The main production area, oddly enough, produces))) Here the technology perfected in pilot batches acquires volumes, and a product on a personality of which worked a team of experts jumps off conveyor belts in the company of thousands of its identical twins.
But there is also place for creativity. Though the number of products is constantly changing, the quality remains the same, and for the implementation of this a lively mind and a creative personality are necessary!
The experimental section is for "break-in" of technological processes. Here the pilot versions are made, and from here the circumstances of their journey through the production cycle reach the chroniclers, constituting the annals of technological regulations. This is a genuine tower of alchemists and a chef's cutting board.
Having personally experienced that the market of raw materials is sometimes looks like the council of Big Numeral (sometimes Four, sometimes Five – depends on the material), we have decided to equip a specialized line for the production of raw materials from separately selected semifinished products. This raw material is used for manufacturing critical components. This, of course, is not about producing our own granulated PVC, but when it comes to silicone, our - at first glance time-consuming approach - allows us to have our own unique and tested product, so as not to depend on the product line of global scale providers, and thus do not allow them to impose their pricing policy.
Of course, we have own raw material tests and trials so that the stated on the label corresponds to the actual quality of the product. There are a lot of pitfalls in this field and the way through all the required procedures of testing is certainly not so fast. But we guarantee that in our medical products we use materials that have passed real tests for toxicity and biocompatibility to ensure full functionality of the product and environmental friendliness.
What's the difference between the component and the finished product? Sometimes it is obvious, sometimes it is very difficult to draw the line. A silicone tube, for example, may be a part of a tubular tool (e.g. a probe), or sometimes many tube segments may connect the nodes of a complex unit - then they are components. But the piece of tube can be used independently without any adapters or accessories - then it is a full-fledged product. Conversely, a probe for a gastric balloon placement – a complicated device, but its' intention of use makes it only a component in the set.
Without going into details, we have decided for ourselves that it is more convenient to consider that the components are products which are provided by a single injection molding machine or a single extruder. In this case, a tube is always a component, and a probe is always a product.
But in general - why is it important to allocate some special site for components? There are two main reasons, and many smaller ones. The first reason - rational and ergonomic - is known to all. It is easier to run the machine and make a million of same type connectors constantly than to interrupt one process and to start a new one, having received several different stampings in small quantities. The second reason is not that evident, even though it is closely related to the first. The issue is about international standards for clean facilities that we have taken as a basis for the organization of production. Requirements for cleanliness, which are affected by the technology itself, by the location of production machines, by the flows of staff, and by the possibility of contamination when the product is changing the life-cycle stage brought us to the solution that the mass production of components for medical devices has been allocated in a separate section with a separate area of responsibility.
Our production of finished products is implemented in accordance with the international standard ISO 14644 "Clean rooms and associated controlled environments" and includes all the basic modules of the production chain - "pre-storage" of raw materials and semi-finished zone rolling - for silicone raw materials, extrusion lines of the tubular elements , a site of injection molding, a press section, sections of the acceptance tests, assembly of finished products, pre-sterilization preparation and packaging.
All stages of the production process controlled by Quality Service and Department of Technical Control, with the possibility of a full traceability of the life cycle of each individual product (from the product in a sterile package, which is being sent into a medical institution, to the bag with plastic granules or a barrel with siloxane fluid).
The manufacturing site can easily become a warehouse for expensive toys that are idle most of the time, and therefore do not justify the money spent on their brand and quality. There is another extreme - the desire to save on everything and to do everything with own hands, even if there is an inexpensive technical solution from the experts of this particular issue. We dare to hope that we were able to avoid these two polar dangers faced by manufacturers, particularly those with a long history.
An agreement on creation and development of Medical technology cluster of Moscow region was signed on 29th of September, 2016. It happened in Special Economic Zone "Dubna" during the VII-th All-Russian research and practice conference "Pricnciples and mechanisms of national innovation system establishment.
Being the guest of the conference, Mystra's Investment Director Rihards Svelpe participated a tour around the SEZ. According to what he has seen, he could affirm that the package for the cluster participants is performed on the world class level of quality. The business incubator as a whole feels like a modern and challenging working space, and, if a company is ready to settle down in Dubna SEZ, all the necessary components for the development of engineering and manufacture on preferential terms are present.
One of the most remarkable parts of the tour, was an excursion to the two medical disposables manufacture sites. Mystra always is interested in medical disposables, and the products from the one site are well-known in our company, and are in our offer for a long time already. So, we had a possibility to check the declared quality of the goods right in the place where their life-cycle begins.
The comparison between two different manufacturer sites was also educative. One of them was established right after the fall of the Soviet Union, and no modernisation efforts were taken during the following years, so some spirit of dilapidation was in the air. The another one turned out to be neatly fresh with a new Italian design.
But! Both of them are situated in classified clean rooms, which correspond the international standards. The feeling of dilapidation or freshness is just an emotion. And more than that - we suppose that the production costs are lower in the post-soviet version. So, that's the question - what is "good" here, what is "bad", and which approach is better for business?