Introduction

The healthcare system is complex and interacts with individuals and communities at multiple levels to improve health.¹ The novel coronavirus disease (COVID-19) pandemic has exposed the vulnerabilities of the healthcare system globally. In this context, innovations in the healthcare sector are helping address these challenges and bridging the gap between the actual and potential performance of healthcare systems. The global healthcare industry is one of the fastest-growing sectors in the world², including India³, and one of the critical drivers of this growth is innovations. Innovators in the healthcare sector have identified ways to deliver effective healthcare at significantly lower costs while improving access and quality.⁴ Disruptive technologies like portable, less invasive diagnostics, integrated digital platforms, artificial intelligence, internet of Things (IoT) are shaping the future of healthcare systems in India.⁵ The COVID-19 pandemic resulted in a wide range of innovations that tried to meet the challenges of a novel virus.⁶ These innovations addressed a broad spectrum of issues related to diagnosis, therapies and supportive care and optimised performance in resource-limited settings.

An analysis of the growth of innovations in the Indian healthcare system reveals that it is transforming at a rapid pace through innovations and applications in digitalisation, personalised care, the Internet of Things, artificial intelligence, biotechnology, nanomedicine, medical devices, etc. An analysis of innovative healthcare startups reveals that currently, digital innovations are the most rapidly diffused, while biotechnology sector innovations are among the oldest in India.⁷ With the launch of the startup policy in 2016 and the push towards indigenous production, innovations in medical devices received a significant push. In April 2023, the first Medical Device Policy was approved by the Government of India. Given the above context, this study discusses the evolution, application and diffusion of innovation in these three sectors- biotechnology, digital healthcare and medical devices. These have emerged as the three significant sectors in terms of innovation and witnessed a recent increase in funding and policy initiatives. The COVID-19 pandemic also created a massive demand for the products and services of these three sectors. Hence, these three sectors have been selected for analysis for this study.

Methods

A broad search of academic and non-academic literature (grey literature) was conducted. The selection criteria of studies were broad-based but specific to include research on the emergence, adoption and diffusion of healthcare innovations in biotechnology, digital healthcare and medical devices within India's healthcare system. Snowball referencing and citation tracking of academic documents was done, and additional studies from grey literature (reports, website publications) were also analysed. In addition, Key Informant Interviews of experts from each sector were conducted to get their perspectives and complement the secondary data. Sixteen Key Informants across the three sectors participated in this study. These included four experts from digital healthcare, two experts from biotechnology and ten experts from the medical device sectors. Data triangulation was conducted from the primary and secondary data sources, and the analysis is presented in the results and discussion section.

Results and Discussion

Biotechnology Sector

The establishment of an independent Department of Biotechnology in 1986 helped create a scientific workforce, infrastructure network, and support for R&D. India was among the first countries in the world to create a Department of Biotechnology. At present, the Indian Biotechnology industry constitutes only 3% of the overall global biotech market ($11.1 billion), but this number is expected to increase to 19% by 2025 ($100 billion). The biotechnology industry in India comprises more than 2700 biotech startups. It is estimated to reach 10,000 by 2024, aiming to provide high-quality drugs, better diagnosis and medical technology products at a reasonable price. Haffkine Biopharmaceutical Corporation Limited was India's first public biotechnology company, established in 1975. This sector benefited from the National Biotechnology Development Strategy (NBDS) developed in 2007, which provides comprehensive, long-term, predictable, transparent fiscal, regulatory and policy support. Two key strategies were initiated to encourage private sector participation. One was the cluster development strategy, which reflects the triple helix (university-industry-government relations) dynamic phase strategies of innovation. The second strategy involved public-private partnership (PPP) to leverage the strengths of the private sector. With several home-grown companies, the private sector has performed well by mainly leveraging its strengths in services and manufacturing. Its strong impact has been on promoting low-cost vaccines (e.g. Hepatitis B vaccine at $1, COVID-19 vaccines, Zika virus vaccine, Rotavirus, Japanese encephalitis, Typhoid, etc.) and other novel healthcare products like biosimilars, which is forcing a price reduction on bio-products of multinational companies.

However, investing in Biotechnology is a cost-intensive, time-consuming exercise as returns on investment take time to materialise. A key policy challenge for biotechnology industries in India is to adapt technologies from the global basket available to make them effective in the Indian context. This would help increase inclusivity while also expanding the growth of this sector. Rigorous impact assessment (including economic evaluations) and quality standard verification are needed for innovation-support programmes in biotechnology. The adoption and diffusion of clinical use biotechnology innovations require rigorous clinical trial data, which would provide the evidence for better adoption and diffusion of these innovations to healthcare providers and patients.

Digital Healthcare Sector

During the COVID-19 pandemic, telehealth services and digital platforms for accessing medicines and healthcare services significantly increased.⁸The increase in digitalisation of healthcare is not limited to the private sector as the Government of India launched its ambitious National Digital Health Mission in September 2021. This digitalisation is part of a technology-centric innovation for the country's public healthcare system. It aims to provide all eligible citizens with digital health cards and link them with the National Health Assurance scheme (Ayushman Bharat). In addition, the use of innovative digital apps for taking doctor appointments, ordering medicines and scheduling COVID-19 vaccination (Co-WIN app) has helped address the information gaps in healthcare between patients and doctors and provided value addition in terms of convenience to patients and caregivers and also encouraged the use of Electronic Health Records (EHR) by healthcare providers. The spread of digital healthcare contributes to a complementary increase in adopting e-pharmacy, telemedicine and telehealth. However, the success of digital innovations depends on the availability, access and quality of the internet and suitable devices, users' digital literacy and data protection. In India, the speed of these innovations has outpaced the development of regulatory policies, infrastructure (availability of internet in rural and tribal areas) and digital literacy. Hence, there is a need for a supportive environment along with a robust, standardised regulatory framework to address these issues for more extensive penetration of digitalised healthcare.

Medical devices Sector

The development of innovative medical devices is significant since India imports around 75% of its medical devices. Hence, innovations in this sector have the potential to make India self-reliant and decrease import expenditures. The medical device innovation ecosystem is evolving very fast in India, reflected by increased funding from private firms, the government, and a vibrant academic research environment. The medical devices industry represents around 5% (USD 5 billion) of the USD 100 billion healthcare industry in India but is expected to reach USD 50 Billion by 2025. The growth in the medical device sector is contributed by epidemiological factors like the increasing prevalence of Non-Communicable Diseases (requiring devices for screening and monitoring), demographic factors like the increasing elderly population and the rise in age-related diseases, economic factors like rising income levels of middle-class population and increasing awareness about health issues and penetration of health insurance. Innovations in medical devices have targeted all levels of care (primary, secondary and tertiary) and prevention. Some medical devices are specific to particular Non-Communicable Diseases (NCDs), like innovative portable screening tests using AI-enabled Thermalytix for breast cancer and chatbots for mental health. Medical devices targeting general primary healthcare diagnosis without drawing blood (using spectroscopy at less than a dollar per test) have the potential to democratise testing and improve accessibility and affordability of diagnosis of diseases. However, other medical device innovations for specialised surgical interventions require skilled healthcare personnel to operate. Hence, there is a variation and gradation to the extent to which these innovations will be available and accessible for different sections of society. Also, while these devices' software components (AI) are evolving fast, India still depends on imports for critical hardware components for many medical devices. Hence, policies must also focus on and fund hardware manufacturing to be self-reliant. The regulatory space has evolved but is still nascent and requires better capacity building. The Medical Device Policy came into effect only in April 2023, and its impact on the medical device sector has scope for future research along with the long-term impact assessment of the applications of medical device innovations in the healthcare systems.

Based on the findings of this study, a comparative framework (Dependency-Imitability Framework) based on the imitability and dependency components of these healthcare innovations is proposed (Table 1) to help understand the diffusion of these innovations.

Table 1: Dependency-Imitability (DI) Framework for comparing healthcare innovations and their diffusion.

Imitability refers to the ability of other companies to imitate and recreate/ manufacture the product or service of the innovating company. Dependency refers to the dependency of the innovation on complementary or supportive assets for its diffusion. For example, dependency on imports of silicon chips used in medical devices, without which the device cannot be manufactured or replicated. Dependency also includes a dependency on supportive infrastructure like the availability of internet, smart phones, etc., required for accessing digital healthcare. A diffusion scale has been created based on the extent of imitability and dependency, as shown in Figure 1.

Figure 1: Diffusion scale

Based on the study findings, the healthcare innovations in Biotechnology, Digital healthcare and Medical devices from India have been categorised using the DI framework in Table 2.

Table 2: Application of the DI framework to healthcare innovations in Biotechnology, Digital Healthcare and Medical Devices.

Based on this framework and diffusion scale developed, the study findings suggest that the innovations in Biotechnology, Digital healthcare and Medical devices have a moderate diffusion rate. However, different strategies would be required to increase the diffusion rate in these three sectors. Since digital healthcare has high imitability, improvements in complementary supportive infrastructure would help increase its diffusion rate. On the other hand, the diffusion rate of Biotechnology would increase by improving the imitability dimension of the products, i.e. through a decrease in the patent period, open source sharing (which happened during COVID-19) and collaborative endeavours. While this framework has been developed for comparing innovations in three sectors (biotechnology, digital healthcare and medical devices) in India, researchers can also use it to compare and contrast innovations in other sectors and in different country settings.

Study limitations

The study is limited to healthcare innovations in three sectors in the Indian context, and hence, the findings cannot be generalised to other sectors. The diffusion scale is a normative tool and subjective assessment based on empirical data and cannot be quantified.

Conclusions

The evolution of healthcare innovations in India is most visible in biotechnology, digital healthcare and medical devices sectors. These innovations have a vital role to play in healthcare service delivery for public health and clinical practice. However, the role of ecosystems, governance and policies affecting the adoption and diffusion of these innovations has yet to be studied and is a research gap. Also, there are research gaps in measuring the long-term impact of innovations in healthcare systems in terms of responsiveness to healthcare equity and sustainability, and there needs to be studies assessing the role of these innovations towards achieving Universal Health Coverage (UHC). Hence, it is recommended that future research should focus on assessing the impact of the innovations in these sectors towards achieving the Sustainable Development Goals and Universal Health Coverage.

References

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