Medikal Export Ocak'12

ACTUAL

Medical Devices and Equipment Sector in Turkey

2 > January 2012

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edical devices and equipment sector is one of the sectors which increased its external trade and production capacity very quickly in recent years.

Considered among advanced technology sectors, medical sector makes innovations in its product portfolio in parallel with its fast improvement in the last years. Even though local production, research and technology is not at desired level, new product manufacturing capacity of the sector is increasing day by day.

Having a constantly increasing product diversity, medical sector covers following product groups: medical imaging systems and devices, operating room devices, respiratory equipment, surgical devices and equipment, dentures, catheters, cannulas, furniture and accessories used in surgery and dentistry, other artifical parts of body, electro diagnostic devices, ozonotherapy, oxygen therapy, other therapic devices and accessories, furniture used in dentistry, mecanotherapy, massage, psychotechnics and test devices, dentistry-specific devices and equipment, sterile catguts, similar sterile suture materials and hemostats, devices and equipment used in eye surgery, dentist lathes, medical/surgical and laboratory sterilizers, x-ray devices and artificial joints, prosthesis and orthesis, sound and hearing instruments, optic medical devices, disposable consumables, radiotherapy systems, physical therapy devices, biochemistry, molecular biology, hematology, genetic and microbiology devices.

Product range manufactured in Turkey are: stone breaker devices, operation tables, operation lamps, anesthesia devices, bed-side monitors, electrocautery, gynaecologic tables, surgical aspirators, oxygenation devices, xray devices, steam and dry air sterilizers, bloodletting chairs, medical gas systems, centrifuge, mixers, patient beds, stretchers, dentist units, hardware and software for hospital information system, surgical equipment, tubing set used in heart and vein surgery, cardioplegia sets and cannulas, drainage tubes, intracet, stent, catheter and probes, blood pressure transducers, i.v. set, blood and blood products, bloodletting and blood transfusion sets, blood bags, operation and examination gloves, suture yarns, operation clothes, catgut, gauze bandage and cotton, orthopedic prosthesis, orthopedic repair materials, x-ray bath solutions, repair materials for dentistry, syringes, injections, medical masks, incubators, centrifuges, water distillation devices, blood keeping refrigerators, climatic test cabins, elastic bandages, bio carriers, defibrillator, hydrophilic urinary catheter, surgical sutures and serum sets.

In Turkey, number of companies operating in this sector increased in the last years. Yet, number of companies conducting production and export is still limited. Sector representatives state that there are approximately 6000 companies in medical sector and that more than 2500 companies among them are suppliers. Approximately 100 companies of 450 middle and big sized companies of the sector are producers and exporters. They conduct their production operations with a wide product range.

These companies are generally in İstanbul, Ankara and İzmir. Yet, medical product groups have been started to be produced in other cities as well, including Samsun.

Medical sector of our country gained momentum with January 2012 > 3

ACTUAL 5. There is a qualified and quality manpower in our country and their fees are relatively low.

Weak Sides 1. Medical devices and equipment are usually imported.

2. Biomedical engineering services are insufficient with regard to maintenance, repair and calibration of current medical devices and equipment.

3. Production of local medical devices, equipment and consumables is insufficient (about 15%).

4. Production is conducted at certain regions and in limited amounts, high foreign-dependence in terms of semiproducts or raw materials. Prepared by: Fatih Saraç.

5. Current medical devices and equipment are not used efficiently, unnecessary or improper devices are purchased because of lack of planning and coordination.

6. Supervision is not appropriate and sufficient with regard to the production, certification, sale and import of medical devices and consumables.

7. Research& Development studies related to the sector are not sufficient because of weakness of universityindustry relations.

8. Employment and personal rights of user personnel are not sufficient. improvement of Turkish health sector, increase in the number of new and private hospitals, increase of quality health service demand, technological innovations and other factors. Companies operating in the medical sector in Turkey plan to establish their own quality systems and to have them certified in order to meet customers’ expectations, improve their efficiency, be successful within EU harmonization process and to establish legal requirements. TS EN ISO 13485 standard is an international standard which covers quality management conditions for medical devices. Established on the process model of ISO 9001: 2000 standard, TS EN ISO 13485 is compatible with other management systems including TS EN ISO 14001 and TS 18001 (OHSAS). TS EN ISO 13485:2003 standard was prepared to replace TS EN ISO 13485:2002 and TS EN ISO 13488:2002 standards.

It is observed that most of the companies in the sector carry CE mark together with this standard. In addition to GMP and GHP standards, it is also observed that there are certain companies in Turkey which hold FDA and TGA certificates which are required by countries including USA and Austria.

Sector Analysis Strong and weak sides of Turkey in medical devices, materials and equipment sector& threats and opportunities

Strong sides: 1. Our country has a young, crowded and dynamic population willing to use information technologies.

2. Communication infrastructure of our country is new and modern.

3. We have universities with high education quality.

4. There are companies which produce medical devices, equipment and materials even though they are small scaled.

4 > January 2012

Risks 1. In case Turkey becomes a member of the European Union, independent technological improvements might be restricted.

2. Employment and personal rights of user personnel are insufficient.

3. Users don’t believe in local producers and local products.

4. Convenient job and pricing opportunities are few. In addition, competent and qualified people seek going abroad or they become obliged to work in another area.

Opportunities 1. Turkey participated in 6th and 7th frame program of the European Union, therefore Turkey will be able to cooperate with companies and universities in European countries with regard to research & development, and our country will be provided with financial resources in this regard.

2. Our citizens who are working abroad and who are specialists in their fields can contribute to the sector directly or indirectly.

3. There is a market potential with a local and natural volume as a result of our young, dynamic and crowded young population.

4. Qualified manpower is available in medical devices and equipment sector to design new technologies.

5. There are few companies that produce medical devices, materials and equipment, which have knowledge in this regard.

6. Fields such as bioengineering, biocompatibility, tissue engineering are still open for improvement for foreign countries.

7. There is the opportunity to utilize from investments made in defense industry, and companies which conduct high technological production

ACTUAL GRANT AND SUPPORT PROGRAMS TOWARDS

Turkish Industry

8 > January 2012

TUBITAK Supports Industry R & D Support: The projects having the qualification of R & D are supported which are carried out in the subjects of the production of new products with R & D Support, and of the development of the new cost-cutting and quality standard raising techniques and the new production technologies.

R & D support covers up the phases from the concept development phase to the end of the trial production, in other words to the pre-production / pre-commercialization phase. The personnel, the acquisitions of tools / equipment / software / publishing projects, the R & D activities which are made by the domestic R & D organizations, the procurement of consulting / service, the material costs, and the expenses of patent which are deemed to have R & D qualification can be supported for maximum three

years on the basis of the project, up to the rates of 60%, and as non-refundable. The level of basic support is calculated based on the R & D intensity of the organization (the Ratio of the value of the R & D Operating Expenses in the detailed income of the organization to the statement of net sales).

EUREKA: It is a network structure which was created for encouraging the research and the development of the advanced technologies, the products, and the services which will increase the competitiveness of the companies, the universities, and the research institutions in the European countries in the world markets, and the creation and the execution of the international joint projects.

All companies may apply to the EUREKA program regardless of their sizes and sectors. In order to start a EUREKA project, it is sufficient at least two participants of EUREKA member countries to come together. EUREKA is a correct address for the companies, especially which want to open up foreign markets and which have the purpose of the transfer of technology leveraging the accumulation of the technological knowledge in Europe. 60% grant assistance is provided to the projects of the Turkish firms which participate in the EUREKA projects. The projects of the firms which participate in the EUREKA projects are supported with the highest rate of support within the scope of TÜBİTAK Industrial R & D Support. In addition to that, there is not any restriction in the period of support to the projects.

SME R & D Funding Program: It is intended with the SME R & D Funding Program that the first two projects be supported by TUBITAK, which are limited to YTL 400,000 budget and 18-month period, conducted by the SMEs in the areas of the production of a new product, the development and the improvement of an existing product, the upgrading of the quality or the standard of the product, or the development of the new techniques and the new production technologies which are cost effective, in order

to ensure that the SMEs overcome their problems. It is aimed with the support of the projects to be provided under the program that the SMEs to be more competitive by developing their capacity of technology and innovation, to be able to carry out projects systematically, to be able to develop products which have a high added value, to have the institutional research and technology development culture, and to take place in the national and the international support programs more effectively.

Technopreneurship: Real persons may apply for the program who are the undergraduate students that are expected to graduate within one year from any undergraduate program of the universities providing formal education, and who are the graduate or the doctoral students, or who got one of the bachelor, the master's or the doctorate degrees up to 5 years prior to the date of the pre-application. Under the program, it is envisaged that after the entrepreneurs found their companies, the expenses of personnel, materials, tools / equipment / software, travel, consulting, and the procurement of services, the rent of the office and the water, electricity, heating and communication costs of the office to be supported by TUBITAK at a ratio of 75%, and up to maximum YTL 100,000 and for a period of one year.

Contact Information for TUBITAK supports: Address: Atatürk Bulvarı No: 221 06100 Kavaklıdere / Ankara Tel: (312) 467 18 01 Fax: (312) 467 32 95 E-mail: teydeb@tubitak.gov.tr Web Address: www.teydeb.tubitak.gov.tr

Supports of the Turkish Technology Development Foundation TTGV R & D Support: The Technology Development Foundation of Turkey, the TTGV, which was established January 2012 > 9

ACTUAL in order to develop and strengthen the technological infrastructure of our country, and to contribute to the increase of the competitiveness of the Turkish industry in the international markets, provides long-term credits up to a maximum of 50% of the amount of the project, to the technology development projects carried out by the company, in a way that the know-how will stay in the company, within the concept of "the technological product and process innovation" conducted by the industry associations and the software companies,. To date, the TTGV provided support in the amount of 95 million U.S. dollars to a total of 240 technology development projects through Technology Development Projects Support.

Contact Information for TTGV supports: Address: Cyberpark, Cyberplaza B Blok Kat :5-6 06800 Bilkent / Ankara Tel: (312) 265 02 72 Fax: (312) 265 02 62 E-mail: info@ttgv.org.tr Web Address: www.ttgv.org.tr

to the products and / or the sectors of the companies and / or the SDSs, b) The reports and the statistics of market research to be purchased from the institutions and / or the organizations which provide market research services, and which are approved by the Undersecretariat, for the purposes of creating marketing strategies and action plans towards foreign markets, c) The participation in the sectoral trade delegation programs which are coordinated by the Undersecretariat, and performed on the basis of a single sector, d) The costs of the membership to the e-commerce sites, which are approved by the Undersecretariat, and which are not oriented towards the final consumer, for the purposes of marketing their products in the electronic media towards the foreign markets are supported.

Educational Assistance: It is intended to meet the 50% of the expenses of the SMEs, and the 75% of the expenses SDSs for maximum 3 months with regard to the training activities to be conducted, which are in accordance with the standards to be determined by the IGEME, and regarding exclusively the foreign trade issues. Support may be requested for a total of 6 training programs, 3 for the domestic programs, and 3 for the overseas programs.

Contact Information for IGEME supports: Address: Mithatpasa Cad. No: 60, 06420 Kızılay – ANKARA Tel: (0312) 417 22 23 Fax: (0312) 417 22 33 E-mail: igeme@igeme.org.tr Web Address: http://www.igeme.org.tr

KOSGEB Supports Various support programs have been developed by the Office of the Chief of the Small and Medium Sized Industry Development and Support Administration (KOSGEB).

Related programs are listed below. Detailed information can be accessed via the mentioned links.

1. Consultancy Support, 2. Support for Entrepreneurship, 3. Education Support, 4. Technology Supports, 5. Industry and Property Incentives, 6. IT Support, 7. Quality Improvement Grants, 8. Market Research and Export Development Incentives, 9. Support for the Development of the International Cooperation, 10. Regional Development Supports.

The Supports Provided by the Export Promotion Studies Center (İGEME) Support for the Market Research and the Marketing: 4 different activities are within the scope of the support. In this context; a) The market research projects carried out in relation

10 > January 2012

Supports of the Undersecretariat of Foreign Trade Assistance with regard to the Support of the Environmental Costs: Only the costs of certification at a ratio of 50% can be supported in providing the documents of ISO 9000, ISO 14000, CE mark, and the other quality and environmental documents which are international, in order to increase the competitiveness of the SMEs in the international markets, and to ensure compliance with the technical regulations of environment, quality and human health. Expenditures should be documented and the documents should be provided by the Turkish Standards Institute or by the accredited institutions.

Its Activities towards the Branding of the Turkish Products in Foreign Markets and the Establishment of the Image of the Products Made in Turkey The companies will apply directly to our Undersecretariat with a project including activities of branding. The Turquality Committee is authorized for opening Turquality stores and for the use of the phrase, Turquality-from Turkey. Providing seven types of support is envisaged within the scope of the notification numbered 2003 / 3.

Detailed information about the mentioned supports can be accessed via the web site of the Undersecretariat of the Foreign Trade.

Contact Information for the supports of the Undersecretariat of the Foreign Trade Address: Inonu Bulvarı, 06510 Emek – Ankara Tel: (0312) 212 88 00 Fax: (0312) 212 88 81 Web Address: http://www.foreigntrade.gov.tr

The Unions of the Exporters It is required to apply to the Union of the Exporters to which the province where the exporter is located is connected, in order to apply for the supports provided by the Unions of the Exporters.

Assistance in Opening Offices-Stores in the Foreign Markets, in their Operation, and in Brand Promotion: Supports are provided to the companies within the framework of the provisions below within the scope of the mentioned support.

• Providing Support to Opening Offices, Warehouses, and Stores in Foreign Markets for the Purposes of Making Sales under its Own Name and Brand in Foreign Markets, • Providing Support to Opening Branches in Foreign Markets in order to Operate as a Broker for the Trade of Goods in Foreign Markets, • Covering the Expenses of the Representation / Distributorship, • The Assistance of the Domestic Trade Fairs, the Nature of which is International, • It is defined as the support provided for the purposes of the international promotion of the domestic trade fairs, the Nature of which is International, and of increasing the participation at the international level. In this context,

a certain ratio of the expenses with regard to the activities of promotion and incentive which are performed before and during the fair by the local organizers, which are in conformance with the criteria to be determined by the Undersecretariat of the Foreign Trade, is covered by the Support and the Price Stabilization Fund.

Support of the Participation in the Foreign Trade Fairs: 65% of the amount paid by the participant to the organizer assigned by the Undersecretariat to arrange the organization of the international fairs is reimbursed to the participant. The amount of the support cannot exceed 10,000 U.S. dollars, in case that the international fair is National Registration, the nature of which is general, or is the Turkish Export Products Fair, and cannot exceed 15,000 U.S. dollars, in case that the international fair is National Registration, the nature of which is sectoral, or is the Sectoral Turkish Export Products Fair. In case of individual participation in the international fairs, the nature of which are sectoral, and which are determined by the General Secretaries of the Unions of the Exporters, and which are deemed appropriate and announced by the Undersecretariat of the Foreign Trade, after obtaining the opinion of the Executive Committee of the Turkish Exporters’ Assembly; For the international fairs, the nature of which are sectoral, 65% of the rent for the empty stands, and 50% of the expenditures of transportation, which do not exceed 15,000 U.S. dollars, are reimbursed; and in case that the participant participating in the international fairs, the nature of which are sectoral, owns a Sectoral Foreign Trade Company (SDS), all of the rent for the empty stands, and 75% of the expenditures of transportation, which do not exceed 15,000 U.S. dollars, are reimbursed.

January 2012 > 11

ACTUAL

2023 Export Target

5

12 > January 2012

Billion Dollars

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edical devices and surgical instruments manufacturing sector announced its target for the 100th anniversary of the Republic of Turkey.

The president of the Samsun Medical Industry Cluster Association (MEDİKÜM), which was founded by approximately seventy companies which came together, Dr. Ahmet Aydemir, announced in a statement that they aim to export 5 billion U.S. dollars in 2023.

The 4th Congress of the National Medical Equipment Manufacturing Industry in Samsun has attracted great interest. The congress to which many local and foreign scientists, company managers and industry representatives attended, added a separate vision and excitement to the medical industry which is clustered in Samsun. MEDİKÜM, which made an evaluation meeting after the Congress, set a target to export 5 billion U.S. dollars in 2023, which is the 100th anniversary of the establishment, hoping to overcome its problems.

The president of the MEDİKÜM, Dr. Ahmet Aydemir said that they will contribute to the achievement of Turkey’s export target of 500 billion U.S. dollars in this significant year, and they are ready to realize their goals, as an association. "In case that the medical production sizes are provided and supported, and the physical working conditions are improved, it is evident that a locomotive sector can be created towards shooting down the imported inputs and reducing the current account deficit. In case that we are supported as a sector, we are ready to perform 5 billion U.S. dollars as the medical sector in the target of exports of 500 billion U.S. dollars," said Dr. Aydemir, The president of the MEDİKÜM, Dr. Ahmet Aydemir, pointing to the importance and the volume of transaction of the medical devices and the surgical hand tools sector in the world markets, and to the value added which countries gained by that sector, said that the situation is not very bright for Turkish businessmen.

Voicing that they expect that their problems will be resolved, Dr. Aydemir said that "The absolute improvement of the physical working conditions of the medical industry is extremely important to increase productivity and production. For that reason, we definitely need Medical Specialization Organized Industrial Zone. Emphasizing vocational education is important in terms of employment, in order for the young labor force in the Republic of Turkey to take place within sustainable economy with added value, and for the creation of the skilled workforce. One of the two people is working in the health sector in Germany. Why not in Turkey?".

Underlining that capturing the desired quality with the manufacturing technology which is used today is not possible, Aydemir used the following expressions, "Technological machinery investment is needed in order to ensure quality. When considered in conjunction with the integrity of the industrial sector with the health services, in a period in which the employment is decreased due to the technological renovation of the industrial sector, it creates a multiplier effect in employment.".

ACTUAL

EMSAS serves with 36 years of experience

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roducing ‘Medium and High Voltage Power Supplies’ mainly in 1975 EMSAS Inc. was founded in Izmir-Turkey, it serves Electric organs and institutions in Turkey.

Customer-Focused We continue production in the heating, cooling and medical sectors with 36 years of production and technology experience.

With its expert staff the company serves in a way of customer-focused service, which serves individually, timeless, unlimited by emphasizing on developed technology, research and education and customer satisfaction objectives are superior of all the company’s.

Solution Partners provide set up a blood laboratory Providing all needed equipment of the blood laboratory safely EMSAS aims to be solution partners of you.

Our products have the thermal printer with RS232 port to transfer to the computer and double-probe feature optionally. In addition, there is warning system in case of power outages and system failures.

Certified Quality The company has TS EN ISO 13485:2003 quality system and EN ISO 9001 CE certificates in ISO certification system.

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ACTUAL

Hygiene steht für uns an erster Stelle Gerade in sensiblen Bereichen wie Krankenhäusern und Arztpraxen sind Hygiene und Desinfektion von höchster Wichtigkeit. Wer möchte schon gern in unsaubereren OPs mit nichtsterilen Geräten operiert werden oder sich in einer Praxis unliebsame Viren einfangen.

Genau hier setzt ACTO GmbH mit einer breiten Palette an Hygieneund Desinfektionsmitteln an.

ACTO GmbH ist ein wichtiger Hersteller für Desinfektions und Reinigungsmittel im medizinischen Bereich//ACTO GmbH is a major supplier of disinfectants and cleaners used in the medical sector

18 > January 2012

ereits seit 13 Jahren ist ACTO in einem sehr sensiblen Feld unterwegs, denn Hygiene und Sauberkeit kann man nur durch die konsequente Anwendung passender Reinigungsmittel erreichen. „Wir arbeiten eng mit Forschungslaboren zusammen, um Produkte zu entwickeln, die höchsten Hygienestandards genügen“, sagt Verena Russ, Assistentin der Geschäftsleitung. So umfasst ACTOs Portfolio Desinfektionsmittel für Haut und Hand, Reinigungsmittel für Kliniken und Praxen sowie Reinigungsmittel für DialyseGeräte und anderes medizinisches Zubehör. „Auch Blutbeutel, Katheter und Instrumente für den Zahnarzt müssen entsprechend gereinigt und desinfiziert werden“, unterstreicht Verena Russ. „Wir bieten die richtigen Mittel.“ Die Produkte werden je nach Anwendungsbereich mit und ohne Alkohol angeboten, wobei mit den alkoholfreien Mitteln selbst Acryloberflächen gereinigt werden können. ACTO bietet zudem die neuste Generation von Mitteln mit Polyhexaniden zur Wundheilung. „Wir sind auf wichtigen Messen vertreten, um unseren Kunden die Qualität und die Wirkung unserer Produkte näherzubringen“, sagt Verena Russ. „So sind wir im November auf der Medica in Düsseldorf, wo Polyhexanide ein Hauptthema für uns sein werden.“ ACTO ist für die Entwicklung und den Vertrieb zuständig, die Produktion übernehmen die ACTO GmbH oder Partnerfirmen. Langfristig ist der Vertrieb in den Niederlanden, Spanien, Italien, der Türkei und in Großbritannien ein vorrangiges Ziel für Eigentümer Ahmed Kilic und seine 50 Mitarbeiter. ACTO ist flexibel in der Produktauswahl und passt seine Palette immer wieder aktuellen Themen an. Neu hat das Unternehmen Kosmetika und Produkte für die Nagelmodellage ins Programm genommen. Alle Produkte werden unter eigenem Namen vertrieben, können aber auch im Auftrag hergestellt werden. Hygiene bleibt dabei immer oberstes Gebot.

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Hygiene always comes first In highly sensitive environments like hospitals and surgeries, hygiene and disinfection are of paramount importance. No one wants to be operated in unclean operating rooms or contract an awkward virus at the surgery.

ACTO GmbH has found appropriate solutions for these situations and provides a vast range of hygiene and disinfection products.

or almost 13 years now, ACTO has been acting in a sensitive sector, where hygiene and disinfection are only to be achieved through the consistent use of cleaning materials. “We closely collaborate with research laboratories in order to offer products which comply with the highest hygiene standards in the market,” points out Verena Russ, assistant of the management. Consequently, ACTO’s portfolio includes disinfectants for hospital and healthcare environments as well as cleaners for dialysis machines and other medical equipment. “Likewise, blood bags, catheters and dental equipment must be cleaned and disinfected thoroughly,” stresses Ms. Russ. “We are able to provide appropriate products.” Depending on the field of application, ACTO’s products are available with or without alcohol. Alcoholfree disinfectants can also be used for cleaning acrylic surfaces. In addition, ACTO provides a new generation of polyhexanide disinfectants for wound treatment. “We are present at influential fairs in order to demonstrate the quality and efficiency of our products,” points out Ms. Russ. “In November, we are going to exhibit at the Medica in Düsseldorf, where polyhexanides will be a key topic for us.” ACTO focuses on R&D and sales, while the actual production is taken over by ACTO GmbH or partner companies. For owner Ahmed Kilic and his team of 50 employees, distribution in the Netherlands, in Spain, Italy, Turkey and the UK is a prime objective for the future. ACTO is highly flexible in its product selection and constantly adjusts its portfolio to current market trends. From now on, cosmetics and products for nail modelling complement the portfolio.

All products are distributed under ACTO’s brand name, however, the company takes on contract manufacturing on request. Nevertheless, hygiene remains its guiding principle.

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ACTO GmbH Büchnerstrasse 11 38118 Braunschweig Germany Phone: +49 531 239508-0 Fax: +49 531 239508-11 info@actogmbh.com www.actogmbh.com www.actoshop.com

January 2012 > 19

ACTUAL

Vacuumed Surgical Positioning Mattress&Cushion

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RGİFORM Vacuumed Surgjcal Positioningjyiattress & Cushion • Its fixation feature enables optimum admission to surgeon for surgical operation area by vacuuming its "Safe Application" System.

• Patient position is provided reliably and in a short period.

• Excessive grading of operation table does not impair ArgiForm's area pressure distribution and the patient position.

• When it is desired to change patient position, the application can be made easily and in a short time.

• The patient can be transferred betvveen clinics vvithout changing the position of patient.

• Safe Fixation • Excessive Grading Tolerance • Fastand

Side Position Half-Side Position Back Position Sitting-Half Sitting Position Bend Position Lithotomy Position Laparoscopic Position • Radiation Oncology • Argiform option appropriate for ali clinics • Product variety appropriate for personal reguirements

Argiform Vacuumed Surgjcal Position Mattress And Cushion • Argiform is a product created by technological and scientific studies of physiotherapists, dermatologists, surgeons and anatomy experts as a result of laboratorial and experimental studies for a long period as well as research and development performed.

• Argiform provides stabilization, temperature maintenance and micro-circulation required by skin and tissues by means of millions of special polystyrene particles inside.

• Argiform minimizes contact pressure of patient body and provides this pressure to be distributed equally to the ali spots of body.

• Argiform accords with the body of patent ergonomically and preserves body temperature.

• Argiform removes complication risk by meeting postoperative and long-period position comfort utilizations in ali surgical positions and it prevents deformatio.

• Argiform makes doctor, patient and operation team to gain safety and time.

• İt provides Maximum Fixation comfort. İt prevents decubitus skin ulceration. İt preserves body temperature. İt prevents complications. İt provides patient and user comfort.

ArgiForm Pump İn hospitals not having vacuum systems, vacuum can be made to the admission area by means of an appropriate pump.

Using ArgiForm: • ArgiForm is spread över operation table.

• When desired, sterile drape or sterile green cover can be spread over.

• Optionally, it is cleaned with disinfectant.

• Desired position is given to patient on ArgiForm.

• ArgiForm is shaped as to the position of patient.

• ArgiForm hose is connected to central vacuum system or vacuum pump. The valve is kept open.

• The stability of patient position is provided now.

• The valve is brought to OFF position.

• When it is desired to change the position of patient or when the operation is finished, vacuum switch is opened again to give it free form. İt does not include latex. İt is suitable for having CT and MR. İt has extensive product options.

ArgiForm meets ali surgical procedures required for positioning patient distinctively. There is alvvays an ArgiForm variety for ali kinds of surgical position. When desired, special size manufacturing can be done. You can see samples and their sizes on the side page.

20 > January 2012

ArgiForm Vacumed Operation Cushion İt has the ali advantages of Surgical Position Mattress; it is just designed for head area positions. İt is ideal for fbcation of Head or Neck area positions.

Emergency Vacuum Strecher It is produced as regarding ISO 9001:2000 quality standartsIt is used to move patient in accidents safety and comfortable. When the air inside the strecher is vacuumed by ‘valve ten ‘pump ,the strecher becomes in the shape of the patient’s body like a taft crust. It provide to take the patient to hospital without any damage by surrounding his/her body as a plaster bed. It is used for the people who injured seriously and have trauma.

Specifıcations It grants support without causing an extra trauma.It stabilizes the body by fitting in with every patient’s body.It X-Ray visible.By the help of 4X2 PCS clips for carriage it can be used as a strecher in every vehicle.Its inside is made of Polystyrene granules.Outer surface is made of Polyurethane fabric.

What is Decubitus?

Decubitus is a damage form caused by a longtime pressure onto skin and tissues under skin. İt is proved in scientific studies that decubitus risk appears after 10-20 minutes under increasing pressure. İt means pain, insulation and decrease of life guality for patient.

Positioning on Operation Table and Decubitus Especially during surgical processes, Acute Decubitus skin ulceration, paresis and bed pain risks appear. This risk is high on ali longtime surgical processes reguiring position.

ArgiFix Raney Plastic Scalp Haemostasis Dip, Steril Raney Clip Is Produced To Control The Bleeding T Hat Occurs As A Result Of The Tear And Perforation In The Scalp.

• Packages whıch are made to stop the bleedıng are composed of 10 sterile pieces.

• The product which has a good design is manufactured from asmooth, non-sharp plastic.

• The routine production color of the product ıs white. Hovvever, optionally other colors can be used.

ACTUAL

The time of T ‘Turkish Goods’ in the Medical Sector

urkish healthcare sector is progressing quickly.

The policy of the state foresees to let the private sector the sector to get acceleration. The development in the healthcare sector affects the medical devices in a positive way. The yearly volume of the medical sector accounts for worth $6 billion.

Still we meet 90 percent of the medical devices by imports. However, Turkey takes place in 30 countries which need medical devices mostly. In other words, the market has a huge potential but domestic made production is limited. In terms of the value added of medical devices’ sector takes top-tier. For example, a pair of

22 > January 2012

scissors which is used in the ocular surgery costs $5 dollar. But such a device can be sold by high brand value owners in $150-200 dollars. For this reason, the sector, which has a high value added, features a great importance in terms of domestic production. Actually both the Ministry of Health and representatives of the sector have awareness of this reality. Even though there are no special incentives for the sector, the foremost domestic investments have been carried out in recent years. Some of them characterize as breakthrough the investments include many things…

Turkey has begun to produce the first cataract lens,

first stent two years ago. In the scope of the surgical devices, the province of Samsun has achieved to be a talent. In the optical sector the investments are being carried out to cut the imports. But these are not enough. Still there is lots of way to be taken.

300 kinds of products According to the report prepared by Medical Council of the TOBB, the medical devices sector shelters over 300 thousand products in its structure. The sub-branches of the sector consists of medical imaging system and devices, all devices in surgery department, respiratory devices, surgical devices and tools, prosthesis teeth, medicine, furniture and parts which are used in surgery and dentistry, electro diagnosis devices and parts, tools and devices in dentistry, sterilized sewing materials, medical devices and tools related with eye, dentistry revolver, X ray devices, artificial joints, prosthesis, sound and auditory devices, optical medical devices, single use consuming matters, radiotherapy systems, physical treatment devices, biochemical, molecular biology, hematology, genetic and microbiology devices.

In Turkey there are nearly 1000 medical device producers. 700 of them are both producers and exporters.

One of the features of the sector any state-run establishment does not take place at all, completely the sector is in the hand of the private sector. The medical material production intensifies in the provinces such as in Istanbul, Ankara, and Izmir.

SMEs undertake

In order to reduce imported goods’ domination in the medical sector, investment action has been started. The period of ‘Made in Turkey’ has been launched in many products ranging from stent to catheter, optic to surgical devices.

According to the report of the TOBB, the medical devices sector has a great importance in Europe. SMEs carry the sector in which nearly 11 thousand producers act. 80 percent of the producers in Europe characterize as SME. Prior to the global economic crisis the growth of the sector reached up to 6 percent per annum. Still employing 530 thousand people across Europe, the sector’s total growth reached by 80 billion euro. Onethird of the medical market in the hand of Germany in Europe. This is followed by the UK, France, Switzerland, Italy, Romania and Sweden respectively.

Incentive is a must In order to enable the sector to grow, R & D studies attract a great attention. In fact, the firms in Europe spend 8 percent of their revenues per annum in R & D investments. In Turkey, the producers, which have difficulty for the high technology, began to allocate resource for R & D. Before, while the sector which was oriented and developed by the health professionals’ wish and recommends, now the qualified engineers and designers have began to join the structures. No doubt, there is a big share of R & D incentives in this development. But, the incentives of R & D are not enough for the development of medical sector. The representatives of the sector January 2012 > 23

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want installing of organized industrial zone in the health sector, as well as15 percent support in favor of the domestic producers in the public purchasing. This incentive finds its return in the application like this. For example, a domestic producer and importer firms bid for the same tender. The domestically producer even offers 15 percent higher price in their tender; the public bodies are advised to buy from the domestic-made firm. But this incentive does not find much sympathy in application. Here are the bravest investors of the medical sector ranging from optic to stent, prosthesis to auditory device.

Problem of auditory devices is wrong perception In Turkey, nearly 25 thousand auditory devices are sold.

The turnover of it is guessed some TL25 million. The biggest buyers of these devices are Social Security Organization, in other words the state. In fact, this is a very low figure in a 70 million populated Turkey. In Denmark where has the population of 4 million, 70 thousand auditory devices are sold.

In the developed countries auditory devices are used like an eyewear as an accessory. As for us, regarded as a sign of disabling condition, its use rate is low. Of course, purchasing power parity of human beings affects buying of the devices.

SOCSO pays TL420 per auditory device since the beginning of 2008. However, the average price of the devices is between TL700 - 1000. In Turkey, there is not 100 percent domestic made production in auditory devices.

There is semi-assembling. The certain parts of the device are brought abroad and mounted in Turkey. One 26 > January 2012

of the firms which work in this way is Esenler Company Group, the owner of Odiomed brand.

Beginning the work by imports in 1983, Esenler Group produces its devices as semi-mounted since 2006 at its center in the district of Şişli. Importing various parts of the loud speakers, microphones from Germany, Switzerland and the UK and then mounts, the firm sells the devices under the name of Odiomed. The firm sells the devices not only in Turkey, but also in Cameron, Syria and Nigeria.

Dr. Murat Esenler, Chairman of the Board of Esenler Companies Group stressed that they produce and sell peculiar to person. Esenler said, “We sell VIP auditory devices. These devices are not seemed from outside featuring computerized and digital. Their prices range between 500 and 5000 euro in the domestic market.”

Esenler Group also brings parts of the devices for tinnitus from Germany and mounts to sell. Esenler believes that the market would grow more by the increase of awareness of the devices in Turkey.

“Still 25 thousand devices are sold in Turkey. The developed societies use the device as an eyewear. In Turkey many people do not use the device saying “I’m not disabled”. In Anatolia, even many people do not know this device. When the necessary awareness is provided, I guess the market will reach by 350 thousand units within 5 years. There is also newly awareness in the markets of the Mideast and Africa. Turkey will be also a sale base for these markets.

Surgical Device Base: Samsun 300 thousand kinds of medical materials are used in the healthcare sector. As for surgical devices 14 thousand kinds of products are made in 27 branches. Turkey has begun to get an outstanding way in the surgical devices’ market in recent years. Samsun has become the third surgical devices’ production base of the world.

Before Samsun there are Tutlingen, Germany and Sialkot, Pakistan. In this business, the German Aeslulap is the number one producer of the world.

In Samsun, currently some 30 firms produce surgical devices. The leadership of this work has been undertaken by Bahadır Tıbbi Alet Cihaz Sanayi ve Aygün Cerrahi Aletler. In fact, these two firms’ stories are the same in this business. While their founders were master in arm making, in the course of time, they began to make medical devices. Bahadır Medical Devices Executive Board Chairman Hasan Bahadır summarize their story by saying; “We are from Trabzon. My father Hasan Bahadır was a blacksmith master. He used to make arms in Trabzon. After migrating to Samsun, maintained blacksmith work and arm work. He began this work at a workshop of 10 sq meters. He ran his works together with his nephews. In the 1980s, when device reduction began, my father had said “we make this

ACTUAL credit worth TL44 thousand from KOSGEB in 2009. Currently they maintain their business at their workshop locating on an area of 270 sq meters. Metin Cansu emphasized that they work on order having production capacity of 15 thousand unit surgical devices yearly.

Mefa sell ophthalmic scissors, tissue scissors to the private hospitals and medical firms. Cansu said, “As long as human beings have been in existence, our sector to be in existence. When human being lie on the surgical table absolutely these devices will be used. In the state tenders there is interest in the foreign firms, but domestically producer firms are also supported.”

Domestic-made cataract lenses

work” and started the work. In the course of time we have expanded our production space up to 11 thousand sq meters. Currently 150 employees work at our company. As for our turnover per annum is some $6 million.”

350 kinds of scissors are used in surgical process. All of them can be produced by the masters in the province of Samsun. There is no problem in quality. However, it is not possible to say that Samsun is a brand sufficiently in this area. Especially, the German firms let their devices produce in Turkey and sells in the world by their own brands. For example, a pair of scissors which is used in the eye surgical can be made $5 dollar in Samsun. As for their retail sales reach by $150-200 dollars. so this situation makes Ahmet Bahadır, as a producer, sad so much.

“Germans are the brand in this work. We have not still become a brand. We try to make production and marketing together. But it is not possible to be both producer and seller. We work apart from university. However, the firms as us should be in the techno-park of universities. We experience lack of qualified staff. If Samsun will be a brand in this work, a healthcare organized industrial zone must be made up. In order to be a brand in this work, state, university and industrialist should work together and cooperate their power.”

Apprentice-Master-Boss The surgical devices’ production is based on handiwork rather than technology. For this reason, apprenticemaster relation is very crucial in this work. Actually most of the entrepreneurs in the sector first had worked in Bahadır and Aygün companies then they set up their own businesses. Just Mefa Cerrahi Aletler Industry’s owners Metin Cansu and Faruk Yıldız…

Cansu and Yıldız have experience for 17 years in this work. They established their own companies by getting 28 > January 2012

In the ophthalmic area, outstanding developments occur on behalf of domestic made production. Known by its investments in real-estate and energy, Varlıbaş Holding has established cataract lens plant in 2008.

The group met 55 percent of Turkey’s cataract lens need last year. Known also as “lens for inside of eye” the cataract lens is implanted into eye of patients by surgery. In Turkey, 300-350 thousand cataract lenses are used per annum. In 2007, entire of these lenses were imported.

In this area, there are some 40 producers across the world. Varlıbaş family was representative of the German Acritech firm for 15 years in Turkey. There is an interesting story of Varlıbaş family which left the imports to direct to set up the plant in 2008. Ercan Varlıbaş is an eye doctor, elder son of Süleyman Varlıbaş founder of Varlıbaş Holding. Ercan Varlıbaş tells the story, “As Varlıbaş we sell for 15 year the imported products in Turkey. We were representative of the German Acritech firm in Turkey. Our market share was in some 30 percentage. When Acritech was offered for sales, we also demanded. We began bargaining with 50 million euro. But Acritech was sold to Zaiss firm by 32 million euro. We were very upset by this situation. When we asked for the reason, the respond was that the ‘Germans did not want the technology to go outside.’ Then we decided to establish our own facility.”

Currently in Turkey it is known that 500 thousand cataract patients exist. When reached by those who did not get cataract surgery the domestic market expected to be bigger. SGK pays TL450 for cataract surgery. The domestic made cataract lenses are sold by TL75, imported ones are sold by TL125. As for the prices of lenses which were specially developed by Varlıbaş for both myopia ana hypermetropia and middle vision are 325 euro. Dr. Ercan Varlıbaş states that when these lenses are implanted the patients do not need to use eyeglasses. Competing of Turkish businessmen in this area made European fairly anxious. Varlıbaş tells the situation Europeans, “The countries such as Germany, Spain, France did not expect that we would enter this business. They were surprised much. But it must be

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some fedayeen in these works. We also did this. Now we would like to produce eye laser. In this issue we wait land allocation. Once the Directorship of Istanbul Healthcare, we will launch production in this area.”

Lens market is very virgin As the voice opened from lens it is not suitable not to mention by Anadolu Tıp Technology which produces eye hydrophobic and contact lens. Having established in the province of Sivas, Anadolu Tıp Teknolojileri, which is the only and first lens plant of Turkey began production in 2005. This firms also exports to Europe and Mideast.

The developments in health sector urge the foremost holdings to pose in this area. For example, Eczacıbaşı İlaç Pazarlama has entered the market of lens and lens care products with the foremost Japanese Menicon firm. According to this, Eczacıbaşı İlaç Pazarlama has owned the rights of products of Menicon which acts over 30 countries including Europe, America and Japan with over 1000 employees in Turkey. Well, why Menico has entered Turkey? For this it is enough to look at the figures. In our country it is guessed that 200 thousand lens users are available. The lens use rate to the total population is 0.25 percent. If though that this rate reaches by 3 percent in Europe, it is putting forward that how much the market is empty.

Chinese threat to surgery yarn In Turkey, many medical materials are produced ranging from surgery yarn to blood bags. For example, Kansuk Laboratory which was established in 1982 the first domestic firm producing blood bags. Established at the beginning of the 1970s, Doğsan headquartered in the province of Trabzon produced first surgery yarn of Turkey. In this area the firm made a breakthrough in the Mideast and Balkans. The company of Saruhan

30 > January 2012

family produces 11 kinds of yarn by polymer. 6 of them are absorbed by body, in other words there is no need to get off yarns after surgery. The market share of Doğsan rises by 30 percent.

There are more domestic firms in this area. SSM, Medeks, Katsan and Orhan Boz from these firms act for years. Nakipoğlu family’s company İpek Plastik Sağlık Ürünleri located in Gaziantep produces surgery yarn since 2004…

Deputy General Manager Çağan Karal of Doğsan Cerrahi Dikiş Malzemeleri, said that the imported products dominate 60 percent of the market. Indicating that consumption of the surgery yarn in Turkey, was at least 2 million boxes, Karal said, “The Chinese firms have entered the market within the last 5 years. There are also European firms that produce in China. One box of the domestic yarns is sold between TL20-200. As for the Chinese products can be sold half, even, one fourth of these prices. This put us into difficulty in competition.”

Dogsan produces annually producing 800 thousand boxes surgical thread. 120 employees work in factory of the company in Trabzon. 30 employees are on duty of sales. Dogsan exports 20 percent of production to many countries such as Germany, Iran, Iraq, Saudi Arabia, Lebanon and Spain through 50 dealers.

The world's largest surgical thread manufacturer, Johnson & Johnson, American company is very active in the market of Turkey. Number of firms participating in both private and public hospitals auctions of surgical thread is 28 in our country.

We do not manufacture the Biochemistry device Biochemistry devices are quiet important products for the health sector. Biochemistry laboratories are needed to make the dozens of test such as blood sugar, hemoglobin and cholesterol tests. A biochemistry laboratory can be installed with 25 different devices and over 500 different materials. There is an interesting form of business. For example, the firm, that take place in hospitals auctions, supplies hospital's equipment free of charge but the firm sells the kit.

Biochemical systems are under the domination of imported brands in Turkey as all the world. Four major companies such Roche, Beckman Coulter, Abbott and Siemens achieved $ 400 million turnover last year. The products sold in laboratories of Turkey are $ 1.5 billion turnover.

Bizim Medical is representative of well-known brands such as Biorad, Roche, and Beckman Coulter in the Eastern Black Sea, Central Anatolia, and Eastern Anatolia. Omer Sen, owner the firm, is also president of the Eastern Black Sea Medical Association. Bizim medical is distributor of Kansu blood bags and Medapex surgical thread. The company taking place in about 300 both

ACTUAL private and public hospitals auctions per year has turnover of 40 million TL. Omer Sen informs that the device is not produced; only a small amount of kit is produced in Turkey. Stressing that even the definitions of the medical sector has not been fully made, Sen says, “I wish we could sell the domestic product.”

By the way, to set a biology lab of a university hospital with the latest technology needs 2-3 million Euros.

Single Pistol in Native Heart Stent To produce the first heart stent in Turkey was only possible 6 years ago. Alvimedica Medical Products is a multi-partner company owned 100 percent of the Turks, like Ishak Alaton, Chairman of Alarko Holding.

Alvimedica founded a catheter factory with the largest 'clean-room’ (germs-free production area) in Europe in Catalca in 2005. Recalling that they are the first and only manufacturer of heart stent in Turkey, Dr. Cem Bozkurt CEO of Alvimedica, said that they established the factory with an investment of $ 22 million. Bozkurt stated that they produced 120 thousand stents with 40 thousand drug-coated stents, 80 thousand balloon catheter, 250 thousand guiding catheters and 750 thousand angio catheters last year.

According to the information given by Bozkurt, 250 thousand Angiomas have been done in Turkey every year. About 10 thousand stents are inserted to the patients during these Angiomas. Currently, 65 percent of the stents used in Turkey have Alvimedica patent. The Company is dominated on the half of the market catheter used.

There are totally 10 companies producing stent in the world. the largest of them are Johnson & Cordis, Abbott, Boston Scientific and Metronic. Prices of the medicated stents of these companies were 3-4 thousand dollar in Turkey. That price falls to 1000 TL as Alvimedica enter to the sector. Alvimedica products also are exported to Western Europe. Preparing to open an office in Russia, Iran and Brazil the company exports 40 percent of production. Declaring that they received 20 patents from foreign universities, Bozkurt said, “We spent 61 million dollars for R & D activities and patents. We would like to enter to India too. We will produce the stent for the brain the next year. We would like to establish a Biomedical Specialized Organized Industrial Zone in Catalca. Talks with Catalca Municipality continue on this subject.”

Orthopaedic Products develop The power of domestic producers on orthopedic surgery is increasing. Though the ruler on the orthopedic market in the World is still Johnson & Johnson Orthopedics, Zimmer, Stryker, Smith & Nephew, Biomet, and Wright, they have also 75 per cent market share of Turkey. Turkey orthopedic implant market is estimated 32 > January 2012

over $ 260 million in volume to hospital purchase price in Turkey. Product prices are between 4 and 4 thousand dollars. But supportive orthopedic products such as neck, kneepad are not involved in these prices.

The number of local companies in the field of orthopedic surgery currently is not two fingers of the hand.

These companies are Ortopro, Tipsan, Hipokrat, Tibmed, Tasarim and TST. Starting by importing in the

early 2008. With 130 employees the company exports to around 30 countries worldwide as well as domestic market. Tolga Yalcinkaya, Chairman of Ortopro, declares that they aim to export 8 million dollars this year.

To Yalcinkaya the required media to develop the product in this field is now available. Recording that scientists and doctors have very creative ideas in this field, Yalcinkaya supposes to benefit of the R & D incentives of SANTES and TUBITAK. Yalcinkaya said, “We expect hospitals to use the option of 15 percent price advantage for domestic property in Turkey. If the state encourages this app, the medical sector grows faster.” $ 150 million investment Recognized real estate and energy investments, Varlibas Holding started R & D activities in 2008 to develop a cataract lens. Proving qualified leads, the group won the 9th TUBITAK Technology Awards leaving behind 221 companies. Then it started to invest. VSY Varlibaslar Health Investments established its first factory an investment of $ 100 million in Atasehir. Now the group founds a new factory with an investment of $ 150 million in Tuzla. Trial production is expected to start in the second factory in June. VSY Varlibaslar Health Investments will reach to produce 1 million cataract lenses annually. Currently 165 employees work at Atasehir facilities. Investment in Tuzla is expected to make an additional employment for 70 employees.

VSY produced 500 thousand lenses in Atasehir plant last year. 165 thousand were sold in Turkey and rests of it were exported to 26 countries. Dr. Ercan Varlibas, General Director of Health VSY Varlibaslar Investments, said that they plan to increase sales by 10-15 per cent in the domestic market this year, rest of it to export.

Declaring that they prevent imports of 20 million dollars last year, Varlibas said, “We do not care to earn money in this business. We could have manufactured revolution cars but not continue. I wish we are not so in the field of health. We both our people and doctors unfortunately have a complex against our own products. Need to overcome them.”

Acoustics Salary £ 3 thousand

sector, Ortopro Medical Instruments, which was founded by a medical doctor Tolga Yalcinkaya and Mehmet Tanyolac in 1995, has been continuing its operates as a manufacturer in Aegean Free Trade Zone in Izmir since 2002. Knee and hip prostheses used in degeneration of the joints, platinums and screws used in trauma like fractures are among 50 kinds of Ortopro product. Is Girisim Sermayesi bought a 30 percent of Ortopro in

Otikon, Phonak, Starkey, Siemens, GN Group, Videx, Ear Teknik are popular hearing aid producers. Ear Teknik operates with 100 percent Turkish capital since 2001. But history in Germany is related the date 40 years ago. Mehmet Emin Agac, Turkish entrepreneurs, bought the company 10 years ago. Establishing a new factory in Corlu, Agac family now competes with the global giants.

Mehmet Emin Agac was born in 1965. He went to Germany for training in the early 1980s. After studying philosophy, he became an acoustics (hearing specialist), then he entered to the sector. Being founded Si-Ser Hearing Center in 1996, began to import hearing aids to January 2012 > 33

ACTUAL aid devices developed in Turkey, 450 thousand devices would sell today. Only one quarter of potential can be used in the market.”

Medical products manufactured in Turkey

Turkey. He founded Ear Teknik with the Germans in 2001. He purchased all the shares of the company in 2005. Bringing know-how and technology of the German company to Turkey, Agac said, “We invest in our business how much we earn.”

According to Agac, Ear Teknik has 30 percent of the market in Turkey. The company's factory in Corlu European Free Trade Zone produces 70 thousand the hearing aids annually. Some parts of the production are exported to 20 countries.

Mehmet Emin Agac said that Turkish people are used to imported hearing aids for many years, so in the beginning they have difficulty to adopt the domestic appliances for both patients and health care workers.

“Now we are writing ‘Made in Turkey' on devices proudly” saying Agac that they are distressed to find a hearing aid specialist (acoustics). Agac said, "Most of the buyers are not satisfied hearing aid in Turkey. That is why there is no enough (acoustics) to adjust devices. Currently, the market needs 1,500 acoustics.

Therefore, we as the Academy Acoustical Society of Hearing Aid (İCADD) have signed a partnership agreement with leading academy of the hearing sector, German Bundesinnung der Hörgerate-Akustik Körperchaft des öffentlichen Rechts Deutschland (BIHA) in order to train acoustics in the sector. Young people graduated from high school will apply to the training, which will start in September. Acoustics certificate will be given to the trainers after two years training with training of four months and 8-month internship. Those who completed three years training will be employed as master acoustics by the society. Those who succeed the mastery exam at the end of the theoretical and practical training of the academy will start to work with 3 thousand TL monthly salary. If the awareness of the hearing

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* operating tables * anesthesia devices * gynecological tables * surgical aspirators * oxygen devices * X ray devices * injections, needles * steam and dry air sterilization devices * blood taking armchairs * Medical gas systems * elastic bandages * patient beds * dentistry units * surgical tools * Drainage * Stent, catheter and drills * stone breaking devices * stretchers

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* blood and blood products, receiving donating sets * blood bags * operation and examination gloves * patient monitoring * orthopedic prosthesis * orthopedic repair materials * operation covers and centrifuge * surgical gauze and cotton * electrocautery, x ray bath solutions * surgical yarns * dentistry repairing materials * Medical masks * blood saving cupboards * bio carriers * defibrillator * serum sets * stainless steel products

SWOT analysis of medical sector Strong sides of the sector • Featuring a high added value sector • Taking place in the 11 sector which are vital for Turkey • Increasing of Product quality day by day • Progressing of quality awareness

38 > January 2012

Poor side of the sector • high technology is not prevalence in Turkey and lack of establishments based on new technology due to being expensive • Costs of the production are high regarding intermediate goods and investment goods are not produced in Turkey and imported • Lack of university-industry and research institution cooperation • Qualified staff need is not met • Production potential cannot be used fully

Opportunities of the sector • Being a big market of Turkey and meets big part of need by the imported goods • Having cheap labor force • Production is supported by the government with new health policies • Development of the international cooperation • Market bigness in Turkey

Sectorial threats • Increasing of the global competition • Domestic producers are not known in the world • Cheap and poor quality production is not hampered • High foreign dependency of the producers

Quality System for Medical Devices EN 46001 ISO 13485

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edical device manufacturers feel the need to install and certify a quality system in order to fulfill the requirements of the existing legal obligations, to ensure customer satisfaction, to improve internal efficiency, and to create a legal safeguard against lawsuits that can be filed. EN 46001 / ISO 13485 Management System include additional special conditions for medical device manufacturers, including ISO 9000 Quality Management System requirements.

The companies which have to put CE Symbol on their products, are also required to obtain EN 46001 / ISO 13485 certification, when they have to use Annex 1 and Annex 2 modules. ISO 13485:2003 standard specifies the specific demands required by the quality system for the ones who work in the field of the medical devices.

ISO 13485:2003 is based on the ISO 9001:2000 standard and replaces the previous 1996 version of it. Its main objective is to provide the global harmonization of medical devices to the quality rules. In other words, it is a standard which defines the specific requirements that the quality systems must provide for the manufacturers operating in the field of manufacturing, trade and distribution of medical devices. ISO 13485:2003, although is a special standard written for the Medical Devices, is organized in accordance with the infrastructure of the ISO 9001:2000. However, some specific issues are differentiated from the ISO 9001:2000 standard. Just as the ISO 9001, the new management system, while switching from the notion of the classical quality control to the process / process-based approach, forecasts to establish a direct link between the main objectives of the organization and the productivity.

The new standard can be used by all companies which cover the medical devices or the project, the production, the installation, and the procurement phases of the services related to those. The CEI EN ISO 13485 and 13488:2002 certificates issued on the basis of previous standards (ISO 13485:1996 and ISO 13488:1996) will be invalid at the end of 2006.

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Aktif X-Ray Lead Aprons Aktif Dış Ticaret manufactures lead aprons in world standards.

Having a comfortable and flexible structure ensuring easy use, Aktif lead aprons are practical and light.

The use of lead aprons is highly essential for human health in any field requiring radiological examinations, regardless of the x-ray dose. Lead aprons are strictly obligatory for institutions related to protective equipment instruction in every country at the licence stage of radiological imaging centers. Depending on the nature of service performed, clothes and equipment such as le ad aprons, go nad prot ec tors, le ad screen, thyroid protector, lead glasses etc. must be provided in highradiation areas, x-ray imaging centers and cardiologic units. In addition, radiographic examinations are among the diagnostic methods which are frequently used in dental clinics. The x-ray amount increases as the field of application varies. Digital technology of the recent years allows for use of low-dose ray in sensors. Nevertheless, protection is required for the personnel serving at clinics where radiography is of ten required, and for patients who are sensitive to x-ray. X-ray bloc king aprons must be used for this purpose.

Manufacturing in ISO, TÜV and CE Standards

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ktif Dış Ticaret was established in 1993 to serve in medical industry.

The company started its trading activities initially by importing special devices which enable archive documents to be transferred to electronic media and ensure recording and storing of such in micro-films and presenting the products to Turkish users.

Having served as a Turkey representative of globally known companies in field of radiological accessories in 1995 and specialized on lead aprons, the company im por ted and dist ri bu ted le ad aprons to all aro und Turkey for a long while, and later, it has started manufacturing of lead shields with its own brand, AKTİF X-RAY since 2002.

40 > January 2012

Aktif Dış Ticaret manufactures lead aprons in world standards. The Company’s ISO, TÜV (quality system)certified and CE-marked products include lead aprons with a wide range of models and sizes, thyroid protectors, gonad protectors, and varying types of x-ray protectors such as upper waist or up per knee. Ha ving a comfortable and flexible structure ensuring easy use, Aktif lead aprons are practical and light. Any model can be made of lead-free material in line with the customer’s request.

‘OXFORD’ type fabrics specially manufactured for lead shields are used in manufacturing process of Aktif. Such fabrics are highly resistant against wear and tear in long-term uses, and can be easily cleaned for hygiene.

Ma nu fac tu red in in ter na ti o nal standards, Ak tif le ad aprons can be subject to special processes in parallel with the customer’s request. In addition to manufacturing lead aprons, ‘AKTİF X-RAY’ is also specialized in fields of lead coating, lead glass, lead screen and lead door.

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88 Years of the Health Sector in Turkey

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tructure of health sector changes in parallel with country population, cultural improvement, natural resources, political and economic system. In addition, increase of the importance of health day by day, as well as rise of quality in healthcare services improve competition among healthcare institutions and contribute to improvement of the sector.

In addition to physical structure, devices& equipment, manpower and finance; presentation of service and satisfaction of customers are among major factors in competition among institutions regarding supply of healthcare services.

Reports which address future of Healthcare Sector emphasize that the sector will change dramatically in the following 10 years. Studies reveal that companies operating in healthcare sector will have to change their business strategies as a result of factors such as changing population character, new diseases, improving technology and significant increase in health expenses.

Improvement of the Sector in Turkey Since the first years of Republic, numerous studies have been conducted to enhance supply of healthcare services and healthcare data. Between 1923-1937, Dr Refik Saydam and Dr Behçet Uz terms were the periods when significant works and reforms were made in medicine history. Socialization of health services, which was introduced in 60s under the leadership of Dr Nusret Fişek was one of the important stages.

The term until 80s witnessed practices regarding improvement of service and regulation of healthcare infrastructure and organization. After the year 1983, health policies changed dramatically. Following 1990, projects that were conducted with support of the World Bank were about reform in health services. During this term, reform works gained speed. ‘Program of Change in Health’, which was introduced in 2003 was one of the most important improvements with regard to health in Turkey. Program of Change in Health consisted of three main components- gathering health and social security institutions under a single roof, family practice and general health insurance.

Following this program, public servants started to receive treatment at private healthcare institutions, reference price application was introduced for human and medical products which mainly consisted of medicines, in addition to all healthcare service corporations within Social Insurance Institutions (SSK); healthcare facilities operated by public institutions were transferred to Ministry of Health, employees and retired persons subject to SSK became entitled to supply their prescription medicines at contractual pharmacies, 42 > January 2012

three social security institutions (Retirement Fund, Social Insurance Institution and Social Security Organization for Artisans and the Self-Employed) were gathered under the roof of ‘Social Security Institution’ (SGK), and General Health Insurance System was introduced.

Sectoral Panorama Private health sector started to improve quickly after 2005 in Turkey. In the health sector which is improving in favor of private institutions, almost 40 new private hospitals were opened last year. While the share of private hospitals in the sector was 8% in 2003, it increased to 35% in 2010. 13 acquisitions and mergers was made in the last three years. It is expected that these figures will increase further in parallel with new works of the Ministry of Health and investment plans of institutions.

21.000 doctors and approximately 200.000 employees are employed at private institutions and organizations, whose 19.500 of them are specialists. With 84 million examinations, 2 million operations and 3 million hospital stays per year, private health institutions reduce the burden on public health service and improve the quality of health services.

On the other hand, medicine sector of Turkey is a sector which has a high capacity and qualified human resources, and of which infrastructure is at a certain level. Approximately 300 companies and 43 production facilities operate in the sector. In addition, almost 25.000 persons are employed in the sector, while approximately 8000 products are offered to the market.

Turkey is among important countries of the world with its medicine volume of total 18 billion TL. Medical devices sector has a broad portfolio with almost 300.000 product types. Main products manufactured in Turkey are x-ray machines, laboratory devices, syringes, cotton, pads, surgical hand equipment, hospital equipment, stents and catheters, rubber and silicon probes. There are 2100 producers, 3100 importers and 3000 vendors registered in the market. 85% of medical device requirement of Turkey is met by import, while local production meets only 15% of the requirement.

Medical device sector is in 13th place in the world with regard to the added value it creates.

Medical Devices and Equipment Turkey is heavily foreign-dependent in technological terms for medical devices, equipment and materials.

Only 15-20% of medical devices and consumables are met by local production. There are about 15.000 companies operating in medical equipment sector of Turkey, yet; no clear data is available regarding size and opera-

ACTUAL ting volume of these companies. Today, Association of Medical Equipment Producers and Representatives (SADER) has 60 members. 60% of these members import, while 40% of them produce medical devices.

Members of SADER have a vendor network of more than 1000 vendors, more than 6000 employees, 200 million dollar export volume, more than 200 company representations abroad and 400 million dollar import volume.

Sector Analysis ‘Program of Change in Health’ has always been on top of the agenda of Medicine and Health Sector since the year 2003; when it was introduced. The program consists of General Health Insurance, Family Practice System, Hospital Autonomy and Health Informatics in general. Within scope of the program, hospitals except for university hospitals were gathered under the roof of Ministry of Health in 2005.

In addition, Social Security Organization for Artisans and the Self Employed, SSK, Retirement Fund and green card was gathered under a single roof as well.

Another major step of the program was taken in the year 2007. In 2007, patients started to utilize from any hospital they prefer, following a service procurement contract signed with private health institutions.

Following these developments, share of private hospitals increased to 35% in Health Sector by 2010, while it was only 8% in 2003.

One of the most important improvements in the sector was that private health institutions were prevented from taking staff on branch and full or part time basis, with a regulation amended by the Ministry of Health on 15 February, 2008.

Therefore hospitals started to seek mergers and acquisitions in order to increase number of their current staff. Between January 2008- February 2011, 13 mergers and acquisitions were made with a total value of 217 million Euro.

Nowadays, the Ministry of Health is preparing a draft law, which stipulates merger of one or more health facilities within a hospital of which capacity, fittings, manpower and income-expense balance are strong, in cities and provinces where several health facilities exist. If said draft becomes a law, mergers and acquisitions will further increase with this draft which aims to ensure more efficient and productive operation of hospitals.

Works are being conducted to facilitate staff increase by private institutions. Accordingly, the Ministry of Health required the Association of Private Hospitals Platform to prepare ‘Additional Staff Demand Form’, to send this form to private health institutions and to submit demands of the sector in a report. Until now, more than 300 health institutions delivered their requests for additional staff. Said effort of the Ministry of Health, which intended to collect additional staff demands is a new hope to increase number of staff for the sector.

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In the meantime, almost 40 private hospitals were opened last year. Growing share of private hospitals reached 15% with these investments. On the other hand, number of private institutions reached almost 2000 by the year 2010, of which 500 of them are private hospitals.

R&D is the biggest problem in medical devices market In medical devices market which has a share of 296 billion dollar worldwide, Turkey has deficits with regard to foreign trade because of technology problem. Turkey meets 85% of its medical device requirement through import, while local production only meets 15% of the requirement. Sector representatives believe that Research& Development problem in medical device market must be eliminated as soon as possible.

Things to do within scope of R&D motivation are listed as follows: ‘’Production manners of regions must be determined according to their facility capacity, each region must specialize in its own area. Specialist organized industry zones and techno-cities must be created, therefore external dependence must be reduced and the sector must be made capable of competing with the world.’’

Strong Sides of the Sector • Continuing investments in private sector, • Sufficient level of modern technologic hardware in most of reference hospitals, • Gain of the habit of going to medical centers for treatment of diseases by Turkish public, • Increase of private health insurances, improvement potential of the same, • Significant achievements in communication and information technology, • Advantage of young manpower with regard to finance and human resources.

Weak Sides of the Sector • Allocation of a limited share from general budget for health services, • Burden by SGK patients at certain hospitals, • Inadequacy of qualified health personnel other than doctor, • Wide informality in employment, • Malfunctions in the collection of social security premiums, • Deficits in social security system arising from lack of supervision, • Low income level of the public, • Medical faculty’s being an unfavorable department for students, • Being foreign-dependent in terms of medicine, healthcare materials and technical hardware to a large extent.

ACTUAL

BeautyEurasia 2012 focused on new categories: Medical aesthetics, spa & wellness, dermocosmetics and otc products

T

he 8th International Cosmetics, Beauty and Hair Exhibition BeautyEurasia 2012 which will be organized from 14th to 16th of June at Tuyap Exhibition Center in Istanbul, well known with its wide products such as cosmetics, personal care and hair care products, hygiene products, enlarged its exhibition profile and dedicated new hall specially for medical aesthetics, professional cosmetics, dermocosmetics, otc products, spa and wellness products.

Increasing its success year by year BeautyEurasia become Turkey’s and Eurasian Region’s number one cosmetics and beauty exhibition and one of the leading trade event in the world.

The 7th International Cosmetics, Beauty and Hair Exhibition BeautyEurasia proved again its reputation as number one trade show with its approximately 400 exhibitors %30 of which was international. BeautyEurasia become an unique platform where exhibitors from 44 countries, including Japan, Germany, France and USA are exhibiting the latest technologies and products.

Compared to the previous year, as of beginnings of January BeautyEurasia grow up 44 %, which is an indicator of its growing success.

In addition to BeautyEurasia’s major product groups such as: cosmetics, perfumery, personal care and hair products, BeautyEurasia 2012 trade show will showca-

46 > January 2012

se variety of products such as; medical aesthetics products and devices, professional cosmetics and products, hand and foot care products, dermocosmetics, weight loss devices, anti-aging technologies, otc/ pharmacy products, Spa & Wellness products and equipment’s, and professional nail products.

The new added exhibition hall and product groups at BeautyEurasia definitely will effect on the enlargement of the visitor profile. BeautyEurasia 2012 will host visitors such as: beauty center managers, beauticians, dermatologist, doctors, pharmaceutical distributors, pharmacists and spa managers coming from Turkey and neighboring countries.

BeautyEurasia 2012 edition expected to exceed 25.000 visitors, which is %10 more than previous years visitors, including 3.101 foreign visitors from 93 countries; who visited BeautyEurasia 2011.

Seminars, workshops, hair shows and other activities are in BeautyEurasia 2012 trade show programme.

Ministry of Economy of Turkey and IKMIB - Istanbul Chemicals and Chemical Products Exporters' Association will support BeautyEurasia 2012.

Let`s’ meet the `Beauty` where the continents meet!

For more information on exhibiting or attending, please visit www.beautyeurasia.com