Over the last 4 months of the Feasibility study we have assessed the technical, commercial and financial viability of BRI.SCREW project. The work done and the results found are summarized below:
- Technical Feasibility: i) Design the alloying and extrusion process: we have optimized the process to stimulate the formation of only favorable intermetallic particles and decrease magnesium corrosion. We have optimized the final composition of the alloy to tailor the degradation rate of the implant, reaching an excellent ratio of Mg, Ca and Zn for slow degradation, ii) Determine the functional properties of the implant: we have defined the properties that BRI.SCREW should present for supporting excellent bone healing in humans, especially in children, and how to achieve those characteristics during production and manufacturing and finally, iii) Define the protocol of a randomized multi-center clinical trial: we have designed a multi-centre clinical trial to validate the superiority of BRI.SCREW compared with titanium implants in fractures in children.
- Commercial Viability: i) Explore the possibilities to get certification needed for commercialization of health care products: we have confirmed the ISO13485 and CE marking needed for medical devices and we have updated our plan accordingly, ii) Search for providers of ultra-pure magnesium and extrusion process, manufactures and providers for cleaning, sterilizing and packaging: we have identified several companies for these actions, and iii) Identify international distributors: we have obtained interest of collaboration from Hofer Medical, distributor of medical devices in Austria and Germany, our first target markets.
- Financial feasibility and Business plan: i) Validate financial and growth strategy, and business model: we have confirmed the cost and price of BRI.SCREW and prepare a 5 years financial forecast to assess the profitability of the project. We have also updated our exploitation and promotion strategy to be able to reach that financial forecast, ii) Competitors, barriers and opportunities analysis: we have updated our main competitors (both for non degradable and degradable implants) and studied the barriers and opportunities for our company using tools like the Porter analysis and SWOT analysis, iii) Target markets and in-depth market study: we have conducted an in-depth analysis of the trauma, orthopedic and osteosynthesis markets, where BRI.SCREW will be introduced. We have quantified the market and calculated the impact of our product: up to €600 million on second surgeries could be saved in osteosynthesis treatments using BRI.SCREW. We have also studied the trends, segments and drivers of the market in order to update our business plan, and the barriers and restrains of the market to update our management plan.
- Establish alliances: i) Determine the need of a partner: we have studied the possibility of partnering with another SME to carry out BRI.SCREW project and concluded that BRI.TECH team hold the necessary experience and knowledge to successfully complete the entire Phase 2 of BRI.SCREW.
- Risk assessment, contingency plan and IPR protection: i) Identify risks and develop a contingency plan: we have identified technical and operation risks that could affect the completion of the project, and drafted the corresponding mitigation plan, and ii) IPR protection: we have defined the IPR landscape for BRI.TECH and performed a FTO to secure our right for commercialization. BRI.SCREW is well protected by two patents and is not in conflict with other existing IP.
