Ensuring the safety and efficacy of an innovative system for controlling and treating abnormal postpartum hemorrhage
Global healthcare company in women's health
How we improved and validated the usability of a life-saving device to support regulatory submission and commercial expansion into Europe.
The challenge
Meeting critical deadlines for ensuring the device could be used quickly and correctly to treat postpartum bleeding.
Postpartum hemorrhage (PPH) continues to be one of the most common complications of childbirth. Even with potentially devastating consequences there are a limited number of devices that can prevent or stop PPH from occurring. Our client’s innovative system uses a low-level intrauterine vacuum to control and treat abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.
Having acquired the device in the US, where it had already been successfully launched and commercialized, our client wanted to expand access to this life-saving treatment by launching into the European market.
Prior to regulatory submission, we needed to update the instructions for use (IFU) and complete the required validation studies to ensure that within minutes of bleeding the device would provide a visible and immediate control of blood loss. Timings were a considerable factor in the completion of the project work, with the target date for launch imminent.
The solution
In order to meet the critical deadline for regulatory submission and market entry we devised a process through which it was possible to complete the formative and validation studies within a condensed period of only 4 months. This was made possible by working in partnership with the client to develop the IFU and labeling which ran in parallel to the protocol creation for both studies.
Our internal prototyping expertise was also fundamental to the speed and success of the project, with our prototyping team creating a simulation mannequin for the study that mimicked blood flow in a patient and could confirm if the device had been used properly and safely.
The execution
To understand how the device fitted with clinical practice in different markets, we began the project by undertaking expert reviews of Obstetricians and Gynacologists in the US, UK, France and Germany. With this input we developed a new Quick Reference Guide and IFU for inclusion in packaging, intended for use by Obstetricians and Gynacologists, professionals and nurses.
To support the studies, our prototyping team adapted a Limbs and Things birthing trainer to create a postpartum hemorrhaging simulator to provide a realistic use setting for usability assessment.
We also undertook a simulated use formative study with UK Obstetricians to verify the understanding of device usage within established clinical practice, and test the draft Quick Reference Guide and IFU.
Based on these learnings, we validated the use of the system in a summative human factors study against defined critical tasks and risks in order to support EU regulatory approvals submission.
The impact
By working in close collaboration, our human factors, prototyping and design teams were able to fast-track a solution for improved usability without compromising quality or compliance. Devising a process to condense the required validation steps into a 4-month timeframe ensured that the device met the deadline for regulatory submission and ultimately achieved its target launch date – enabling many more women access to this life-saving device.
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