Spearheading innovation to develop affordable surgical navigation systems

1. How HRS Navigation is making surgical navigation technology more affordable and accessible, especially to hospitals and patients in India?

HRS Navigation is at the forefront of making surgical navigation technology more affordable and accessible for hospitals and patients in India. As the first domestic manufacturer of surgical navigation systems for neurosurgery, spine surgery, and ENT surgery, HRS Navigation is breaking barriers traditionally associated with high costs and complex technology in surgical settings.

• Eliminating consumables: One of the significant ways we reduce costs is by designing our navigation systems to operate without consumables. Unlike other systems that require ongoing purchases of disposable components, our systems represent a one-time investment, significantly lowering operational expenses for hospitals.
• Designed for Indian operating theatres: Our navigation systems are specifically designed to integrate seamlessly into the varied operating theatre environments across India. Whether in high-end metropolitan hospitals or more modest setups in smaller towns, our systems are versatile and do not necessitate costly infrastructure changes.
• Universal integration with C-Arms: easyNav, our flagship product, is engineered to work universally with any C-Arm. This compatibility ensures that hospitals do not need to invest in additional or specific equipment, further reducing costs and making advanced navigation technology more accessible.
• User-friendly and efficient: Our systems are known for their simplicity and ease of use, with a short learning curve that allows healthcare professionals to integrate them quickly into their workflow. This efficiency is crucial for expanding the adoption of our technology in diverse healthcare settings, enhancing overall surgical precision and patient outcomes.
• Democratising healthcare: By focusing on affordability and accessibility, HRS Navigation is bringing high-quality surgical navigation technology to hospitals outside major metropolitan areas. Our solutions are designed to be cost-effective for healthcare facilities in smaller cities, aligning with our goal of expanding advanced surgical care to underserved regions.
• Local manufacturing: Embracing the “Make in India” initiative, our local manufacturing efforts contribute to cost efficiencies and ensure that advanced surgical technologies are within reach for a broader range of hospitals and patients across the country.

HRS Navigation is committed to revolutionising the surgical landscape in India by providing innovative, cost-effective solutions that enhance surgical precision while making cutting-edge technology accessible to all.

2. How can AI and machine learning be effectively integrated into surgical navigation systems to enhance precision and outcomes in Indian hospitals?

Integrating AI and machine learning (ML) into surgical navigation systems represents a transformative approach to improving precision and surgical outcomes in Indian hospitals.

• Enhanced surgical precision: AI and ML algorithms can analyse vast amounts of medical imaging data to provide real-time, highly accurate guidance during surgeries. These technologies can detect subtle anatomical variations, identify optimal surgical pathways, and predict potential complications, thereby assisting surgeons in achieving unprecedented precision.
• Real-time decision support: AI-driven systems offer real-time decision support by continuously analysing intraoperative data and providing actionable insights. This capability helps surgeons make informed decisions on the fly, adapting to dynamic surgical environments and improving patient outcomes.
• Automated workflow optimisation: AI can streamline surgical workflows by automating repetitive tasks, such as image registration and instrument tracking. This automation reduces the cognitive load on surgeons, enhances procedural efficiency, and minimises human error.
• Training and simulation: AI-powered simulations and virtual training modules provide surgeons with immersive, hands-on experience in a controlled environment. These tools accelerate the learning curve, improve surgical skills, and ensure consistent high-quality care across varying levels of surgical expertise.

3.  What innovative approaches are Indian startups taking to develop affordable surgical navigation systems without compromising quality?

Indian startups are spearheading innovative approaches to develop affordable surgical navigation systems without compromising on quality. By leveraging advanced technologies such as artificial intelligence and machine learning, these startups enhance the precision and efficiency of navigation systems, reducing the reliance on expensive hardware. Additionally, optimising supply chains through local sourcing and lean manufacturing techniques minimises waste and production expenses, making these advanced systems more accessible to a wider range of healthcare providers.

Moreover, startups are creating modular and scalable systems that can be easily upgraded and tailored to fit various hospital sizes and budgets. Integrating remote assistance features allows for remote installation, training, and support, cutting down on the costs associated with on-site visits. Utilising cloud computing and data analytics not only reduces the need for expensive IT infrastructure but also provides surgeons with actionable insights to improve patient outcomes. Collaborative innovation through partnerships with academic institutions ensures that these startups stay at the forefront of cutting-edge research and development, offering high-quality surgical navigation solutions at an affordable price.

4. What are the key regulatory hurdles that health tech startups face in India, and how can they navigate these to bring surgical devices to market?

Health tech startups in India encounter significant regulatory hurdles when bringing surgical devices to market. Some of these challenges include:

• Regulatory compliance: Understanding and adhering to the regulatory requirements established by CDSCO is crucial for obtaining timely approval for medical devices. Non-compliance can lead to rejections, delays, and missed opportunities for market entry.
• Adapting to evolving regulations: India’s regulatory landscape for medical devices is continually evolving. Startups must stay updated with new requirements and adapt their processes and documentation accordingly to ensure compliance.
• Validation procedures: Medical devices must undergo thorough validation procedures according to CDSCO standards. Failure to adhere to these procedures can significantly delay the approval process and impact market entry timelines.

To navigate these hurdles effectively, health tech startups can take several steps:

• Early engagement with regulatory experts/ consultants: Startups should engage with regulatory experts/ consultants early in the development process to understand requirements and seek guidance.
• Compliance with standards: Ensuring compliance with international standards such as ISO certifications can streamline the regulatory approval process.
• Strategic partnerships: Collaborating with established healthcare institutions or experts can provide startups with valuable insights and credibility.
• Adaptation to local needs: Understanding and adapting to the specific needs and challenges of the Indian healthcare system can facilitate market entry and adoption.

5. What measures are necessary to ensure data security and patient privacy in the development and deployment of surgical navigation technologies?

As a leading Indian surgical navigation company, we prioritise data security and patient privacy in all stages of development and deployment. Our approach is multi-faceted, adhering to the highest standards to protect sensitive information.

Ensuring data security and patient privacy in the development and deployment of surgical navigation technologies is crucial to maintain trust and comply with regulations like HIPAA (Health Insurance Portability and Accountability Act). Here are several essential measures:

• Data encryption: All patient data, whether at rest or in transit, should be encrypted using strong encryption methods to prevent unauthorised access.
• Access control: Implement strict access control mechanisms to ensure that only authorised personnel can access patient data. Use role-based access controls (RBAC) and ensure strong authentication methods (e.g., multi-factor authentication).
• Anonymisation and de-identification: Before storing or transmitting data, ensure that personally identifiable information (PII) is anonymised or de-identified whenever possible to protect patient identities.
• Secure data storage: Use secure storage solutions with access controls and regular security audits. Consider using cloud services that comply with relevant security standards (e.g., ISO 27001).
• Data minimisation: Only collect and retain patient data that is necessary for the intended purpose of the surgical navigation technology. Avoid unnecessary data collection.
• Audit trails: Maintain audit logs of all accesses and activities involving patient data. These logs should be regularly monitored and reviewed for any unauthorised access or anomalies.
• Secure communication channels: Ensure that communication channels used to transmit patient data are encrypted and secure (e.g., TLS/SSL for web-based communication).
• Training and awareness: Train all personnel involved in the development and deployment of the technology about data security best practices and the importance of patient privacy.
• Compliance with Regulations: Adhere to relevant laws and regulations (e.g., HIPAA in the United States, GDPR in Europe) concerning data privacy and security in healthcare.
• Regular security assessments: Conduct regular security assessments, penetration testing, and vulnerability assessments to identify and mitigate potential security risks.
• Incident response plan: Develop and maintain an incident response plan to quickly address and mitigate any data breaches or security incidents involving patient data.
• User consent and transparency: Obtain explicit consent from patients regarding the collection, use, and storage of their data. Provide transparent information about how their data will be used and protected.

By implementing these measures, developers and healthcare providers can significantly enhance the security and privacy of patient data in the context of surgical navigation technologies. This not only protects patient confidentiality but also helps in building trust among patients and stakeholders in the healthcare ecosystem.

6. What are the main challenges health tech startups face in attracting investment, and what strategies can they employ to secure funding for surgical navigation systems?

Health tech startups in India, particularly those focused on surgical navigation systems, face unique challenges in attracting investment. These include high capital requirements, regulatory hurdles, and proving clinical efficacy.

• High capital requirements: Developing and bringing surgical navigation systems to market involves significant R&D and regulatory compliance costs. Startups must demonstrate the scalability and potential return on investment (ROI) of their technology to attract investors.
• Regulatory uncertainty: Navigating complex regulatory landscapes can deter investors concerned about time-to-market and compliance costs. Startups should proactively engage with regulatory bodies and showcase a clear pathway to approval to reassure potential investors.
• Proof of clinical efficacy: Investors need evidence that the technology improves surgical outcomes. Startups must conduct robust clinical trials and generate compelling data to validate their device’s effectiveness and safety.

Strategies to Secure Funding:

• Comprehensive Business Plan: Develop a detailed business plan outlining market opportunity, competitive advantage, and financial projections. Highlighting a clear go-to-market strategy and potential ROI can attract investors.
• Strategic partnerships: Form alliances with established healthcare providers and academic institutions to enhance credibility and access resources for development and validation.
• Proof of concept: Develop a working prototype or pilot program to demonstrate the technology’s potential and gather initial feedback and data.
• Regulatory strategy: Clearly outline a regulatory strategy showing readiness to navigate compliance requirements, thereby mitigating investor concerns.
• Pitch to specialised investors: Target investors with a focus on healthcare and medical technology who understand the regulatory and development timelines unique to this sector.

7. HRS Navigation expansion plans?

Currently, we specialise in surgical navigation systems for Neurosurgery, ENT surgery, Spine surgery and soon to be a venture into orthopaedic surgeries as well.

Looking ahead, our vision involves a comprehensive expansion and enhancement of our existing product offerings. We plan to introduce additional functionalities to our software, which will provide surgeons with a more comprehensive and detailed visualisation, leading to improved decision-making during surgical procedures.

Expanding our orthopaedic navigation system offerings remains a strategic focus for us. Following the imminent launch of the knee navigation system, we plan to expand to other specialities in the orthopaedic surgery domain. This expansion aligns with our commitment to providing comprehensive solutions for a variety of orthopaedic procedures. 

In a groundbreaking move, we are gearing up to move into robotic surgeries as well. This addition represents our dedication to advancing surgical techniques and empowering surgeons with state-of-the-art technology to achieve unprecedented levels of precision in spinal interventions.

Furthermore, HRS Navigation also has global expansion plans over the next 2-3 years. In alignment with governmental initiatives, particularly ‘Make in India for the World,’ we aim to bring our innovative surgical navigation systems to a global audience. This initiative reflects our vision to contribute to the global healthcare landscape by providing advanced and locally manufactured technologies. 

In summary, our plans involve a multifaceted approach, combining technological innovation, software enhancements, and an expanded product portfolio. 

[email protected]

[email protected]