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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - BSPA (Bone Surgery Preparation AIde)

Teaser

Summary

Planning for trauma surgery is complex. Bone segmentation allows the creation of a quantitative 3D model from a computed tomography (CT) scan (Q3DCT). Use of Q3DCT has proven repeatedly to reduce surgery and recovery time, and improve functional outcome, and cost efficiency. Q3DCT is better for the >5.0 million relevant patients globally per year, their surgical team, hospital
and insurance companies.

Currently, the process to transform a normal CT scan into an accurate Q3DCT for planning and measurements is extensive. As mathematical models fall short in their accuracy by several millimetres at least, it takes several hours to manually annotate the border of the bone in all the slides of the scan. In addition, several expensive non-linked software tools are needed. The current solution is costly (>â‚¬1,000), requires manual labour, and costs hours of time (>2.5h), which makes 3DCT useless in practical and especially in high-turnover settings. This means that this type of preparation is rarely
done. As accurate measurements are not done beforehand, extensive trauma surgical kits need to be present that are consigned and returned almost unused to device manufacturer, which adds to the cost of all
parties. Surgeonsâ€™ desire is to prepare with Q3DCT but current time and financial limitations withhold them.

The overall objective is to offer a digital planning service (SAAIS) that takes minutes, is fun to work with and is highly accurate. As this type of planning is normally outsourced and limited to complex surgery, we democratise virtual and 3D based planning and peer-to-peer communication and open it up to become the standard for all patients and surgeons.The objective for this project was to further study the commercial and legal framework for marketing of our Bone Surgery Preparation AIde Tool, extend and intensify our network of partners (corporate and clinical) and investigate IPR options, for Europe and with specific focus on the UK, Germany and Spain.

Work performed

For this project we covered the following topics with interviews and the results can be found in the report;
- Market analysis with end-users, stakeholders (patient organizations, insurance companies, radiologists), 3D printing companies, prostehtic deviec makers and PACS vendors
- Assessment of competition and future developments
- Partnership options with orthopedic device makers
- Market access
- Academic and research topics
- IPR challenges and regulatory path
- Acquisition of more data and annotations

Final results

Based on our findings we have devised a strategy to go to market. We have pivoted from orthopedic to more complex bone surgery (predominantly trauma surgery);
- Democratise the Q3DCT preparation of trauma and other complex bone related surgery to be done by the physician quickly, immediately, accurately
- To provide a platform to share best practices and learnings with peers and students
- To improve the

The (socio-economic) impact of this will be (and this remains to be proven largely through clinical and economic validation trials);
- Reduced cost of materials (35% of current cost is related to the supply chain) by introducing JIT to trauma surgery
- Improved outcome, recovery time, throughput and cost efficiency by allowing Q3DCT preparation in bone related surgery
- Closed loop improvement cycle with introduction of best practices exchange platform