MedTech Dive November 3, 2025
Innovation in MedTech is surging, with AI-powered devices and digital therapeutics redefining what’s possible. But as technology evolves, so do the challenges of clinical development. Developers must now navigate complex regulatory landscapes, justify value to payers, and manage costs while ensuring their devices meet high standards for safety and performance.
“Advanced wearables and AI-driven tools won’t reach patients unless trials are designed to meet both regulatory and reimbursement expectations,” says Lisa Beck, BSN, M.S., Senior Director of Clinical Affairs at MCRA, an IQVIA business. “Developers must design trials that are lean, data-driven, and strategically aligned with both regulatory and market needs.”
Optimizing trial design is critical to success. A robust and strategic trial design helps manage the risk of costly...
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