1. What policy changes, and ecosystem challenges need to be addressed for Designed/Made in India medical equipment to make an impact in India?
Despite India’s growing healthcare industry, significant policy changes and ecosystem challenges need to be addressed to make a real impact with Designed/Made in India medical equipment. Here’s a breakdown of key areas:
Incentivising research and development (R&D):
- Increase tax breaks and grants for domestic R&D in medical devices
- Encourage collaboration between research institutions and private companies through joint ventures and funding programmes
- Focus on Specific Needs: Additionally, incentivise R&D efforts towards medical equipment addressing India’s specific healthcare challenges
Building manufacturing capabilities:
- Offer subsidies and tax benefits for setting up domestic manufacturing facilities
- Promote the development of Medical Device Parks with infrastructure, skilled workforce, and streamlined regulatory processes
- Simplify import procedures for essential raw materials and components used in medical device manufacturing
Quality assurance: Fast-Track Certifications: Facilitate faster access to globally recognised quality certifications (eg, FDA or FDA equivalent) through a subsidised, fast-track process. This will enhance international credibility and market access for Made in India medical devices.
Development of a holistic ecosystem: Foster collaboration between research academia and private companies through:
- Joint research projects with funding opportunities
- Student internships and exchange programmes
- Faculty exchange programmes to leverage academic expertise in real-world applications
Encourage technology transfer from research institutions to startups and established companies. Support the creation of incubation centres and accelerators specifically focused on medical devices. These centres can provide:
- Mentorship from experienced industry professionals
- Access to shared lab facilities and equipment
- Assistance with business development and fundraising for promising ventures (entrepreneurs)
By strengthening these linkages, India can create a fertile ground for innovation where academic research translates into commercially viable medical devices, driven by entrepreneurial spirit and industry expertise.
- Access to Patient Capital: Encourage funding agencies, including private equity and venture capital firms, to provide patient capital for inclusive business models. These models should cater to underprivileged segments while promoting local manufacturing.
By addressing these policy changes and ecosystem challenges, India can cultivate a thriving medical device sector. This will not only improve access to affordable and high-quality medical equipment but also position India as a global leader in medical device innovation.
2. How can medtech startups effectively navigate complex regulations to achieve market success?
Medtech startups can effectively navigate complex regulations to achieve market success by focusing on several strategic areas outlined in the document. Key strategies include:
Understanding and adapting to regulatory frameworks: Medtech startups need to stay informed about the evolving regulatory landscape. In India, the new draft bill called ‘The Drugs, Medical Devices & Cosmetics Bill 2022’ aims to address current legislative issues by treating medical devices independently from pharmaceutical products. This bill is expected to streamline regulatory processes and provide clearer guidelines tailored to the medical device sector.
Harmonising standards with global norms: Aligning with global standards is crucial. India is working towards harmonising its quality standards with international norms to position itself as a reliable hub for medical devices. This involves regulatory reliance and convergence with other regulators and adherence to international standards such as those proposed by the American Standard Test Method (ASTM)
Leveraging innovation-friendly IP laws: Simplifying and streamlining intellectual property (IP) processes can significantly reduce the time and costs associated with obtaining and maintaining patents. Medtech startups should be proactive in understanding and utilising these streamlined IP processes to protect their innovations and encourage further development.
Adopting best practices from global markets: Learning from the best practices of developed and emerging markets can accelerate innovation and regulatory compliance. For instance, Singapore’s consultation services and regulatory reviews during the development phase of a medical device can expedite the approval process. Similarly, Thailand’s third-party review system and resubmission allowances for rejected applications can improve the efficiency of the registration process.
By focusing on these areas, medtech startups can effectively navigate complex regulations and achieve market success while fostering innovation and growth within the sector.
3. How can investors better identify high-potential medtech startups in a competitive landscape?
Identifying high-potential medtech startups in a competitive landscape requires a nuanced approach. Here are several key strategies to enhance this process:
Leverage domain expertise: Investors should prioritise insights from professionals with deep knowledge of the healthcare industry. This means hiring or consulting with experts who understand the nuances and complexities of healthcare, rather than relying solely on generic consulting firms. Their specialised expertise can provide a more accurate assessment of a startup’s potential.
Collaborate with industry insiders: Engage with individuals and organisations that are deeply embedded in the healthcare ecosystem. This includes collaborating with clinicians, healthcare administrators, and other stakeholders who have firsthand experience with the challenges and opportunities within the sector. Their practical insights can highlight which startups are addressing real, unmet needs.
Comprehensive due diligence: Perform thorough due diligence that goes beyond financial metrics. This should include an evaluation of the startup’s technology, clinical validation, regulatory pathway, market potential, and competitive landscape. A detailed analysis of these factors can help identify startups with a sustainable competitive advantage.
Focus on unmet needs and market fit: Assess whether the startup is addressing a significant unmet need in the healthcare market. Startups that offer innovative solutions to pressing healthcare problems are more likely to achieve long-term success. Evaluate the product-market fit and the scalability of the startup’s solution.
4. What role does innovation play in enhancing operational efficiency in hospitals and diagnostic centres?
Innovation plays a transformative role in enhancing operational efficiency for hospitals and diagnostic centres. Artificial intelligence (AI) stands out as a game changer, impacting various aspects of healthcare delivery. AI has the potential to:
- Streamlining patient care: AI-powered assistants can answer basic patient questions, schedule appointments, and even provide preliminary symptom analysis, freeing up human staff for more complex tasks.
- Generative AI for better management: AI algorithms can analyse vast amounts of patient data to predict potential health issues, personalise treatment plans, and optimise resource allocation.
- Revolutionising medical imaging: AI has revolutionised radiology by automating routine tasks like image analysis and report generation. This not only saves time but also allows for remote interpretation, making specialist services accessible in remote areas.
While AI is a powerful tool, it’s not the only innovation driving efficiency. Other advancements include:
- Telehealth and remote monitoring: Technologies like video conferencing and wearable sensors allow for virtual consultations and remote patient monitoring, reducing the need for in-person visits.
- Robotics and automation: Automated lab processes, robotic surgery, and medication dispensing systems can streamline workflows and minimise human error.
- Data analytics and cloud computing: Analysing operational data can identify bottlenecks and areas for improvement. Cloud computing provides secure, scalable storage and access to patient information, enhancing collaboration and decision-making.
5. What are the biggest challenges medtech companies face in the Indian market today?
Medtech companies in India encounter several key challenges:
Limited R&D incentives and ecosystem: There is a lack of adequate incentives and an underdeveloped R&D ecosystem to support innovation in the medical device sector. This hampers companies’ ability to create advanced medical technologies.
Skilled workforce deficiency: Despite India producing a significant number of STEM graduates, there is a gap in skilled professionals specifically trained for the medical device industry. Coordination between biomedical education and engineering disciplines is lacking, particularly in areas requiring specialised knowledge in hardware, software, and advanced R&D technologies.
Inadequate infrastructure: The supply chain infrastructure, especially in rural areas, is insufficient, resulting in higher costs and longer lead times for transporting medical products. Additionally, advanced research facilities are concentrated in a few states, limiting widespread innovation.
Low insurance coverage: With only 37 per cent of the population having health insurance, access to high-end medical treatments is restricted, reducing the financial resources available for medical device companies. Furthermore, low reimbursement rates from schemes like Ayushman Bharat discourage the adoption of innovative medical technologies.
Need for innovation and competition: The Indian medical device market is highly fragmented, with fierce competition among manufacturers of low-cost, high-volume devices. Companies must innovate to enhance their profit margins and address patient-specific challenges, yet balancing affordability with advanced technological development remains a significant hurdle
6. How do you see data-driven insights transforming healthcare in the next five years?
Data-driven insights hold immense potential to revolutionise the Indian healthcare landscape in the next five years.
Addressing local challenges: Data-driven insights can help identify specific clinical and operational issues unique to India. This understanding enables the development of tailored products and solutions that directly address these challenges, improving patient outcomes and healthcare efficiency.
Innovation for India: By understanding the specific challenges faced by the Indian healthcare system through data insights, the development of targeted “Make in India” solutions can be accelerated. This includes creating affordable and accessible medical technologies, telemedicine solutions for remote areas, and AI-powered diagnostics tools tailored to the Indian context.
Market adoption and impact: Data-driven insights can guide the development of healthcare solutions that cater directly to the needs and preferences of the Indian population. This can lead to higher user adoption and a more sustainable healthcare ecosystem.
Precision medicine: By analysing vast sets of medical data, including genetics, lifestyle factors, and electronic health records, healthcare providers can personalise treatment plans for individual patients. This can lead to more effective therapies, reduced side effects, and improved patient outcomes.
Data-driven insights will impact various facets of the healthcare industry, from clinical decision-making to policy formulation. They enable evidence-based decisions, enhance research and development, and foster a more proactive approach to healthcare management.