Proving your product concept will work
Proofs of concept verify that the basic principles of the device are feasible and that its business case is sound. They are also the first opportunity to capture data that evidence efficacy and support applications for certification.
Perhaps you have a vision for a completely novel software or hardware medical device, 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.
Our patient-centric project strategy
At Camgenium, we have a patient / user centric approach.
Putting the patient at the centre of the project ensures that we deliver products that can deliver the benefits that are its reasons to exist. They are safe, meet requirements, improve patients' lives, and work with patients' and users' needs, limitations and preferences.
We achieve this through a risk-driven approach. This ensures safety, regulatory compliance, and by also identifying the opportunities for excellent results (the positive side of risks) we have a framework for achieving true, world-leading innovation.
At Proof of Concept stage, we identify these risks, from technical to patient usability and commercial issues, in particular the hazards that could prevent your product getting to market, and we characterise these risks.
Fortunately, many technical, data security, compliance & commercial risks can be removed simply by developing and deploying on the Camgenium platform.
Dr Olga Zadvorna
Applications Manager
We use proofs of concept to characterise all the risks and identify what excellent looks like, in the eyes of the patient, clinically, operationally and from the regulatory perspective.
Risks could include:
- Functional risks (for example whether a sensor will perform in real-world use)
- Not fully understanding clinical and patient user needs
- The possibility of causing harm to users or patients
- Data security risks
- Commercial risks
- Interoperability risks
All our work meets global regulatory requirements for medical device development, data privacy and Good Clinical Practice.
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.
By the end of the Proof of Concept stage, most if not all of the major risks that could block a project will have been addressed.
James Belcher
Quality Manager