We encourage our awardees to take into account both medical needs and market requirements already at the early-stages of development. This way, they increase their chances of success.
We provide them with the necessary tools and knowledge to make relevant decisions regarding future development and minimize risk.
Here are some of the tools we use:
Market Research studies
We perform and/or buy market research studies to gather information on markets, customers and competitors. By analyzing market needs and competitors we obtain a SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats) and find the competitive advantage of each project we support.
Freedom to operate (FTO)
Freedom to operate definition
An FTO begins with a search of patent literature for issued or pending patents, results in reaching an evaluation on whether the innovation infringes an in-force patent, design or trademark right already belonging to another entity.
By performing freedom to operate analysis we minimize the risk of infringing patents owned by others. If a patent search reveals that there are one or more patents that limit the freedom to operate, the decision may be to:
- Stop the project
- to conclude intellectual property license agreements with third-parties
- Adapt the product/test
Freedom to operate analysis is a must before approaching potential partners and attracting investors (partnering).
Focus group for medical value assessment
By organizing focus group research with physicians we gather information on specifications of tests under development with 3 objectives:
- Have a clear view on current practice
- Identify real medical needs
- Check adequacy of the product profile:
- Product’s use as cancer diagnostic, prognostic and/or predictive tool.
- Level of specificity and sensitivity
- Level of practicability
- Product cost
Focus group for assessment of companion diagnostics
Similar research is also performed with pharmaceutical companies to assess relevance of tests as a companion diagnostic.
Companion diagnostic Definition (www.fda.org):
An IVD companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic.
A companion diagnostic could be essential for the safe and effective use of a corresponding targeted therapy(ies) to:
- Identify patients who are most likely to benefit from it.
- Identify patients likely to be at increased risk of serious adverse reactions as a result of the treatment.
- Monitor response to the treatment (e.g., schedule, dose, discontinuation) to achieve improved safety and/or effectiveness.