The Spanish healthcare market, representing 10% of the national
GDP, is characterized by extreme risk aversion and a preference
for clinical evidence over digital "wellness" trends.
For digital health companies, the transition to Europe involves
navigating the fully enforced EU Medical Device Regulation (MDR)
and the strict oversight of the Spanish Agency of Medicines and
Medical Products (AEMPS). In this environment, the "fake it till
you make it" startup culture is a recipe for market exclusion.
Success requires a transition from being a "healthtech app" to
becoming a "validated clinical partner."
A common failure point for healthcare entrants is the misuse of
therapeutic claims. Under AEMPS and EU MDR, claims like
"improves health" or "treats symptoms" require specific medical
device classifications and peer-reviewed clinical data.
Furthermore, the GDPR’s Article 9 introduces a layer of
complexity regarding "special category" health data that far
exceeds standard privacy laws. Many companies arrive with data
protocols that are insufficient for the European landscape,
leading to rejected hospital contracts and potential fines of up
to 4% of global revenue. In the Spanish B2B healthcare world,
where 80% of procurement is public, these compliance failures
are terminal to a brand’s reputation.
Healthcare Industry
Solves these complexities by developing an AEMPS Compliance Playbook that maps your existing data and claims against European medical device classifications. We pivot your messaging from "wellness" to "evidence," replacing testimonials with a Clinical Evidence Framework that highlights peer-reviewed studies and ISO certifications. To address the sluggish 12-to-18-month hospital sales cycle, we implement a Lighthouse Pilot Strategy, targeting respected Spanish institutions to secure the local references necessary to unlock broader regional health authorities. By combining GDPR-compliant consent architectures with a narrative of institutional stability, Lexa ensures your brand is viewed as a safe, credible, and indispensable partner for the Spanish healthcare system.