Last, but by no means least, are the constraints related to technical feasibility, which in most cases mean constraints bounded by the laws of physics. With this in mind, it is no surprise that technical constraints can be expensive and time consuming to overcome in MedTech product design, and in some cases the laws of physics can be showstoppers.
When taking a harmonious approach to competing constraints, it can sometimes be more viable for technical constraints to be overcome by easing back on desirability and adopting a technical development ethos where form follows function. For example, in the case of miniaturising technologies, such as in the growing area of wearable devices, it can sometimes be that a small compromise in size or shape can significantly reduce your technical development risks related to thermal and power management. Nevertheless, when a client has the appetite and budget to take on technical risk, then some truly disruptive and inspirational products can emerge from an unconstrained quest for visionary form. In the case of LumiraDx, a client who set out to change the landscape of diagnostic testing by bringing laboratory level sensing to a point of care environment, the visionary output received high praise from Bill Gates, who said: “This diagnostic, the LumiraDx, is amazing. An innovation cheaper and smaller than the diagnostic devices that came before”.
At Team, we address technical feasibility from the outset. We create early-stage concepts and ensure that their selection and evolution is based on engineering judgements already focused on likelihood of success and the need for smooth transition to production. We use cutting edge prototyping techniques to review performance quickly and effectively, alongside utilising a wide range of analysis and modelling tools to challenge and build confidence in the technical feasibility of a design approach.
In all cases, we are seeking the most balanced approach to achieve effective results, at the appropriate resolution, in the most efficient manner. In some cases, for example with haemostat devices, where complex powder flow characteristics are in play, we may lean more towards rapid build/test/iterate loops than detailed analysis, because the analysis will be too complex and time consuming. The key for all developments, however, is to balance the use of empirical and analytical methods as appropriate.
It is also important to consider constraints related to manufacture. At Team, we advocate working closely with manufacturing partners as early as possible, in order to ensure that product designs are fully capable and realisable from fully validated processes. The key is to utilise tools and techniques such as Process FMEA and process mapping to identify critical failures as early as possible in the development process and to mitigate those failures before they occur.