Jaisy - icke invasiv gulsotsmätare med hög noggrannhet men låg kostnad

Viktiga resultat som projektet gav

1)New prototype: A smaller and more accurate has been developed and tested in a clinical trial at Karolinska Hospital in Huddinge. Our accuracy is 95% 2)Market Investigation: Go-to-market strategy has been determined and the first potential market has been identified. 3)Regulatory Investigation: Jaisy´s medical device class has been identified and the roadmap for the CE mark has been clarified. 4)Patent Application: Started working on the patent application with a law firm. 5)Clinical Study: A big clinical study has been conducted at Karolinska Hospital in Huddinge.

Långsiktiga effekter som förväntas

1) We have developed a more accurate (95%) and smaller prototype. 2) We have a better understanding of the potential market and we have a clear go-to-market strategy. 3) We have identified that Jaisy fits into medical device class IIA and we have learnt all the requirements and set the roadmap. 4) We started drafting the patent application with a law firm. Once the bluetooth version is ready, the application will be ready to submit. 5) We have conducted the clinical study between July-November 2020 and collected data from 141 babies. The accuracy of Jaisy is estimates as 95%.

Upplägg och genomförande

1) We have designed a new prototype and altered some of the components we have used. 2) We worked with a consulting firm to conduct the market investigation. 3) We worked with a consulting firm to conduct the market investigation. 4) We hired a law firm to prepare the patent application. 5) Our advisor Prof Mikael Norman has done all the necessary preparations and the document work to start the clinical study at Karolinska Hospital in Huddinge.