Kishen Gohil

Consultant design manager for a start-up medical/ diagnostics company in Bedford. This was through experience with developing key diagnostic devices including Persona and Clearblue One Step in the 90’s and early 2K for Unipath who then evolved to Alere International.

The past two years I have been involved with a complete turn-key involvement program for a innovative fertility diagnostic device to be launched in mainland China completing the following:

- Initial evaluation of requirements needed for the system and device with internal lab specialists.
- Producing design concepts for how the system could work for the disposable test and Meter that reads these.
- Taking these comments and then producing CAD based technical designs to focus assembly logic as practical design strategy forward.
- Taking CAD data produced and producing test prototypes for clinical evaluation/ certification from CFDA, and regulatory compliance/ 13485.
- Liaison with manufacturing partners in EU and China to take the above to volume manufacture.
- Providing cost estimates for above.
- Evolving Brand Graphics (Have achieved global registration for these).
- Packaging design work to house the system when launched.
- App UI strategy/ graphics and help on design logic of how test results are displayed via Android and OX platforms.
- Implementing all design criteria into database with internal client team as this company was a start-up and did not have this in place.