Innokas was chosen by Orla DTx to design and develop a software library for asthma-related calculations to ensure their product meets MDR requirements as a Class IIa medical device. The collaboration ensured high standards of quality and compliance, resulting in a refined and modernized product that strengthens Orla DTx's remote asthma care offering.
Customer: Orla DTx Oy
Project: Design and development of a software library for asthma-related calculations
Technologies: C# .NET, GitHub, JetBrains Rider, xUnit, Xray, Jira
Compliance: MDR Class IIa Medical Device Software
Orla DTx Oy, an innovative company in remote asthma care, aimed to refine and enhance their existing solution to better serve future market needs. Their goal was to modernize the peak expiratory flow (PEF) monitoring process and strengthen asthma diagnostics and controls. To achieve this, they needed their product to acquire medical device certification, which required isolating the medical device functionality as (MDSW) component into its own library and integrating it back into the existing system. This process simplifies the implementation to ensure compliance with MDR as a Class IIa medical device. The project also required strict adherence to Orla DTx’s Quality Management System (QMS).
Innokas partnered with Orla DTx to optimize development using the latest technologies with the focus on ensuring consistent redesign and implementation of the medical device software library. The project was guided by Orla DTx's technology preferences, including .NET, GitHub, Xray, and Jira. Additionally, the Innokas team incorporated tools like JetBrains Rider and xUnit to enhance collaboration and streamline development.
.NET: Orla DTx’s existing product was a .NET Framework monolithic application. We developed a new library targeting .NET Standard 2.0, bridging the gap between legacy .NET Framework and modern .NET versions. This ensured compatibility and futureproofing of the product.
GitHub: GitHub served as a central collaboration platform. The source code was managed within a customer-controlled GitHub Organization, where we facilitated code reviews and implemented a Continuous Integration (CI) pipeline using GitHub Actions. This pipeline handled software builds, executed tests, and generated test reports.
JetBrains Rider: This advanced IDE for .NET development was utilized for its robust features, improving efficiency in coding and debugging.
xUnit: The open source xUnit framework was employed for unit testing, ensuring the reliability and quality of the software.
Jira: Jira was used as a collaboration tool, for effective team synergy throughout the project as well as for requirement management.
Confluence: For document management and our quality assurance system, we utilized Confluence to ensure the project conformed to the required standards.
The collaboration between Innokas and Orla DTx resulted in a successfully re-implemented software library that met all regulatory requirements and integrated seamlessly into Orla DTx’s existing system. By using modern technologies and adhering to Orla DTx’s QMS, Innokas ensured high standards of quality and compliance during the project. The refined and modernized product strengthens Orla DTx's remote asthma care offering and positioned it for future advancements and scalability.
"Innokas Medical demonstrated a clear understanding of both our technological vision and regulatory obligations,” comments Tuomas Mäkynen, CEO and Co-founder of Orla DTx. “Their structured and collaborative development process supported the successful implementation of a certified medical device component that aligns with our strategic objective: delivering cost-efficient, high-quality digital solutions that improve patient outcomes.”
By digitalizing PEF measurements, Orla PEF Remote Monitoring ensures high-quality data, aiding in accurate asthma diagnosis and control. This solution reduces unnecessary healthcare visits and reallocates resources to other patient groups, saving time and costs for both healthcare providers and patients. Additionally, patients benefit from continuous interaction with healthcare professionals and experience fewer disruptions in their daily lives. Orla PEF Remote Monitoring offers a cost-effective, efficient, and patient-friendly approach to managing asthma.
More information about Olra DTx and their solution
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"Innokas Medical demonstrated a clear understanding of both our technological vision and regulatory obligations"
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Tuomas Mäkynen, CEO and Co-founder of Orla DTx
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