Post by Alira Health

Regulatory approval has long defined success in medtech development. However, the conditions for market success have shifted. Today, approval alone rarely guarantees adoption, reimbursement, or commercial viability. A more market-driven approach is now required, where companies build for approval, reimbursement, adoption, and scale in parallel, putting them in a much stronger position. It helps reduce delays, strengthens market access, and increases the likelihood that a product will succeed beyond approval. To learn more about creating development strategies that keep pace with the broader demands of the healthcare ecosystem, we spoke with Mercè Guerra Albà, Associate Director, Regulatory Affairs Medtech at Alira Health. Check out Mercè’s insights below to explore how a more integrated approach that aligns patient needs, evidence generation, and market access from the outset can result in improved commercial outcomes.