SET Medical Chairman Dr. Ali İhsan Şerbetçi:
“FDA’dan As the first Turkish company to receive syringe clearance, we have increased our production capacity to 1 billion units."
SET Medical Chairman Dr. Ali İhsan Şerbetçi and the US Food and Drug Administration (FDA)'from We talked about the syringe clearance they received and their activities:
SET Medikal Can you introduce a little?
Set Medikal, which is the first and largest "Disposable Sterile Syringe" manufacturer of Turkey, was established in Istanbul in 1977 as a production and marketing center. Management, production, warehouse and shipment activities on a total area of 10,000 square meters, of which 4,000 square meters are closed and 6000 square meters are open, will be shown as an example to the equivalent factories in Europe, syringes in modern facilities in accordance with GMP rules, hipodermik continues to produce needles and insulin pen needles. Set Medikal, where microbiological control of the production line is carried out regularly, produces in a modern and clean environment in accordance with GMP, ISO9001, ISO13485 standards without touching hands with automation. In addition, it has adopted the principle of developing its production park by closely following technological innovations, and quality production respecting human and environment by using raw materials of medical purity with its experienced and trained international expert staff. SET Medikal, which has 100 percent domestic capital, has the standardization and certificates necessary to export to every point of the world. In the total quality system aiming to meet customer expectations and the happiness of employees, ISO 9001, ISO 13485 in management, good manufacturing conditions (GMP) in production and national and international standards in product quality and European Union medical device directives (93 / 42 / EEC), official procedures are applied. SET Medikal, which advances with safe steps to the future by continuing its information and technology investments without sacrificing customer satisfaction and quality, continues to raise the needs of the sector to a higher level day by day and to meet the expectations of its customers within the understanding of "perfectionism". SET Medikal, which has been the "Symbol of Safety in Human Health" since its establishment, has developed product and production technology, quality working environment, employees supported by continuous training. With aims to increase its competitiveness in the market and to become the leading brand in its sector abroad as well as at home.
Recently FDA’dan you have received syringe clearance. Can you tell us a little bit about that?
As a 44-year-old company, we have done a good job. Recently in the United States FDA’dan We became the first Turkish company to receive syringe clearance. As SET Medikal, this made us proud. The success of our quality system has brought us this clearance. The FDA process is a 7-month process though Of FDA’i It is actually the result of 40 years of effort. Although we medical device manufacturers check each product individually, we have to trust the system. Quality is created by the fact that our system works in an orderly manner. Especially technical equipment, materials used by the supply chain, the experience of our personnel in production, quality awareness of our employees can get FDA as a result. Getting an FDA alone isn't enough. It is also important to maintain this and, furthermore, to produce according to the standards of other developed countries. We are a company that has completed and passed the certification of the Ministry of Health of Japan. I can say that Japan also has a high standardization expectation from the United States. We have successfully passed all kinds of requirements of Canada and countries with various certifications. This has been part of our goal to produce at world standards since the beginning. If that weren't the case, we wouldn't have any of that today. All of our employees are directly related to human life. conscious. We do not look at our production as a commercial commodity. We are aware and responsible for our production. And since we produce with this sense of responsibility, success comes by itself. We do not produce to be successful, we are successful because we make this production. This is an ideal that will never change for us. Our employees have a great share in this success. Success comes with the team. Success doesn't just come from buying the best machine in the world and using its raw materials. But if you do not have a successful, experienced team, you cannot make quality production.
You have increased capacity on the demand for vaccine syringes. Can you give us some information about that?
COVID-19 pandemisi In order to meet the demand for vaccine syringes in the world, especially in Turkey, we have become one of the top 5 syringe manufacturers in the world by increasing our annual production capacity to 500 million units per year and our total syringe production capacity to 1 billion units with an additional investment of 20 million TL. We have gone from being a country where 400 million syringes were imported annually until a few years ago to a country that exports 300 million units today. Our 2021 target is to reach 500 million units in exports. We are currently the leading manufacturer in syringe production in Turkey and in the region. 2nd in Europe We are big factory. Our company, which has the largest production volume not only in Turkey but also in the region in terms of capacity, with our 150 employees, 40 percent of whom are women, especially in Europe; we supply products to many countries of the world. 30 percent of our employees are highly trained personnel. We accelerated our efforts to meet the demands from the USA for a while and became the first syringe factory in Turkey to receive FDA Certificate in these product groups. SET Medical has an important place in the world with its modern and high production capacity. In this growth momentum, which is proud for our country, the kindness and support shown by our President to the sector in the production of medical products also have an important share.
Will you have productions other than syringes? Are you considering new investments?
Our pandemic It meets with significant interest depending on the needs that arise due to it. Our company, which is the leader in the sector with a significant growth momentum every year; continues to invest in the increase of production capacity and the addition of new products to the product range without interruption in this period. On this path, we are preparing to make a new investment of 50 million TL in order to increase capacity in a short time. We have a total investment plan of 200 million TL in 3 years. The existing knowledge and experience brings the ability to produce other medical supplies. We owe a debt to this country, to this nation, to actually produce. Companies like ours that have reached a certain level should lead the production of medical devices in our country to a higher level. We allocate a significant share of our budget every year to R&D, which is indispensable for our sector. With our infrastructure and experienced team in R&D, we continue to create value in terms of new product developments and improvement of existing products. We will have new productions. Some of these are personal diagnostic devices, wearable technologies and various devices and consumables used in intensive care. We plan to add the consumables needed in the emergency response room to our production group. Perfüzyon Pumps infüzyon pumps, nutrition pumps. High montanlı We want to pioneer the production of medical devices used. While doing this, to produce products with high added value and sometimes to produce strategic products. For example, the syringe is not a high value-added product, but a strategic product. Turkey should be able to produce basic medical devices. At this point, the state also needs to show the way. At the moment there is a problem of vision or mission. New investors are existing they can only venture with product groups. However, directions can be made within the framework of a plan. In this sense, supports can be given by distributing them to different products. In the last two years, 5 new syringe factories have been established in Turkey. While there are hundreds of product groups that are not produced in Turkey, resources are wasted. The medical device is a shining star. One master these investments need to be planned within the framework of the plan.
What is your market share in Turkey? We have a 60 percent market share in syringes in Turkey. A part of our annual turnover of around 20 million dollars comes from 6 million dollars from exports.
What can you say about your exports?
Set Medical syringe, insulin syringe, hipodermik It has a significant production capacity in groups such as needles, insulin pen needles and exports to many countries in the world. Pandemiyle together especially in Europe, especially in the recent period at the point of vaccine syringe; we supply many manufacturers around the world. Our cooperation negotiations with the U.S. and our market infrastructure preparations continue to accelerate. We are tying very strong long-term contracts from Europe and the USA. Europe and the US now come from a single source Supply from other countries by finding it risky of As an alternative to China, it turned to quality, uninterrupted supply sources. One of the strongest candidates here is Turkey. This is an opportunity for our industry. We are currently exporting to 45 countries. Among these countries; Germany, France, Poland, Spain, Algeria, Iraq, Azerbaijan, Uzbekistan, Turkmenistan, Greece, Ukraine, Russia, Qatar, Saudi Arabia and the UAE.
What's in your product line?
We have a wide product profile. We have nearly 40 syringe types. Our product group; 2p Syringes, 3p Syringes, 50ml Syringes, 50ml (Perfüzyon), Insulin and Tuberculin, Dental Syringes, Vaccine Syringes, Veterinary Syringes, Hats Lock Şırıngalar, Hipodermik Needles, Insulin Pen Needles, Serum Set, Extension line, IV Kanul products. We are the only ones who produce some syringes such as locked syringes and feeding syringes in Turkey. Our goal is to be a company that can produce all kinds of syringes in the region.
You are a company that respects the environment...
Yes. In addition to the quality of SET Medical products, it always prioritizes the most efficient and sensitive methods to the environment, human and nature from production to the end user. Our company, which respects the environment in the use of natural resources, does all the necessary work by providing recycling that will prevent and reduce the amount of waste, protects the environment, attaches importance to occupational health and safety. Adopts and implements customer conditions and demands with environmental awareness.
SET Medikal, which is in a leading position with its strong dealer network spread throughout Turkey, is in the world market; Being the preferred brand in Europe, Asia, Africa, the Middle East and Latin American countries is the result of the value it attaches to people and the environment. By investing in its strong technical capacity and knowledge, it offers fast, economical and quality solutions to its customers with R&D, production, purchasing, warehouse, marketing, sales and shipment without compromising health, safety and environmental factors. With its new identity, SET Medikal aims to be a universal brand that comes to mind first in the international market.
Can you tell us about your Industry 4.0 studies?
We started Industry 4.0 studies in 2018. In this sense, we made a situation analysis. We measured our level. And our goal is to complete Industry 4.0 in 2022. We have made all our machines available for information from a center. The next stage is the entire production dijitalize to be fully automated. Here too, we have passed a certain stage, we are moving step by step.
How do you evaluate our country's health system and medical device sector?
In order for the Medical Device Industry in our country to develop, domestic production should be encouraged. At this point, as the biggest buyer, we appreciate the efforts of our state. However, this is not enough at this point. Especially where the lowest price is given, the price is not the quality, but the öncelendiği we can't achieve this with a purchase policy. A strategic master plan, purchase guaranteed, we must reveal the producers who will make quality production with a model and stand on their feet at the end of a certain period. Of course, production should be aimed at a level that can compete with the quality and the world. We should not forget that while a quality medical device saves lives, a product of poor quality can als