The Clinical Flexible Analyzer- a new generation IVD testing device aimed to increase the competitiveness of local healthcare vs. large laboratories

Informations projet

CFA

N° de convention de subvention: 832358

DOI

10.3030/832358

Projet clôturé

Date de signature de la CE 19 Novembre 2018

Date de début 1 Novembre 2018

Date de fin 28 Février 2019

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

MEON MEDICAL SOLUTIONS GMBH & CO KG
Austria

Periodic Reporting for period 1 - CFA (The Clinical Flexible Analyzer- a new generation IVD testing device aimed to increase the competitiveness of local healthcare vs. large laboratories)

Période du rapport: 2018-11-01 au 2019-02-28

Résumé du contexte et des objectifs généraux du projet

MEON Medical Solutions is a company established in 2012 by formed healthcare specialists coming mainly from Roche Diagnostics and AVL medical, two groups with a long history in medical devices and in vitro diagnostics. Currently, with a team of over 40 highly skilled professionals, MEON is developing affordable, innovative and highly-precise in vitro diagnostic tool to support medical professionals in clinical diagnostics. Their objective is to improve global healthcare and become a leading manufacturer of in vitro diagnostic devices. The market of IVD is constantly growing and evolving, however, current combined immunochemical (clinical chemistry and immunoassay) analyzers present several limitations and are not available/affordable for all market segments. In 2014 MEON started developing the “Clinical Flexible Analyzer”, a next-generation instrument for immunochemical & electrolyte testing with unique features, designed for small labs and clinics. This feasibility study was performed to assess the technical, commercial and financial elements required for a successful commercialization of CFA.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

The first part of this study, evaluated the technical feasibility of CFA. Among other tasks, we identified all the elements needed to complete the pilot, make it functional, evaluate its performance and put it into the market. We prepared a detail work plan and scheduled the remaining activities to reach the market, including operational tasks and resources. The second part of this report present the results of a detailed market study, confirming the adequacy of the commercialization strategy previously defined for CFA. Work in this phase included refining our business model, extending our list of potential customers, and identifying competitors, market barriers and regulations needed for commercialization. Additionally, we present an update of the FTO and IP strategy implemented to protect our innovation. The last part of this report is devoted to demonstrate the economic viability of our project, performing a stress test contemplating different scenarios and preparing a detailed forecast for CFA.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

This financial study confirmed the technical, commercial and financial feasibility of our project. We conclude that CFA will have a major economic impact for our company by becoming our main source of revenues by 2024. In terms of socio-economic implications, we calculate our project will help create employment internally, as we estimate at least a 50% growth in personnel. Moreover, CFA will have a major social impact by helping increase efficacy in patient diagnosis and opportune treatment, which will have a positive impact for global healthcare.

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