Interreg Baltic Sea Region - European Regional Development Fund

BIC review tool and flowchart

Designed to improve communication

The Biomarker Commercialization BIC Review Tool is a comprehensive checklist for selection of the most promising invention for further commercialization of IVD-applicable biomarkers.

The BIC Review Tool allows an “inventors interview”-type of approach, in addition to being a checklist for Technology Transfer Offices (TTO) and Researchers. The tool provides a fill-in form for following the progress of a project and fluently discussing the next steps and main decision gates with the TTO. Similarly to the other BiC Tools, the contents are aligned with the phases and TRL’s along the IVD-applicable biomarker development project. It is designed to improve communication between the stakeholders involved in the commercialization process and to facilitate collaboration.

The Flowchart provides a simplified overview of the entire process from discovery to market maturity.

Three central aspects are always highlighted:

  • Does the invention address a real clinical need?
  • Is it commercially viable to develop the invention further?
  • Is it feasible - including economic, technical, legal and scheduling considerations - to address this need?

Feasibility, clinical need, market size

Be aware of 3 central questions!

In any applications of biomarkers, the clinical benefit and the analytical and diagnostic accuracy of the biomarker are crucial to enable efficient translation from the discovery to the use in the real-life settings.

From a commercialization perspective, successful IP protection, competitiveness with existing or alternative solutions, as well as fluent interaction and collaboration between the academia, industry and end users form the other three cornerstones of successful biomarker commercialization.

When commercializing an invention, 3 central questions should always be answered positively:

  • Does your invention address a clinical need?
  • Is it technically feasible to address this need?
  • Is the market large or the demand high enough for your invention?

Remember, commercialization is the aim. IP, regulatory and technical features of the product are all meant to serve the goal of creating a commercially viable product. Patents, regulatory certifications, and tech features are a business tool to help you build a business.