Hardware/software Development

There should be clear evidence for 'proof of concept' for the proposed technology and the status of development of that technology should be described.  It is expected that  experimental data to support the case for further development has been generated.

Any key data generated in prior studies should be presented.

Product development should enable the product to be clinically evaluated and allow for future scale-up manufacture for market readiness. Small-scale manufacture should provide sufficient numbers of the product to be produced for evaluation.

The project plan should support all aspects of prototyping and manufacturing, engineering and performance testing, clinical evaluation, intellectual property protection, market analysis, business case development, health economic analyses, etc.

Product development may require external expertise and/or specialist services to be added to the team as consultants or sub-contractors. This is acceptable assuming adequate justification is provided.

WPX: Device Development | Months xxx | Cost £xK | Lead: xxx

Aims: To develop and produce a commercial and clinically applicable model of the XXX device, including device hardware and software.

The proof-of-concept prototype device will be developed into a final design for manufacture at pilot scale. The device has already been designed with insight from end-users, and public involvement sessions. Public involvement input will be central to the human-centered design phase of development. Hardware and software development will be compliant with applicable standards and be appropriate for clinical evaluation and validation.

The clinical trial data will develop the design file further to support CE/UKCA marking. Software and communication links will be developed in parallel to support the device and its use in the NHS.

Deliverables
D1 Prototype improvement and development to produce workable hardware
D2 Develop supporting user-friendly software
D3 Device production for the clinical study
D4 Quality assurance assessments of hardware/software

Milestones:
M1 Device developed and evaluated ready for clinical investigation by month xx