Summary
The requirements for safety and analytical performance change significantly from one medical area of application to the next. Testing guidelines and protocols tend to be tailored specifically for each medical area. Developers need to stay up-to-date with the medical and technical advances and regulations that apply to the specific area of application for which the medical device is intended. Developers also need to give ample considerations to important biological and analytical aspects when designing the various components of a quantitative medical device. These aspects include sample matrix, interfering endogenous and exogenous substances and the robustness of system calibration. It is also critical that target performance goals be realistic and compatible with the chemistry, physics and engineering of the medical device being developed.
While the size of the potential market and revenues deserve due consideration, investors need to realize that time-to-market is one of the most critical considerations. Because competition and regulations do not stand still, new technologies do not stay dominant forever. It is therefore important for investors to select technologies that maintain superiority over the competition when development is complete. A common mistake is to invest in a technology that is very competitive at the start of development, but loses its advantages by the time the device is ready for the market.
Ultimately a quantitative medical device is judged based on its performance and analytical capabilities. Allowable total error plots and the frequency of obtaining results in the erroneous zones are simple and effective ways to evaluate and monitor the readiness of a new device. A successful quantitative medical device is one that provides a result that the treating physicians, and/or the patients, understand and can act on it.