FDA Cleared Software as a Medical Device (Mobile Stethoscope App) Development

The client approached Belitsoft immediately after securing a patent for an algorithm that was supposed to become the basis for the future revolutionary mobile application.

Get FDA Clearance for the Innovative Product and Enter the Market First

The specifics of the healthcare industry is that it doesn't permit starting the development right away and simply launching software as a medical device once it's ready to go.

Legal compliance with FDA clearance is a prerequisite for marketing any Software as a Medical Device (SaMD) in Canada. The evaluation process safeguards patient safety, enhances treatment outcomes, and maintains public health standards.

Yet, the client was eager to launch the software as a medical device quickly to enter the market first with the game-changing invention to gain an edge and establish brand recognition in the healthcare industry.

These goals, while somewhat conflicting, presented a unique challenge. The meticulous preparation of documents for each feature and tool, comprehensive testing protocols, along with multiple reports and plans, presented a daunting task for the small in-house team, especially with their ambitious timeline.

The Urgent Need for a Highly Performing, Reliable Experts in HealthTech

The client's team started developing the mobile app but faced a tight deadline. They planned to showcase their product and meet with potential clients at a major innovation conference in the US.

At the same time, the development of the Software as a Medical Device (SaMD) required timely delivery of extensive documentation for FDA compliance.

To develop the SaMD within the required timeline without compromising quality, they needed to double their team size with specialists proficient in React Native, Node.js, and healthcare software development urgently.

Outsourcing App Development to Belitsoft to Bypass Time-Consuming In-house Hiring

The startup's co-founder had previously received positive reference about Belitsoft and knew our reputation as reliable partners with skilled developers who build complex custom solutions from the ground up.

The startup's decision-makers were confident in our ability to meet tough deadlines and maintain exceptional quality standards, leading them to quickly engage Belitsoft. Our specialists immediately jumped into the project and got to work.

Achieving FDA Clearance and Swift Product Launch

By effectively dividing responsibilities with the client's team, we could keep the development process swift and well-organized throughout all stages.

Belitsoft built a team from a vast pool of employees, avoiding a time-consuming recruiting process.

At this stage, we had to take another game-changing decision aimed at delivering the software as a medical device on time. The Client's research showed that iOS was the preferred platform for healthcare providers and medical professionals, so we have focused on iOS app development for all models, starting from iPhone 6.

Without delay, our specialists started developing a mobile app. Our applied expertise in developing HealthTech apps, effective communication and knowledge-sharing between the in-house and the remote team, adaptability to the client's requirements, and team management enabled us to achieve this.

The Client aligned FDA documentation with the development process. The Quality Management team on the Client side conducted regular design delivery meetings to approve crucial decisions and track project progress, critical for healthcare. For example, any integration through API should have always been approved and well-documented.

To manage the extensive documentation required for FDA compliance, we brought two Business Analysts onto the project. They served as the primary points of communication with the Client. Their dual roles in both documentation and project management provided a cost-effective solution for the Client.

The procedure of adding a feature to the mobile app was:

1. A design review meeting to approve and specify the feature details, with an emphasis on security.
2. The development phase, accompanied by preparing necessary documentation.
3. Software testing.
4. Verification and validation of the developed features.
5. Drafting documentation and reports for further approval at the ensuing design review meeting.

The development was iterative, ensuring the Client received a fully functional mobile app on schedule, adding and improving the details in new iterations. Gradual refinements and feature adjustments were possible due to this approach. By focusing on essential functionalities, they could deliver the initial version of the medical device software in time for their event.

Keeping cybersecurity in priority, our developers applied Amazon Inspector - a security assessment service by AWS. This tool helped detect potential security vulnerabilities and compliance concerns by implementing a set of pre-configured rules and best practices checks.

As of today, the mobile app received FDA clearance. The startup became the first to enter the market with a game-changing, safe, and effective software product, transforming any mobile phone into a class-leading stethoscope capable of capturing, analyzing, and sharing cardio data. Apart from enhanced audio, the app offers dynamic visualizations of recordings and sharing this data with the family and doctors.

The app's quality is high, with 70% of healthcare professionals rating it superior in diagnostic sound performance to other leading devices.

Belitsoft team delivered a high-quality product on time together with all the required documentation. The Client, being fully satisfied with the cooperation and the obtained results, decided to involve our team in further app improvement.

It's expected to launch version 2.0 for Android, enhance UI for both platforms and improve the user workflow, for example, by facilitating the registration process and data sharing. There are also plans for AI implementation.