Rapid prototyping and development of emergency ventilator

In the winter of 2020, the COVID-19 virus spread rapidly across borders. A global shortage of personal protective equipment and ventilators prompted nations to place restrictions on international trade and shipments. Concurrently in Norway, attention was brought to the scarcity of intensive care unit (ICU) beds. The lack of ventilators and health care personnel created a gap between current ICU capacity and the potential increase in ICU patients.

The mission of the Norwegian Defence Research Establishment (FFI) is to advise and develop solutions to strengthen the Norwegian Armed Forces and the Comprehensive Defence, including developing solutions that can contribute to national crisis preparedness. Moreover, FFI has designed a model for rapid innovation and has gained valuable experience in developing new solutions in cooperation with industry and end user.

In the period of 16 March to 27 March, FFI, Edge Health Technologies AS, Laerdal Medical AS and Servi AS collaborates to develop an emergency ventilator prototype. The purpose of the ventilator is to serve as an emergency solution in the event of failure to control the spread of the virus.

Close to 70 similar development processes are undertaken globally. The greatest challenge – in the Norwegian project as well as the international projects – is to balance the trade-off between functionality necessary for maintaining patient safety on the one side, and functionality that is fast to realize and can alleviate the lack of qualified health care personnel on the other side.

Three weeks after the initiation of the prototype development, Servi conducts a successful demonstration of the functional design of their prototype. This design was comprehensive to the extent that it was deemed unnecessary to incorporate elements from the two other prototypes being developed by Edge and FFI.

The funding of the following phase was established on 30 March, with the confirmation from South-Eastern Norway Regional Health Authority (Helse Sør-Øst) stating they will fund further development of the prototype recommended by FFI. As several other nations are developing similar emergency ventilators, there is a great demand for critical components. This has an impact for de decision process.

Shortly after the decision to purchase the emergency ventilator, Norway’s infection curve flattens out. The development schedule was adjusted accordingly, and a requirement of CE Certification is made.

On 14 May, FFI hosted a new demonstration with technical and functional evaluation of the updated solution. The anesthesiologists conclude that the functionality is superior to prior expectations and confirm the range of use. The complete evaluation can be found in this report.

In the days that followed the presentation of the prototype version of the product, it was subjected to harsh criticism. A great deal of this criticism was based on a lack of comprehensive knowledge and information. The purpose of this report is to shed light on the innovation process itself and the functionality of the Laerdal Servi Ventilator. We wish to emphasize the importance of politicians, leaders and development communities continuing to risk taking a chance on innovation projects. It is paramount to solve new and important challenges in society, and to contribute to value creation and development of new business in Norway beyond the COVID-19 crisis