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

Project Information

GRUNDIUM

Grant agreement ID: 822227

DOI

10.3030/822227

Project closed

EC signature date 2 July 2018

Start date 1 July 2018

End date 30 June 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 2 786 250,00

EU contribution

€ 1 950 375,00

Coordinated by

GRUNDIUM OY
Finland

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

Reporting period: 2019-07-01 to 2020-06-30

Summary of the context and overall objectives of the project

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

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

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.

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)

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