Healthcare
Empowering Women To Treat Incontinence

Pelvital

We built a mobile app and web portal to improve the experience of patients with urinary incontinence and provide their physicians with actionable data.
Overview

Going Digital To Improve Pelvic Floor Health

Pelvital USA believes that one should treat the cause of a health issue, not just manage its symptoms. Using a novel mechanism of action, the company’s 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. 

Challenge

The Flyte® device provides women with a non-surgical therapeutic treatment of weakened pelvic floor and bladder leaks. However, the hardware alone lacked capabilities such as capturing patient-reported outcomes, maintaining treatment history, and handing important details to clinicians.

Insight

To further improve the quality of life for women with SUI, Pelvital was set to pair the use of its physical device with a digital companion app providing education authored by pelvic floor physical therapists, encouragement, and an enhanced user experience. 

Solution

We built two digital components connected with the hardware device via a secure cloud database. A mobile app serves patients by giving them a history of their treatment sessions and the ability to track their progress. Additionally, a web portal tied to the app grants clinicians access to treatment records and helps them guide patients more efficiently.

PELVIC FLOOR DEVICE

Non-Surgical Treatment at Home

Following extensive clinical research and FDA clearance received in 2020, Flyte® has been used for at-home treatment by female patients with stress urinary incontinence. The device 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.  

Services
Strategic Consulting
Align Your Vision and Business Strategy
UX / UI Design
Elevate Your User Experience
Web Development
Consistent Experience Across Platforms
Mobile Development
Connect With Your Users
Quality Assurance
Ensure the quality of your software
Support
Keep Your Software Running at its Best
Technical Architecture
Lay the Foundation for Your Software
Security & Compliance
Protect Your Digital Ecosystem
We wanted an established strong partner, a company with experience building solutions in the healthcare sector and the expertise to deliver according to the security requirements specific to the industry.

Amanda Franey

Director of Operations, Pelvital

DIGITAL SOLUTION

Caring for Both Patients and 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.    

Anything we can do to provide easily digestible and more comprehensive information to the patient enhances their experience, adherence, and outcomes. At the same time, clinicians have access to detailed device data that allows them to make more informed care decisions and track the impact on patient health.

Lydia Zeller

President & CEO, Pelvital

SECURITY

Adhering to Industry Requirements

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.

DESIGN

Visually Presenting Valuable Data

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.  

PROCESS

Seamless Collaboration of a Global Team

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. 

Nothing is ever as simple as one might hope at the beginning. We had some challenges, but what set MentorMate apart was their proactive and collaborative approach to working through those challenges. That mindset is the hallmark of a good partner, manifested by leadership and embodied throughout the organization. We also appreciate the high level of communication. The team asked good questions throughout the project to ensure that architecture can seamlessly expand as the product evolves with future generations.

Lydia Zeller

President & CEO, Pelvital

IMPACT

Growing the Business with the Power of Data

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.  

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SERIOUSLY CUSTOM SOFTWARE

Distinctly Designed. Brilliantly Built.

Everyone working on your project is fully invested in its success. We care just as much about how your software looks and performs as we do about the problem that it’s solving. We work, learn, and celebrate together, measuring success by the duration of our long-term partnerships.

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