Among the very common problems faced by product developers (especially the ones in the Lansdowne VA health care sector) is having an understanding of the exact pediatric diagnostics that are required in the marketplace and the contexts in which they are supposed to be utilized. For certain types of pediatric diagnostics, inclusive of EID which comes in handy at the POC (point-of-care), clear and detailed Target Product Profiles are availed for the purposes of providing necessary guidance. However, even with the availability of this kind of guidance, it has been established that the market for a particular examination may either go down or up as a result of adjustments in guidelines alongside several other variables. For instance, because of the new World Health Organization’s direction regarding the viral load test for observing individuals on ART back in 2013, the country has witnessed a drop in the market for CD4 tests. The immediate outcome has been recognized as the inability of certain point-of-care examinations reaching the marketplace due to little or no funding at all.
The moment a product developer in Lansdowne VA has targeted a test to develop, the immediate drawbacks usually are inclusive of technology concerns, i.e. inadequacy of the performance of the assay. It is said that in the worst case scenario, it may force the product developer to return to the drawing board with the agenda of redesigning the product, a process that may take an extended period of time in the timeline. Besides, experts point out that funding is regularly a drawback that comes early in the process of product development and has the potential of slowing down the whole procedure. Mobilization of financing for pediatric diagnostic products that are specially crafted for the advancing world seems to be relatively problematic owing to the fact that return on investment on the product is anticipated to be very low.
Upon overcoming the technology and monetary challenges and proving the concept or developing the prototype, the product developer can proceed to refining and targeting the usage of the product on the basis of the outcomes of initial assessments, a process known as pre-market validation. Upon completion of all these processes, it is paramount that every pediatric diagnostic undergoes assessment in the laboratory with the purpose of evaluating their analytical capabilities in comparison to references tests. The developers are also supposed to look for regulatory endorsements for the tests, including pre-qualification.