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

Project Information

CFA

Grant agreement ID: 832358

DOI

10.3030/832358

Project closed

EC signature date 19 November 2018

Start date 1 November 2018

End date 28 February 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

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)

Reporting period: 2018-11-01 to 2019-02-28

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

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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