Prolight’s COO comments on partnership with FlexMedical Solutions
Prolight Diagnostics has appointed FlexMedical Solutions as contract manufacturing partner for the disposable cartridge in the Psyros point-of-care system. Prolight’s COO, Karl Bullen, has highlighted the simplicity and cost-effectiveness of the cartridge as a key competitive advantage. BioStock reached out to Karl to learn more.
Prolight Diagnostics is developing an innovative Point-of-Care (POC) system called Psyros, designed for the precise measurement of troponin levels to assist in the diagnosis of myocardial infarction. Psyros is a small, portable instrument equipped with a disposable cartridge, enabling in-vitro diagnostic (IVD) tests using just a single drop of blood.
Selection of CMO for cartridge
At the end of March, Prolight appointed FlexMedical Solutions as its contract manufacturing (CMO) partner for the Psyros disposable cartridge. FlexMedical emerged as the preferred choice after a rigorous selection process.
Based near Edinburgh, Scotland, FlexMedical specialises in contract manufacturing of disposable components for POC IVD systems. With ISO 13485 certification for the Development and Manufacturing of Medical Devices, FlexMedical is extremely well-equipped for the manufacturing of the Psyros disposable cartridge.
COO insights
Prolight Diagnostics’ COO Karl Bullen commented on the partnership in a press release:
“The partnership is a major step forward in the development of the pilot manufacturing capabilities, utilizing FlexMedical’s existing fully validated facilities and extensive IVD experience. One of the unique selling points of our technology is the simplicity of the disposable cartridge which also enables outsourcing and a very competitive cost of goods from launch.”
BioStock got in touch with Karl to learn more about the disposable cartridge and partnership with FlexMedical.
What were the key factors that led you to select FlexMedical Solutions as contract manufacturing partner for the disposable cartridge in Psyros?
– There were two key factors that gave FlexMedical the edge. Firstly, FlexMedical has extensive experience across a broad spectrum of IVD cartridge manufacturing processes. Prolight needed a CMO partner who could efficiently adopt its unique production processes.
– Secondly, FlexMedical performed strongly during the feasibility phase of the selection process when a small quantity of Psyros sensors were produced at FlexMedical using Prolight’s production process. Through this trial, FlexMedical demonstrated their capability to quickly establish new processes and work collaboratively with the Prolight develoment team.
What are the upcoming development milestones in the partnership between Prolight Diagnostics and FlexMedical Solutions?
– The first major milestone will be for FlexMedical to setup pilot manufacturing processes to enable the supply of cartridges for verification activites in the second half of 2024. These verification activites will lead into the process validation of the manufacturing line at FlexMedical in readiness to supply cartridges for our clinical performance study planned for 2025.
Lastly, could you tell us a bit about how the cartridge works and how it enables low cost of production?
– The Psyros cartridge has been designed to be very simple. Assembled from only four low-cost components, it can easily be produced at scale using high levels of automation. Throughout the entire design process, each component has been carefully selected for manufacturability, with a strong focus on eliminating the need for complex features and assembly processes. The result of this focused effort is a cartridge design that can be efficiently manufactured from a small number of low-cost components.
The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.
