Advice for Healthcare Startup Owners from Industry Experts

In the complex area of health tech, understanding the market and navigating regulatory challenges are crucial. 

During the HLTH Europe conference in June 2024, experienced startup owners and industry experts gathered to discuss the most important health-tech issues and share their insights and experiences, offering perspectives on the future of healthcare, which could be a gold mine for startups entering this field.

Understanding the Market

Navigating the healthcare industry requires understanding its complexities. Knowing the key players and specific regulatory environments, whether in the diverse U.S. market or Spain's unique pilot study approach, is crucial. This knowledge helps craft effective strategies and successfully launch innovations

• “First, understand the market. It sounds simple, but the buyers can be confusing. For example, some companies want to work with a healthcare system but need to be selling to a payer. Or they aim to work with physicians, not recognizing that about 80% of physician groups are employed by hospital systems or payers. Understanding the buyer and payer dynamics is crucial. The regulatory space is another challenge. Having FDA approval is not enough—you also need CMS and Medicaid approval to pay for your product or device. Without this, your product or service won't be implemented or used in the US.” - Dr. Adam Brown, Founder @ ABIG HEALTH
• "The U.S. healthcare system's complexity is pivotal to understand, as different states have different regulations and market dynamics." — Aahuti Rai, Strategic Advisor and Venture Partner @ Four Points Consulting
•  “The Spanish market is quite complicated. Everyone will ask you to start with a pilot study, which is important. My advice is to perform a paid pilot study, even if it's a small amount of money. This shows commitment and value. Assess the results, demonstrate the technology's value, and then move to a contract.” - Silvia Raga, CEO & Founder @ DyCare

• "I think that now you have a unique opportunity in France to actually deploy your solution thanks to the reimbursement model that has been decided over the past two years, especially in the remote monitoring field and now in the DTX field. And I think that France is investing in digital health solutions and is also trying to help healthcare professionals digitalize their practice by compensating the time they spend using those digital solutions. I think that digital solutions are going to become a must-have once healthcare professionals actually embrace those solutions. This is why I think that France is really in a unique position in Europe." - Edouard Gasser, Co-Founder & CEO @ Tilak Healthcare

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Navigating Regulatory Challenges

Healthcare is one of the most regulated industries. There are many legal regulations that health tech companies must follow, including obtaining approvals from relevant institutions and acquiring necessary certifications before entering the market.

• "Familiarize yourself with FDA and CMS approvals to ensure your product can be implemented and reimbursed in the U.S. market." — Dr. Adam Brown
• "Be aware of regulatory differences across states and tailor your approach accordingly." — Aahuti Rai
•  "The main challenge is ensuring the clinical validation of our technology since it's a medical device. This is the real challenge of what we do." - Silvia Raga

Building Credibility and Trust

Trust is one of the most important things in healthcare. Your users need to know that the solution they are using is safe and based on legitimate knowledge.

• "Ensure medical credibility by involving practitioners and experts in your development process." — Dr. Claudia Pastides, Director of Medical Accuracy @ FLO Health
• "For digital health solutions, establish trust by ensuring data security and compliance with privacy regulations." — Dr. Claudia Pastides

Adapting to Cultural and Mindset Shift

In the healthcare industry, adapting to cultural and mindset shifts is essential for integrating new technologies. Thoroughly considering the challenges of overcoming cultural resistance and strategies for engaging stakeholders is crucial when developing a new product.

• "Be prepared to address cultural resistance within healthcare systems, which often lag behind technological advancements." — Aahuti Rai
• "In Brazil, our biggest challenge is the mindset of healthcare leaders. Patients often need to opt in to share their data for better outcomes, and regulatory bodies and healthcare providers can be resistant to data exchange. Payers and providers often operate independently, leaving patients caught in the middle. Changing this mindset requires educating stakeholders about the benefits of data sharing." - Fernando Campos, Founder & CEO @ Nuria
• "Engage stakeholders effectively to foster acceptance and buy-in for new technologies." — Aahuti Rai

Leveraging Interoperability

Interoperability, or the ability for health IT systems to talk to each other without needing a translator, is now recognized as a crucial ingredient for the smooth operation of future healthcare systems.

• "Focus on creating solutions that enhance interoperability between different healthcare systems and EHRs." — Dr. Adam Brown
• "The ability for different systems to communicate has a profound impact on patients getting the right care." - Dr. Adam Brown
• "Highlight the benefits of your solution in reducing redundancies and improving patient care through seamless data sharing." — Dr. Adam Brown

Strategic Adaptations and Mindsets for Success

In the fast-paced startup world, strategic adaptation and the right mindset are crucial for success. Being able to make slow, deliberate decisions, demonstrating resilience, and maintaining consistency are essential qualities for business owners.

• "Be prepared for slow decisions and price-sensitive public sectors. Investors may push for speed, but high quality at low costs is crucial." — Mohammad Al Ubaydli, Founder & CEO @ PHIN
• "Move fast and focus on solving one problem at a time. If possible, sell your solution outside of medical device categorization to start generating revenue and gather real-world evidence quickly." — Michel Valstar, Co-Founder & CSO @ BLUESKEYE AI
• "Founding a company requires resilience, purpose, and willpower to persist through challenges. Embrace failure as a step towards success, solve problems rather than clinging to ideas, and build a strong team." — Fernando Campos

These expert-driven insights outline the best practices for developing a health tech product, offering a simpler path through this complex industry. Although challenging, this path rewards those who skillfully manage innovation, regulatory compliance, and market dynamics.