Ensuring safety and efficacy of the postpartum haemorrhaging system

Anonymous

Jada

Improving and testing the usability of this life saving device, to support submission in Europe.

The Challenge

Ensuring this device can be used quickly and correctly to treat postpartum bleeding.

Postpartum hemorrhage continues to be one of the most common complications of childbirth, the device can provide visible and observable control of bleeding within minutes.

The Solution

Completion of the formative and validation study within 6 months to support regulatory submission. This was possible by working in partnership with the client to develop the IFU and labelling, in parallel to the protocol creation for both studies. Supported by the use of our internal prototyping team to create a simulation mannequin for the study.

Postpartum training device in operating theathre

The Execution

Starting with Expert Reviews with OBS/GYN professionals in US, UK, France and Germany to understand product fit with clinical practice.

Based on input, we developed a new Quick Reference Guide and IFU for inclusion in packaging and for use by OBS/GYN 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 undertook a simulated use Formative study with UK Obstetricians to verify understanding of device usage against established clinical practice and to test the draft Quick Reference Guide and IFU.

Based on these learnings, we validated the use of the system in a Summative HF study against defined critical tasks and risks in order to support EU regulatory approvals submission.

The Impact

This device improves accessibility to treatment for this dangerous condition affecting women.

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