The first end-to-end version of your product
Camgenium’s platform rapidly creates prototypes to full medical device standards, allowing a wide range of commercial and product / clinical trial activities to start during this phase.
Perhaps you have a vision for a completely novel software or hardware medical device or in-vitro diagnostic (IVD), or you want to create an enhancement of an existing device. Your idea could stem from a clinician’s observation of a gap in patient care, an engineer’s or scientist’s breakthrough innovation, or collaboration between interdisciplinary teams.
Once sufficient risk analysis and investigation has been done, the first full product requirements document can be finalised. At Camgenium we treat this as the point when work can start on prototypes. Work on the requirements will normally start during Proof of Concept, or earlier, and it will have been refined using information from risk analyses.
It is critical that the requirements clearly state both the clinical needs and the intended use. The intended use must define the healthcare setting, for example use by a patient at home or by a trained professional in an intensive care unit, and the condition and criticality of the application. These factors inform the class of the medical device or IVD and the accessibility requirements, which, in turn, inform the choice of development patterns.
Regulatory, legal and health service requirements often drive layers of complexity that do not create competitive edge but sink limited resources and can greatly delay delivery of the prototype. The temptation is to produce a prototype without adhering to medical device standards to arrive at the end point quickly. But the result is very limited, it cannot be used for clinical trial, and it is often necessary to start again when developing the compliant production prototype.
The prototype is a tangible model, or sequence of models, that embody the design and function of the device. Iterations allow engineers to identify design flaws, technical challenges and then refine concepts.
The Camgenium platform allows multiple prototypes to be created rapidly, either simultaneously or in quick succession. As each one is built to standards, they can be used to generate aspects of product trial and clinical trial data in parallel with other development processes, thus reducing the time taken required for trial at the end of development.
Our platform has been built to standards and has a wide range of functionality that is common to many devices that you can instantly use in your product. What is the point in redeveloping functionality that does not provide your product with a competitive edge? It also has a rapid designer to create richly featured, sophisticated and versatile websites and apps. These web sites and apps will automatically run in all common browsers as well as iOS and Android devices.
The Soft Silicon technology that connects physical devices to the internet provides exceptional, world-class functionality with high security.
Moreover, using the platform eliminates many project risks that could derail your development schedule and resource budget. And example could be a major upgrade to iOS that changes how a core function operates that is required by your product. It is our job to keep the platform up to date and to ensure that it remains functional and fully maintained at all times. And it automatically creates an audit trail of all changes to websites and apps.
And a final key part of developing prototypes is to develop test cases that tie into the product requirements. We produce both manual test cases and automated test routines that can be used for regression testing of each subsequent version of the product.
