Usability of Sterile Medical Packaging

HealthPack 2018 Spurs Additional Interest in Usability of Medical Packaging

With the recent updates to EN ISO/DIS 11607:2017, usability of aseptic presentation continues to be a key area of interest for many medical packaging stakeholders. Similarly, the Medical Device Regulation (MDR), adopted in April 2017, has also introduced changes and new requirements versus the existing MDD. With such new attention focused on usability, manufacturers should continue to prioritize packaging usability and design sterile packaging that is increasingly user-centric.

Our DuPont Medical Packaging experts were excited to learn more about this topic while attending Healthpack 2018 in Kansas City, Missouri. At the conference, DuPont colleagues administered a poll to 171 conference attendees made up of packaging engineers, sourcing representatives, quality assurance workers, and other professionals in the medical device packaging industry to look into the topic further.

It is exciting to see the similar energy for usability reflected in the industry, with almost half of poll respondents performing usability testing in the package design process:


While there is no doubt that usability testing is abundant in the industry, it is especially interesting that the poll respondents expressed variability in how the testing is completed. Many respondents indicated that their organizations use their own process for testing, rather than following ISO 62366:


Within Tyvek® Medical & Pharmaceutical Protection, we continuously strive to engage with industry and academic partners to learn on subjects of interest in the industry such as usability. For this reason, DuPont is conducting a survey to dive deeper into the subject of usability and further capture the trends indicated in the HealthPack poll. DuPont asks for your participation in a brief 13-question survey from which results will be used to learn more about the industry’s approach to package design usability and human factors testing/evaluation.

This data will allow medical device manufacturers to:

  • Assess their status vs industry common and best practices
  • Assess their status vs regulatory changes
  • Assess their status vs industry plans to comply with regulations

A summary of the results will be shared with all participants. Individual data will be treated with confidentiality in accordance with our DuPont privacy policy. We hope that you will join us in learning more about usability by taking part in this important initiative.

Click here to take the survey >>

For further information on this usability study, please refer to this presentation.