Managing risks through Proof of Concept

At Camgenium, we have a risk driven approach to projects.   At the Proof of Concept stage, we identify  the potential problems, or hazards, that could prevent your product coming to market and characterise the risks related to them, not least the risks of not understanding user and patient needs properly.   We record the risks that your device could present to patients, clinicians or other stakeholders and any other risks such as commercial risks and the many data security risks due to today’s complex socio-technical environments.   These are particularly important as so many devices are now intended for home use and detailed understanding of human factors is critical. 

The product requirements document will be worked on during this phase, and the results of risk investigation will inform this document

Fortunately, many technical, data security and compliance risks, can be removed simply by developing and deploying on the Camgenium platform.   We rank the remaining risks that can’t be easily addressed by the level of impact they could have on the project.

The main purpose of the Proof of Concept stage is to address the serious risks that could sabotage your product. 

Using the Camgenium ultra-rapid development platform, we quickly produce test cells that allow each risk to be fully investigated. 

A test cell might be a data capture and logging module that allows your novel sensor to be fully characterised, tested for accuracy, precision and repeatability, and then verified.   Because the Camgenium platform is fully auditable, all the data captured through this process are automatically signed, time and date stamped in accordance with regulated requirements.  They can also be annotated using the built-in notebook.   These efficacy data are extremely valuable, particularly as the technology used to capture them will then be used in the actual product if it is built using the Camgenium platform. 

Aspects of the user interface can be built into branded test cells to which we can add questionnaires.  This lets you gain valuable end-user feedback at an early stage of the project, and at a point where learning can be easily accommodated without forcing major rework.  Moreover, the Camgenium platform has a unique feature that allows all end-user actions to be tracked, thus providing highly sophisticated and nuanced data about how people interact with the interface.    As the Camgenium platform meets full data privacy requirements, medical device regulations and Good Clinical Practice  globally, any data captured can be submitted with the technical file for device certification.

Your product may need to be able to communicate with healthcare systems.  Camgenium systems have all the required features to be trusted by third-party healthcare systems and they meet governance requirements.  However the ability to communicate cannot be assumed as it may, for example, require cooperation from an IT supplier who proves obstructive.   So, if interoperability is required, we will produce a test cell to interface with the healthcare system and evidence data transfer.   Interoperability is an issue that has defeated many novel products, often when the rest of the development is complete, and often for reasons that are not technical.  So, by bringing this problem to the start of the project, the time available to resolve it is maximised, and any necessary constraints are known early and can be worked around.

Everything we do for Proof of Concept meets global regulatory requirements for medical device development, data security and privacy and all data captured at this stage has value in supporting applications for device regulation and certification.

So, by the end of this stage, all the major risks that could block the project will have been addressed.  Sometimes the outcome of an investigation proves to be a major block to the project, such as data showing that a sensor that works in vitro simply fails to perform in vivo.   But if there are no major blocks, then it will be possible to plan the rest of the project with reasonably certainty for both time and budget.  And if there are major blocks, it must be better to know at this stage of the project.

Once the critical risks have been investigated and overcome, any work undertaken as part of Proof of Concept models can be taken forward to be built into prototypes on the Camgenium platform.