During the lifespan of the project (July 2016 - October 2018) in total 16 Deliverables have been delivered within budget and specifications, 8 Milestones have been reached successfully. Two of the key milestones were the CE Marking for the NFMS obtained on 9 and 31 October 2018 (Annex III and IV of the Medical Device Directive 93/42/EEC) and the preparation for the FDA Premarket Notification (510 k) completed with submission of the technical file on 22 October 2018 and acknowledgement of completeness by FDA on 31 October 2018.
Achievements on Technical Validation
The main objective for the Technical Validation phase was to further develop Nemo’s proof-of-concept technology into a patient monitoring system for safe and accurate fetal monitoring for commercial release (TRL9). To achieve this goal, the technology has not only been further improved but also miniaturized. The technology improvement includes improvement of the data acquisition hardware and improvement and embedding of the signal processing algorithms that are aimed at providing maternal heart rate, fetal heart rate, and uterine activity.
Achievements on Clinical Validation
The main objective of the clinical validation was to validate the NFMS in a multicentre clinical study performed by key opinion leaders within the European Association of Obstetrics and Gynaecology. Overall performance of the NFMS device is good. NFMS has a very high reliability for MHR and a high reliability for FHR (superior to conventional techniques), even in obesity. Uterine activity measurements could not be evaluated for clinical reasons, but bench-tests to a CE- and FDA-approved competitor (PUREtrace) shows an improved output of uterine activity.
Achievements on Dissemination and Exploitation
The dissemination and exploitation activities have been reported regularly as part of the periodic reports, the dissemination activities have been shared publicly via our project website www.nemohealthcare.com which has been updated regularly. During the last project period, efforts have been put on the exploitation of the results, anticipating and following the official market launch of the NFMS on 20 November 2018.
Throughout the Horizon 2020 project there was much enthusiasm among national and international gynaecologists to participate in our projects. Our sales funnel is developing well and first NFMS customer orders are expected soonest.
Before the official product launch (20 November 2018), Nemo has already visited over 50 customers in target markets, introducing Nemo and showing the product. There has not been a single customer yet that has not shown interest in the product or technology. The added value is clearly recognized. Approximately 20% of the visited customers has already asked and received a quotation and the amount of quotation requests is building up.
