WP1: Project management
Our first WP was dedicated to three main topics:
-Project management (stricto sensu)
-Risk management
-And IP management
As a result, one of our main activities in this WP was the consolidation of our project implementation team. This allowed us to better separate and attribute roles to specific teams as it refers to the implementation of our project. We prioritised different activities and assigned goals and deadlines to our technical teams that would be overseen by the executive. We strengthened R&D and support teams - from 23 FTEs to 41 FTEs - and welcomed transformative talents -including VP Quality & Regulatory, VP Marketing, Program Manager, Clinical Manager and Lead System Engineer - who all have a solid experience in bringing medical devices to market.
This also allowed us to improve our project overview strategy with regular meetings at both levels, allowing for better oversight, constant communication which better enabled us to foresee and find solutions for any difficulties that our technical teams could face. This was done both at the technical and the management level.
Finally, we also took the time to focus on the tools that would be best suited to assist in the storage and sharing of information internally. A new tool was selected and implemented, and this also trickled down to project management software that we have integrated into our workflow. We selected new tools & implemented new processes to improve information sharing, project management, talent management and quality management - all within an agile approach.
As it relates to risk management, this is an integral part of our business strategy. As such, analyses are currently ongoing and will be updated regularly as the project moves forward.
With a project as innovative as ours, the protection of the intellectual property generated throughout the implementation of our project is of utmost importance. The aim here is to build a large and internationally defensible IP portfolio to protect our innovation in a highly competitive landscape and as a basis for the value of the company. As a result, several patents have been requested both in Europe and abroad and other requests are currently being prepared.
WP3: Design Finalization
Work Package 3 as one of our technical work packages, was focussed on the finalisation of our design in three different aspects:
-Hardware
-Software
-Ancillaries and Ergonomics
Over the period, we finalized the robot development, specified design inputs, ran key prequal tests and entered a phase of Verification & Validation. We gathered extensive feedback from the market (demo, cad lab and VOC) that confirmed our appeal and differentiation. We also developed and shared a vision for a staged market approach and a clear R&D roadmap.
From a hardware perspective, after succeeding with our proof of concept, we are now in the last phase of finalising the development of our robot. In this perspective, we’ve also validated a number of major milestones.
From a software perspective, following on from the proof of concept, this allowed us to pursue the development and industrialisation of our software. One notable milestone was the closing of our clinical trial on 91 patients. This was also another major step in the development of our solution as it allowed to validate the performance of our algorithms in the real-life conditions of an operating room.
On the third point as it relates to ancillaries and ergonomics, significant progress has been made. The focus is currently on developing all necessary ancillaries to propose a fully functional, stand-alone product.
WP4: Verification and testing
Work package 4 is focussed on testing and verification and this was done to fully test all components of our solution.
The objective of the verification and testing phase is to demonstrate that the device meets performance specifications, normative specifications and also risk control measurement specifications. These activities involved the development of test protocols and the performance of tests, including tests in a representative environment on an anatomical body part (12 Cadaver Labs had been performed at the end of 2023)
These included notably, the successful completion of our non-interventional “Valalgon” clinical trial which is a single-centre clinical trial aimed at collecting data on patients undergoing routine total knee arthroplasty (TKA) in order to test our algorithms on real data (authorisation was first received in May 2021). From then, a total of 91 patients were included in our trial with the last operation being performed in July 2022.
