Betthera s.r.o.

Health Technology Assessment (HTA) 

HTA is a systematic approach to evaluating health technologies. Its goal is to assess the overall value of a technology, not merely its technical functionality. HTA addresses questions such as: 

• What benefits does the technology bring to patients? 

• Does it improve clinical outcomes compared to existing solutions? 

• What impact does it have on the healthcare system? 

• Is it economically sustainable? 

• How will it be accepted by patients, healthcare professionals, and other stakeholders? 

For startups and early-stage companies, HTA is particularly important because it: 

• forms the basis for reimbursement and institutional decision-making, 

• helps structure arguments for investors, 

• creates a clear value narrative for the technology. 

Betthera conducts HTA in a way that is practically applicable—not academic, but oriented toward real-world decision-making. 

A regulatory strategy represents a comprehensive plan for bringing a technology or medical device to market in compliance with applicable regulatory requirements, both within the EU and internationally. Betthera supports companies in developing, setting up, and implementing regulatory strategies that are realistic, efficient, and minimize regulatory risks and unnecessary costs. 

This support includes detailed analysis of legislative requirements, including mapping relevant directives, regulations, standards, and guidance documents (e.g., MDR, related harmonized standards, and national implementations). Betthera also provides regulatory consulting and risk analysis, identifies potential regulatory barriers, and proposes mitigation strategies, which may include product modifications, additional safety measures, or improvements to processes and training.