Collaboration among stakeholders in India could be the key to further promote the development of quality, high-end medical devices that can identify and address patient needs and provide sustainability.
KPMG in India, in collaboration with the Asia Pacific Medical Technology Association, recently published a report that highlights existing policies and initiatives that enable innovation in the Indian medical devices sector. It also highlights challenges and offers recommendations to address them. Ultimately, the report aims to serve as a guide for stakeholders to navigate the transformation journey of the medical devices industry.
WHY IS THIS IMPORTANT
The report identified six key themes which will drive innovation in the Indian medical devices sector:
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Favorable regulations and policies: The report suggests that the Drugs, Medical Devices & Cosmetics Bill 2022, upcoming legislation that will update the Drug and Cosmetics Act of 1940, considers medical devices independent of pharmaceuticals and addresses the nuances of the cosmetics industry. medical devices. . It also encourages India’s alignment with global norms and standards and to explore regulatory dependency and convergence with other regulators and available international standards. India should also work towards simplifying and streamlining intellectual property processes, which will help reduce the costs associated with maintaining intellectual property. Finally, it is recommended to have a strong monitoring mechanism to ensure rapid implementation of policies and initiatives.
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Encourage research: KPMG highlighted some areas that can be incentivized to promote research, including tax incentives for innovation, research subsidies, workforce training, clinical trials and patent regimes.
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Robust digital infrastructure: By implementing the Healthcare Digital Information Security Act and other data privacy laws, India should promote the use of data for innovation without compromising data security. sensitive data, suggests KPMG. The country should adopt more digital health technologies, such as AI-based diagnostics, telemedicine and wearable devices, but also ensure that the necessary funds are allocated to both maintain its existing digital stack and to the development of its digital capabilities. The National Medical Devices Policy, released this year, already states that investments in 5G and IoMT will be key to boosting innovation in the country.
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Integrate public-private partnerships (PPP): Manufacturers are suggested to use PPP frequently. The Indian government, for its part, should facilitate dialogue and promote partnerships between public sector academia, healthcare providers and private medical device sector players. Medical device companies should form partnerships aimed at serving the domestic market.
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A favorable ecosystem: A dialogue between hospitals, manufacturers and start-ups can be the key to boosting the growth of medical devices in India, says the KPMG report. By supporting a globally focused startup ecosystem, India can position its academic and research institutions, with the support of manufacturers, as a foundation. At the same time, the government can channel resources to a specific area of medical technology in medical device parks to reduce competition for investments. Manufacturers are also recommended to highlight clinical evidence and publish the results in industry journals to build consumer confidence. Investors should explore innovative financing models such as risk sharing and helping manufacturers access global markets. Finally, healthcare providers can work closely with innovators to identify patient needs, evaluate solutions and provide design elements, as well as adopt and integrate their digital tools to create an interoperable ecosystem. They can also offer test benches to help validate new products.
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Skills development and transversal skills of the workforce: Industry-academia collaborations can also be ways to upskill the workforce, the report notes. It is also recommended that organizations train their staff in assembling high-end devices and learn about R&D, product lifecycle management, and manufacturing so they can add lifecycle value of innovation. It is said that an environment conducive to growth and learning is necessary to retain employees and develop their skills.
THE BIGGER CONTEXT
Still in its infancy, India’s medical devices sector, whose manufacturing is currently focused on consumables and disposables, is expected to reach a figure of $50 billion by 2030, up from $11 billion last year.
The KPMG report shows how India is seeking to evolve the sector into a global leader and powerhouse. After focusing on developing technologies that help reduce healthcare costs, it is evolving into a value-based and innovation-driven industry. It also advocates for autonomy in the manufacturing of medical devices, encourages local innovation and guarantees the accessibility and affordability of medical devices to the entire population. However, local medical device innovation is hampered by a lack of skilled labor, limited infrastructure and inadequate insurance coverage.
To address these challenges, the government has played a crucial role in catalyzing innovation in the local production of medical devices by launching several initiatives, including the National Policy for Research, Development and Innovation in the Pharma-Medtech Sector, the Promotion of research and innovation in the Pharma-Medtech sector. the program, the National Medical Device Policy, Assistance to Medical Device Consortiums for Common Facilities, the National Research Foundation Bill, the Production Linked Incentives Program and the promotion of medical device parks. In 2021, the government, through the Biotechnology Industry Research Assistance Council, launched a incentive scheme supporting 75 startups in the fields of telemedicine, digital health and AI.
Apart from the government, research institutes, such as the Indian Council of Medical Research, academic research institutes and even private players like startups and local medtech companies, have been instrumental in the advancement of R&D on medical devices.