Collaboration among stakeholders in India could be key to further advancing the development of high-quality, high-quality medical devices that can pinpoint and address patient needs and deliver sustainability.
KPMG in India, together with the Asia Pacific Medical Technology Association, recently published a report which highlights the existing policies and initiatives that enable innovation in the Indian medical device sector. It also highlights challenges and makes recommendations to address them. Ultimately, the report aims to serve as a guide for stakeholders as they navigate the medical device industry’s transformation journey.
WHY IT MATTERS
The report identified six main themes that will drive innovation in the Indian medical device sector:
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Supporting regulations and policies: The report suggests that the Drugs, Medical Devices & Cosmetics Bill 2022, a forthcoming legislation that will update the Drugs and Cosmetics Act, 1940, considers medical devices as independent of pharmaceuticals and caters to the nuances of the medical device sector. It also encourages India to align itself with global norms and standards and explore regulatory dependence and convergence with other regulators and available international standards. India should also strive to simplify and streamline IP processes, which can reduce the costs associated with maintaining IP. Finally, it is recommended to have a strong monitoring mechanism in place to ensure rapid implementation of policies and initiatives.
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Stimulate research: KPMG has noted a number of areas that could be incentivized to promote research, including tax incentives for innovation, research grants, workforce training, clinical trials and patent box regimes.
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Robust digital infrastructure: As it implements the Digital Information Security in Healthcare Act and other data privacy laws, India should promote the use of data for innovation without compromising the security of sensitive data, suggests KPMG. The country should adopt more digital health technologies such as AI-driven diagnostics, telemedicine and wearable devices, but also ensure that necessary funds are allocated for both maintaining the existing digital stack and expanding digital capabilities. The National Medical Device Policy, released this year, already stated that investments in 5G and IoT will be crucial in driving innovation in the country.
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Making public-private partnerships (PPP) mainstream: It is suggested that manufacturers regularly use PPPs. The Indian government, meanwhile, should facilitate dialogue and promote partnerships between public sector academia, healthcare providers and private sector medical device players. Medical device companies must form partnerships aimed at serving the domestic market.
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Beneficial ecosystemAccording to the KPMG report, a dialogue between hospitals, manufacturers and startups could be key to driving the growth of medical devices in India. By sustaining a globally oriented startup ecosystem, India can position its academic and research institutions, with the support of manufacturers, as a base. Meanwhile, the government can channel resources in a specific area of medical technology to medical equipment parks to reduce competition for investments. It is also recommended that manufacturers highlight clinical evidence and publish results in peer-reviewed journals to build consumer confidence. Investors should explore innovative financing models such as risk sharing and help manufacturers access global markets. Finally, healthcare providers can work closely with innovators to identify patient needs, evaluate solutions and provide design inputs, and adopt and integrate their digital tools to create an interoperable ecosystem. They can also offer testbeds to help validate new products.
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Further training and cross-skilling of staffCollaboration between industry and academia can also be a way to upskill the workforce, the report notes. It is also recommended that organizations train their workforce in assembling high-performance devices and learn about R&D, product lifecycle management and manufacturing so that they can add value to the innovation lifecycle. It is said that a conducive environment for growth and learning is necessary to retain employees and build their skills.
THE GREATER CONTEXT
India’s medical device sector, whose production is currently focused on consumables and disposables, is still in its infancy and is expected to grow to a $50 billion sector by 2030 from $11 billion last year.
The KPMG report notes how India wants to develop the sector into a global leader and powerhouse. From focusing on developing technologies that help reduce healthcare costs, the sector is transitioning to a values-based and innovation-driven sector. The country also pushes for self-reliance in medical device production, encourages local innovation and ensures the accessibility and affordability of medical devices for the entire population. However, innovation in local medical devices is hampered by a shortage of skilled workers, infrastructure limitations and inadequate insurance coverage.
To address these challenges, the government has played a crucial role in catalyzing innovation in local medical device manufacturing by launching several initiatives including the National Policy on Research and Development and Innovation in the Pharma-Medtech Sector, the promotion of research and innovation in the Pharma-Medtech sector. scheme, the National Medical Device Policy, the Assistance to Medical Device Clusters for Common Facilities, the National Research Foundation Bill, the Production Linked Incentives scheme and the Promotion of Medical Device Parks scheme. In 2021, the government, through the Biotechnology Industry Research Assistance Council, launched a incentive program to support 75 startups in the fields of telemedicine, digital health and AI.
Besides the government, research institutes such as the Indian Council of Medical Research, academic research institutions and even private players such as startups and local medical technology companies have played an important role in advancing medical device R&D.