product has been developed with a focus on clinician-led human factors and preparation for manufacturing, underpinned by a solid foundation in regulatory and commercial activity. With the consortium of four partners, two of which are academic hospitals and two are industry, the work performed has been specific to each partners’ need, as well as the overall goals of the joint project. Although affected due to supply chain impacts, the project has progressed according to plan, with each technology maturing to manufacturing stage as per ISO 13485 medical device standards. The industry partners have evaluated and engaged with specialist EU suppliers with signed agreements to produce first products.
As per planned activity, the major developments in P2 have been regulatory and manufacturing, with planning of clinical trials for the two technologies, ReLink and AirVault. Each company has engaged established Regulatory Notified Bodies to assess the technical documentation and approve the technologies for clinical use in due course. To support this regulatory submission, planned for P3, detailed technical testing for biocompatibility, sterility and performance have been completed. The outcomes of these tests have been positive and both technologies are finalising reports accordingly. The sourcing and management of multiple external vendors, as well as manufacturing partners, suppliers and clinical partners has been effectively delivered over the course of this reporting period.
The two separate technologies have additional intellectual property rights, technical features, clear user documentation and designs frozen for scale-up manufacturing. Additional testing with expert end-users in animal and human infusion centres has shaped a targeted technical product as well as the commercial approach to market.
The planned market launch of the subcomponents and the joint ReAL system has been optimised based on activity throughout this period, the project has gathered significant commercial attention through attendance at industry trade shows and events, as well as dissemination of updates across various media channels. The continuous growth of the brands and SWIRL is planned for the year ahead, including engagement with the Horizon Booster program.
On-going discussions with relevant distribution channels, end users and potential customers indicates that this SAFE-Infusion project is on track to deliver an impactful result, in line with its core mission to improve delivery of IV medicines for patients in the EU and globally.
As per planned activity, the major developments in P2 have been regulatory and manufacturing, with planning of clinical trials for the two technologies, ReLink and AirVault. Each company has engaged established Regulatory Notified Bodies to assess the technical documentation and approve the technologies for clinical use in due course. To support this regulatory submission, planned for P3, detailed technical testing for biocompatibility, sterility and performance have been completed. The outcomes of these tests have been positive and both technologies are finalising reports accordingly. The sourcing and management of multiple external vendors, as well as manufacturing partners, suppliers and clinical partners has been effectively delivered over the course of this reporting period.
The two separate technologies have additional intellectual property rights, technical features, clear user documentation and designs frozen for scale-up manufacturing. Additional testing with expert end-users in animal and human infusion centres has shaped a targeted technical product as well as the commercial approach to market.
The planned market launch of the subcomponents and the joint ReAL system has been optimised based on activity throughout this period, the project has gathered significant commercial attention through attendance at industry trade shows and events, as well as dissemination of updates across various media channels. The continuous growth of the brands and SWIRL is planned for the year ahead, including engagement with the Horizon Booster program.
On-going discussions with relevant distribution channels, end users and potential customers indicates that this SAFE-Infusion project is on track to deliver an impactful result, in line with its core mission to improve delivery of IV medicines for patients in the EU and globally.
Continuing from the activity and goals set out in P1, solid progress has been achieved in P2 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 P2, 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 2027. 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.
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 P2, 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 2027. 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.