Eventually, if product lines prove viable and sales go well, an American manufacturer of medical devices will begin looking beyond US borders. The European Union (EU) is a popular first choice, followed by such top world economies as China, India and Russia. A less obvious choice, Turkey, punches far above its weight in terms of market attractiveness. With the 15th largest economy in the world and an annualized average gross domestic product growth of 4%, the country represents a terrific opportunity for US manufacturers. The Emergo Group ranks Turkey among the top 20 medical device markets in the world in terms of value.
According to a 2013 report by the US Department of Commerce, about 6,000 medical technology companies operate within the Turkish health care market. Of these, approximately 100 manufacture medical devices and equipment. Most of these domestic manufacturers, however, make relatively low-tech items such as hospital furniture, surgical tools, disposable items, stents and the like. A joint Dutch-Turkish study concluded that Turkish medical device manufacturers, for the most part, “are more focused on low value added products.”
It’s not as though Turkey lacks health care innovation. Turkish companies and research and development incubators spin off such technological marvels as the Robogait. Unfortunately — or fortunately, if you happen to be a US company seeking to enter the Turkish market — such developments serve as notable exceptions to the general “low value added” trend. Where US, EU and Japanese companies benefit from the titanic research and development legacies of their respective countries, Turkey is a relative latecomer to high-tech medical development.
To its credit, the Turkish government welcomes foreign medical device suppliers into the country. Turkey lacks any legislation that would favor domestic manufacturers and penalize imports. The European Union-Turkey Customs Union facilitates bilateral, duty-free commerce between Turkey and the EU. More significantly for US manufacturers, American medical devices are, for the most part, allowed in-country duty free as well. In general, Turkey has made every effort to streamline the approval process for European and American health care manufacturers to do business there.
Favorable factors driving Turkey’s health care industry
Turkey’s near-universal health care covers 95% of its population. With such extensive coverage, Turkish physicians, clinicians and other stakeholders have the latitude to implement those technologies that they judge most effective. If you, as a medical device manufacturer, get your product approved by the Turkish Ministry of Health (MoH), you will have the financial might of the Turkish Social Security Institution (SSI) compensating you.
Turkey has a fantastic health care system that is getting better every year. They have always had some of the best doctors in the world, but their downfall in the past was decrepit infrastructure and a shortage of qualified nurses and other supporting personnel. Recep Tayyip Erdo?an, president of Turkey, has focused on revolutionizing Turkish medicine. In the 2002-2013 period, Turkey built 327 new health care facilities and upgraded numerous existing ones. Country-wide, hospital beds increased by 23% between 2002 and 2012. MoH has invested considerable resources into education and training to expand the ranks of health care staff. The drive toward improvement shows no signs of abating; rather, Turkish health care investment appears poised to continue into the foreseeable future.
All of this modernization is working: per capita spending on health care increased 236% over the 2002-2013 interval. Increasing numbers of Turks are opting to have surgeries of various types: between 2002 and 2011, Turkish surgical procedures grew by 162%. Organ transplants jumped five-fold in the same timeframe.
As Turkey’s economy has revved up over the last few decades, better quality of life has resulted in longer lifespans. As a result, Turkey has a larger population of relatively affluent elderly people who desire sophisticated health care solutions and can afford to pay for them. Counterbalancing this geriatric customer base, Turkey benefits from a young, educated workforce. Turks have a median age of 29 years. Turkey’s literacy rate is 94%, and more than half of Turks opt for a secondary education.
Turkey’s quality of service and low health care prices have put it on the map as a medical tourism destination. From cosmetic alterations (who knew that hair transplants were booming there?) to life-saving operations, patients flock from all of Turkey’s neighbor countries, as well as from the EU, the UK, the US and other places. The Turkish MoH claimed 74,000 international patients in 2008 and 262,000 in 2012; it projects two million annually by 2023. Several Istanbul facilities claim to get half of their revenue from foreign customers. Of the 11 “top destinations” for medical tourism, Turkey offers the fourth greatest cost savings, following India, Malaysia and Thailand. A coronary angioplasty, for example, costs, on average, around $21,000 in the United States but only $6,000 in Turkey. A hip replacement costs roughly half of what it would in the UK. A Turkish adenoidectomy is discounted 75% from its Spanish equivalent. Such low prices are complemented by Turkey’s cosmopolitan, multilingual staff — which helps its international clientele feel at ease — and world-class facilities.
The Ministry of Health is aggressively adopting electronic recordkeeping and patient management systems nationwide. The Turkish government launched a 2005 initiative, in partnership with private industry, to update all medical records, databases and other administrative systems with custom software solutions. As part of this ambitious effort, a telemedicine system will allow urban and semi-urban caregivers to interact instantaneously with remote populations. Ultimately, all components of the Turkish health care system will be funneled through and integrated into a single user-friendly electronic interface.
Although a number of complications need to be resolved, Turkey has a shot at EU membership. As though in anticipation of EU accession, Turkey recognizes the EU Medical Devices Directive (MDD), a set of harmonized standards for devices sold within the EU. So, if a medical device is cleared for sale in the European Union, it is cleared for sale in Turkey, pending some formalities.
How to sell medical devices in Turkey
Turkey requires imported medical devices to have the CE (Conformité Européenne) marking. CE marking represents a stamp of conformity to applicable EC (European Community) directives that regulate commerce within the EEA (European Economic Area). “Custom-made medical devices,” a hazy category referring to products intended for clinical trials, exhibitions, and highly specialized applications, enjoy exemption from CE marking. Again, as with the MDD, if a device is cleared for the EU marketplace, it will already have the CE marking. The CE mark consists of the CE logo, and typically a four-digit ID number; the number refers to a specific “notified body” that assessed the product — a so-called “conformity assessment” — and approved it for certification.
Another requirement: all accompanying textual material must be localized. Turkish law requires all foreign medical devices companies to translate their manuals, promotional materials, labels, instructions, legal documents and all else into Turkish. The translator must hold an MoH certification; fluency in English and Turkish is not sufficient in itself. If the translator is not certified by the Turkish government, the translation will not be approved.
Importers must register their medical device with the MoH if they wish to be eligible for insurance reimbursement. This reimbursement falls under the SGK (Sosyal Güvenlik Kurumu), the Turkish Social Security Institution. The SGK assigns a reimbursement value based on their Health Care Implementation Communique (acronym SUT), a table of medical technologies and their associated reimbursement schedules. SGK updates SUT periodically to reflect advances in technology. The device must also be registered in the Turkish Pharmaceutical and Medical Device National Databank (TITUBB).
Turkey does not allow foreign suppliers to sell in-country without a Turkish base of operations. In practical terms, this leaves US medical device manufacturers with two options. First, they can open a branch or office in Turkey. The second alternative is some sort of partnership with a Turkish firm that can act as a distributor for incoming products. The first option requires significant investment, which is why so many US exporters choose the second. As an additional advantage of the partnership route, the Turkish party to the coalition can usually handle all registration and regulatory compliance hurdles.
American companies should be aware of Turkish advertising restrictions. The 2014 Regulation on Sales, Advertising and Promotion of Medical Devices distinguishes between those devices intended for industry professionals and those designed for the general public. The regulation gets particular about advertising a device only to the demographic for which it is designed; if it is intended for surgeons, for example, a company cannot promote it to the public at large. While one may wonder why anybody would ever do such a thing anyway, one has no choice but to comply.
What medical devices to sell in Turkey
Market research reveals a demand in the Turkish market for US medical devices that are less invasive, more cutting-edge (no pun intended), or that offer more value per lira than available alternatives. Specifically, a US Department of Commerce report details a need for devices that fall under the following categories:
Diagnostics. Turkish hospitals and clinics want the latest and best imaging and diagnostic solutions. From MRIs to molecular imaging to cytogenetic pathology tests, US makers of diagnostic solutions are poised to prosper in Turkey.
Point-of-care solutions. Rapid-result technologies such as pulse oximetry, antigen detection and portable ultrasonography are in demand. Turkish caregivers want mobile, accurate and user-friendly devices that make their jobs easier.
Advanced surgical devices. Robotics, lasers, endoscopy — surgical technologies continue to improve. Naturally, Turkish surgeons want the best tools. If a device makes a surgery less invasive, more precise, cheaper or otherwise improves patient outcomes, it should find high demand in Turkish operating rooms.
Cancer treatment technologies.Turkish oncologists and cancer centers want the latest US product advances in needle-free drug transfer, IV management, localized drug and anesthesia delivery, ultrasound therapies, radiosurgery, and other rapidly developing oncology treatment arenas.
Clinical research tools. Europe and the US have centuries of medical research history. Universities and other research institutions have pursued biomedical engineering, clinical drug trials and other forms of medical exploration. These require extensive tools and equipment. Engineers have improved upon existing lab technologies and spawned new ones, only to replace those, and have repeated the cycle countless times. With its upgraded facilities and focus on research and development, Turkey wants these tools. After all, why reinvent the centrifuge when Turkish engineers can buy the latest from a US manufacturer? Turkish clinicians and biomedical engineers are the ideal demographic for innovative research technologies from US manufacturers. From electrosensors to biorobotics, if it pushes the biomedical envelope and empowers researchers more than a previous solution, a clinical research technology will have a promising future in Turkey.
Electronic data management and communication systems. As noted above, Turkey’s Ministry of Health is moving toward a fully-integrated, data-sharing electronic record and communication system. Such a system comprises hundreds or thousands of disparate subsystems and smaller technologies that must cooperate for the whole to provide a seamless interface. Telemedicine, mobile health applications, database administration, data capture, biofeedback and many other functions will each require its own integration with all the other components and with the whole. Undoubtedly, such a massive undertaking will be a work in progress, with a certain amount of trial and error; constituent systems will be winnowed and replaced with better alternatives. All of which is great for American manufacturers of informatics technologies and data control systems, which will be able to augment, or in many cases edge out, technologies used by the MoH as they push toward a holistic electronic network.
Prosthetics and implants. US biomedical innovation companies tend to develop the most cutting edge prosthetics, orthopedics and trauma-related implants. Such innovations in surgical implant technology are finding their way into the operating rooms of Turkish orthopedic surgeons and other specialists. Many of these devices result from technological spillover from US aerospace, defense and space exploration sectors; they incorporate the latest developments in advanced composites and other developments in materials science. These improvements in prosthetics, then, arise from a particular industrial and research and development synergy unique to the United States (and, perhaps to a lesser degree, Europe as well); as such, they are unlikely to face significant domestic competition in the Turkish marketplace.
Remote monitoring. With many Turkish patients outside of major cities, remote monitoring will grow in prevalence. Via remote technologies, doctors will have vital health data from far-flung populations at their fingertips. Smaller satellite clinics will be armed with vital information about the physical condition of their constituents, allowing them to prioritize their limited resources. Disruptive or improved monitoring technologies will have an excellent shot at edging into Turkey’s market, especially if they manage to offer ready integration into other database systems, covered above.
Risk is endemic to any major market pivot; entering the Turkish medical device market is no exception. Additionally, Turkey presents a couple of specific concerns.
Allegations of official corruption point to a possible culture of bribery in which Turkish officials solicit “donations” from foreign corporations. Needless to say, such conduct is illegal, both in Turkey’s own criminal code and also in the Foreign Corrupt Practices Act of 1977. It is highly advisable to deal only with trusted contacts, and to report solicited bribes immediately to avoid being implicated as a party to them.
The specter of civil unrest has haunted Turkey for a long time. For example, Erdo?an faced significant popular pushback during the so-called Arab Spring of 2014. ISIS (also known as ISIL or Daesh) controls regions of Iraq and Syria, keeping the possibility of terrorist acts in the public mind. Kurdish insurgencies flare up from time to time. More recently, the July 15, 2016, attempted military coup d’état left over 260 Turks dead. The coup appears to have been foiled. Erdo?an, love him or hate him, seems to have tightened his grip on power even more as a result. And, as we have already observed, Erdo?an is committed to driving Turkish medical innovation and health care improvement. It is the analysis of this author that recent events will have little impact on overall market conditions and on the possibilities of US manufacturers entering the country to sell their wares.
Summary of market conditions
Now is the time to enter Turkey’s health care market. Making the move to sell medical devices in Turkey requires some time, expense and difficulty; significant research is advisable. Despite troubling events and other geopolitical realities, Turkey remains a strong, surprisingly stable and relatively affluent market for American manufacturers. If you decide that your product fills a demand in the Turkish market, any barriers to entry should offer a huge return on investment.