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On-demand production of entirely customised minimally invasive medical devices

Periodic Reporting for period 2 - OPENMIND (On-demand production of entirely customised minimally invasive medical devices)

Reporting period: 2017-03-01 to 2018-08-31

With the development of powerful real-time imaging modalities, the sector of minimally invasive surgery has grown massively in the last decades. The easy and reliable navigation of the medical devices used in these environments is one of the key aspects for the success of such an operation. Currently, only a limited spectrum of devices for these interventions is available defined by the medical device manufacturers. The physician has to choose from this available (predefined) product range. However, for a successful outcome of advanced minimally invasive interventions it is essential to fulfil the needs of the physician who has to solve a complex task: navigating and operating in the human vascular system without having a direct view. Each physician has her or his own imagination of the ideal device for a specific intervention regarding handling and visibility. To maximise the ease of use of the medical devices and, thus, to optimise the outcome of the intervention a customised product would be the perfect solution.
Therefore, the OPENMIND project has developed the first highly flexible process chain for the on-demand production of entirely customised minimally invasive medical devices. This process chain closes the gap between efficiently produced standard products and individually designed products, enabling even the production of small batch sizes down to single batches in a continuous, automated and fully monitored process chain. The OPENMIND project is using a guide wire as demonstrator device for showing the successful outcome of the project. The process chain was completed by a comprehensive monitoring and data mining toolset. All relevant process data will be monitored and analysed in order to reduce development times by predicting appropriate parameter sets for the manufacturing of new customised products. Furthermore, the data will be used to realise automated optimisation of the running process.
The contents of the project were spread via the webpage of the project (www.openmind-project.eu) including project news and current activities. Our social media profiles on Twitter and LinkedIn help us to interact with our stakeholders and the general public. An online configurator has been launched (www.configurator-openmind.eu) where the idea of individual medical disposable configuration is shown in an easy to use manner. To transfer the generated knowledge and the vision of the project, several videos were produced and shared. The approach was presented on different trade fares and conferences.
The consortium analysed all involved manufacturing processes and determined the most important influencing parameters for each process. The machine developers performed initial tests with existing manufacturing systems to quantify the contributions of these parameters to the outcome of each process and started to design new manufacturing systems and in-process inspection systems that are capable to process fibre reinforced micro profiles. In parallel, the software developers evaluated different approaches to translate the quantitative results of the tests into a machine learning model as digital representation of the real process. Finally, the whole consortium developed a future proof architecture to link all involved systems such as production hardware, inspection hardware, inspection software, databases and process models.
To link all these different development, an overall control system is developed, which was develop to ensure the transfer of data and parameters between the different hardware parts and the software side of the project. The linking part is the measurement system including an optical system using camera systems to evaluate customizable parameters, like the diameter or the winding angle of the demonstrator.
In summary, the following milestones were reached:
M1 Project Web Portal (intranet) (Nov '15)
M2 Quantified process model after (June '16)
M3 Completely defined interfaces after Month 15 (Nov '16)
M4 Implemented process monitoring methode (March '18)
M5 Implemented similarity algorithm (Aug '18)
M6 Operational hardware modules (March '18)
M7 Implemented overall control interface (Aug '18)
M8 Operational process chain (Aug '18)
M9 Evaluated process chain and demonstrator (Aug '18)
M10 Evaluated RA issues (Sep '18)
M11 OPENMIND business plan (Sep '18)
The OPENMIND project provides the first continuous and fully automated process chain for the on-demand manufacturing of entirely customised medical devices. The direct outcome from the project is a production system that will be able to manufacture endless micro-profiles with individual characteristics in a continuous process. The full implementation of the OPENMIND system is enabling highest possible individualisation in an endless production process and thus close the gap between efficient series production and on-demand customisation. The products (guide wires, catheters, micro-instruments) will be customisable by the end-users themselves and hence will be at the very front of current market developments. The OPENMIND system combines a highly customisable continuous process chain for very cost efficient fully automated production of medical devices with comprehensive data mining functionalities using similarity considerations based on formerly developed processes in order to accelerate process development times significantly. Due to this two-fold approach fast and reliable production of customised parts is guaranteed. In the end, this will give the physician the opportunity to tailor the device to her or his specific needs and will thus maximise the efficiency of minimally invasive surgery.
Thanks to the OPENMIND concept, combining highly flexible processes and intelligent data mining functionality, new perspectives for personalised medical devices will open. Improvements are expected in terms of reduction of lead-times for manufacturing of custom made parts (by 50%) due to continuous manufacturing, as well as reduction of process development time (by 50%) and costs (by 20%) due to data mining assisted parametrisation resulting in a reduced time to market (by 30%).
The development of new compatible devices and advancements in the MRI technology will be the next revolution in the field of minimally invasive surgery and will lead to completely new procedures grouped under the term interventional MRI (iMRI). The demonstrator devices of the OPENMIND project will be manufactured without any macroscopic metallic components and thus will be inherently MRI-safe. Therefore, they fully comply with the requirements of future iMRI procedures. This will perfectly fit into the upcoming trend of combining MRI and CT settings to new and powerful multi-modal imaging suites.
Due to the fact, that cardiovascular diseases (CVD) are the leading cause of death in the EU, this will have a strong social impact: regardless of the direct health care costs, the productivity loss due to CVD adds up to over 45 billion € per year only in Europe. With the help of customised minimally invasive medical devices physicians will be able to maximise the outcome of modern keyhole surgery reducing the time for recovery and the risk of medical complications. The added value of the project is that Openmind will develop a flexible technology, metal free, compatibility with diagnostic images, transforming MRI from a sophisticated diagnostic technology to a powerful therapeutic tool.
Ambition and approach of the Openmind project
Software architecture and data cycle
Stages of process model development