Periodic Reporting for period 2 - RondelO (RondelO - the first medical stopcock designed for sequential intraveneous infusion of incompatible drugs)
Período documentado: 2023-11-01 hasta 2025-04-30
RondelO™ is the name of the EIC backed innovation that aims to make infusion therapy safer for both patient and nurses. RondelO™ is a key component within an intravenous infusion set (IV-set), that is used to deliver medication to patients. With RondelO™ integrated into an IV-set, it is possible to connect multiple drugs via secondary lines to the RondelO™ inlets and give those drugs one by one without risk of mixing them. Mixing drugs can cause drug incompatibility with severe adverse advents as a result. RondelO™ reduce the risk of human error caused by the nurse by being the only physical device to force drugs to be given in sequence where parallel flow is not possible due to its turn valve design. Furthermore, RondelO™ contributes potentially to less occupationally exposure of hazardous drugs in the workplace for the nurses if they connect their multiple drug infusion lines before use to the RondelO™ and leave them connected. Then discard the complete IV-set including the drug lines still being connected after treatment as hazardous waste. The potential risk reduction may have a great impact on the 7.3 M nurses exposed to Hazardous Drugs in Europe alone every year causing 2200 leukaemia cases. Also there are 17 000 incremental spontaneous abortions per year occurring among nurses handling hazardous drugs, and there are 10 000 children born with malformations where their mothers have been nurses handling hazardous drugs.
The project itself is designed to address the issues with scalability and pricing. In order to commercialize RondeO™, significant effort is required to reduce cost of goods (COGS) and increase automation level in the production.
The largest players need strong incentives to include the new RondelO™ product into their portfolio. To address this, the project is supporting the development of final devices to demonstrate the advantages of RondelO™ to the market, and push the adoption.
The project itself is designed to address the issues with scalability and pricing. In order to commercialize RondeO™, significant effort is required to reduce cost of goods (COGS) and increase automation level in the production.
The largest players need strong incentives to include the new RondelO™ product into their portfolio. To address this, the project is supporting the development of final devices to demonstrate the advantages of RondelO™ to the market, and push the adoption.
RondelO™ is made by injection moulded plastic and consists of only two parts, a house part and a handle part that together become the RondelO™ turn valve. Within this project, a multicavity injection mould tool has been developed and reduced the COGS drastically. The complex design of the RondelO™ house part requires up to 8 moving cores to form the drug inlets of the RondelO™ turn valve. All these cores requires individual cooling to be able to form the RondelO™ house part with tight tolerances to be compliant with the Luer standard ISO 80369-7, meanwhile keeping the cycle time low to avoid degradation of the plastic material used. The Co-polyester used to mould the RondelO™ house part is superior in its properties to withstand drugs that will be used in for example in an oncology setting, but it requires some special attention during the manufacturing process.
To be able to assemble the RondelO™ house and handle part to form a complete turn valve, an automation for the assembly was developed. It has an in-process quality control of all parameters such as measuring mounting force, torque force, leakage and marking a unique QR code on each individual RondelO™, meanwhile having a production output capacity of 1 RondelO™ per second. All these testing parameters are saved and can be fetched by scanning the QR code at any time.
A modular cleanroom was designed where the RondelO™ automation will be placed and thereby it completes our own in-house Quality Control center.
The project supported the development of a range of Final Device IV-sets with certification that will be introduced to the market to make adoption happen of the larger companies that dominates the market. Also, indications from early market communications are that the larger players appreciate that going all the distance from development of a new product to certification differentiates our company from many others and it actually helps them to achieve their potential implementation of RondelO™ faster.
To be able to assemble the RondelO™ house and handle part to form a complete turn valve, an automation for the assembly was developed. It has an in-process quality control of all parameters such as measuring mounting force, torque force, leakage and marking a unique QR code on each individual RondelO™, meanwhile having a production output capacity of 1 RondelO™ per second. All these testing parameters are saved and can be fetched by scanning the QR code at any time.
A modular cleanroom was designed where the RondelO™ automation will be placed and thereby it completes our own in-house Quality Control center.
The project supported the development of a range of Final Device IV-sets with certification that will be introduced to the market to make adoption happen of the larger companies that dominates the market. Also, indications from early market communications are that the larger players appreciate that going all the distance from development of a new product to certification differentiates our company from many others and it actually helps them to achieve their potential implementation of RondelO™ faster.
Financing of a startup within the med-tech field requires large investments, meanwhile investments from VC requires that certain risk development steps regarding technology are behind. With the EIC grant we were able to reach that development we believe is needed. Even more so, in recession access to capital is even harder and requires more milestones to have been achieved. With the EIC grant we managed to bridge the worst part of the recession in 2023 and are soon ready to introduce RondelO IV-set to the market and get that additional market traction that VC often asks for. Timely, the medtech field now see early signs of an upswing again.