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A pilot line for the next generation of smart catheters and implants

Periodic Reporting for period 3 - POSITION-II (A pilot line for the next generation of smart catheters and implants)

Reporting period: 2020-06-01 to 2021-09-30

About 10% of the western population will at a certain stage in their life be taken to a Cathlab for angioplasty surgery (stent placement), treatment of an arrhythmia or a heart valve replacement. Fortunately, most of these interventions can be carried out using minimally invasive procedures that are assisted by a host of smart imaging and sensing catheters that are the “eyes and ears” of the surgeon directly at the point of intervention.
Essential and lifesaving as these smart instruments are, they are without exception manufactured using outdated and obsolete technology. Surprisingly, over the past decade there has been little to no innovation, while clinicians are asking for instruments with better functionality that are smaller, cheaper and easier to use. The main reason for the lack of innovation is that these instruments are manufactured using technological point solutions, which on their own do not generate enough production volume to justify continuous innovation.
It is the ambition of the POSITION-II project to realize a breakthrough in this impasse situation by the introduction of open technology platforms for miniaturization, in-tip AD conversion, wireless communication, MEMS transducer technology and encapsulation. These platforms are open to multiple users and for multiple applications. The availability of these open platforms will allow manufacturers to improve the performance of smart catheters at a lower cost. Additionally, it will enable the development of completely new smart minimally invasive instruments. The platform approach will generate the production volume needed for a sustainable innovation that is guided by roadmaps.
The production activities will be centered around the (pilot) manufacturing facility realized in the ECSEL “InForMed” project in Eindhoven in the center of Europe. In the “InForMed” project, this pilot line is linked to key European partners that provide advanced materials, integration, and assembly services. It is the explicit ambition of the project to break the US monopoly in the development and production of smart catheters and position Europe as primary innovator and manufacturer in this economically and socially relevant market.
In the first year of the project, essential steps have been made detailing the work and defining roles and intermediate deliverables and milestones: all of the demonstrator and work package teams had a very good start and are on schedule with the execution of the plans. First experimental results have become available and most results prove to be very promising, indicating that the feasibility to reach the end goals of the project is very high.

In the second year of the project, in most work packages the actual realization work, based on the preparatory work of the first year, has started and was brought to an advanced level of execution. This is the part with the highest level of uncertainty, because unforeseen risks may materialize, and critical delays may occur. Until Covid-19, all risks were manageable and the work in the individual work packages was on track. Adaptions due to changed circumstances have been implemented and opportunities based on newly gained insights have been captured with change request #3, which was defined, approved and implemented in the course of the second year.
The final impact of Covid-19 is still to be assessed, but despite the closure of labs and cleanrooms at several partner locations, the impact on the planned work in Y2 is still relatively limited, thanks to the creativity and agility of the consortium partners. Almost all of the Y2 planned deliverables have been realized and all planned Y2 milestones have been achieved.

In the third year all the preparatory work of the first two years of the project has come together and allowed to create the envisioned fully integrated demonstrators.
During the year, the impact of the COVID-19 restrictions became clearer. This was reflected in a change request (CR#4) where extension of the project with 4 months was proposed to accommodate for some delays in a few deliverables.
With this limited extension, it proved to be possible to realize the project objectives and planned results, so that the project can be successfully closed.
The POSITION-II project will contribute to industrial competitiveness, growth and sustainability by enabling the electronic industry in Europe to use its expertise in high-speed digital interfaces, miniaturization, heterogeneous integration, wireless communication and high-volume manufacturing to take the lead in the development of technology platforms for the next generation of smart catheters and implants and enter this high revenue market. The POSITION-II project will:
• Bring smart catheter development and production back to Europe;
• Strengthen and expand Europe’s premier position in Cathlab infrastructure;
• Strengthen Europe’s technology position for smart implants.
The smart medical devices developed within the POSITION-II project will help fighting the increasing cost of healthcare by the development of better and more affordable minimally invasive instruments and implants.

The second generation of smart catheters will be more and more driven by the electronic industry, thereby moving to mass manufacturable platform technologies and resulting in an optimal integration into the Cathlab infrastructure.

The POSITION-II project will increase the innovation capacity of Europe in the field of minimally invasive devices, smart catheters and implants through two mechanisms:
• Platforms enable new products with a shorter time to market
By introducing platforms for miniaturization, digitization and integration in the Cathlab, catheter manufacturers who develop new and better instruments can concentrate on developing the application itself, rather than having to worry and deal with the underlying technologies. This will result in faster development cycles of better products that are directly accessible in the main patient visualization system.
• Enabling the next generation of implantable devices.
The technologies developed in POSITION-II for the second generation of smart catheters are easily adapted to suit the requirements of the next generation of bioelectronic implants. These bioelectronic implants are expected to become a strong competitor of traditional pharmaceuticals, and as such represent a huge market potential

The five demonstrators that are being developed in POSITION-II, each have their own specific economic and societal impact by improving patient outcomes, lowering healthcare costs and enhancing patient and (medical) staff experience.