“Navigating diverse regulatory requirements for global med-tech products in the Indian healthcare ecosystem requires a strategic and systematic approach, given the unique challenges of the country’s healthcare system.”
Reflecting on the last decade, what innovations or shifts in the med-tech space do you believe have had the most significant impact in India?
I began my career in the medical devices industry in early 1996, during a time when the industry was still in its infancy. There were few regulations, limited infrastructure, and a shortage of trained doctors capable of performing advanced surgical procedures. Less invasive techniques like angiography and endoscopy were just being introduced and were primarily used as diagnostic tools rather than therapeutic ones. Key pioneers in interventional cardiology and endoscopy such as, Dr Samuel Mathew, Dr Ashwin Mehta, Dr Ashok Seth, Dr. Maydeo and Dr. D.N. Reddy, played a crucial role in advancing less invasive medicine in India. Their contributions, alongside industry collaborations, have significantly shaped the growth of less invasive medicine in India.
Over the past decades, India has seen transformative innovations and shifts in the med-tech space that have significantly impacted healthcare delivery and access. The expansion of tertiary care facilities in Tier II and Tier III, towns coupled with government initiatives, has made advanced care, especially in the management of CVDs, cancer, etc. more accessible. Additionally, the rise of affordable medical devices tailored to the Indian market has made healthcare more accessible to the masses. One of the most notable advancements is the widespread adoption of telemedicine and digital health platforms. Telemedicine, accelerated by mobile connectivity, has bridged the rural-urban divide, enabling remote consultations and diagnostics. Platforms offering consultations, diagnostics, and follow-up care have become essential, especially during the COVID-19 pandemic.
AI and machine learning have revolutionized diagnostics, enabling faster and more accurate identification of conditions like cancer, diabetes, and heart diseases. AI-driven imaging tools and predictive analytics are enhancing decision-making processes for healthcare professionals, while wearables and remote monitoring support proactive care.
Innovations in low-cost diagnostics, point-of-care devices, and portable imaging have transformed healthcare access, quality, and affordability for both urban and rural populations, significantly improving public health outcomes.
India’s regulatory framework for health tech is constantly evolving. What specific policy changes do you believe are critical to fostering innovative growth?
India’s health-tech sector has witnessed significant growth in recent years, but to truly foster innovation, the regulatory framework must evolve to address emerging challenges while promoting sustainable growth. The introduction of the Medical Devices Rules, 2017, is a positive step forward, establishing guidelines for the safety, efficacy, and quality of medical devices. However, further streamlining of the regulatory processes is necessary to nurture innovation.
One of the most pressing issues is the approval of medical devices and health-tech products. Simplifying the approval process, particularly for low-risk devices and software, would help accelerate time-to-market for innovative solutions. Alongside this, the need for robust data privacy regulations is critical. Health-tech heavily depends on the connection and analysis of sensitive data, and India must adopt robust data protection laws akin to the EU’s GDPR. Clear guidelines on patient consent, data storage, and sharing will help build trust in digital health solutions while safeguarding privacy.
The COVID-19 pandemic accelerated telemedicine adoption, yet the regulatory framework for telemedicine remains underdeveloped. Expanding the telemedicine guidelines to include cross-state telemedicine practices, licensing requirements, and reimbursement models is essential for scaling health-tech services and providing high-quality, remote care. In addition, offering tax incentives and grants for research and development (R&D) in health tech will stimulate innovation, particularly in areas like AI, IoT, and precision medicine. Strengthening partnerships between startups and academic institutions can further fuel advancements in medical technology.
A regulatory sandbox could also help by providing a controlled environment where companies can test new health-tech solutions, minimizing the risk of regulatory overreach while promoting experimentation. One of the barriers to the widespread adoption of health-tech solutions in India is the lack of clear reimbursement policies from insurance providers and government programs. A national policy framework that integrates digital health solutions into insurance coverage and government health schemes would incentivize providers to adopt these technologies.
Together, these regulatory changes can foster a supportive ecosystem that encourages innovation, ensuring both patient safety and the continued growth of India’s health-tech sector.
How do you approach navigating diverse regulatory requirements for global med-tech products being adapted to Indian healthcare needs?
Navigating diverse regulatory requirements for global med-tech products in the Indian healthcare ecosystem requires a strategic and systematic approach, given the unique challenges of the country’s healthcare system. India’s diverse patient population, varying regulatory standards, and cultural differences necessitate careful adaptation of global products to meet local needs.The first critical step is to thoroughly understand India’s regulatory environment, particularly the Central Drugs Standard Control Organization (CDSCO), which governs medical device and drug approvals. The regulations for medical devices are outlined under the Medical Device Rules, 2017, which require classification based on risk and the relevant approval pathways. It’s crucial to differentiate between low-risk and high-risk products, as the approval processes can vary significantly.
While global products may already adhere to international standards, they often need adaptation to suit local healthcare needs. This includes ensuring the product addresses specific Indian healthcare challenges, such as affordability for a vast, diverse population and the high prevalence of conditions like diabetes and hypertension.
Conducting local clinical trials or studies is another key step. Global med-tech products often require adaptation based on regional health conditions, population characteristics, and usage patterns. Conducting local clinical trials or studies is critical to ensuring the product’s safety, efficacy, and relevance to the Indian market. Compliance with both international quality standards, like ISO certifications, and Indian-specific standards, such as Good Manufacturing Practices (GMP), is essential for approval.
Given the complexity of the regulatory landscape, working with local regulatory experts is invaluable. They provide valuable insights into the nuances of navigating India’s approval process, including document requirements, clinical trials, and timelines. Building strong relationships with local regulatory bodies and understanding the nuances of the Indian approval process can expedite product entry. Understanding India’s pricing and reimbursement policies is also vital. Working with insurers and the National Pharmaceutical Pricing Authority (NPPA) helps make products accessible to the wider population.
I think navigating the regulatory landscape for global med-tech products in India requires an understanding of both local regulations and the specific needs of the population. Adaptation, collaboration with local authorities, and meticulous planning ensure smoother market entry and long-term success.
India is investing in digital health missions. How can public-private partnerships help address bottlenecks in scaling digital and AI-driven healthcare?
Public-private partnerships (PPPs) have the potential to play a critical role in addressing the bottlenecks in scaling digital and AI-driven healthcare in India. As the country invests heavily in digital health initiatives, PPPs can harness the strengths of both the public and private sectors to overcome key bottlenecks such as infrastructure gaps, data security concerns, lack of interoperability, and the need for capacity building.
India faces significant disparities in healthcare infrastructure, particularly in rural and remote areas. The public sector has an extensive reach and infrastructure that can be enhanced by private sector innovation. Through PPPs, the government can collaborate with private companies to build robust digital healthcare infrastructure, such as telemedicine platforms, e-health records, and diagnostic tools. Private partners can bring in cutting-edge technology and expertise while the government leverages existing infrastructure to ensure that these solutions reach underserved populations. This collaboration can bridge the urban-rural divide, providing quality healthcare to millions in remote areas who currently lack access to basic services.
A key bottleneck in scaling AI-driven healthcare is the lack of data integration and interoperability between different health systems. The public sector is making progress with initiatives like the National Health Stack and Ayushman Bharat Digital Mission (ABDM), which aim to create a standardized digital health infrastructure. Private sector’s technological capabilities can help ensure seamless data sharing across platforms, enabling AI algorithms to access comprehensive data for accurate diagnostics and treatment. Through PPPs, the government and private players can work together to standardize data formats, improve infrastructure, and create interoperable solutions for the entire healthcare ecosystem.
AI-powered tools hold great promise for revolutionizing healthcare delivery, but developing and scaling these solutions requires substantial investment in research and development (R&D). PPPs can combine the public sector’s funding and large-scale data with the private sector’s R&D capabilities to develop AI solutions tailored to India’s specific healthcare challenges, such as rural health monitoring and managing chronic diseases.
Capacity building is another area where PPPs can make a significant impact. To effectively scale digital healthcare, India requires skilled professionals capable of operating these technologies. Public-private partnerships can focus on training healthcare workers, technicians, and administrators to use digital health tools, AI applications, and telemedicine platforms. Private companies can provide training resources, while the government ensures these programs are accessible.
A clear regulatory framework is crucial for scaling digital health solutions. PPPs can help develop guidelines for the approval and deployment of digital health tools and AI algorithms, ensuring the safety, efficacy, and ethical use of AI in healthcare while also promoting innovation.
Finally, scaling digital health requires significant financial investment. PPPs can provide seed funding, grants, and policy incentives, while private companies contribute venture capital and expertise.
By combining the resources, expertise, and capabilities of both sectors, PPPs can overcome barriers in scaling digital and AI-driven healthcare, enabling India to harness the full potential of digital health technologies. This will ultimately improve healthcare accessibility, quality, and affordability for millions in the country.
Given the transformative potential of AI in diagnostics, what are the ethical and regulatory implications that need to be addressed?
The potential of AI to transform diagnostics is immense, offering faster, more accurate diagnoses and improved patient outcomes. However, this progress raises significant ethical and regulatory concerns that need to be carefully addressed to ensure safe, effective, and equitable healthcare delivery.
One of the most pressing ethical issues is the risk of bias in AI systems. AI systems are trained on large datasets, and if these datasets lack diversity, the resulting algorithms may perpetuate biases, leading to unequal healthcare outcomes. For example, if AI models are trained predominantly on data from one demographic, they may perform inaccurately for others. To mitigate this, datasets must be inclusive, representing diverse patient populations across different ages, genders, ethnicities, and health conditions.
Another key issue is transparency and accountability. AI-driven diagnostic tools are often seen as “black boxes” where the decision-making process is unclear. This lack of transparency can be problematic, especially If a misdiagnosis occurs. Developing explainable AI (XAI) is crucial so that healthcare providers understand how AI models reach their conclusions.
Finally, informed consent must evolve to reflect AI’s role in healthcare. Patients need to be clearly informed when AI is part of their diagnosis or treatment, understanding how it contributes to decision-making and whether human judgement is involved in the final outcome.
On the regulatory front, AI-based systems must be rigorously tested for safety and efficacy before being deployed in healthcare settings. Agencies like the FDA or CDSCO need to establish clear guidelines for testing and certifying AI-driven diagnostics.
Data privacy and security are also critical concerns, as AI systems in healthcare rely on large volumes of sensitive patient data. Stringent data protection laws, such as the GDPR or India’s Personal Data Protection Bill, must be enforced to prevent misuse or breaches.
Lastly, AI systems should be subject to continuous monitoring to ensure their ongoing accuracy and safety in clinical settings. Regulatory frameworks must adapt to address potential risks and unintended consequences as AI systems evolve.
In the coming decade, how do you envision the convergence of robotics, AI, and personalized medicine transforming healthcare delivery in India?
In the coming decade, the convergence of robotics, AI, and personalized medicine is poised to revolutionize healthcare delivery in India. AI-powered diagnostic tools, such as machine learning algorithms and deep learning models, will enhance diagnostic accuracy across specialties like radiology and pathology. These tools can detect diseases earlier, often before symptoms emerge, leading to improved outcomes.
Robotics, coupled with AI, will enable highly precise, minimally invasive surgeries. A defining example is the first-ever remote robotic angioplasty conducted on humans showcasing India’s ability to lead in groundbreaking medical innovation. In the future, as this technology expands, it could help bridge the healthcare gap between urban and rural regions, where skilled surgeons are often in short supply. Additionally, personalized medicine, powered by AI and genomics, will enable tailored treatments based on an individual’s genetic makeup, improving the effectiveness of treatments for conditions like cancer and chronic diseases.
The integration of these technologies will also streamline healthcare delivery by automating administrative tasks and managing patient data more efficiently. Robotics will enhance rehabilitation and physical therapy, accelerating recovery, while personalized medicine will reduce trial-and-error treatments, optimizing healthcare spending.
I believe that the integration of AI, robotics, and personalized medicine will make healthcare in India more accessible, affordable, and effective. This transformation will enhance the patient experience and improve public health outcomes. By minimizing operator variability and human errors, we will see significant improvements in clinical results.
About Riyaz Desai:
Riyaz Desai is a seasoned healthcare professional with over 25 years of expertise in the medical device industry, including leadership roles at prestigious Fortune 500 companies like Boston Scientific, Medtronic, and Smith & Nephew. As the Founder Director of Innovant Scientific Pvt Ltd and Crescente Innovative Therapeutics, Riyaz has been at the forefront of pioneering medical innovations in India and the Asia-Pacific region.
His visionary leadership led to groundbreaking achievements, such as the introduction of the world’s first vascular robot outside the USA, the launch of an orthopedic robot in the Asia-Pacific market, and the commercialization of voice-biomarkers in the region. With a wealth of experience in strategic tie-ups, licensing, M&A, and navigating multicultural, matrix organizations, Riyaz Desai continues to shape the future of healthcare with a passion for transformative technologies.
3 Comments
Great benchmark by Mr. Riyaz…..keep it and I congratulate you for this fabulous achievement.
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