Byteflies Success Story

Making at-home monitoring easy

Founded in 2015 and headquartered in Antwerp, Belgium, Byteflies specializes in wearable sensor technology that streamlines and automates healthcare monitoring. By combining raw biometric data with advanced analytics models, Byteflies empowers physicians to monitor patients for heart disease, seizures, strokes, and more via an easy-to-use online dashboard.

Niels Van Thienen, Process Engineer at Byteflies, says: “Our goal is to help healthcare teams deliver effective long-term monitoring for people with chronic conditions. All the patient needs to do is wear a comfortable sensor patch on their wrist, chest or neck. In the background, our solution sends biometric data to a secure cloud portal, ready for analysis by their doctor.”

From the very beginning, Byteflies pioneered a modular design philosophy to ensure its solutions will integrate successfully with future patient monitoring techniques and support multiple vendors.

Reducing the risk of error

At Byteflies, regulatory duties are shared across all teams and not concentrated within a single QA/RA department. When it embarked on its development journey, Byteflies relied on a document editing platform to create and maintain around 2,500 documents in its quality management system (QMS).

Whenever a member of the team updated a document in the QMS, there was always the risk that they would forget to update linked documents. Updating a large volume of complex instructions and procedures by hand was time-consuming and prone to error, and as the company continued to grow this manual process became unsustainable.

Agnieszka Swiatek, Regulations Manager at Byteflies, confirms: “Printing, reviewing and signing off our design history file was a massive job, and the resulting paper document made it hard to find information during audits. Our manual approach to quality management was making it increasingly difficult to comply with ISO 13485.”

Sofie Buysse, Product Owner at Byteflies, adds: “In the past, we also used a manual approach for requirements management. As we added new solutions to our offering, we had an ever-growing number of requirements, specifications, tests and risks to manage. It was becoming extremely complex to keep track of the hundreds of dependencies between all these design objects.”

Automating manual processes

Byteflies looked to remove the delays and risks associated with the manual approach, and invited specialist vendors to showcase their solutions.

“A Matrix Requirements representative came to our head office to give us a live demonstration of MatrixQMS and MatrixALM, and we were very impressed with their capabilities,” recalls Van Thienen. “Following the demo, we were convinced we’d found what we needed—soon after, we worked with a Matrix Requirements consultant to deploy and configure the solutions.”

Using MatrixQMS, the company can leverage pre-built templates for standards and procedures to help maintain regulatory compliance. And with MatrixALM, Byteflies can automatically trace the relationships between all the design objects in its devices, significantly reducing the risk of human error.

Maintaining agility and compliance

With support and guidance from Matrix Requirements, Byteflies migrated its existing documentation to the new solutions, and all users adopted the new digital workflows available in MatrixQMS and MatrixALM.

“Since the company was founded, we’ve taken an agile approach to solution development, but agility can never come at the expense of regulatory compliance,” says Van Thienen. “When we make a change to a product, with MatrixQMS and MatrixALM it’s now much easier to ensure that our teams are following the latest procedures, and to update our specifications, risks and test cases.”

Swiatek adds: “With the Matrix Requirements solutions, all employees enjoy access to up-to-date information, helping us to manage regulatory activities effectively.”

Integrating with key tools

Byteflies uses a wide range of digital tools, including Jira for issue tracking and Slack for collaboration. To enable rapid, effective teamworking, Byteflies has taken advantage of the Matrix Requirements platform APIs, providing authorised users with direct access to MatrixQMS and MatrixALM data from Jira and Slack.

Buysse explains: “We use Jira to support our development process, and the Matrix Requirements solutions to track all our regulatory work—so it’s important that we can share information between both systems. Integrating the two systems lets us display the latest requirements and specifications in Jira, stay on top of bug reports and take corrective and preventive actions.”

Swiatek comments: “The integration between the Matrix Requirements platform and Slack helps me to maintain clear visibility of regulatory processes across the business. We automatically push change notifications from MatrixALM and MatrixQMS into Slack. Since we first deployed the solutions, we’ve scaled from 10 to 40 employees, and automated updates are a powerful way for me to maintain effective oversight for a growing business.”

Enabling end-to-end traceability

Today, Byteflies uses MatrixQMS and MatrixALM to support the full development lifecycle. By automating and digitizing the process, the company both saving valuable time and helping to maintain compliance.

“We tried managing our quality and requirements processes manually, but nothing compares to using a purpose-built solution designed by medical device experts,” says Van Thienen. “MatrixQMS makes it so much easier to ensure we’re following the latest versions of our procedures and work instructions. Similarly, with MatrixALM we can trace all the relationships between requirements, specifications and risks automatically, which makes it straightforward to keep all the information in the platform up to date.”

Generating documentation 10x faster

Byteflies is confident that Matrix Requirements accelerates solution development activities, while maintaining regulatory compliance.

Swiatek confirms: “In a previous role, my team used manual tools to create design and development documents. For complex projects with hundreds of requirements, this approach took at least three full days of work. With Matrix Requirements, we can complete the same process in less than a day—up to ten times faster.”

Buysse adds: “If we didn’t have the Matrix Requirements solutions, we would not have been able to sustain the level of detail required by the MDR without significantly increasing our headcount. Thanks to MatrixQMS and MatrixALM, we can combine our modular components into new offerings significantly faster than with manual tools.”

Accelerating audit-related activities threefold

Following the move to the Matrix Requirements solutions, the huge majority of manual working has been eliminated, and administration workload greatly reduced. During audits, the Byteflies team no longer spends time searching for paperwork, as the data is instantly available on the central Matrix Requirements platform—helping to accelerate audit-related activities by a factor of three.

Van Thienen explains: “With Matrix Requirements, we have a complete and immutable audit trail of every change and every document version. During audits, we used to be constantly dashing to and from our storage closet to retrieve paper records. Today, we can give auditors the information they need at the touch of a button. The time we’re saving is a big advantage—but the most important thing is that we can trust the information in the Matrix Requirements solutions is correct and will stay correct.”

Swiatek adds: “We assign one product owner to each project and technical file, and the owner often needs to collaborate with colleagues on writing and reviewing documents. The tracking functionality in the Matrix Requirements platform is very useful during audits, as it provides an intuitive overview of all these activities.”

Looking ahead, Byteflies plans to explore additional capabilities, to help the company accelerate its expansion. “MatrixQMS and MatrixALM are very powerful solutions, and we’ve only scratched the surface of what they can do,” concludes Van Thienen. “The support we receive from Matrix Requirements is excellent—and we’re looking forward to working with them to discover new ways we can leverage the solutions to streamline our compliance processes.”