Case Study 2 : Prototype to Manufacture

Coherent design specification

How to Finish Prototyping and Get to Market

Challenge :  It sometimes happens that a good idea comes out of left-field. Not a designated project, but a side spin .... an idea that keeps growing until someone thinks it's good enough to become a product. This was the history of a hospital diagnostic machine which we were asked to get involved with. It had been well constructed but without a full design pedigree, and little regard for ISO 13485 processes or IEC 60601-1 regulations. We were specifically asked to look at a large piece of electronic and mechanic hardware. Of course, there was no formal project plan, no real R&D assigned budget, and a team which was multi-tasking on other projects.

Approach : The first thing to think about when bringing a new product to market is - is there a market to bring it to? We performed an analysis of the competition - drew up a table of performance specifications, and identified what would be required to deliver USPs. From this we could establish critical specifications, based on certain functional and performance criteria crucial to marketing the product.

The end result :  UDA delivered a coherent design specification based on market / clinical performance requirements. The company benefitted from this both in terms of moving the prototype forwards, but also for the product lifecycle. It enabled them to rapidly achieve a second generation prototype through engagement with a third party, large-scale electro-mechanical prototyping facility provider. We then evaluated the new prototype against the new specifications, moving it successfully to full product viability.