Creation of Prototype
Designing of implants and prosthetic components as well as the medical instruments is a complicated, multiple-stage and expensive process. The creation of medical product prototypes is an important stage in the work of our Design Engineering Bureau while developing the medical products.
A prototype of medical product is its full-scale model made being based on the results of design engineering required for:
• carrying out of laboratory and full-scale physicochemical tests, testing of implants and prosthetic components for their compliance with specified characteristics and the сustomer’s requirements;
• elaboration of manufacturing process with a focus on the economics of serial production.
The need for permanent manufacturing of prototypes and prosthetic suprastructures is defined by a high share of novelty and unicity in their design and geometry. This is due to the dynamism of updates in the branch as well as a high degree of individuality in the use of our products. The innovative models of products, new materials, method and techniques of their processing permanently appear in the area of prosthetic surgery. In this context, the results obtained in the course of design-and-engineering calculations and modelling are obviously insufficient. The peculiarities of our specific area of medical product manufacturing are such that the designers cannot rely only on the reference characteristics of materials and the characteristics of manufacturing equipment because of very high responsibility for the result and large activity of the updates taking place.
All these innovations and modifications (of the materials, technologies, and models) are liable for mandatory elaboration in the product prototypes. It is required for checking of their efficiency and acceptance in actual practice of the application and manufacturing.
A prototype of medical product is far from its final shape. The necessary alterations are permanently made in its design and shape (geometry) up to the achievement of desired result by dint of a set of physicochemical and structural tests being carried out.
Our prototypes of implants and prosthetic components are made on the same CNC machines as the serialized products. Thus, a principal opportunity for their manufacturing with the use of machinery available at our enterprise is being elaborated along with the determination of optimal sequence of manufacturing operations for formation of clear manufacturing process of future serial production.
After manufacturing, the experimental prototypes of medical products get into our test laboratory. In this laboratory, they are subjected to multidirectional static and dynamic loads being placed in the specific chemical environments so as maximally simulate the situations in which may occur a real prosthetic suprastructure in actual practice of the application and use.
However, sometimes it so happens in practice that we are unable to attain properties and characteristics of product required by the сustomer with all available range of equipment possessed by us, processing technologies, and the potential stock of instruments. In this situation, we do not refuse an order and use it maximally for our professional advancement and improvement of our quality of work. Encountering obstructions, we seek for and order the new materials, instruments up to the purchase of relevant industrial machinery. And as a result, we rise to a qualitatively new level with the increased technological capabilities and the new operational experience along with the fulfilment of a complicated order being new for us.