NEUROCLUES PRODUCT-MARKET FIT STUDY/NEURO-OPHTHALMOLOGICAL EXAMINATION
NeuroClues has defined a complete Usability plan. The document sets the framework for and provides the results of the usability test performed for the neuroClues version 1.0 product as specified per IEC 60601-1-6 [1]. It ensures that the developed product is both safe and effective for use. In parallel, a complete test strategy was defined to make sure neuroClues V1.0 would meet the defined used needs.
An ESD compliant production was set up, a series of work instructions and SOP were included in NeuroClues’ Quality Management System (QMS) and the assembly procedure has been tested on more than 10 assemblies. In parallel, NeuroClues has started the contractual discussions with several TIER1 hospitals and KOL. The integration of neuroClues within the IT infrastructure of a hospital has become one of the most complex tasks. For this purpose, a complete set of documentation providing detailed information about our system and how to integrate it in the hospital setup was written.
Making use of on-site interviews, presence to several events with a booth allowing to showcase the device, and integration in a study where neuroClues is weekly used on patients, allowed to collect valuable market and usability feedback that was integrated directly in the development of the V1 version. It also allowed to identify critical product improvements that were needed before introducing the first version on the market.
CLINICAL INVESTIGATION
neuroClues has been integrated in the biggest Parkinson’s cohort in France, and further integration is being negotiated with a multitude of high impact KOL and Tier 1 institutions interested to start a project with neuroClues.
To date, 10 neuroClues V1 devices were produced, that helped to industrialize the production process. This first batch was used to improve the manufacturing process and hardware properties. In addition, customized protocols were developed in which part of the analysis is done directly in the workflow and part post processing.To customize the protocols, a protocol engine was developed allowing to efficiently provide customized protocols to clients on demand.
GO-TO-MARKET STRATEGY AND TACTICAL PLAN
The best use case has been identified and confirmed through several interactions during interviews and discussions with KOL. This use case has been detailed in a patient journey. Based on this, a complete analysis of the reimbursement codes was performed for the different geographies.
PRODUCT
The neuroClues V1.0 passed all safety tests on biocompatibility, photo-biocompatibility, EMC, transport and electrical tests (IEC 60601). The MDR certificate was achieved, enabling CE marking of neuroClues V1.0 as a class IIA medical device approved and available for clinical use across Europe. In addition, 2 EU patents were granted. A complete product design & development freeze was achieved, and the V1.0 product is continuously being build and sold on the market:
https://neuroclues.com/product/(odnośnik otworzy się w nowym oknie).
