In 2018, Biorithm challenged LOAD to design and develop a mobile app that would serve as an interface between the mother and the fetal monitor to retrieve and send data to the backend platform. This was our opportunity to continue to grow as a medical device manufacturer in the e-health sector, allowing our team to create a solution that would be so useful for mothers-to-be. Essentially, the app needed to provide the following flow:
The physician registers the patient on the platform.
The physician schedules a virtual care plan.
The patient receives the Femom monitor, and also any needed Point of Care devices, such as BP monitors and glucometers.
The patient downloads the Patient mobile app.
The patient completes virtual visits according to a predefined schedule (day/time)
The patient enters their physiological data and symptoms into the Patient app.
Automatically classify the patient based on thresholds.
Confirm results and send receipts to patients if needed.
To simplify such a complex solution, we list the most important guidelines for the mobile app, so you can better understand what we had to consider during the development phase:
To meet these requirements, an Android mobile application was developed that has a special feature – it would have to be a medical device with fetal monitor classification. This would mean that the design, development, and testing processes would have to comply with the ISO 13485 standard for medical device development and consequently with IEC 62304 (for software) and ISO 14971 (related to risk management).
This can only be done by certified companies such as LOAD.
This is how Femom came into being. Femom is a comprehensive remote obstetric monitoring solution that includes:
The connected platform provides clinicians with new insights into maternal and child health and offers expectant mothers better access to healthcare, more convenience, and more information about their pregnancy.
As agreed with Biorithm, the first version of the app was developed by our team. In the meantime, Biorithm set up its own development team, which later received the source code, documentation, and necessary training and continued the app development on its own.
This was another successful partnership with a medical device company, and the solution is currently on the market.
As a SaMD-certified company, we are very confident that we can slowly but surely shape the future of medicine by delivering digital products that are fully customized to our customer’s needs. Contact us for more information.