Suturion implements best practise for abdominal closure to prevent incisional hernia
| Reference number | |
| Coordinator | Suturion AB |
| Funding from Vinnova | SEK 900 000 |
| Project duration | June 2019 - March 2020 |
| Status | Completed |
| Venture | Innovative Startups |
| Call | Innovative Startups stage 2 - spring 2019 |
Purpose and goal
Suturion sought funding with the overall goal of taking the project with a surgical sewing machine for abdominal closure to the market and developing a strategy for market entry. In the project we have developed a disposable instrument and carried out the necessary regulatory activities to be able to do a usability study with scientific and regulatory data. We have also developed a Goto-market strategy to understand what the strategically important markets are and to identify and mitigate entrance barriers.
Expected results and effects
In the project, we technically and regulatory developed the sewing machine as a single-use product. This allows us to perform necessary technical and usability evaluation of the sewing machine in a realistic model. The data generated by the user study is necessary to seek additional funding and to conduct a clinical pilot study.
Planned approach and implementation
In a project group consisting of two regulatory experts and two engineers, and a project manager, a structured development work has been conducted. The regulatory work has gone hand in hand with the technical and was based on the risk analysisl. Continuous iteration tests have been conducted which resulted in a disposable sewing machine ready for usability testing. An interview-based Gotomarket-strategy was developed in close collaboration with Suturion. The report will be used in communication with financiers.