The Global Future Of Clinical Trials For The Medical Device Industry

This article was originally published in the Clinical Research Blog by Forte Research Systems on 01/30/15.

Medical devices – everything from clinical trials equipment and medical thermometers, to MRI machines and pacemakers – are a hundred billion dollar a year business. In 2011, the medical device industry was valued at $266 billion and is predicted to grow to over $500 billion before the decade is out. It is crucial that new medical devices are developed to maximise efficiency, minimise cost and, most importantly, ensure patient safety. The landscape of medical device development is changing fast with rapidly expanding markets in Asia fueling on-going regulatory changes that endeavour to streamline and optimise the processes of testing, licencing, and monitoring worldwide.

Safety, Testing, and Regulation in the Medical Device Industry
There are over half a million different types of medical devices produced globally, including the ordinary (spectacles, dentures, and plasters), high-tech (MRI and X-ray equipment), and various others (apparatus, diagnostic equipment, implants, etc.). Just like pharmaceutical drug development, safety for new medical devices is paramount. However, the testing of medical devices presents a unique set of challenges that are not faced by the much larger pharmaceutical industry. For instance, while the randomised controlled trial is the cornerstone of pharmaceutical clinical testing, this is rarely possible for medical devices because of logistical and ethical issues. Furthermore, the efficacy and safety of a medical device depends not only on its design and manufacture, but also on the skill and expertise of the medical practitioner using or implementing it. Medical device testing therefore relies on a combination of preliminary testing followed by rigorous long-term monitoring and reporting of adverse effects after the device becomes available on the market. The time between the development and sale of new device improvements is typically between 18 and 36 months, which is significantly shorter than that of pharmaceutical developments.

The speed with which new medical devices become available depends upon the regulatory framework in place in the country developing or importing the device, the risk category of the device, and whether it utilises technology that has been previously tested in other devices. Around two-thirds of countries currently have at least partial regulation in place to govern testing and licencing of medical devices. In the US and EU, medical device manufacturers are required to apply for pre-market approval based on clinical safety data and must implement an acceptable post-market surveillance system to monitor adverse effects. However, regulations are slightly less stringent in the EU, with medical devices typically reaching the market at least a year earlier than in the US. There is a careful balance between the availability of new technology and patient safety, and while the US government is under pressure to relax regulations in order to remain competitive, EU regulations are under review to ensure patient safety is maximised.

Outside of Europe and North America, regulation is more varied, although major regulatory changes are in motion across East Asia, where the medical device industry is expected to grow rapidly over the next decade. The Association of Southeast Asian Nations (ASEAN)’s Medical Device Directive, signed by member states in 2014, aims to harmonise medical device classification, clinical testing, assessment, and monitoring across Southeast Asia. Regulatory harmonisation across the region will act to eliminate trade barriers and make Southeast Asia a more attractive investment opportunity for foreign manufacturers.

Reducing Costs and Maximising Efficiency
Improving the efficiency and effectiveness of medical devices in an increasingly cost-conscious environment will be a major priority for medical device research in the future. Increasingly, manufacturers in Europe and North America are under pressure to reduce costs, especially in light of new economic policies such as the recently introduced medical device excise tax in the US. As the regulatory climate in Asia becomes more stringent, safety concerns are easing and companies in Europe and North America are increasingly able to outsource manufacturing to Asian companies, enabling them to reduce costs by up to 30%.

The Emerging Medical Device Industry in Asia
Historically, US and European markets have dominated medical device development and manufacturing. However, increasing economic development across Asia is driving a flourishing new medical device industry, particularly in Japan, China, Vietnam, and Malaysia. Valued at $4.5 billion, the Southeast Asian medical device market is expected to grow to $9 billion by 2019. This growth will be bolstered by standardisation of safety and regulatory procedures outlined in the ASEAN Medical Device Directive and other international bodies aimed at harmonising the global procedures for medical device testing and approval. Further, governments in many Asian countries are prioritising expansion and improvement of the medical device industry, which will lead to increased investment in research, development, and safety.

The growth of the medical device industry in Asia is matched by overall increases in demand globally. Economic development in countries such as Brazil, India, and China is producing ageing populations and a growing middle class that demand access to a greater range and quality of medical devices. The world of medical device development is opening up, and standardisation of safety and regulatory procedures will greatly facilitate trade and investment in this rapidly expanding sector.

This article was provided by Richmond Pharmacology, a clinical research organisation (CRO) based in London providing Japanese Bridging Studies, Early Phase studies and Patient recruitment.

References
VisionGain (2013). Medical device contract manufacturing: world market outlook 2013-2023. www.visiongain.com/Report/970/Medical-Device-Contract-Manufacturing-World-Market-Outlook-2013-2023

ASEAN Briefing (2014). Key Industries for Investment in ASEAN. www.aseanbriefing.com/news/2014/12/03/key-industries-investment-asean