Development of a prototype of a new bone cement for osteoporotic patients and its business model
|Funding from Vinnova||SEK 300 000|
|Project duration||October 2017 - March 2018|
Purpose and goal
The purpose of the project was to develop a product prototype and to develop a business model for commercialization of a new, softer, bone cement that is more adapted to osteoporotic bone. We have met both targets and today we have a sterile product that meets the regulatory requirements for sterilization and labeling to get the CE-mark which enables sales within the EU. We have also developed a business model for how to commercialize and sell our additive, which makes existing bone cements softer and better suited for osteoporotic bone.
Expected results and effects
We have developed a product prototype and the next step is to perform a sharp production for the use in stability studies and final quality validation of the product and the methods we will use in the future for quality control of the product (QC). We have developed a license agreement with our first customer / partner and expect to have it signed before the summer. It will ensure continued funding and that our partner takes responsability and manage the regulatory process to CE-mark the product.
Planned approach and implementation
The project was performed in two work packages, pilot production and business model development. Pilot Production: We investigated and found a vial that minimizes the risk of mistake at the moment of mixing. It also makes it possible to homogeneously mix the additive with the cement. A successful sterilization of the additive in the new vial was conducted and it was ensured that it meets the quality requirements imposed on packages for sale in the EU. Business Model: We did a market analysis, validated a high demand for our product and developed a license agreement with our first customer.