ClariMed's Jenny Collinson Featured in MD+DI on Medical Device Packaging as a Patient-Critical User Interface

ClariMed is proud to share that Jenny Collinson, Director of Human Factors Strategy & Advisory, co-authored a feature in Medical Device + Diagnostics Industry (MD+DI) with packaging and sterilization engineer Connor Francek. Their article challenges the long-held view that packaging is a finishing step in device development and argues that it sits at the critical intersection of package engineering and human factors, where patient safety, regulatory compliance, and commercial success converge.

Jenny and Connor make the case that packaging is the first user interface a clinician encounters. When opening guides are unclear, seals require excessive force, or orientation is ambiguous, clinicians improvise under time pressure, introducing contamination risk, device damage, and workflow delays at critical moments. FDA recall analyses have shown that a meaningful share of device recalls tie back to packaging and labeling failures rather than the device itself, and many more usability issues never surface in formal complaints because clinicians attribute difficulty to personal error.

The authors highlight how the 2019 revision of ISO 11607-1, particularly Section 7, formally requires usability evaluation of aseptic presentation. This signals that packaging usability is no longer implicit or optional, but an established regulatory baseline. They outline how integrated packaging and human factors work across early development, design iteration, verification and validation, and post-market surveillance reduces downstream risk, prevents costly retooling, and delivers products that perform better in real clinical use.

As Jenny and Connor put it, packaging is no longer just about protecting the device. It is about enabling safe use and protecting the patient.

Read the full article: https://www.mddionline.com/packaging/medical-device-packaging-is-a-patient-critical-user-interface