Pelvital: Empowering women to treat incontinence

Pelvital USA believes that one should treat the cause of a health issue, not just manage its symptoms. Using a novel mechanism of action, its at-home intravaginal device helps women strengthen their pelvic floor and treat stress urinary incontinence (SUI). 

Pelvital partnered with us to create digital solutions that allow patients and healthcare providers to capture and interpret data from treatment sessions. We built the software using our IEC 62304 project management framework and ensured the necessary criteria were met to deliver software that would pass the FDA’s software validation requirements.

After receiving FDA clearance in 2020, the Flyte® device has provided women with a non-surgical at-home therapeutic treatment of weakened pelvic floor and bladder leaks. It consists of a controller that manages the treatment and guides the patient and an intravaginal wand that delivers transvaginal mechanotherapy in five-minute daily sessions over six weeks. This treatment rehabilitates muscles and other tissues, restoring bladder control and reducing leakage accidents that millions of women around the globe experience every day.  

However, the hardware alone lacked capabilities such as capturing patient-reported outcomes, maintaining treatment history, and handing important details to clinicians. 

With Flyte® already in commercial use, Pelvital set out to deliver an enhanced end-to-end experience where the data from treatment sessions is no longer trapped within the hardware device. As their digital technology partner on this journey, we created a mobile application to extract data from the device and visualize it to show the patient how she has performed and is progressing through treatment. The app also enables the patient to set individual goals and see how close she is to achieving them. Highlighting the importance of data, the mobile app is tied to a web portal where authorized clinicians can access stats from the treatment sessions and provide guidance to their patients. 

Pelvital worked with their hardware partner to develop a Bluetooth-enabled device that connects to the new digital solutions. Our team created custom software that complies with all the requirements within the medical devices space. While working on the Bluetooth integration, we collaborated closely with the hardware partner manufacturing the device to validate our approach to data processing. We gave the manufacturer valuable feedback, which led to the creating of a new version of the device firmware. 

In adherence to FDA requirements, we worked within a rigid software development lifecycle and project management framework compliant with the IEC 62304 quality standard. Additionally, our team performed penetration testing both on the software and prototype devices to ensure Pelvital brings a safe and secure product to market. Using threat modeling and virtual pen-testing, our certified penetration testers looked for vulnerabilities in the cloud while specialized hardware was used to pen-test the prototypes.

We carried out the design work in the project in two phases. First, our design team interviewed stakeholders within our client’s organization to gather insights into the digital solutions’ purpose and intended interface. In phase two, we created a low-fidelity clickable prototype that provided a basis for conducting tests with some of Pelvital’s existing users. We implemented the users’ feedback and leveraged the company’s existing brand guidelines to create a UI concept that we applied to the mobile solution and the clinician portal. This design process was valid for both the application and the portal.  

Our project for Pelvital included a combined team of tech experts based in Bulgaria and Paraguay. Having such a diverse and well-integrated team working together to deliver on the client’s business goals allowed for additional service hours and more convenient opportunities to meet with our US-based partner. Thanks to the smooth collaboration between team members across the ocean, we built Flyte®’s digital dimension within a tight time frame while adhering to all license requirements related to FDA-regulated medical devices. 

Pelvital gave patients and clinicians visual access to important data by adding a digital dimension to their product offerings. In addition to enhancing the customer experience, the company benefits from the ability to analyze anonymized aggregated data to see trends that provide an increasingly higher level of understanding of how people use the device and drive future product development efforts.