How should medical devices be designed and constructed so that they can also be produced outside the medical technology industry via alternative value chains - quickly and regionally scalable? The answer is AuraSpe - a ventilator constructed from available, extremely reliable components from the field of automation technology. The device also offers significantly simplified operation. Information is clearly displayed, and settings can be made intuitively. This benefits both untrained assistants and medically trained personnel equally.
AuraSpe was developed from components that have been in service in the industry for years. The existing knowledge of the components and the highly optimized production processes from the industry allow a fast development and transition to the production of the ventilator.
The ventilator was developed jointly by an interdisciplinary team. Our colleague Albert Linder played a key role in this with his professional and academic know-how as a thoracic surgeon and physicist. His knowledge and the helpfulness of experienced doctors, researchers and clinicians in the network made it possible to quickly develop a concept that covered all the vital functions for an adequate oxygen supply for Covid-19 patients.
When intensive care units are overloaded and full of highly infectious patients, monitoring must be efficient, safe and flexible. That's why AuraSpe is designed from the ground up to be digital and connected. An integration into existing infrastructures such as database systems or apps is possible without any problems. All data can be viewed and monitored on the move using a stand-alone app. At the same time, personnel can be warned quickly and effectively in case of emergencies.
Like many other courageous initiatives in the spring of 2020, our ventilator was created out of an impulse - in the expectation that the first corona wave would soon rage in Germany as it did elsewhere. In contrast to the many handicraft solutions based on 3D printing, our idea was to bundle the region's existing expertise and put it into a new context.
The aim was to create a device that was as easy to operate as possible, and that could be quickly manufactured from proven industrial components in the freestanding production lines of medium-sized companies in Baden-Württemberg. Away from the completely overburdened global supply chains of medical technology. The challenging aspect of the situation was to innovate at lightning speed and to work with equal care. And all of this under the volatile conditions of this period: Firstly, the medical insights in treating COVID-19 patients evolved rapidly in parallel to our developments. Secondly, regulatory uncertainties in the emergency situation made it difficult to work.
„Designing and implementing a solution in an environment that changes so quickly was extremely challenging. At the same time it was inspiring to work with the strong limitations.”
Interdisciplinary and agile cooperation was very beneficial. However, there was no finished script for a development of this kind. We rewrote it with every day. A crucial driving factor in the process was the trustful exchange with many different partners from our network. The broad spectrum of the insights gained played a decisive role in shaping our path. In just a few intensive weeks, the proof of concept could be provided via preclinical tests. Our breakthrough was met with great enthusiasm in the simulation center of the Klinikum Stuttgart.
Due to the positive course of the pandemic in Germany, there was fortunately no reason for the Federal Government to have ventilators certified by means of a special approval according to §11 MPG. One of the central working hypotheses did not materialize. Although there is still an urgent need elsewhere, approval by the normal route would take two years. We therefore decided to put the series development of AuraSpe on hold as long as no new emergency need arises in Germany. We are well prepared for the next time.
„Magic happens when competence and cooperation come together. The idea of AuraSpe quickly generated enormous willingness to help and formed a capable team that was effective far beyond Intuity.”
Although fast and agile development is one of Intuity's core competencies, AuraSpe was fundamentally different due to the circumstances - more of a mission than a project. Only by open collaboration within the team and with external partners can a product like AuraSpe become a reality.