Veranex has premiered the medtech industry’s first Innovation CRO (iCRO)—an integrated development and research platform engineered to move medical devices and in-vitro diagnostics (IVDs) from concept to commercial success faster, with tighter budget control and a built-in path to payer adoption.

iCRO: Innovation Without Waste

The Veranex iCRO model is built on four core pillars:

• Speed and Capital Efficiency: Integrated teams and workflows can cut three to six months per development phase and reduce budget variance 18% versus transactional (traditional) outsourcing. Flexible partnership tiers—Full Stack, Stage Select, and Strategic Augment—let sponsors deploy only the iCRO services they need while retaining velocity.
• Evidence Integration from Day One: Product design research, human factors engineering, and reimbursement strategists collaborate upfront in the iCRO model to identify data packages that resonate with regulators, investors, and payers—reducing the likelihood of late-stage pivots currently encountered.
• Device and IVD Specific Depth: More than 1,000 device & IVD programs and 2,500 clinical trials completed by a team of 800-plus experts across North America, Europe, and APAC. Veranex brings deep expertise in cardiovascular, neurovascular, ophthalmology, in-vitro diagnostics and more.
• Regulatory and Market Access Alignment: A 96% approval rate and proven market access pathways in more than 30 countries, guided by in-house health economics analysts and payer panels.

“Speed and capital efficiency are no longer competitive advantages—they are survival mandates,” Veranex CEO Patrick Donnelly said. “Our Innovation CRO answers that mandate with excellence and rigor, integrating every critical discipline—design, engineering, preclinical, clinical, regulatory, quality, manufacturing, market access—into one accountable team that delivers validated evidence at every step.”

The iCRO model addresses evolving industry challenges where venture investment and access to cheap capital in medtech have dropped significantly from recent highs. Constrained teams face industry consolidation and internal capability gaps, while evolving EU MDR/IVDR and U.S. Food and Drug Administration requirements extend market clearance timelines. At the same time, artificial intelligence features are racing into next-generation devices, raising both regulatory scrutiny and evidence demands. In this complex landscape, today’s innovators need more than traditional vendors. They need strategic partners who can deliver integrated solutions with speed and certainty.

“Whether you’re a seed-stage innovator or a global strategic, our iCRO partnerships enable clients to focus scarce capital on innovation while we derisk execution across multiple geographies,” Veranex Chief Commercial Officer Ryan Roberts stated. “We provide access to cross-functional expertise precisely where and when it’s needed, accelerating progress toward critical milestones.”

Veranex is a global, fully integrated Innovation CRO dedicated to accelerating medtech innovation from early concept through commercialization. Headquartered in Raleigh, N.C., and powered by more than 800 specialists worldwide, Veranex combines design and engineering, preclinical, clinical, regulatory, manufacturing, and market access expertise to deliver clarity, confidence, and speed—turning vision into velocity for device and diagnostics innovators.