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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - TRACY (Innovative RFID-UHF Traceability Platform for Human-Derived Products)

Teaser

Summary

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Summary of context and overall objectives
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AT-Biotech Traceability Information Systems, S.L. (AT-BIOTECH) is a well-established Spanish SME that offers high quality RFID traceability solutions to its clients in the healthcare sector. We have already developed a system, Rhesus, that focuses in the blood donor-to-patient cycle. Rhesus significantly improves patient safety and blood quality, but also optimises the efficiency of all operational processes. At the time of writing this feasibility study, we have successfully identified ~251K products & patients, identified, stored and distributed ~232K blood components, and helped complete ~23K transfusions in our current installations in Spain and the DACH region (Germany, Austria and Switzerland).

Current traceability solutions are too paper based, and the introduction of new technologies, i.e. RFID is restrained because RFID-HF is too expensive, and RFID-UHF does not perform well with liquids (e.g. blood, plasma and most biological products). We have produced novel design of RFID-UHF antennas that solve these problems and produced a full traceability solution that covers all needs of traceability for the healthcare market.

TRACY, our innovative RFID-UHF traceability platform for human-derived products, is an evolution of our former Rhesus platform that will help us to up-scale our production and fully internationalise our business, while providing citizens and society important benefits:
1. Huge SAFETY improvement. We intend to achieve 75% safety improvement in the transfusion stage (blood products).
2. Huge PRODUCTIVITY and EFFICIENCY improvement. We intend to achieve 15% improvement in the production stage.
3. Huge QUALITY improvement. As a result of a thorough traceability and cold-chain control in the whole blood lifeâ€™s cycle.

The overall objectives of this feasibilty study are validating the technical, commercial and financial viability of TRACY, where main areas of concern were:
1) Internationalisation.
1a) Make all necessary refactoring to allow for easy adaptation of TRACY to countriesâ€™ regulations (local changes to EU directives), agent/playersâ€™ protocols (e.g. German hospitals) and site-specific procedure (e.g. Spanish blood establishments).
1b) Improve our knowledge of the DACH market and better adapt our portfolio to the needs of the upcoming international clients (short-term focus on Spain and DACH region, but also the UK, France and Italy).
2) Production-upscaling and industrialisation. Carry out a thorough study to up-scale production (e.g. full industrial designs, specific country HW-SW certifications) of our full portfolio of products, which is currently mostly manufactured on demand, to evolve to a full automated mass-production industrial process to boost our profit margin.
3) Improve our reporting capability introducting machine-learning and big-data analytics.

Work performed

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Summary of achievements
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TECHNICAL
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1. We have increased our manufacturing readingess level: Updating our current production methodology and reengineering our manufacturing processes, including a thorough process up-scaling and industrialisation study of current RFID equipment, to improve our production quality and pave the way for mass production

2. We have redesigned (refactored) our software platform to further increase our clients\' processes safety and security by incorporating a whole new cloud-ready, iot-ready, machine-learning and big-data analytics module that will improve analytics and error prevention;

3. We have Redesigned (refactored) our software to increase our market adaptation, by incorporating
(a) specification of a regulations/procedures characterisation module to seamlessly adapt our platform to any country/site specifics;
(b) specification of a biological product characterisation module to consider any product specifics (focus on blood components (red cells, platelets and plasma) in the short-term);

4. Design the work plan to be executed during the upcoming Phase-2 to complete all developments and actions to prepare for commercialisation.

COMMERCIAL
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1. We have run a thorough market study of the new market opened in the DACH region with the help of renowned experts to be subcontracted (Herr Stephan Neuner). The conclusions of this study have been used as specifications for the refactoring of the SW platform, and fully assess our expectation in regards with trading projections in the most conservative assumptions.
2. We have redesigned our portfolio of products with emphasis in new features (regulation / procedure- wise, big-data analytics ready, etcetera) to make it easily adapt the characteristics of our short- and mid-term targeted markets (Spain and DACH region primarily, then UK, FR, IT, then EU-wide and US).
3. We have finalised a preliminary commercialisation plan to introduce TRACY in the new markets that include opening commercial offices in Germany and the UK duirng first year of business, possibly also in the US.
4. We have designed a dissemination plan to be executed during Phase-2, as part of the aforementioned work-plan, and during Phase-3, including (a) H2020 Phase-3 support to disseminate results; (b) intâ€™l marketing campaign including web, direct marketing, trade-fairs presence; and (c) execution of the internationalisation plan derived from marketing studies.

FINANCIAL
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1. We have built precise cost structure and trading projections for the first 5 years of business.
2. We have built 5-years financial projections considering realistic and pessimistic scenarios to validate our financial viability. In the realistic scenario we project ~â‚¬18-million revenues and RoI of 4.36 by the fifth year of business exploitation. These projections are conservative, as they have been built under the assumption that we will directly take care of all pre-sales and post-sales actions, while, during Phase-2, a strong effort will be made towards identifying the right companies to take care of pre-/post-sales actions as homologated busienss partners.

Final results

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Progress beyond state of art
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TRACY is the only RFID-UHF traceability tool in the market, 2-years ahead any competitor. Moreover, TRACY clearly outperforms any competition today, achieving up to 100 tags read per second, and adjustable reading distance, which improves productivity and ergonomics. Furthermore, we are the only tool in the market able to detect 22 out of the 26 catalogued sources of error (3.5 times more than our nearest competitor!). This capability is very important (see details in the specific annex in section 4.1.B), an asset valued to produce reliable metrics for haemovigilance reports, healthcare quality assessments and UKâ€™s CAPA (Corrective And Preventive Actions).

Additionally, during the feasibility study we have also unveiled a new opportunity of collaborating with another company, FARSENS, to develop a novel RFID-Tag design that will incorporate our current antenna design and a temperature sensor to produce the first RFID-UHF tag with integrated coldchain control, which will also be a unique selling point, a high entry barrier for followers.

We have concluded that the project is feasible, both from a technical, commercial and financial point of view, and have designed a 24-month work plan (Phase-2) to complete all developments and actions needed to commercialiase TRACY worldwide within 12 months after finalising Phase-2.