How Founders Can Ensure Safety, Effectiveness, and Equity

Most HealthTech founders won't tell you this secret, but 70% of healthcare innovations fail to get implemented. Why? Because they're missing two critical pieces of the implementation puzzle.

At ViVE, I had enlightening conversations with two industry leaders that revealed complementary pieces of the healthcare innovation puzzle. Their insights show exactly why successful HealthTech implementation requires both operational excellence and technological safety.

Here's what caught my attention: While Steven Gerhardt from Element Blue focuses on automating soul-crushing administrative tasks, Enes Ho?g?r, Ph.D. from Gesund.AI ensures AI implementations are safe and trustworthy. Together, they're tackling the two biggest barriers to healthcare innovation adoption.

Let me share what I learned about creating solutions that actually get implemented:

1. Start With Process Optimization

Steven revealed that some of their automation work has shown a "10 to 15X ROI on somebody that's a very high-level, high credential type of person." This is crucial because it allows healthcare professionals to work at the top of their license – something I deeply understand from my days as a cardiothoracic surgery PA.

Let's break down what this means in practice:

• Front-line Process Automation: Element Blue has spent 20 years focusing on automating administrative processes that drain healthcare professionals' time. Think about the countless hours clinicians spend on paperwork instead of patient care. By automating these processes, they're not just saving time – they're giving healthcare providers their purpose back.
• Revenue Cycle Enhancement: The automation extends beyond clinical workflows into the business side of healthcare. When administrative tasks are streamlined, the entire revenue cycle becomes more efficient, creating a positive ripple effect throughout the organization.
• HR and Workforce Management: In today's challenging healthcare staffing environment, automated processes help organizations better manage their workforce, reducing burnout and improving job satisfaction.

2. Build Trust Through Validation

As Enes pointed out, even with 700+ FDA-approved AI-enabled medical devices, many practitioners remain skeptical. The solution? Robust validation processes that prove your technology is safe, effective, and equitable across different patient populations.

Here's how successful founders are building trust:

• Data Quality Assurance: Gesund.AI has developed a technology platform that brings AI models together with case-based datasets from partner health systems. This ensures that AI solutions are tested against real-world scenarios before implementation.
• Expert Validation: They work with U.S. board-certified physician experts to evaluate AI model performance. This third-party validation is crucial for building credibility and trust among potential users.
• Regulatory Navigation: Understanding and complying with FDA requirements isn't just about checking boxes. It's about proving your solution's worth in a way that resonates with both regulators and end-users.

3. Focus on Real Implementation Challenges

Both leaders emphasized a critical point: Innovation must fit into existing workflows. Steven shared an example from pediatrics where they redesigned workflows around newborn care, allowing healthcare providers to spend more time with patients instead of paperwork.

Let's dive deeper into implementation success factors:

• Workflow Integration: The early dementia detection tool example shows that even a reimbursable solution can fail if it doesn't integrate smoothly with existing systems. Success requires understanding and adapting to current workflows rather than forcing users to adapt to your solution.
• Stakeholder Engagement: Enes emphasized the importance of engaging with the entire spectrum of stakeholders – from medical AI developers to government bodies and healthcare systems. This comprehensive approach ensures that solutions meet the needs of all users.
• Testing Infrastructure: Both leaders highlighted the need for proper testing environments. Steven specifically mentioned the challenge of not having adequate infrastructure to test innovations before full implementation.

"Your technology is only as useful as what the end-users see it is." - Enes Hosgor, Gesund.AI

"We see a lot of movement around innovation, but there's a big challenge in the regulation and protection of course of the safety of our systems." - Steven Gerhardt, Element Blue

The Reality Check

Here's what I've observed working with healthcare founders: We often get caught up in the excitement of new technology without considering the full implementation picture. As I mentioned during our conversations, "At the end of the day, what we're improving is the end users' adaptation. If we're creating something amazing but the patients and caregivers can't use it, what are we truly building?"

Let's look at what successful implementation really requires:

1. Understanding Your Users
2. Building for Integration
3. Proving Your Value

??Resources: What level of impact have you created so you know where you need to uplevel? Find out your Impact Quotient score now?? https://PulsePointPath.com/Quiz

The Path to Successful Implementation:

• Identify and automate administrative burdens
• Validate safety and effectiveness across diverse populations
• Ensure seamless integration with existing workflows
• Build trust through transparent testing and validation
• Create clear ROI metrics that matter to stakeholders

Taking Action

The key to successful implementation lies in balancing innovation with practicality. Here's your action plan:

1. Start with the End User
2. Build Trust Through Evidence
3. Focus on Integration

Remember, successful healthcare innovation isn't just about having great technology – it's about creating solutions that work in the real world, with real people, under real constraints.

Let's hear your thoughts: How are you balancing automation and safety validation in your healthcare innovation??

What implementation challenges have you overcome? Share your experiences below ??

#HealthTechInnovation #HealthcareAI #FounderSuccess

About the author: Sabrina Runbeck, MPH, MHS, PA-C, empowers healthcare innovators to streamline their businesses so they can scale effortlessly---even while taking a 4-week vacation. A former Cardiothoracic Surgery Physician Associate, she co-founded PulsePoint Path, working with an advisory board to help founders amplify their social impact and profits. A bestselling author and sought-after speaker, Sabrina hosts the "Provider's Edge" and "HealthTech Growth" podcasts, while leading Healthcare Amplified, a network focused on boosting visibility and relationships for innovative healthcare leaders.