Partnering with King’s College London & Guy’s & St Thomas’ Hospital on the development of a Class I medical device app designed to help reduce the risk of spontaneous preterm birth
This clinical tool was created for the Woman’s Health Academic Centre, Kings College London and is based on a study of over 1000 women in conjunction with Guy’s & St. Thomas’ NHS Foundation Trust.
The university’s predictive algorithm was refactored into the main engine of the QUiPP app to create a medical calculator that looks at different measures that can affect how likely it is for a woman to give birth early: quantitative fetal fibronectin (fFn), cervical length, and whether a woman has previously had a premature birth.
Working closely with the Medical Physics Department at Guy’s & St Thomas’ Hospital we also took the medical device app through the CE marking process by producing the necessary paperwork and technical file that was required to support the app’s application for CE marking. This means that QUiPP is classified as software as a medical device (SaMD) and registered with the MHRA as a Class I device.
We also developed a web based version of the QuiPP application: https://quipp.org/
The QUiPP app won two prizes in 2016:
“Genetic Digital have been extremely flexible, efficient and reliable partners in working with our multi-disciplinary technologically-naive team to create a new healthcare app. They realised our brief to translate an advanced statistical formulae into an app to predict premature birth, ahead of predicted timelines. Their assistance with navigating the allied NHS, University and Government/EU policy and QUiPP that we built for King’s College / Guy’s and St Thomas’ has made it on to the #HealthTech Awards Shortlist for ‘Best App'”
Dr Helena Watson