Paradigm

Project description

Hematology analyzers and problems

At present, the market of Hematology analyzers are represented mainly by instruments intended for operation in stationary laboratory conditions: M Medonic, Swelab (Boule, Sweden), VS-2800 (Myndray, China), URIT-2900 (China), the Mythic 18 (CORMAY S. A, Poland), etc.

In the operation of named and similar devices experience the following difficulties:

  1. Since the device is stationary, it is necessary to deliver the sample from the place of capture to the laboratory – this may take quite a long time.

Or will have to deliver the patient to the lab to score for the research sample – that is not always possible.

  1. Devices steady performance require appropriate space: must be respected the normal power supply, earthing.
  2. Most of the devices steady performance imply a permanent connection to electroepitaxy network containers with reagents and plum.
  3. The vast majority of analyzers adapted for the collection of blood from an open or a closed (vacuum) tubes. It is necessary to collect not less than 200 µl sample of whole blood. The capillary end-tu-end (20 µl), which allows to dispense with the tube entirely, can be applied only with analyzers Swedish company Boule (M Medonic, Swelab). But these devices are absolutely not designed to work in portable environments.
  4. If the analyzer is used with minor load, the specific volume of reagents per case increases dramatically because of the need during each on and off to perform activities for filling and flushing the hydraulic system. The smaller measurements in each operating cycle, the higher specific consumption of reagents in each study.
  5. If necessary, transportation of the unit (or idle time) necessary to make the procedure of conservation, which leads to higher reagent consumption, which in turn leads to an increase in the cost of research.
  6. All existing Hematology analyzers have a complex hydraulic system with a large number of lines, valves, pumps, gauges, and recording devices. This design involves the maintenance of highly qualified engineering staff.

Hematology analyzers, specialized mobile teams to conduct the study the General composition of the blood does not currently exist (with the exception of devices using disposable cartridges)

The project implementation will allow to create a Hematology analyzer for conducting researches General analysis of blood in any conditions: clinics and in the field.

The device will be modular (to eliminate the need for highly skilled maintenance), minimized consumption of reagents, samples and reference materials.

In the proposed device the following nodes:

device, dosing systems, executed as a single unit for microfluidic technologies;

— hydraulic system: the dilution of the sample, the mixing device of the specimen, the device for registration of blood cells (formed elements) and hemoglobin concentration. All of these nodes are executed as a single unit for microfluidic technologies;

— block reagents, executed as a single unit;

vacuum pump and receiver;

— Board management controller;

— Board data processor;

— touch LCD display;

— built-in thermal printer;

the battery power of the device;

— the power adapter;

The hydraulic system of the analyzer of microfluidic and will be executed in a single block for the film technology. The use of such a construction of the hydraulic system of the device will significantly reduce reagent consumption at the study, which in turn will allow you to carry the device in a portable design.

The intake device of the dilution of the sample diluent (one reagent) not containing actuators and engines, has no analogues. Minimizes the amount of sample and reagents.

Expendables are loaded in the cassette (you can think of the cartridge). Consumption diluent approx. 10 ml (lysing solution of 3-3, 5 ml). Detergent — 3, 5 ml. of Plums is carried out in a container in the same cassette. A collection container has a volume sum of the volumes of all the reagents set in the cassette. When filling out the drain tank (in fact — when spent the rest of the reagents) is required, the sensor and the analyzer generates a message prompting replacement of the cassette with the reagents. Cassette sealed, which avoids leaks of potentially dangerous liquids outside the device, making the analyzer suitable for transport without interim measures.

When you turn off the analyzer, there is a complete flushing of the hydraulic system and purge air, which will allow no further operations to perform conservation.

Additional information

The project implementation will allow to create a Hematology analyzer for conducting researches General analysis of blood in any conditions: clinics, in the field, in terms of medical and obstetric point (FAP), in the ambulance.

The device will be modular, minimized consumption of reagents, samples and reference materials.

In the proposed device the following nodes:

  • device, dosing systems, executed as a single unit for microfluidic technologies;
  • device for dilution of a sample performed in a single unit for microfluidic technologies;
  • the mixing device of the specimen, performed in a single unit of microfluidic technologies;
  • device for registration of blood cells (formed elements) and hemoglobin concentration, performed in a single unit of microfluidic technologies;
  • block reagents, executed as a single unit;
  • vacuum pump and receiver;
  • charge management controller;
  • Board data processor;
  • touch LCD display;
  • built-in thermal printer;

When you turn off the analyzer, there is a complete flushing of the hydraulic system and purge air, which will allow no further operations to perform conservation.

The intake device of the dilution of the sample diluent (one reagent) not containing actuators and engines, has no analogues. Minimizes the amount of sample and reagents.

Expendables are loaded in the cassette (you can think of the cartridge). Consumption diluent approx. 10 ml (lysing solution of 3-3, 5 ml). Detergent — 3, 5 ml. of Plums is carried out in a container in the same cassette. A collection container has a volume sum of the volumes of all the reagents set in the cassette. When filling out the drain tank (in fact — when spent the rest of the reagents) is required, the sensor and the analyzer generates a message prompting replacement of the cassette with the reagents. Cassette sealed, which avoids leaks of potentially dangerous liquids outside the device.

Market analytics

Currently in operation is about 10,000 Hematology analyzers with similar analytical parameters of the proposed device. The life of the analyzer 5 — 7 years. This implies that the annual need to update the Park equipment is 1, 5 — 2 thousand units.

However, you should take into account the fact that the current devices are stationary devices which can be operated only in a laboratory.

Portable (handheld) devices in the market.

If necessary, equip the medical centres, ambulances, industrial health centers, remote locations of mining operations, rescue services and disaster medicine, the need for such appliances is estimated to be not less than 1000 units per year.

The uniqueness of the project

Hematology analyzers that are present in the market and in laboratories typically have a stationary version, implying a continuous connection of the hydraulic analyzer to the power of reagents, electroepitaxy network require quality of grounding. Such analyzers are not suitable for transport, as operating conditions require such actions for the preservation of the instrument, which is often not able to perform the lab staff without the participation of technical experts.

If the analyzer is used with minor load, the specific volume of reagents per case increases dramatically because of the need during each on and off to perform activities for filling and flushing the hydraulic system. The smaller measurements in each operating cycle, the higher specific consumption of reagents.

In addition, always-on analyzer requires specific climatic conditions (usually 18 — 25). If necessary, transportation of produce in the cold period it is necessary to produce a complex for preservation of the instrument.

The vast majority of analyzers adapted for the collection of blood from an open or a closed (vacuum) tubes. It is necessary to collect not less than 200 µl sample of whole blood. The capillary end-tu-end (20 µl), which allows to dispense with the tube entirely, can be applied only with analyzers Swedish company Boule (Exigo). But all these devices are absolutely not designed to work in portable environments.

All existing Hematology analyzers have a complex hydraulic system with a large number of lines, valves, pumps, gauges, and recording devices. This design involves the maintenance of a highly qualified engineering staff.

Analyzers for the mobile teams to conduct the study the General composition of the blood does not currently exist

Monetization sources

Commercialization of the project

Under commercialization means the transformation generated by the Project technology, medical equipment and expense materials to him in the sources of active and passive income (profit).

Produced in the framework of the project equipment has no analogues in the world, and the scope is much wider than currently existing devices for the clinical analysis of blood. With the application of the developed equipment can be seriously improved standards of medical care

In the course of the Project will be developed and continually updated the following documents:

Investment plan

Production plan

Organizational plan

Financial plan and project performance indicators

Marketing plan

Risk analysis (sensitivity analysis) of the project.

Inherent in the idea of principles and plans will be refined and developed at each stage of the Project.

To implement a long-term Project, it is planned to seek grant support of the Innovation Center "SKOLKOVO" and to attract the necessary co-financing

The term bench models — up to 6 months from the date of funding of the Project

Expert estimation. Because of the specificity of the equipment is expected to involve as experts of recognized professionals, including leading veterinarians, and the chief experts of the ministries of health of regions of the Russian Federation, to assess the prospects of development

It is expected to achieve the main result – the positive conclusion about prospects of application of the analyzer in the following areas and directions:

Veterinary medicine.

Emergency medicine.

Ambulance and emergency care.

Feldsher-midwife points.

Intensive care unit, including perinatal centers.

Medicine of the Armed forces and Navy.

Medicine of the Federal border service of the FSB.

Private medicine (hospitals engaged in oral and maxillofacial surgery and implantology, plastic surgery, other types of surgery).

The main feature of the market for such devices is that it is mostly imported equipment. Because the generated parser has including the purpose of import substitution, then the price should be considerably lower foreign "counterparts". Analyzing the state of the market for such devices at the time of the drafting of the document, it is safe to say that the suggested retail price of US $ 6000 for a basic model produced in Russia innovative product will be, first, considerably lower (about 30%) than the import competitors, and, secondly, contains a "reserve" for the provision of wholesale and discount sales incentive terms and conditions

In the period of small-scale production is planned to produce and sell about 60 devices for the needs of veterinary medicine. Average selling price should take 4000 dollars for the device. Thus we can assume that the first commercial result will be fixing the revenue at the level of 260 000 USD for 9 months of production of instruments and reagents cartridges to them. Gross profit is estimated at $ 165000 $.

Implementation at the stage of serial production will work on the following key areas (distribution channels):

Own direct sales in hospitals (PP)

Dealer network (DS)

Project detailed information is available to investors after authorization.

Project detailed information is available to investors after authorization.

Translated by "Yandex.Translator"
Project No. 37735
Created on: 26.07.2018

Russia, Moscow City


Project price: 200 000 000

Investments volume: 50 000 000


Stage: Idea


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Contact details of entrepreneur

Dyildin Dmitriy Rudolfovich

Russia, Moscow City
Biotechnologies, Medicine/ pharmaceutics