CASE STUDIES
Retinal Imaging Densitometer
Network & Market Positioning
User Centred Design
Value Proposition Development
In partnership with the UK Astronomy Technology Centre, Prof Tom Margrain’s Macular Research Group at Cardiff University has developed a new technique called high fidelity Imaging Retinal Densitometry (IRD) that probes the functional integrity of the outer retinal complex. This unique device will deliver a paradigm shift in understanding the role of retinal function in health and disease. Together with more conventional technologies they are currently using IRD in a clinical trial of a new therapeutic compound for age-related macular degeneration.
Headquarters
Wales
Founded
2018
Services
Commercialisation, clinical trials.
Sector
Medical devices, macular degeneration
The Challenge
The IRD project had secured a number of high-profile research grants and translational awards and had been developed through proof of concept and several iterations of prototyping into a fully fit-for-purpose advanced prototype instrument. The project used imaging technology from the space industry applied to creating functional maps of the health of the RPE. The challenge was to explore the commercial potential of the device and plan a route to market initially as a research tool and extrapolate into a mass-market technology for the very early detection and subsequent progression monitoring of disease and interventions in macular degeneration.
The Process
The Crucible team worked closely with Prof Margrain at Cardiff and his collaborators at the UK Astronomy Technology Centre in Edinburgh. We carried out a gap analysis across various aspects of product realisation, manufacturing, validation, compliance, and commercialisation. We identified key assumptions and developed a value proposition to challenge and validate. We identified potential partners, customers, and collaborators and we set up and participated in interviews and discussions with them to test our value proposition and validate critical project assumptions. We advised the project team on securing investment and on positioning the technology on the market in the context of therapeutic developments in the field and in the relationship between patient-reported outcome measures in drug trials, and the validation and use of technology as exploratory and surrogate outcome measures.
The team was also instrumental in preparing the document pack and application to MHRA for the IRD technology to be used in a drug trial and validated alongside conventional outcome measures for its utility in monitoring the progression of age-related macular degeneration. The documentation was particularly extensive because the IRD was not at the time CE or UKCA certificated and as a class 2 device it was necessary to provide a complete technical and quality management pack. In addition to our involvement in preparing the application, we also drafted three rounds of responses to and advised the project principals on queries from MHRA.
The Outcome
The IRD device is now in clinical trials and as therapeutic interventions for AMD come onto the market, the value proposition, cost, and potential utility of the device will converge. Currently, it is an invaluable research tool. As the AMD field progresses to early pre-symptomatic detection of AMD-associated changes in the context of available therapies, the IRD is positioned to be a mass-market ophthalmic technology allowing sophisticated pre-symptomatic detection and treatment of AMD. It is likely to sit alongside OCT in the optometry clinic in the near future.
Pathway
Will people but it?
How can I gain
an advantage?
“Peter and his colleagues had an excellent grasp of the IRD technology, its value and its potential in the detection and management of AMD. They did a great job and their contribution to the commercial development of the project and preparing for the trial was invaluable”
