Strategic regulatory support for a self-administered IV device

Usability engineering strategy and file generation for a drug delivery device

Our client, a pharmaceutical company, was developing a new reconstituted drug therapy that needed to be prepared and administered by the patient via intravenous (IV) infusion. As part of their EU regulatory submission, they needed a partner to help them generate both the required usability engineering (UE) and design verification documentation. We carried out a rapid design verification testing programme, UE file generation and a formative evaluation of the device’s user interface, helping the client make a successful regulatory submission.

Drug delivery | Human factors | Testing and de-risking | Design verification testing | Regulatory support

Lab technician adjusting medical device testing equipment m

Rapid design verification testing

To help the client meet their tight deadlines, we performed the design verification (DV) process in just 3 weeks, including DV protocols, test method development, test method validation, device testing and data analysis. Our device testing experts summarised these results in a design verification report, ready for regulatory submission.

Syringe held in clamps for medical device testing

Bespoke test method development

Working in compliance with ISO 11608-1, we designed a bespoke test method to assess the functional requirements of the IV device. This involved building a custom script for a tensometer force testing machine, to automatically calculate and measure both the break-loose force and extrusion force.

As part of the device testing process, we helped the client clarify their design input requirements, focusing on key aspects such as extrusion force for the syringe, minimum delivered volume, as well as functional verification of the device and ancillary equipment.

We helped the client define a UE strategy and produce a coherent UE file, conforming with IEC 62366-1:2015, while ensuring alignment with their existing documentation.
Mark Di Cioccio, Managing Consultant QA/RA, Team Consulting

Person conducting a human factors user study with a camera

User interface evaluation of a self-administered IV device

We also provided formative user interface evaluations, leading to a redesign and optimisation of the instructions for use and carton. This culminated in a final summative usability study in the form of a simulated use test, which we performed with the clients’ target users.

Outcome

Through a rapid design verification testing programme, UE file generation and a formative evaluation of the device’s user interface, we helped the client make a successful regulatory submission. The final IV device was approved and is now on sale in the EU.