Development and design of hi-tech production of medical articles and equipment for cardiovascular surgery.

Development and design of hi-tech production of medical articles and equipment for cardiovascular surgery.
Technology description
As part of the innovation project “Development and design of hi-tech production of medical articles and equipment for cardiovascular surgery, osteosynthesis and knee-joint surgery, treatment of dermic oncological diseases and manufacture of extra strong sealant compounds for stomatology” it is planned to carry out development and launch manufacturing of new type of product samples for medical purposes in the area of cardiac surgery, stomatology, traumatology and prosthetics:
 system of aortal stentgraft for correction of laminating aneurysm of aorta thoracica;
 devices for minimally invasive myocardial revasculization;
 valve-containing stents for correction of heart defects;
 device for LA appendage clipping;
 thrombus filter-traps;
 metrical and webbed stents of various;
 prosthetic devices for vessels;
 acoustic system for endovascular destruction when treating subjects with diabetic foot infections;

There is the same product on the market, but the technology has higher quality basic specifications
new for region
There is an opportunity for practical implementation
Implementation of technology is economically reasonable

Solved problems
According to World Health Organization cardiovascular diseases (CVD) are the main cause of death worldwide. It is estimated that in 2010 17,3 millions of people died of CVD, which was 30% of all deaths in the world. This problem to different extents affects countries with low and medium income level. More than 80% of deaths with CVD in these types of countries happen in equal measure among men and women. By the year 2030 about 23,3 millions of people are going to die of CVD, for the most part of heart diseases and insult that, according to prognosis, will remain the leading causes of death.
End of the second millennium was marked by the rapid progress of cardiovascular surgery. This process was constantly stimulated by new developments in the field of pharmacology, polymer chemistry, physics, electronics, and its introduction in clinical use, as well as fundamental research of blood circulation physiology.
Surgical correction of coronary pathology in patients with diffuse atherosclerotic cardiosclerosis and a decrease in myocardial contractile function, as well as surgery complications of myocardial infarction
(ventricular septal defect, mitral valve incompetence, left ventricular aneurysm) are the most complex problems in the world of cardiac surgery.
Extensive global experience of artificial mechanical heart valves appliance made it clear that despite their reliability and endurance the use of prosthesis is not ideal. In this regard further development of this branch of cardiosurgery is associated with design improvement of domestic prosthesis.
Surgical treatment of thoracic aneurysm is one of the most dramatic branches of cardiovascular surgery, which is concerned with myocardium and brain shielding during the surgery on ascending aortic arch and prevention of blood effusion.
Surgical treatment of cardiac insufficiency. Congestive cardiac failure has become a major challenge for health protection. The increase in average-expectancy life and advanced therapy have multiplied number of people that live with chronic heart diseases more than ever before. Successful and long-term results of heart transplantation made it procedure of choice for patients with absence of medication effect. Unfortunately, obvious limitation of the transplantation method, which include the need for immunodepression and essential lack of “imported” organs, resulted in the fact that for the last decade the annual number of transplantations, performed in the world, was less than 6000.
The experience of national cardiosurgery allowed developing the unique methods of treatment, which have already been successfully applying in clinical practice for 10 years.
The production of medical equipment and healthcare products is top-priority around the world, it is profitable and prospective because of prominent social significance of the health maintenance problem and prolongation of the active phase of human life.
In this regard, the production of high-tech medical products is actively supported by the governments of leading foreign countries. Among the determinative factors of the world market of science-intensive medical equipment are increasing longevity, common aging and rise of income of population, advanced medical awareness and others. The development of this particular area of production is stimulated by key investments of the governments into research and development, improvement of internal support system for manufacturers to enlarge export markets, etc.

Stage of Development
Prototype with favorable lab results and available for demonstration

The marketing analysis conducted just in the area of stents showed that in developed countries of Europe and USA total annual stenting reaches 0,2– 0,4 % from general population. At the moment about 1 500 surgeries using coronary stents are carried out annually in the Republic of Belarus. At the same time the need for stents in CIS countries, according to expert’s estimation, is more than 30 000 pieces annually. Nowadays more than 5 000 surgeries using the stenting method are carried out annually only in Russia.

Risks of the project and anti-risk activities
The implementation of the project is accompanied by various risks that could affect the final result. Among the main risks are the following:
Marketing risks. Major marketing risks are assessed as medium. Marketing risks are minimized due to the fact that the existing analogues in the market have significantly higher cost. In addition, it is planned to organize and conduct complex marketing activities that will enable rapid response to changing market conditions.
Technological risks. This type of risks also include problems with the maintenance of machinery and equipment, acquisition of quality raw materials, availability of skilled manpower for operation of the purchased equipment, as well as factors affecting the quality of the products and methods of its support. These risks are assessed as medium. State Enterprise "Scientific and Technology Park of BNTU "Polytechnic" has the necessary experience in the selection of high-quality technical equipment and highly qualified management personnel who have experience in the industry. To reduce the technological risks, selection of equipment will be performed by qualified personnel for the sake of the innovation project and its needs.
Financial risks. Financial risks can be expressed in the inability to achieve the planned targets in terms of sales, due to the influence of both macro-economic factors (high inflation and the decline in effective demand, etc..), as well as factors related to toughening of requirements of banks at crediting.
The risk of resource supply and sales. To date, this type of risk is assessed as high, given the absence of the arrangements for the delivery of raw materials and well-established sales channels. The reduction of this risk is also planned as part of the marketing complex.
The risk of market oversupply and falling price for the product. The risk arises from the possibility that the company will not work on the planned production volume. The risk is assessed as low, as the demand for goods (work, services) of the enterprise, owing to specificity of its activity, is steady and stable.
Inflation risk. This risk is assessed as high, and belongs to the group of so-called systemic risks as the company cannot render immediate influence on it in order to minimize its negative effect.
Organizational risk. This risk is associated with the work in strict accordance with the schedule, as well as the timely commissioning of the equipment at the new site. Given the experience of the State Enterprise "Science and Technology Park of BNTU "Polytechnic" in the field of new productions, this risk can be assessed as low.