At Centivis we have the privilege to serve global, specialized, and start-up diagnostics developers. Depending on the size and maturity of the businesses, unique access challenges arise. We are thrilled to support start-ups / scale-ups since they are the engine of innovation in the field.
Start-up dx developers in general are:
very focused
cash conscious
and thrive to reach the next development milestone and investment round
On the flipside though short-term thinking prevails over the longer-term potential of their precious solution. Companies, especially the ones developing both instruments and assays tend to focus more on the technological aspects of their instrument and less on fulfilling an unmet medical need with their tests.
Closer to launch they realize that the test(s) running on the platform:
has already numerous well established, competitive solutions
generally reimbursed on a price that does not necessarily make their business case viable
intended use is not really thought through or addresses the wrong unmet need
There is no silver bullet for these problems, but reflecting on a few key topics early in the development process can help a lot:
Does that company target laboratory professionals and rather optimize for the technical benefits of the instrument OR aim to serve physicians and patients with better tests in screening, diagnosis, prediction, or monitoring various diseases? In an ideal world, both would be the best but given the start-up limitations mentioned above, usually one is feasible.
If it is the latter and the focus is on fulfilling an unmet medical need:
develop intended use, target test profile scenarios early on
assess where the new test fits in the diagnostics pathway (e.g., replaces current solution, improves triage or add-on)
reflect if the test is applicable in inpatient, outpatient, or home use and who the ultimate target user is
there is hardly any launch in the “vacuum” as such understand competitive solutions, the standard of care
define value proposition accordingly and work on a compelling evidence package to convince physicians and payers
These points might look scary, time and resource-intensive, but luckily, they can be tackled iteratively and with internal capabilities. The earlier the start-ups address those questions the better the business plan and product development approach can be adjusted.
Since every organization is unique, these points are rather general reflections. Individual company assessment helps to identify specific access challenges and recommend tailor-made solutions.
Should you have time in your summer vacation, read more about the dx access topic here or schedule a short call