Innovative 5-part haematology analyser for near-patient diagnostics

Project Information

INNOHEM

Grant agreement ID: 710477

DOI

10.3030/710477

Project closed

EC signature date 17 December 2015

Start date 1 December 2015

End date 31 May 2016

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

BOULE MEDICAL AB
Sweden

Periodic Reporting for period 1 - INNOHEM (Innovative 5-part haematology analyser for near-patient diagnostics)

Reporting period: 2015-12-01 to 2016-05-31

Summary of the context and overall objectives of the project

The objective of INNOHEM is to commercialize the first Complete Blood cell Count (CBC) haematology analyser including 5-part differential and reticulocytes for the decentralized, low-volume testing haematology market. Today, CBC testing is one of the most commonly ordered blood tests in the world, used to evaluate overall health of the patient and detect a wide range of disorders. The tests are performed using two types of haematology analysers: 3-part or 5-part analysers. The latter are growing in importance worldwide as they are able to provide much more detailed information about the underlying medical condition of the patient, e.g. by detecting reticulocytes (immature red blood cells). However, 5-part haematology analysers are currently designed entirely for the high-volume testing market with complex, centralized laboratories equipped with large sample automation devices. The technological design of those analysers make them inapplicable in smaller settings, where physicians need testing to be done closer to the patient to enable faster and accurate diagnosis.
Recognising a strong business opportunity, Boule will create a revolutionary point-of-care haematology analyser that will provide reliable and accurate 5-part haematology results from a finger-stick blood sample. The new analyser will be based on Boule’s patented in-line device for finger-stick blood samples. The new system will disrupt the existing marketplace by redefining the segment for the commercial application of 5-part analysers (from high-volume centralized testing to low-volume decentralized and near-patient testing). This will lead to improved diagnostic decisions and more personalized and cost-efficient approaches to healthcare. The commercial output will be new growth possibilities and long-term competitive advantages for Boule.

Objectives of the Phase 1 project:
a) to perform market investigations
b) to develop a business plan for the commercialisation of the new 5-part haematology analyser for the low-volume testing market

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

The study identify the key factors and market constraints influencing the future marketing and sales and confirm the market potential of the new product.
The areas that were analysed and turned into a business plan are:

- Market potential: which European markets offer the biggest potential in terms of future investments in decentralized healthcare and 5-part haematology analysers?
- Geography of the business: identify optimal markets for the initial launch of the new analyser.
- Detailed user need mapping: an analysis of the users’ need. The value proposition will be mapped out for primary health care providers, physicians' office labs (POL), small and midsized hospitals, clinics and laboratories in outpatient care.
- Key stakeholders on the market: strategy to engage key stakeholders on the market.
- Strategy to reach the targeted users: define the strategy with the view to the user need mapping. Develop marketing and promotional strategies.
- Competitors: develop a better understanding of the competitive landscape in terms of 5-part analysers, as well as existing market barriers. Development of the strategy to position the offer against competing solutions.
- Structuring the offer: develop the business model and pricing strategy that incorporates expectations of the users and secures Boule’s long-term growth possibilities.
- The economics of the business: establish in what ways different business models influence revenue streams including pricing structure, costs, margins and expenses.
- Definition of financial projections and forecasts to determine the volume of sales needed to cover the expenses and to become profitable.

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)

Boule will propose a new 5-part analyser that addresses the needs of the decentralized healthcare and the growing number of patients in need of qualitative primary care services.
The disruptiveness and market potential of the new device will lie in its capacity to deliver 5-part haematology results from a finger-stick blood sample, in a close-to-patient setting.
The device will redefine the commercial application segment for 5 part haematology analysers by moving them downwards from the high-volume and middle-volume testing segments to the low-volume testing segment. In this way, the new device will fill the niche on the market and contribute to better diagnostic standards for the patients. The device will also build a strong case for introducing more cost-effective, personalised medicine approaches in decentralized health care. This will make the tool attractive for healthcare payers interested in the cost containment in the health care system.

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