India’s MedTech industry is poised for significant growth, yet it is dealing with certain challenges that hinder its full potential. Among the most pressing issues is the compliance burden, complex legal frameworks, rising operational costs and talent shortages. To unlock the sector’s growth, it’s crucial to understand these challenges and address them strategically. There is an urgent need for regulatory harmonization in which regulatory requirements converge and facilitate expedited product approvals both domestically and globally.
Regulatory Hurdles and Compliance
A robust regulatory system has a significant role in the MedTech industry, and the industry truly appreciates the rigorous efforts that regulators around the world, especially India is taking to ensure the safety and efficacy of the products which would ensure quality patient outcomes. Navigating these complex regulatory landscapes is no small feat and its commendable how organizations work tirelessly to meet the required global accelerated standards while simultaneously striving to bring innovative solutions to market.
The industry recognizes the promising developments in India, particularly with the introduction of the National Medical Devices Policy, 2023, which aims to promote local manufacturing and reduce import dependency along with India’s move to join the International Medical Device Regulators Forum (IMDRF) as an affiliate member which will result in regulatory harmonization. Additionally, the focus on post-marketing surveillance will also help to ensure the safety and effectiveness of products in the market. This regulatory policy shift holds great potential, especially if it is consistent, transparent, and long term as frequent updates to policies and standards may create some uncertainty, especially for start-ups and smaller organizations.Given the high cost and complexity of achieving certifications like FDA clearance or CE marking approvals, would it be possible to explore ways to support smaller organizations in managing these challenges? Perhaps there could be opportunities for regulators to simplify processes or enhance international collaboration, which would provide significant relief to the industry and foster innovation.
The continued efforts to balance safety, innovation and market accessibility are truly appreciated and the medical device industry looks forward to any potential developments that can further ease this regulatory journey.
Compliance and Quality Control
Ensuring strict adherence to quality management standards is vital in the MedTech sector. Standards like ISO 13485 govern the entire process of designing, manufacturing, and maintaining medical devices. The challenge lies in ensuring that every step of the process, from raw material sourcing to post-market surveillance, complies with these standards. It is crucial for companies to work closely with outsourced partners to meet regulatory expectations. Proper quality control mechanisms not only ensure patient safety but also protect businesses from potential legal and financial penalties associated with non-compliance. There is also a need to have a strong product quality standard ecosystem in the country, which is harmonized with global standards, leading to better global acceptance of locally manufactured products.
Talent and Supply Chain Challenges
A shortage of skilled talent in areas like research and development (R&D) further exacerbates challenges in the MedTech space. Specialized training programs have so far been a few, leaving companies to develop their own in-house training modules. The government is cognizant of the fact and has undertaken initiatives such as the Human Resource Development (HRD) Scheme and the Capacity Building and Skill Development in the Medical Device Sector Scheme by the Department of Pharmaceuticals (DoP) which could play a crucial role by promoting specialized education programs that align with the needs of the MedTech sector. Additionally, the lack of local component suppliers makes it difficult for companies to scale operations. With many components still imported, the cost of goods remains high, making it hard for companies to offer competitive pricing.
Balancing Safety and Market Speed
For regulatory bodies, the task of keeping up with the fast-evolving MedTech industry is increasingly difficult. While it is essential to maintain stringent safety standards, there is also pressure to expedite product approvals to meet market demand. Striking a balance between ensuring patient safety and minimizing time-to-market is a critical issue. Regulatory agencies must adapt to emerging technologies while ensuring products meet high standards for efficacy and safety. This delicate balancing act presents a challenge for both regulators and manufacturers alike.
Implications of Policy Changes and Schemes
The Indian government has introduced various initiatives aimed at strengthening the MedTech sector, such as the Scheme for Strengthening of Medical Device Industry (SMDI) which has a clear focus on marginal investment for reducing the import dependence by providing support for production of key components, raw materials & accessories used in manufacturing of medical devices, generation of clinical evidence, creation of common facilities, promotion of ‘Make in India’ medical devices globally and the Promotion of Research and Innovation in Pharma-MedTech (PRIP) scheme, which fosters collaboration between industry and research/ academic institutions. The National Medical Devices Policy aims to enhance domestic manufacturing capabilities, reduce reliance on imports and promote innovation.
Approval Processes and Classification
One of the primary regulatory challenges in MedTech is the approval process, particularly when different regions have varying device classifications and regulatory requirements. For example, a medical device classified as low risk in one market may be classified as high-risk in another, impacting approval timelines and associated costs. These discrepancies can significantly affect a company’s ability to plan for global market access. Understanding these different classification systems and approval processes is essential for MedTech companies to successfully navigate global markets.
Overcoming Regulatory and Compliance Overhaul
To alleviate some of these compliance burdens, the medical device industry has proposed financial assistance and subsidies for the industry to help with certification processes, such as CE marking and FDA 510 (k) clearance. Additionally, establishing more local high-end testing laboratories for biocompatibility and electrical safety would reduce dependency on foreign labs, lowering testing costs and shortening certification timelines. Streamlined governance, risk and compliance (GRC) systems can help companies manage regulatory compliance more efficiently while maintaining enterprise risk oversight.
Investment and Growth in the Sector
The recent regulatory streamlining and policy changes have led to increased investment in the MedTech sector. Start-ups focusing on low-risk devices have attracted venture capital and established companies are diversifying their portfolios to cater to India’s unique healthcare needs. This influx of investment is driving R&D, which could lead to the development of innovative solutions that serve the Indian market. However, the high costs of clinical testing, documentation and international certification still pose a significant barrier, especially for smaller players.
Government’s Role in Fostering Growth
For the MedTech industry to reach its full potential, government intervention is critical. Support through harmonized regulatory frameworks, subsidies, and the creation of dedicated infrastructure, such as medical device parks, can reduce the operational burden on manufacturers. The Production-Linked Incentive (PLI) scheme and the development of medical device parks aim to attract foreign investment and strengthen local manufacturing capabilities. As multinational companies diversify their supply chains away from China, India’s MedTech sector is well-positioned to benefit from this global shift.
Conclusion: India’s MedTech industry holds immense promise, but it faces certain hurdles, particularly around regulatory compliances, cost pressures and talent shortages. By addressing these challenges through supportive government policies, fostering innovation and investing in local infrastructure, India can position itself as a global leader in MedTech.
The article is written by Anish Bafna, Secretary, NATHEALTH, CEO & MD, Healthium Medtech
(DISCLAIMER: The views expressed are solely of the author and ETHealthworld.com does not necessarily subscribe to it. ETHealthworld.com shall not be responsible for any damage caused to any person/organisation directly or indirectly)
