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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - GRUNDIUM (The worldÂ´s first portable and smart digital microscope scanner for clinical and research use)

Teaser

Summary

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

Work Package 1
WP1 is concentrated on hardware. During the first project year, we managed to finalise the first commercial version of our HW and also it received the CE-IVD certificate. For the first version, we also managed to significantly reduce the bill of material cost. The design for the next product is almost completed and the focus of the second project year will be the next version.

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. during the first year, we continuously executed tests to keep improving the SW. We will continue that work during the second project year as well.

Work Package 3
Regarding WP3 (Piloting work package), we carried out three pilots in three different countries. Piloting activities have so far been successful. We also received the declaration of conformity.

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 first year, we have almost world-wide distribution partner network and have made sales in many parts of the world. We have formed successful partnerships with several stakeholders. Next year, our goal is to put more and more effort on developing partnerships with other partners in the value chain by tighter technical integration and joined commercial activities.

Final results

During the first year 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.