Cardiaccs AS together with Norner AS shall develop a next generation heart sensor. Through improved design, lean manufacturing processes and with new materials, the project goal is to enable high volume manufacturing of the sensor at a lower cost. In the first phase, this includes the definition of requirements and materials in order to ensure that the sensor is safe for use inside the body, placed on the heart surface, and when connect to equipment outside of the body.
So far, the project has succeeded in developing a new design that significantly simplifies the production processes and makes it possible to produce the sensor in larger volumes. The new design also makes the placement of the sensor on the heart's surface more robust. Thorough analyses of different material types and alternatives suitable for micro-injection molding have been carried out, but the conclusion is that the material used in the first version is the most suitable. Through the work in the project, testing procedures have been developed that make it possible to verify that the sensor can withstand mechanical stresses during the period it remains on the heart, and measures have been implemented to make it possible to move production to Norway.
The overall idea of the AMPliSens project is to enable high volume manufacturing of the next generation heart monitoring sensor through advanced design, a lean process and with new materials. The manufacturing will be done with a design and material selection aiming to increase the production rate, lower the cost and make the production more automated. The ultimate result is a medical device that improves outcomes for patients undergoing open heart surgery and increases health economic benefits.
The primary objective of the project is to develop a novel and game changing process with the right materials and design that increase the production rate, lower the production cost and make the manufacturing process more automated for the next generation heart monitoring sensor. The most challenging R&D challenge will be to combine an optimal combination of materials for a new production process with optimal design of the sensor.
Cardiaccs has already developed a proprietary sensor – CardiSense™ – consisting of an accelerometer coupled with standard temporary pacemaker electrodes placed on the heart surface during cardiac surgery, for a real time and accurate measurement of the cardiac function. Together with Norner Research, Cardiaccs wants to create a cost-efficient and scalable process for the next generation sensor to improve patient outcomes for a larger patient group. With a successful establishment of a high volume manufacturing process, the foundation is laid for a product which can be used in all open-heart surgeries. The AMPliSens project will be crucial to position Cardiaccs as a market leader in the cardiac monitoring devices’ segment.