Digital Therapeutics: The Future of Mental Health with Hannes, CEO of HelloBetter

🎙️ EPISODE 9 - DIGITAL THERAPEUTICS: THE FUTURE OF MENTAL HEALTH WITH HANNES, CEO OF HELLOBETTER



How does a digital mental health program prove it works and get covered by national healthcare systems?

In this crucial episode, host Rudi Adigbli speaks with *Hannes*, CEO and co-founder of *HelloBetter*, a leading European digital therapeutics company. Hannes shares his journey from EdTech to MedTech and breaks down the rigorous process of securing government reimbursement for mental health apps.

We dive deep into the unique DTx business model*, the challenge of integrating fast-moving *Generative AI into regulated products, and the optimistic, but complex, future of accessible mental healthcare.

In this episode, you will learn:

EdTech to MedTech Pivot: Why the core product is an education product (Cognitive Behavioral Therapy) and why healthcare offers superior methods for proving efficacy (Randomized Controlled Trials).
The DIGA Hurdle: The immense, complex process of getting six products approved by Germany’s regulatory body (BFARM) and why this approval is essential for scaling.
The DTx Business Model: Why the recurring element is the prescriber (doctors) and not the patient, and how this unique approach drives sustainable growth.
AI vs. Regulation: The core challenge of integrating unpredictable Generative AI (which "hallucinates") into medical devices that require 100% predictable outcomes, and the need for regulators to adapt.
The Hybrid Strategy: HelloBetter’s approach to launching a separate, adaptable AI wellness product outside of medical regulation to test, learn, and pave the way for future approved DTx solutions.
The Seven-Founder Advantage: How a large, interdisciplinary founding team manages complex decision-making under uncertainty, which is a competitive advantage in the regulated MedTech space.
The Future Vision: Moving towards an integrated care system combining digital therapeutics, human care, and AI for early intervention, especially for children.


[00:00] Introduction & Pivot from EdTech to Mental Health (The CBT Link)
[06:49] The DTx Debate: Why We Can Confidently Say Digital Therapeutics Work
[08:29] The DIGA Approval Process: Navigating the Regulatory Landscape
[11:00] Why Scale Requires Regulation (Moving Beyond Direct Insurance Contracts)
[16:35] AI & The Regulatory Dilemma: Why DTx Cannot Use Generative AI (The Black Box Problem)
[25:45] Correlation: Digital Lifestyle and Mental Health Decline
[27:46] Fundraising Lesson: Never Give Up & Finding Pre-Convinced Investors
[41:40] The Future of Digital Mental Health: Integrated Care Systems
[44:07] Optimistic vs. Pessimistic Future Scenarios

👉 Read the full episode summary on my Substack: [https://reethink.substack.com/?r=5rf5...]

👉 Join The ReeShaper Circle to connect with others shaping the neurotech industry: [https://www.skool.com/fundrazr-3557/a...]

🎧 Listen on:
Apple podcast: https://podcasts.apple.com/us/podcast...
Spotify: https://open.spotify.com/episode/1EPm...

#DigitalTherapeutics #DTx #HelloBetter #MentalHealth #AIinHealthcare #DTxRegulation #BFARM #DIGA #GenerativeAI #MedTech #VentureCapital #CBT #IntegratedCare #ReeThink