Medical device design in emerging markets : Challenges and opportunities

Research says that the global market for medical device technologies reached nearly $521.2 billion in 2017 and should reach $674.5 billion by 2022, at a compound annual growth rate (CAGR) of 5.3% for the period of 2017-2022.

Author: Vasanthan Mani, Lead Design Engineer, Tata Elxsi

The World Health Organisation (WHO) defines a medical device as any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more specific medical purpose(s). Some forms of medical devices that are being used prominently by doctors and hospitals in today’s time across the globe are injectables, patches, wearables, connected healthcare devices, implants, etc.

Research says that the global market for medical device technologies reached nearly $521.2 billion in 2017 and should reach $674.5 billion by 2022, at a compound annual growth rate (CAGR) of 5.3% for the period of 2017-2022. Emerging markets like Brazil, Russia, India, China, and South Africa (BRICS) offer tremendous opportunities and significant challenges to medical device designers and manufacturers. Regulations in these emerging markets are constantly adopting safe, reliable, and quality medical products, which are at par with international standards, with tight control on the price of lifesaving drugs and devices.

Need and adoption of medical devices

Taking a close look at emerging markets makes one realize that the need for medical device design and technology was always there. Still, it has now become more imperative and essential than ever. The foremost reason for the demand for medical devices is an increase in the GDP of these countries and a rise in per capita income, leading to the patient making well-informed and analyzed decisions with respect to their treatment plans and devices. An evident rise in living standards also increases the need for safe, reliable, and highest-quality medical devices. It is also needless to mention that the explosive growth of health insurance complements the growth of medical devices in emerging markets.

An example of regular use of a medical device such as an auto-injector pen is insulin injections for people who have severe diabetes. India is the second-largest diabetic country globally, which makes it a gigantic market for insulin injector pens. Having said that, it has been observed that reusable pens have found popularity among the cost-conscious BRICS nations, while developed nations find disposable injector pens more convenient. Additionally, the same auto-injector device can also be customized for multiple treatments like infertility and emergency drug delivery. Other attractive fields are nephrology (portable dialysis machines), neurosurgery (image-guided stereotactic surgery), and safety syringes (auto-retracting and needleless injectors). Large device companies have also begun tailoring their auto-injector platforms to local markets for various treatments. There is explosive growth in the combination drug product category, such as pre-filled syringes, disposable insulin pens, and antimicrobial coated catheters. Upcoming trends in this space will be led by needle-less drug injection via a patch, which has a micro-array of nano-needles or high-pressure drug delivery directly into the skin without any needles.

Challenges to battle in emerging markets

Similar to any other technological innovation, the medical devices industry also is currently facing certain challenges. Medical device manufacturers in emerging markets need to tackle challenges that come with research, design, testing, and validation to successfully bring out cost-effective products in the extremely competitive global healthcare ecosystem. Due to mass production in developed countries, medical devices are highly patent-protected and expensive. In emerging markets, there is a lack of reputed design houses that design and innovate on the device front. Device testing labs for testing medical devices and accessories manufacturing have not reached quality levels, offering superior results and products with greater significance on value addition/analysis and value engineering (VAVE). As per ISO regulations, biocompatibility and animal testing are other challenges for device design houses and manufacturers for design validation and verification, owing to limited resources and a lack of safety protocols.

Technology transformation and future outlook

As technology transforms industries and individual lives, one cannot be oblivious to the impact of technological transformation on the healthcare ecosystem. Telehealth and IoT-based devices will revolutionize the healthcare system in emerging markets by providing ultra low cost point-of-care diagnostic devices in remote areas with minimal medical facilities, IoT-based mobile testing labs in areas affected by an epidemic for diagnosis, testing, and treatment, and IoT-coupled devices that will help the patient and his doctor monitor, customize and maintain treatment plans remotely, without actually visiting the hospital.

The design and development of medical devices are notably shaping healthcare as well as patient’s lives. We see a long and successful journey ahead for a combination of devices used for drug delivery and connected devices that monitor, record, store, transmit, and display patient information and enable seamless communication between patients, doctors, and insurance firms. Owing to the rapid changes and developments in the healthcare industry, patients and doctors are becoming more open and accepting newer technologies and devices. To meet patients’ needs and expectations, healthcare enablers and providers need to gear up for this new wave of medical devices and telehealth products.