This document presents the key takeaways from the insightful webinar “Preparing for Funding: Key Steps for HealthTech Startups,” organised by QuorumVeda Consulting Services. The webinar delved into the myriad challenges health tech startups face and explored strategic solutions across crucial areas such as regulatory compliance, market validation, clinical evidence, investor pitches, partnerships, and exit strategies.
Designed to inform healthcare sector stakeholders and policymakers, this summary aims to enhance understanding of the innovation and startup ecosystem, ultimately supporting emerging health tech ventures more effectively.
The journey of health tech startups is fraught with obstacles, from navigating regulatory pathways to securing funding and achieving market acceptance. Based on an in-depth discussion among experts, this article provides a comprehensive overview of these challenges and potential solutions. The insights shared aim to guide aspiring entrepreneurs, innovators, and stakeholders in the health tech sector, offering practical advice and strategies to overcome common hurdles and drive innovation in healthcare.
Motivation and initial challenges
The motivation behind founding a health tech startup often stems from a desire to address critical gaps in the healthcare system. One primary motivation is developing diagnostic equipment tailored for specific populations, addressing issues such as racial disparities and the high costs associated with imported equipment.
However, the initial phase is rife with challenges. Navigating regulatory pathways is particularly daunting, especially in regions with evolving frameworks. Securing funding for regulatory approvals, such as those from CIDSCO, the US FDA, or European CE, requires substantial financial resources and the right consultants. The journey from concept to market is long, requiring significant investment even before the product can be tested on patients.
Developing innovative solutions
Developing innovative solutions like non-invasive diagnostic devices for detecting bacterial infections involves rigorous research and development. The goal is to create products that can provide real-time diagnostics, thereby reducing the misuse of antibiotics and preventing severe outcomes like sepsis or limb amputations in a diabetic foot infection. Despite the potential benefits, these innovations face hurdles in gaining acceptance from the medical community, which often adheres to traditional diagnostic protocols.
Regulatory compliance
Importance of regulatory approvals: Regulatory compliance is crucial for any health tech product to be accepted in the market. Regulatory bodies ensure that products meet safety and efficacy standards, which is essential when dealing with human health. However, the path to obtaining these approvals is complex and resource-intensive.
Challenges in the regulatory process: Startups often struggle with understanding and navigating the regulatory landscape. The process involves multiple steps, including obtaining no-objection certificates, test licences, and ethical clearances. Each step can take several months, and any delay can significantly impact the project timeline. Additionally, the lack of clear guidelines and support from regulatory bodies can further complicate the process.
For example, during the COVID-19 pandemic, a government push led to the development of a remote health monitoring system by a public sector undertaking. Despite the robust technology, gaining approval and acceptance from the medical community was an uphill battle due to regulatory hurdles and the need for additional certifications.
Strategies for overcoming regulatory hurdles: To overcome these challenges, startups need to engage with regulatory consultants who have a deep understanding of the requirements and processes. Building a robust regulatory strategy from the outset can help streamline the approval process. Additionally, engaging with policymakers and advocating for clearer and more supportive regulatory frameworks can benefit the broader startup ecosystem.
An entrepreneur highlighted the importance of patience and meticulous planning. They shared how writing to over 100 doctors to validate their new technology led to responses from only three top innovative doctors. This emphasises the need for persistence and the importance of targeting early adopters who can champion the technology.
Market validation and acceptance
Demonstrating need and demand: One of the critical steps in bringing a health tech product to market is demonstrating a clear need and demand for the solution. This involves conducting thorough market research and engaging with potential users, such as doctors and healthcare providers. However, convincing the medical community to adopt new technology can be challenging, especially when it involves changing established diagnostic protocols.
An entrepreneur shared their journey of validating a non-invasive diagnostic device. Despite promising market survey data, real-world validation required hands-on testing by doctors. This disconnect highlights the importance of practical demonstrations to gain genuine feedback and acceptance.
Conducting clinical trials: Clinical trials are essential for validating the efficacy and safety of health tech products. These trials provide the data needed to gain regulatory approvals and convince the medical community of the product’s value. However, conducting clinical trials is expensive and time-consuming, often requiring substantial funding and collaboration with medical institutions.
One entrepreneur detailed their experience with conducting clinical trials, emphasising the need for substantial funding and planning. They shared how securing a grant for a minimum viable prototype was only the first step. Subsequent grants were necessary for clinical trials, which involved ethical clearances, registrations, and extensive testing across multiple hospital settings.
Building a strong case with data: Data is crucial for market validation. Startups need to gather and present robust clinical data to demonstrate the effectiveness of their products. This involves not only conducting trials but also publishing the results in reputable journals and presenting them at medical conferences. Building a strong case with data helps in gaining the trust of both regulators and the medical community.
Experts emphasised that data-driven validation is essential for gaining market acceptance. Without comprehensive data, even the most innovative products may struggle to convince sceptical healthcare professionals. This underscores the importance of ongoing validation and continuous improvement based on feedback.
Securing funding
Stages of funding: Securing funding is one of the most critical aspects of a startup’s journey. The funding process typically involves multiple stages:
- Pre-seed funding: Covers initial startup costs, market research, product development, and prototyping. Often self-funded or supported by friends and family.
- Seed funding: Supports product development, initial marketing, and acquiring the first customers. This stage validates the product-market fit and scales the business model.
- Series A funding: Focuses on scaling the product and operations after market validation. Enhances product features, expands operations, and achieves solid revenue growth.
- Series B funding: Involves extensive scaling, broadening market reach, hiring high-level executives, and improving capacity. Aims to grow market share with a solid financial base.
- Series C funding and beyond: Includes continued growth, market expansion, and achieving profitability.
For example, a company that secured $16 million in Series B funding was able to expand operations, increase inventory, and significantly enhance market reach. This underscores the importance of a clear growth path and strategic planning at each funding stage.
Preparing for investor pitches: Crafting a compelling story and financial projections for investors is crucial. Key aspects include clearly defining the problem, understanding the value chain, providing data on current spending, having sufficient intellectual property assets, showing successful exit strategies, and highlighting the strength of the founding team. Transparency during due diligence is also essential to build trust with investors.
One entrepreneur shared their experience in preparing for investor pitches, emphasising the need for thorough preparation and understanding investor expectations. They highlighted the importance of transparency and clarity during due diligence to build credibility and trust with potential investors.
Addressing investor expectations: Investors look for a clear growth path and value proposition. Each funding stage has specific requirements and goals, and startups need to prepare adequately for each stage. Bridge funding rounds can also help meet interim funding needs and avoid diluting equity stakes.
Experts discussed the importance of addressing investor expectations through detailed financial forecasts, a robust business plan, and a strong team. They emphasised that investors evaluate the viability of the project and the potential for a profitable exit, making it crucial for startups to demonstrate a clear and achievable growth strategy.
Partnerships and collaborations
Importance of strategic partnerships: Forming strategic partnerships is crucial for scaling health tech innovations. These partnerships can provide access to resources, expertise, and markets that startups might not be able to reach on their own. Collaborating with established companies, healthcare providers, and research institutions can help bring products to market more efficiently.
Experts highlighted the importance of finding the right partners who can support the startup’s growth and provide the necessary resources. They emphasised that strategic alliances with healthcare providers, research institutions, and marketing companies can significantly enhance the startup’s reach and impact.
Structuring financial agreements: Properly structuring financial agreements ensures mutual benefit and long-term success. This involves legal safeguarding and a clear understanding of what each party brings to the table. Transparency and clear communication are key to building successful partnerships.
Experts shared their insights on structuring financial agreements, emphasising the need for legal teams to safeguard interests and ensure clarity in agreements. They highlighted that many innovators struggle with knowing what they want, leading to challenges in forming successful partnerships.
Letting go for greater success: Startups often need to adopt a philosophical approach, sometimes letting go of some control to see their innovation succeed on a larger scale. This might involve licensing the product to a larger company or forming joint ventures. While it may mean sharing the profits, it ensures that the product reaches the market and benefits patients.
Experts discussed the concept of ‘detached attachment,’ where innovators let go of some control to achieve greater success. They emphasised that this approach allows startups to leverage the resources and expertise of larger players, ensuring that their innovations reach a wider audience and have a more significant impact.
The Role of incubators and support systems
Support from incubation centres: Incubation centres play a vital role in supporting health tech startups. They provide access to mentors, facilities, and funding opportunities. These centres help startups navigate the complex ecosystem, offering support in areas such as intellectual property, business modelling, financial projections, and technology development.
Entrepreneurs shared their positive experience with incubation centres, highlighting the support they received in the form of mentorship, facilities, and funding opportunities. They emphasised that these centres are crucial for startups to navigate the complex ecosystem and achieve success.
Grants and funding programs: Government and private grants are essential for supporting early-stage startups. Programs like BIRAC in India offer initial seed funding, growth funds, and commercialization funds. These grants help startups develop prototypes, conduct clinical trials, and bring their products to market.
Experts discussed the importance of grants and funding programs in supporting early-stage startups. They highlighted that these programs provide crucial financial support and resources, enabling startups to develop prototypes, conduct clinical trials, and bring their products to market.
Building a supportive ecosystem: Creating a supportive ecosystem involves collaboration between startups, incubators, investors, and policymakers. By working together, these stakeholders can address common challenges, streamline regulatory processes, and provide the necessary resources for startups to succeed.
Experts emphasised the need for a collaborative ecosystem to support startups. They highlighted that collaboration between startups, incubators, investors, and policymakers is essential for addressing common challenges, streamlining regulatory processes, and providing the necessary resources for startups to succeed.
Conclusion
The journey of health tech startups is challenging but rewarding. Navigating regulatory compliance, securing funding, validating the market, and forming strategic partnerships are critical steps in bringing innovative solutions to market. By understanding these challenges and leveraging the support of incubation centres, grants, and strategic partners, startups can overcome obstacles and achieve success. This article provides valuable insights for aspiring entrepreneurs and stakeholders in the health tech sector, fostering a better understanding and collaboration to drive innovation in healthcare.
In conclusion, the discussion highlighted the importance of transparency, compliance, and strategic partnerships in navigating the challenges faced by health tech startups. It also emphasised the role of data-driven validation and the need for a supportive ecosystem to ensure the success of innovative solutions in healthcare. By addressing these key areas, startups can improve their chances of securing funding, gaining market acceptance, and ultimately making a significant impact on patient care and outcomes.
Panellists and Moderator of the webinar
Panellists:
Geethanjali Radhakrishnan, CEO and MD of Adiuvo Diagnostics; a HealthTech Startup
- Ranjit Karthikeyan, Partner at Ranjit Karthikeyan Associates LLP, a distinguished chartered accountant
Moderator: Dr Abdul Ghafur MD MRCP FRCPath, Lead Strategist, QuorumVeda Consulting Services LLP and an Infectious Diseases Consultant and health policy maker