India is positioned as a significant voice of global critical care devices

One of the fastest expanding segments in the Indian Healthcare space is its medical device industry that was earlier eclipsed by the pharma industry till Covid changed its course. With India's healthcare sector poised to reach Rs 18.5 Bn by FY 2027, the country is witnessing unprecedented growth in indigenous medical technology development.

Among high impact sectors within the industry, coronary stents occupy an integral space as India witnesses over 4.5 angioplasty procedures annually. The demand for stents is increasing with domestic manufacturers slowly increasing their market share amidst price controls and regulations.

With several indigenous companies now making globally certified and high quality Drug Eluting stents, things are looking bright with less dependence on imports and more affordability for end users, making life saving treatment more accessible though with some debates around investments and innovations.

In an atmosphere of an evolving landscape, there is a push for Atmanirbhar Bharat in Medtech and brings to focus India's growing potential as a hub for life saving devices in global manufacturing. We bring to you an interesting and valuable insight from Dr Rajiv Chhibber, Vice President External Affairs at Sahajanand Medical Technologies Ltd who has been at the helm of communication, policy advocacy and business strategy.

1. What has been your key philosophy that has allowed you to successfully address medical professionals and policy makers?

I am a strong believer of ecosystem development. Individually a person has limitations, but when an ecosystem moves, it paves way for Policy Change and development. Healthcare in India remains at the forefront, yet the ecosystem works in silos. None of the stakeholders in hospitals, diagnostic centers, Medical Device Companies, Pharma or API companies' team up to address challenges, while Academia, NGOs and HCPs shy away from corporate synergies, giving mixed signals to policymakers. As a catalyst, I work towards creating a healthcare landscape which involves all stakeholders for improving patient outcomes and ensuring equitable access to innovative care.

2. What are the key regulatory challenges in India's medical device sector and how is the regulatory framework evolving?

Regulatory challenges in the medical device industry include keeping up with constantly evolving regulations as newer devices get entry into the market, navigating complex international standards, and addressing cybersecurity & sustainability concerns. Manufacturers have challenges of balancing innovation with stringent regulatory requirements while ensuring global market access and post-market compliance.

While there are ongoing regulatory challenges, efforts to streamline processes are increasing ease of doing business. The CDSCO, India's apex body, assisted in initiatives to improve infrastructure, enhance supply chains, and promote collaboration across value chains. With the Indian Drug Regulator now being a member of International Medical Device Regulators Forum (IMDRF), it will help to promote global collaboration, harmonize international regulatory requirements, and strengthen the Indian medical device sector as we become a $7 Trillion economy.

3. SMT has won several accolades and your flagship product has been in use across 69 countries. What has been the mantra for SMT's success?

At SMT, our philosophy and guiding principle laid by our Chairman Sh. Dhirajlal Kotadia has always been "Pledged to Save Millions" by making critical healthcare in the vascular domain affordable for millions of people around the world. Over time SMT have restructured facilities and operating models with clear priority-setting processes, evidence-based decision-making, and making use of the latest efficient technologies to cater to a larger population reeling under the burden of cardiovascular disease.

To align with global competition, SMT is continuously upgrading our technology and R&D in the vascular space, with better products already in the pipeline and at advanced stages, also exploring new and emerging markets with quality meeting global standards. But there needs to be a tectonic shift in the mindset of physicians and policymakers with regards to quality Indian products that are meeting and perhaps exceeding the applicable quality and regulatory requirements.

4. How do you balance innovation with affordability in emerging markets?

Affordable healthcare in emerging markets is crucial for economic growth and social equity, especially given rising health expenditures, elderly population and a growing middle class. Strategies could include mooting cost-effective production in key regions which can be collective pools, resource optimization, infrastructure enhancement and leveraging technology, while also considering public-private partnerships to achieve Universal Health Coverage.

Leveraging AI and digital health solutions can enhance diagnostic capabilities and improve healthcare access in resource-constrained areas, especially since GDP spending on Healthcare in Emerging Markets is skewed and low. The idea should be 'Embracing Innovation to Deliver Healthcare,' that can lead to disrupting the present healthcare system to build the future. India's philosophy of 'Availability, Accessibility and Affordability, coupled with Advancements' can lead the way to address primary gaps and ensure mechanisms for scaling health technology.

5. How can government partnerships encourage more homegrown innovation in MedTech?

The pandemic has presented a unique opportunity for India to emerge as the new manufacturing hub of the world. Post the pandemic, a huge focus has been given to the Medical Device Sector, especially with Prime Minister Modi calling out this sector as the "sunshine sector." Today with more conducive policies in healthcare, especially sector specific reforms such as the PLI Scheme, making of Bulk, API and Medical Device parks by the government and the PRIP scheme has helped the sector thrive.

To boost "Make in India for the World," the Government should:

• Increase spending in healthcare and making timely and faster payments towards reimbursement accounts. There is need to expand the Medical Device Market for Domestic Manufacturers and position India to be a big consumption market with sufficient average sale prices, and better procedure prices for Ayushman Bharat and other state level schemes.
• Bring in R&D incentives or separate pricing for Evidence based Devices which have global equivalence. The Government should encourage procurement of such Innovative devices in central and state government purchase programs, ensuring quality.
• Capital and OpEx subsidies can encourage more innovation and create quality low-cost devices accepted globally. These could be incentivised pricing for evidence-based devices having robust clinical trials, Tax exemptions in medical devices parks, which have shared infrastructure to support med-tech innovation such as shared raw material supplier base, testing services, ease of supply chains among others.
• The road map should focus on the Prime Minister Jai Vigyan-Jai Anusandhan call making innovation and R&D as a strong pillar of building India’s best-in-class manufacturing ecosystem.

With such policies in place, by 2047, India can emerge as a significant medical device manufacturer and become a factory for the world like the pharma industry.

6. How do you handle public perception and engage with the media in times of regulatory scrutiny?

I have always combined the optimal usage of Policymakers and Media to dispel any myths around Medical Devices in India. During COVID, we were able to build the narrative on the Indian MedTech industry with Media, contributing to stories on the importance of local manufacturing, the domestic market and strengthening the local supply chains.

Trade shows, expos and conventions have been a part of the strategy plan and showcasing at globally acclaimed platforms like WHX-Dubai, CPHI etc, has put India as a focal destination for investments, research, quality, innovation, and reliability. This changes the narrative on how India is driving innovation and latest technologies. Global conventions bring investments and new-age technology that further assists in taking forward the 'atmanirbhar bharat' dream.

7. What advice would you give to aspiring professionals in the MedTech industry?

The Indian Medical Device Industry is at the cusp of transformation. For aspiring professionals my response would be to take forward Atmanirbhar Bharat with Atmavishwas. A skilled workforce is the foundation of growth and economic prosperity for both the country and industrial sector. So investing and aggregating skills with creativity, resilience and diversity aids in being relevant and employable. Widening technical knowledge, analytical skills, communication skills, and the ability to navigate between cross-functional teams of engineering, life sciences and healthcare is also needed.