Middle East: New Frontier for Medical Device Clinical Evidence

The Middle Eastern market for medical devices is displaying extraordinary growth and significant progress. It is expected to increase around 41% by 2014. Uprising demand is a feature of all the Middle Eastern countries, driven by the population growth and urbanisation, and by increasing government investments in healthcare.

Middle Eastern region, particularly oil wealthy countries such as the United Arab Emirates (UAE), Kingdom of Saudi Arabia (KSA), Qatar and Bahrain, offers many incentives to conduct outsourced clinical trials, including:

• Increased prevalence of diabetes, obesity, cardiovascular diseases and cancer. According to the World Health Organization, 15-20% of the Middle Eastern population aged between 20 and 60 years, the highest rate in the world, suffer from type 2 diabetes. Furthermore, there is a high prevalence of obesity, estimated to 30% in the Gulf Co-operation Council countries: Bahrain, Kuwait, Qatar, Oman, KSA and UAE. In some cases, the rate of affected patients exceeds 25% of the population. Cancer malignancy affects 60-216 per 100 000 of the population across the region, with the highest prevalence in Qatar.
• Genetic diversity: more than 900 common genetic disorders have been identified across the Middle East by the Centre for Arab Genomic Studies, based in the UAE.

• Medical infrastructures: Hospitals and Institutions. Governments are successfully employing strategies to invest in and develop their national medical infrastructure to supply the region’s growing population as well as to attract foreign investments. For example, in the last five years, more than 14 hospitals only in the UAE have been accredited by the Joint Commission International, one of the World’s leading accreditation organisations. One of these is Sheikh Khalifa Medical City in Abu Dhabi. The UAE has also collaborated with Harvard Medical School to found Dubai Healthcare City (DHCC). DHCC is an integrated “centre of excellence” for clinical services, medical education and research, offering a competitive medical care system in Asia.

  Furthermore, several world-renowned institutions have been established in this region with a mission to enhance life sciences and clinical research, and to foster innovations and collaborations, such as Dubai Biotechnology and Research Park (Dubiotech), King Faisal Specialist Hospital & Research Centre and King Fahd Medical City in KSA and Qatar Biomedical Research institute.

• Specialist schools for clinical research: a number of international and national schools and foundations for biomedical research have been implanted in the Middle East in order to support cutting-edge collaborative research and to establish sustainable research and education programs. These schools include, among others, Dubai Harvard Foundation and Weill Cornell Medical College in Qatar.

• Medical device regulatory environment: Regulatory authorities in the Middle East play a key role in ensuring the quality, the safety and the effectiveness of medical devices. Middle Eastern governments have published regulatory guidance for the marketing authorization of medical devices, in line with standard recognised guidance. Furthermore, some Middle Eastern countries, including UAE and KSA, participate in the Asian Harmonization Working Party (AHWP) for medical devices. AHWP goals are to harmonize medical device regulations in the Asian regions, to work in coordination with the Global Harmonization Task Force, Asia-Pacific Economic Cooperation and other related international organizations, and to establish harmonized clinical evidence requirements, procedures and standards.
• Trial feasibility: Many incentives are offered for companies to run clinical trials in the Middle Eastern countries; such as governmental and institutional efforts to support evidence-based medicine and innovations in medical device. The investment in health and research is thus proportional to the wealth owned by the Gulf Council Cooperation countries. Moreover, several additional advantages for trial feasibility are offered in this region: good health care system and free public services, lower research costs and shorter timelines for trial approval compared with European and North American countries, and rapid patient recruitment due to the close relationship between physicians and patients.

Middle East is becoming a more attractive market for clinical research because of the rising costs of clinical trials in the West and the need for a greater market. The growing scientific and medical community coupled with good international collaborations is promoting medical research in the region. Nevertheless, Middle East remains a relatively untapped resource and uncharted territory for many biopharmaceutical and medical device companies.

ClinSearch provides expert advice for strategic development plan and regulatory process required to run clinical trials in the Middle East. Our team includes staff members fully fluent in Arabic, who can assist with the regulatory submissions, site project management and monitoring, medical writing, as well as other relevant services. Our in-depth understanding of the Middle East cultural context and current regulatory environment enables us to conduct high quality research in the Middle Eastern countries.