Patient safety is a fundamental element of health care and is expressed as freedom for a patient from unnecessary harm associated with a health care facility, device or drug. Patient safety has been increasingly recognised as an issue of global importance. We all know that the world has changed post 2020. One of the most drastic changes that happened, is in the area of healthcare. There has been a specific focus on accessibility, availability and affordability of quality healthcare globally with a strong focus on patient safety. This also includes the medical devices industry.  

The global medical devices industry has been on the growth curve for the last decade. This can be largely connected to the growing geriatric population and the growing trend for preventive, therapeutic and rehabilitative treatments that are becoming increasingly accessible to the general population. This growth rate of the medical devices industry was further accelerated with the arrival of the pandemic and is currently slated to be around USD 658 Billion by 2028 as per a market research report. 

The current challenges in the medical devices industry

With the industry set to grow at an exponential scale, the regulators and medical device manufacturers must work towards fixing the areas of improvement to reach its true potential. Some of them are: 

Regulatory and Quality Challenges: There is a disparity in the regulations around medical devices around the world – The rules are very stringent in the developed markets whereas they are relaxed in some of the developing markets. This results in differences in the quality of the products being developed for consumption in different parts of the world. 

Cybersecurity Concerns: With more medical devices becoming digital and connected to the digital ecosystem, there are relevant concerns about patient privacy and protection per HIPAA. Developing compliant smart devices have become more complex and costly. This has additional implications for the approval process in some countries. 

Imitations and Counterfeits: There are increasing counterfeits of successful medical devices that are being developed in multiple markets in violation of Intellectual property rights. Additionally, multiple imitations of the original products have resulted in substitution, resulting in possible risks to human lives. 

Device Recalls and Lawsuits: With multiple companies facing lawsuits around the world for endangering the lives of people who use implants or medical devices that are key to maintaining life, it becomes necessary for companies to ensure that they are maintaining all the necessary quality aspects connected to the regulatory requirements of the intended country. 

Fixing the medical device industry limitations  

Keeping these important parameters in mind, countries in the European Union have implemented the ‘EU Medical Device Regulation’ (EU-MDR) to ensure that manufacturers produce safe products to get the new CE certification. This regulation will now ensure the ‘traceability’ of a medical device from its development to expiry with the help of a Unique Device Identification (UDI). The UDI that is implemented will help track the devices throughout the supply chain resulting in curbing counterfeits and imitations. This will also ensure the global quality standards that are expected from the manufacturer of the device are maintained for their products. 

While India is largely an import market, several medical device companies have garnered a niche for themselves in the global market. According to Frost & Sullivan, the export of medical devices from India is estimated to be US$ 1,180 million in 2020 growing a CAGR of 20.2% from 2020-2025 indicating the growing potential of leveraging domestic manufacturing to target global medical device markets. 

Based on the global changes, select  Indian companies that have been focusing on exporting all classes of medical devices and consumables to Europe and the United States of America have already started following the guidelines related to traceability as well as robust clinical investigation to ensure the safety and efficacy of their products. Additional testing related to extraction, leachability and biological safety is also being carried out along with relevant reports that can be evidenced to regulators in the developed and developing markets. 

Implementation of EU-MDR guidelines and the way forward  

With more companies in India working on meeting the EU-MDR guidelines, the overall industry quality and efficacy standards will improve, resulting in the standardisation of products that could be used around the world. While there will be cost implications during the early days, this is expected to even out with the global volumes that would be required to meet the growing demands of 7.5 billion people. As more countries start to focus on quality standardization, prevention of substitution, safety and efficacy of medical devices, the aspects connected to accessibility, affordability and availability of quality medical devices will become a reality.