The main objective of DIADEM project has been the identification of the best go-to-market strategies for BluSense POCT technology. In order to identify the best approaches for penetrating the market, we have performed a thorough analysis of the market segments in EU and US, analyzing the reimbursement system, the distribution models and the competition landscape. We have performed a research on the largest distribution and GPOs in Germany, Italy, Scandinavia and US, analyzed their market shares and distribution pricing and strategies. In order to characterize the promising market segment of pharmacies, which more and more offer off-the-counter blood testing for HbA1c and cholesterols, we decide to run a market survey on the field interviewing 50 pharmacies in Northern Italy.
The aimed outcome of the project was to obtain a comprehensive overview of the addressable market segments, so to prepare a successful market launch strategy to be refined in the months to come. Additionally, we aimed at having a on-field feedback from direct users on BluSense technology value proposition, technology features, and product specifications.
We believe the combination of multiple blood tests and multiple type of analysis into a single platform to be the key need in the current POCT landscape. This challenge requires a significant boost in terms of performance compared to the existing products in the market, both in terms of core technology capability, assay development, reagent production and integration in disposable cartridges. We aim at creating value focusing on these areas and implementing the most appropriate regulatory and product commercialization strategy. The products developed at BluSense have been proven to have significant market-access capabilities, supported by the following value prepositions:
1 - One step, more robust: A single-step assay, which requires the minimum amount of sample exchange and reagents, thus minimizing the complexity of the microfluidics.
2 - One drop of blood, high sensitivity: In terms of sensitivity and robustness, this technology competes with enzyme-linked immunosorbent assay test (ELISA) with possibility of multiplexed.
3 - One reader, multiple tests: The same readout unit will be used for all immunoassays - not limited to HbA1c – through the opto-magnetic readout method.
4 - Consumer electronics for POCT: the product uses mainly off-the-shelf components derived from Blu-ray optical units (OPU), enabling large-volumes and low-cost device production.
5 - Simple and smart cartridge: The microfluidic consumables are based on centrifugal microfluidics, therefore eliminating the need for pumps and tubing. One test per cartridge or multiple tests per cartridge are easily designed through modification of the microfluidics structures.
Therefore reliable, rapid and cost-effective risk detection, allowing intervention and disease prevention through point of care blood testing (POCT), is not only beneficial for the patient but would reduce hospitalization costs, thus enabling a more sustainable healthcare system.Few main adoption barriers nowadays prevent large-scale adoption of POCT technologies:
A - Lack of versatility & sensitivity: POCT devices can measure just very few parameters as most of current technologies are limited in sensitivity and multiplex analysis. Different machines may have to be purchased for different blood tests, when available. For low-concentration biomarkers, hospital labs are in most of the cases the only available solution.
B - Large amount of sample required: More advanced tests, targeting low concentration biomarkers are mostly not compatible with a single drop of blood from a finger-prick. The need of specialized phlebotomist hampers the adoption of POCT test, e.g. at GPs offices and at pharmacies.
C - Equipment Cost: a family doctor purchasing a POCT currently spends on average between €3,000 and €10,000 on the equipment. At an average rate of 5-10 tests a week and at an average profit of €3/test (examples surveyed in densely populated middle-class EU areas), it requires over 2 years for paying back the initial investment.
D - Tedious operability: Most of the devices in the market still require manual sample preparation steps. These procedures need a trained operator and are very prone to procedural mistakes. A survey conducted with Danish General Practitioners (GPs) especially showed concerns over tedious manual calibration processes of many of the current POCT devices in the market.
E - Lack of connectivity: Surveys show that most of POCT operators complain about the tediousness of manually reporting the test results generated (often still on paper) by the POCT equipment. Newly-designed products have to focus on data integration and accessibility for operators and patients, including automated maintenance services and consumables stockpile management.
Evaluating and confirming the above assumptions have been the major task of the DIADEM project, which brought BluSense technology's value propositions in front of a audience of final users.
