Planes, trains, and device regulation – the fatigue of regulatory challenges: MTI REGULATORY REPORT 2024 (part 1)

By Rich West

MTI Regulatory Report 2024 data overwhelmingly suggests regulatory resources throughout the industry are being stretched. Time/Bandwidth is the top medical device regulatory challenge faced during 2024, potentially leading to industry-wide regulatory fatigue and driven by changing global compliance regulations in recent years.

Continue reading

MDIC Annual Public Forum
MDIC Annual Public Forum

APF 2024: Shaping the Future of Real-World Evidence and AI in Healthcare

By Erica Freeze

The MDIC Annual Public Forum 2024 kicked off this week with experts from the National Evaluation System for health Technology (NEST), the Centers for Medicare and Medicaid Services (CMS), and the FDA. Topics included the future of real-world evidence (RWE) and the integration of AI into the healthcare ecosystem and how can we leverage emerging technologies to bring innovative and safer solutions to patients.

Continue reading

Biocompatibility
Biocompatibility

What’s Biocompatibility?

By Marina Daineko

Recently, biocompatibility consultant, MedTech enthusiast and chemist, Marina Daineko, shared a series of LinkedIn posts defining, medical device biocompatibility and the need for a Medical Device biological risk assessment “framework.” Following is a reposting of Marina’s original LinkedIn series.

Continue reading