Kickstart your way into the IVD world
Thinking about entering the IVD market? Or planning to expand?
Future Diagnostics performs pre-feasibility studies for third parties within the global medical technology and IVD market.
These pre-feasibility studies are performed on different types of raw materials or assays. It can also be done on a variety of technologies and analyzers, both immunologically or molecular based.
Our goal is to estimate development time. We identify (technical) risks, and include a reasonable accurate budget estimation for further development.
Within pre-feasibility studies, a first indication of key raw materials or assay/technology performance is given: “Is something working according to a certain idea?” For instance, we determine if there is anything that needs extra attention during developments. We carry out pre-feasibility studies as minimalistic or comprehensive as requested by a customer. In general, the more extensive a pre-feasibility is done, the less surprises you will find later in the process. This ultimately results in reducing overall project costs.
Let us perform the pre-feasibility studies for you
Is your assay / technology feasible?
Pre-feasibility studies give a rough estimation of specificity, sensitivity, stability, background, what the critical components are, or whether it is basically a good-working assay suitable for the IVD market. In short: a first indication on whether your assay is feasible. What are the (technical) risks and timelines if you decide to move forward to the next step or steps? After all, it can also be seen as a custom-made 'test' project.
Things to keep in mind are: Could there be any issues in the supply chain? Are the raw materials available for the lifetime of the product and is quality guaranteed? Which specifications are minimally required? Are certain specifications easy to reach? Obviously, we do assist companies in getting the right answers to these questions.
Are your key raw materials feasible?
An example of pre-feasibility studies on key raw materials is a bead evaluation project. We have been requested by customers to enter a program on evaluating technologies with specific paramagnetic particles on a certain analyzer. Beads from different vendors were coupled with fixed antibody concentrations and evaluated. We demonstrated the impact of the beads on signal quenching and assess the effect of different wash cycles on different beads by measuring signal output from a model system. This can also be done on antibodies, conjugates or buffers.
After the preliminary experiments are run we always give an advice to our customers. An advice can be whether it is worthwhile to perform additional experiments or if we are ready to proceed to the feasibility phase. The feasibility phase is performed to meet the design requirements and to be compatible with manufacturing requirements. Our assay developers are always pleased to continue with the feasibility phase. But after all, the customer is free to decide if they want to do further development within their own R&D.