Health & Education

Slice of life

Turkey-made medical devices

Turkey is a tried-and-true manufacturer of local products, a manufacturing base for numerous brands that are household names. Soon, those names could include Turkish-made medical devices as well.

Turkey has an active program of advancing local content across the economic spectrum, from electronic gadgetry for civilians to military hardware. It is also making headway in the medical equipment market, catering to the needs of specific local demographics while also tapping diverse foreign markets.

The Project-Based Incentive System, revealed in 2018, included the market for medical devices, initially with emphasis on cardiovascular devices. A particular focus was on stents for heart surgery. These tiny life savers have evolved from bare metal mechanisms to today’s polymer-free medicated stents. For their makers, stents offer a high return on investment. Market data shows that annual state expenditure on stents averages at around USD200 million, the bulk being imported. The government hopes that stent sales can help reverse its current account deficit and bring more foreign capital into the country.

Regulation
Medical devices are regulated by the General Directorate of Pharmaceuticals and Pharmacy Department of Medical Device Services, which is part of the Ministry of Health. Medical device production in Turkey must comply with the regulations on active implantable medical devices and in-vitro diagnostic medical devices, schemes that are largely in step with current EU directives. These certifications allow medical device makers to swiftly take locally produced products to market, both in Turkey and abroad. Of course, it explains the appeal of producing under license for foreign companies. Devices sold in Turkey are registered in the Turkish National Pharmaceutical and Medical Device Database (TITUBB), a key mechanism of the quality verification process that the health ministry relies upon, along with the social security department and public procurement authority.
In contrast to the pharmaceutical component of the healthcare industry, medical devices in Turkey are not subject to state-defined reference prices. However, when it comes to reimbursement, there is a stipulated maximum price for each category. One recent challenge has been the tendency for exchange rate fluctuations in the lira to outpace adjustments to these price ceilings.

Disruptive Force
Souheil El Hakim, CEO of Bıçakcılar, a producer and distributor of medical devices, equipment, and disposable products, told TBY the company is not that focused on competing on price, but rather on the need to bring “disruptive solutions or innovation” to the market.
Alvimedica is a start-up seeking to make money while decreasing Turkey’s import dependence on medical devices. Alvimedica’s president, Leyla Alaton, notes that the firm, which manufactures 900,000 drug-delivering stents per year, exports to more than 70 countries. Alvimedica’s expects its annual revenue of USD50 million to increase to USD80 million by 2020, leveraging incentives, “for funding, incentives for high salaries paid for skilled workforce, such as specialized engineers, and support for certain R&D projects.” Meanwhile, in pursuit of growth opportunities, Alvimedica intends to identify a strategic partner.
In September 2019, it emerged that the Junior Chamber International (JCI), a global network of young professionals and entrepreneurs, had chosen two Turks for their list of “10 Outstanding Young Persons of the World.” Both were from the medical world. One, Gözde Durmuş, an assistant professor of radiology at Stanford University School of Medicine, focuses on antibiotic-resistant infections. Her team looks to advance early diagnosis with a disease-diagnosing microchip that takes just 20 minutes to manufacture. These are the kind of innovations that Turkish medical device designers are bringing to the market for the benefit of their home country and the world at large.

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