Lenka Šomvárska on clinical evidence, regulation, reimbursement, startup mistakes, and bringing digital therapeutics into real-world healthcare

• Lenka’s journey from economics, finance, and pharma into digital health entrepreneurship
• Why joining a startup was never part of a five-year career plan
• Opportunity costs and the decisions that shape an early career
• How Vitadio evolved from a wellness and obesity product into a digital therapeutic for type 2 diabetes
• Why healthcare startups need to define their long-term business model early
• Building a product for patients who may not actually enjoy using apps
• Using small behavioral changes to support long-term lifestyle improvement
• Why Vitadio chose the regulated medical-device route instead of remaining a wellness app
• Learning regulation, clinical research, and medical-device requirements as a startup
• Generating the first clinical evidence with limited resources
• CE marking under the Medical Devices Directive and the transition toward MDR
• What the first clinical study taught the team about trial design and missing data
• Translating clinical practice into digital product features
• Why reimbursement models in the Czech Republic and Slovakia were difficult to scale
• Discovering the German DiGA pathway
• Why existing Czech clinical evidence was not enough for the German market
• RCTs, observational studies, and the importance of testing products in the intended population
• Achieving permanent DiGA listing and discovering that this was not the finish line
• Why reimbursement does not automatically create market adoption
• Moving from scientific development toward commercialization
• Digital therapeutics versus traditional pharmaceuticals and medical devices
• The challenge of continuously improving regulated software
• Risk-based approaches to software changes and the potential role of PCCPs
• Performance-based reimbursement and the difficulty of measuring real-world outcomes
• How regulation can protect patients without making compliant innovation commercially impossible
• The fragmentation of European digital-health and reimbursement pathways
• Why greater European harmonization could benefit both companies and patients
• Lessons from the setbacks, pivots, and persistence required to bring a DTx to market