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

Jenny Collinson, Director of Human Factors Strategy & Advisory, has co-authored a new feature in Medical Device + Diagnostics Industry (MD+DI) with Connor Francek, packaging and sterilization engineer at Canyon Labs. Their argument: medical device packaging is not a finishing step in development. It is the first user interface a clinician ever touches in the sterile field, and the place where patient safety, regulatory compliance, and commercial outcomes are decided.

When opening guides are unclear, seals require excessive force, or orientation is ambiguous, clinicians improvise under time pressure. The cost shows up as contamination risk, device damage, and workflow delays at the moments that matter most. FDA recall analyses indicate that a meaningful share of device recalls trace back to packaging and labeling rather than to the device itself, and many more usability issues never reach a formal complaint because clinicians attribute the difficulty to personal error.

The authors point out that the 2019 revision of ISO 11607-1, particularly Section 7, formally requires usability evaluation of aseptic presentation. Packaging usability is no longer implicit or optional. It is an established regulatory baseline. Jenny and Connor show how integrating packaging engineering and human factors across the full lifecycle, from early development through design iteration, verification and validation, and post-market surveillance, reduces downstream risk, prevents costly retooling, and produces products that perform better in real clinical use.

As the authors put it, packaging is no longer just about protecting the device. It is also 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