The world´s first portable and smart digital microscope scanner for clinical and research use

Informazioni relative al progetto

GRUNDIUM

ID dell’accordo di sovvenzione: 822227

DOI

10.3030/822227

Progetto chiuso

Data della firma CE 2 Luglio 2018

Data di avvio 1 Luglio 2018

Data di completamento 30 Giugno 2020

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 2 786 250,00

Contributo UE

€ 1 950 375,00

Coordinato da

GRUNDIUM OY
Finland

Periodic Reporting for period 2 - GRUNDIUM (The world´s first portable and smart digital microscope scanner for clinical and research use)

Periodo di rendicontazione: 2019-07-01 al 2020-06-30

Sintesi del contesto e degli obiettivi generali del progetto

The SME-project strategy follows our overall business strategy and in phase-2 project we will focus on activities that are perquisites for reaching EU- and world-wide markets:

1. Finalising the Grundium technology development and launching a market-ready solution
HW: Electronics and mechanics performance improvements, HW cost reduction
SW: Imaging algorithms, cloud support, user-interfaces, open API, adaption to 3rd party services
Design and manufacturing: Mechanical design, scalable manufacturing concept

2. Ensuring market validation and clearing all market access barriers and
Conducting pilots in leading medical research laboratories in Finland (FIMM) and Sweden (Karolinska) and validating the portable Grundium WSI device in field tests in Africa
Achieving CE-mark and FDA approval for the Grundium WSI devices

3. Reaching EU-markets and preparing for global market uptake
Setting up business value-chains, ensuring sustainable organisation growth
Engaging pathologists, Key-Opinion Leaders (KOLs) and other stakeholders at targeted markets through our established medical community networks and targeted dissemination
From Scandinavia to EU-wide coverage by 2019, preparing for Canada and USA entry in 2020

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

Work Package 1
WP1 is concentrated on hardware. By the end of the project, we have managed to finalise the commercial version of our HW and also it received the CE-IVD certificate. We have also managed to finalise the HW for our second product. We are happy with the designs and also with the BOM cost.

Work Package 2
WP2 focuses on software development. First year, we concentrated on releasing the first commercial SW. We also received CE-IVD certification for the SW. By the end of the project, we have updated the SW and offer several features that customers deemed necessary.

Work Package 3
We tested Grundium WSI in real operating environments to get feedback, data and references from the users. We tested our product around the world. We have also received the required regulatory approvals.

Work Package 4
WP4 concentrates on commercialisation. We found that participating at events and making direct contacts is the most successful way for us to attract new clients. By the end of the project, we have a world-wide distribution partner network and have made sales in many parts of the world. We have formed successful partnerships with several stakeholders.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

We have established relationship with the best-known medical institutes and KOLs in the USA and Europe. Probably the biggest achievement is collaboration with Harvard Medical School and Massachusetts General Hospital in the USA. They are our customers and partners, using the scanner in Boston for molecular pathology studies and working on a project in Uganda to help train the local pathologists.
In the USA organ procurement organisations have deployed the scanner to more accurately evaluate and screen organs before deciding if they are good enough to be transplanted. This has potentially big impact to the number of available organs as the decision can be done based on accurate analysis instead of evaluating the donor more generally.
In Kenya we have had a cervical cancer screening project going on in collaboration with Karolinska Institute for 10 months. Tens of samples are scanned in Kenya on daily basis and analysed in Helsinki.

Grundium device