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Prevention of injuries to patients and nurses due to intravenous line dislodgement

Periodic Reporting for period 1 - ReLink (Prevention of injuries to patients and nurses due to intravenous line dislodgement)

Reporting period: 2020-09-01 to 2021-08-31

The need for quality healthcare constantly grows as the global population and life expectancy increases. At the same time, hospitals struggle with budget deficits, personnel shortages, and stressful working environments. Tada Medical’s innovation ReLink aims to significantly contribute to a sustainable, efficient, affordable, and safe healthcare system of tomorrow. Intravenous (IV) therapy is the most common invasive treatment in the world received by 90% of in-hospital patients. However, around 10% of all IV lines are accidentally ripped from the patient’s vein during treatment, i.e. IV dislodgement. This results in consequences such as loss of medication, interrupted therapy, patient injury, and increased personnel workload. Our patented technology, ReLink targets the safety issues with accidental dislodgement of IV lines. Its breakaway connector approach significantly reduces the risk for dislodgement, and its unique design minimises the adverse consequences. ReLink keeps patients and nurses safe, supports accurate drug delivery and saves nursing time.
Relink makes IV therapy safer, accurate and efficient. This proposition plays out in multiple ways for our stakeholders.
• OEM partners – improve competitiveness of the IV infusion product portfolio
o Opportunity to integrate ReLink in their portfolio and offer a differentiated solution in a mature market. Improve price realization
o Offer efficiency, a better infection protection solution and reduced bedside time for care to your healthcare partners (which has become crucial with Covid 19)
• Patients - significantly enhanced safety, and avoidance of injuries and wounds.
• Payers- reduction in treatment costs
• Nurses – Improved workplace safety and efficiency (90% reduction in number of hours to manage IV disconnections -estimated to be over 90,000h annually in Europe and US.
• Hospitals - cost reduction, improved nursing efficiency, reduced risk of legal liabilities towards emerging regulations for workplaces hazards, reduced plastic waste
The main objectives of the project are to evolve the Tada Medical´s breakaway connector ReLink from its current prototype phase to a market ready product. The project is divided into five work packages (WPs), sub-objectives for these are 1) prototyping and production of ReLink devices for testing and demonstrations, 2) ISO 13485 certification, CE mark and FDA submission, 3) extended patent protection, 4) dissemination through conference contributions, trade fairs, press releases, white papers etc., 5) project management.
This report highlights the key project activities reflecting advancement in the production, development, and commercialisation of ReLink.

In the spring of 2020, the company was approved funding for development of ReLink through the EIC Accelerator programme, and the project started in September 2020. The team has now expanded to 12 full time employees, 2 part time employees and 2 interns all in the company, because they trust that ReLink can bring immense value to hospitals across the globe and since then we are moving full speed ahead.
Tada's Quality Management System is certified and fulfils the requirements of ISO 13485:2016. Relink Care the first product in the ReLink family has received the CE mark under the MDD guidelines. Our long-term goal is to submit a technical file for the FDA approval as mentioned in the objectives.
The overall status till date states that the technical solution for ReLink is patent protected. Other IP assets are know-how and trademarks. Trademark for ReLink has been granted in 2020. Patents have so far been granted in Sweden, Europe, USA, Australia, South Africa, Russia, and Indonesia.
Our marketing materials and commercialisation activities are all based on showcasing ReLink through different platforms whether it be scientific conferences, pitching events or any other educational events. We have an impressive track record of participation in exhibitions, trade fairs and pitch events and are an active member of several networks both in Sweden and in Europe. We have been featured for several achievements in the Dagens Industri, Break It, Svenska Dagbladet, Health Tech World magazine, EIT Health webpage, KTH Royal Institute of Technology Magazine and have won several competitions.
Tada Medical has also been supporting students from several partner universities by involving them in the ongoing project activities. This gives them a fair chance to learn about both the business and to keep the innovations alive in the world of MedTech.
The overall work plan ensures the achievement of a set of well-defined technology and market maturation activities to further advance our current solution in the TRL scale. Our technology is the result of our work together with end users to ensure that our products fit their existing needs, while providing effective and accessible patient and user protection. Its primary goal is to provide an improvement in patient safety and saving valuable nursing time spent by the patient bedside. The secondary goal is to evaluate and prove economic value of implementing this technology in the healthcare facility compared to state-of-the-art solutions. Our scale up strategy will have a significant potential of job creation in the value chain and will also support us in accelerating product development. The project not only focuses on fulfilment of unmet healthcare needs but also to have a focused plan to bring a financially viable and sustainable solution to the market. The goal is to bring together a product that fits the need/demand of the end users, promotes global business growth, and brings measurable benefits to the society. The marketed innovations will directly have an impact on the number of citizens/patients benefitted from the solution. This will build up trust and credibility towards the project and products and will help us attract more funding in our organisation.
ReLink breakaway connector features diagram
Relink breakaway connector parts
ReLink Trademark
ReLink breakaway connector in use with IV lines
Relink breakaway connector