Ridgeway develops point-of-care assays for use outside the laboratory — in a clinic, a pharmacy, or a community setting where there is no cold chain and no technician.
Their founding team included someone who had previously taken a device most of the way to market and watched it fail on reprocessing. The consequence is a company that is unusually disciplined about the boring parts: the risk file was opened in the first month, the quality system followed shortly after, and the usability work was done while changes were still cheap.
The technical work is in assay stability and in reader design for environments that are warm, dusty and operated by people with other things to do. Neither problem is glamorous. Both determine whether the product is usable where it is needed.
They are open about being pre-revenue and about the length of the regulatory road ahead. What they will not do is describe a pilot as adoption, which makes them easier to work with than some better-funded neighbours.
Capabilities
- Point-of-care assay development
- Reader instrumentation for non-laboratory settings
- Design for single-use consumables
- Quality management system operation to ISO 13485
- Usability and human factors evidence
- Assay stability under uncontrolled storage
Ways in
The routes that exist, and what each is suited to.
Published work packages
Usability studies, bench validation and clinical feasibility work put to the network, where an accredited laboratory or clinical partner is required.
Clinical evaluation partnerships
Collaborations with clinical research groups for formative and early feasibility studies under an approved protocol.
Manufacturing development
Work with manufacturers on consumable production at volumes that do not yet justify dedicated tooling.
How to approach them
They approach partners with a protocol outline rather than an ambition, and appreciate the same in return. Applications that demonstrate familiarity with device evidence requirements are read first.
They will share negative validation data with partners under agreement, which is not universal in this sector and makes the collaboration considerably more useful.
Known for
- An assay platform validated on bench against a recognised comparator method
- A formative usability programme that produced three design changes before tooling
- A reprocessing analysis that redirected the product to a single-use consumable architecture