India's healthcare landscape is a stark contrast between advanced medical technology and the vast population lacking access to quality care. While the country boasts cutting-edge medical facilities in major cities, rural and underserved areas often struggle with access to basic technology and insufficient resources. This disparity disproportionately affects the poor and marginalized, who bear the brunt of the healthcare burden.
Take for example this statistic - India has fewer than 5000 Magnetic Resonance Imaging (MRI) machines, according to the Union Ministry of Science & Technology. This translates to a paltry 3.5 machines per million. The prohibitive cost of these machines plays a major factor in the low penetration levels creating an affordability and access conundrum. To bridge this gap, companies have introduced refurbished medical devices, restoring the end-of-lifecycle machinery to continue to meet quality, safety, and performance standards, thereby offering huge cost savings – as much as 50 per cent less than new equipment. The refurbishment process is often very rigorous including cleaning, testing, repairing, calibrating, and ensuring compliance with regulations.
With the market for refurbished medical equipment expected to grow from USD 721.4 million in 2024 to USD 2,765.1 million by 2033, the increasing acceptance and demand for such equipment is clear.
Given the dismal penetration levels, most analysts would agree that by creating this secondary market, refurbishment in fact is helping to build the Indian domestic market. It is indeed not a threat to our Make in India vision or policies since the import of refurbished equipment is only limited to high-end and high-value medical devices, where domestic manufacturing is insufficient.
It is important to note that domestic manufacturers currently fulfil only 20-30 per cent of the nation's high-value equipment needs. In this context, the refurbished market emerges not as a competitor but as a complementary solution, bridging the crucial gap between immediate healthcare needs and developing domestic manufacturing capabilities. This alignment is evident in government initiatives like the National Health Mission and Ayushman Bharat, which prioritise the modernisation of healthcare infrastructure through economical solutions, including refurbished medical devices, especially in rural and semi-urban areas where brand-new equipment may be financially unfeasible.
Specifically, some of the key advantages of the refurbished medical equipment market include:
· Accessibility and Affordability: Refurbished equipment is financially viable for healthcare providers in tier II and III cities, reducing the financial barriers to adopting advanced medical technologies. This democratises access to sophisticated surgical interventions, improving patient outcomes across diverse demographics.
· Environmental Sustainability: Refurbishing reduces the environmental impact associated with manufacturing new equipment, conserving energy and raw materials, and supporting India’s commitment to becoming a net-zero nation by 2070. The refurbishment of some high-end, high value equipment significantly contributes to this goal, given the high resource intensity involved in their production.
· Capacity Building: Access to refurbishing equipment helps healthcare professionals in smaller cities gain expertise in advanced technologies. This capacity building is essential for the long-term sustainability of India’s healthcare system, ensuring that medical professionals are equipped with the skills and knowledge needed to deliver high-quality care using modern equipment. It also makes India a more robust healthcare provider, enhancing the country’s appeal as a medical tourism destination.
Busting myths of the market
Owing to a lack of awareness regarding refurbished medical equipment, many think them to be of sub-standard quality. Nothing could be farther from the truth.
· Imported Refurbished Devices: These devices often come from highly regulated markets such as the USA, UK, and Europe, where refurbishment standards are stringent. Imported refurbished devices are typically restored by OEMs or authorised facilities, ensuring high quality and compliance with international standards. They offer advanced technological features and are backed by comprehensive warranties and after-sales support.
· Domestic Refurbished Devices: In India, domestic refurbishment facilities are also emerging to meet local demand. These facilities are increasingly adhering to global standards, such as ISO 13485:2016, ensuring that refurbished devices meet stringent quality and performance benchmarks. Domestic refurbishment helps in reducing lead times, customising equipment to specific local needs, and supporting the local economy by creating skilled jobs and reducing dependency on imports.
· Regulatory Landscape: The medical devices industry complies to stringent standards for product safety such as IEC 60601-1. What is lacking is a robust policy for refurbished medical devices.
Immediate call to action
The refurbishment of medical equipment plays a vital role in democratizing access to advanced healthcare technologies in India. To maximize this potential, there is an immediate need of a speedy and robust regulatory framework/approval mechanism that allows the import & refurbishment of high end, high value medical devices (approved 38 devices as recommended by DGHS) in the country. This framework will create an enabling policy environment that encourages legitimate players while protecting healthcare providers and patients.
Furthermore, to ensure consistent quality across all players, mandatory quality certification processes must be implemented across the industry. Additionally, regular audits of refurbishment facilities should be conducted to maintain standards wherein clear documentation requirements for
device history and maintenance are established and enforced. Finally, standardized performance testing benchmarks must be developed and implemented across the industry.
By implementing comprehensive quality control measures and standardized testing protocols, India can effectively leverage refurbished medical devices to expand healthcare access while also maintaining the highest standards of patient safety.
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