Working for 15 years in healthcare, West understands the lack of real hospital contact by R&D personnel of many multinationals. Further, clinical research and co-design often lacks an understanding of downstream needs. This research aims to span this divide, using inclusive design techniques across all stakeholders.

Evidence of errors in setting infusion rates is common. Innovations addressing these errors (e.g. US4136692) date back decades, but resulted in more expensive products which failed commercially. Research with healthcare procurement showed the need for cost equivalence with current ‘drips’. This design constraint led to the central innovation: the avoidance of drip formation using a U-bend, giving reliability without need for precision manufacturing, and achievable with regular manufacturing techniques.

The design relies on basic physics principles; however, at low flow rates these do not accurately describe fluid behaviour; first prototypes were unreliable. Rapid prototyping and bench testing of over 100 designs led to an understanding of the problem of drop formation. Avoiding drops in flow led to a reliable design, which was tested: twelve infusions (one litre infused over twelve hours) were recorded against a control (standard ‘drip’); the results showed an improved fidelity to the set rate.

The design makes it easier for clinical staff to set up and alter infusion rates. This has merit in low resource settings where pumps are not viable. Setup time was tested with twelve clinical staff, compared with a control; the results showed significant time savings.

Research into regulatory requirements led to design improvements (adding drops later in flow), and the components were refined with manufacturers.

Leading figures in the industry have confirmed that the innovation has commercial merit: two multinationals have tabled offers; initial licensing terms are agreed. Independent research by potential licensees within their procurement networks confirms that there is a desire for the Flomark.