Clinical verification of smart pillbox according to ISO/IEC 62366
|Funding from Vinnova||SEK 480 000|
|Project duration||January 2017 - February 2018|
Purpose and goal
The purpose and goal of the project was to evaluate user-friendliness, patient satisfaction and the product according to the ISO 62366 standard. We also evaluated that the functions of the product are working as intended and is safe to use. The goals above have been met since the usability has been evaluated according to ISO 62 366. User satisfaction has been evaluated in surveys and the regulatory work of getting the product CE-marked has successfully been completed.
Expected results and effects
From the application: We hope that the effect of the project will be that the product is safe to use in a clinical environment, and hopefully it will also be appreciated by users. Outcome: The product is CE marked and can thus be used safely in a clinical environment. We have also received indications from surveys that users like using the product. Currently, the product is used daily by about 45 users.
Planned approach and implementation
WP1, Plan for Formative- and Summative Evaluation was made by Pilloxa in consultation with the Transplantation Clinic in early 2017. WP2, User Interface and Formative Evaluation were conducted by Pilloxa in spring 2017, where the Transplantation Clinic also participated. WP3, Performance of Summative Evaluation was done in Autumn 2017 and WP4, analysis of WP2 and WP3 results were made in late 2017. WP1-3 was performed according to schedule, WP4 was completed before dead-line.