The MedTech Edge: May 2026 Edition

Strategies, regulatory intel, and expert guidance across the full lifecycle of MedTech innovation: concept to commercialization. ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏ ͏

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This month, we’re exploring what it takes to navigate complexity in today’s medtech landscape, from the critical role of ethnographic research in shaping better solutions to the evolving regulatory and operational demands facing teams across the product lifecycle. Inside, you’ll find insights on strengthening your preclinical approach, closing compliance gaps, and making smarter decisions, along with the latest updates and opportunities to connect with experts in the field.

Voices of Veranex | Ethnography In Healthcare

In this conversation, Mitchell Leverstone explores the role of ethnographic research in healthcare and medtech, highlighting how observing users in real-world environments uncovers critical insights that traditional methods miss.

She shares firsthand stories from operating rooms around the world to illustrate how subtle behaviors, workflows, and human dynamics can reveal hidden risks and opportunities.

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Blog featured_Leveraging AI and ML in Medical Products – Part 1

Built for Complex Preclinical Research

Complex programs need more than lab capacity. They need the right models, the right expertise, and the right support around every stage of execution.

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QMSR Gap Assessment and Planning

QMSR is now in effect, and FDA expectations are aligned to ISO 13485. If you have not mapped your gaps and inspection readiness, we can help you prioritize fixes and move fast.

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MEET OUR EXPERTS IN PERSON

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INDUSTRY INSIGHTS FROM THE VERANEX BLOG

The Cost of Waiting on QMSR Is Rising

As FDA enforcement sharpens, companies are starting to face the consequences of weak quality systems.

Behind on IVDR? The Window Is Shrinking

If you're behind or uncertain, reduce the risk for documentation, evidence, and Notified Body steps needed to stay on market.

Don’t Let a Bad Manufacturing Contract Derail Your Device

The wrong agreement can expose you to quality gaps, unclear responsibilities, and costly surprises later. Ensure the contract protects your program.

What the New HE75:2025 Standard Means for Device Teams

The updated standard brings human factors guidance closer to current FDA and global expectations. Teams planning usability work should review it now.

Device Trials Don’t Have Time for Slow EDC Builds

In device studies, the bottleneck is usually planning, not the platform. Bring data, clinical, and regulatory teams in early to avoid rework and keep it moving.

Medical Device Workshops Are Too Expensive to Waste

When a workshop carries real development decisions, loose agendas and unclear goals add up fast. The best turn discussion into action.

Product Design & Engineering
Preclinical & Pathology | Clinical Research (CRO)

Regulatory Quality | Commercialization