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IDMED Success Story

IDMED streamlines innovation for anesthesia and intensive care

Specialist device manufacturer reaches out to new markets by accelerating key requirements management processes with MatrixALM.

ChallengeIDMED aimed to reach new global markets with its innovative solutions, but found manual processes for requirements management were cumbersome, complex, and relatively slow.
SolutionUsing MatrixALM, IDMED can create traceability matrices and generate technical and design history documentation with one click, saving time and effort and facilitating access to new markets.

Results

Enablescompliance with IEC 62304 and ISO 13485 standards
Acceleratesaudit-related activities
20% time-saving on future development projects
Device type:Medical Equipment Software
Device class:Class IIa
Medical speciality: Intensive Care Anesthesiology
Geography:France
Solution components:MatrixALM

Innovating in anesthesia for operating rooms and intensive care units

Headquartered in Marseille, France, IDMED develops and markets innovative medical devices for anesthesia and intensive care. The company’s solutions are deployed in operating theaters, intensive care units, and research laboratories worldwide.

Aurélie Gruener, Quality and Regulatory Affairs Director at IDMED, says: “For example, with our AlgiScan® solution, anesthetists can measure a patient’s level of analgesia objectively based on their pupillary responses. And with NeuroLight®, physicians can get absolute measurements of a patient’s pupil size and pupillary light reflex, facilitating the diagnosis and monitoring of brain injuries.”

Shining a spotlight on regulatory compliance

With IDMED systems in use all around the world, compliance is a prerequisite, meeting the stringent requirements of regulatory authorities in Europe the United States and individual countries where the solutions will be sold.

Marvin Sanchez, R&D Engineer at IDMED, continues: “We develop devices that combine both hardware and software components, and it’s vital that we can show the relationships between requirements, specifications, risks and tests for each design object.”

Manual processes cause delays

In the past, IDMED used manual processes to create and update its traceability matrices. However, with hundreds of dependencies to manage for each solution, relying on spreadsheets and text documents was time-consuming and labor-intensive.

Gruener confirms: “We wanted to enable our lean team to spend more of their time on solution development. To achieve that goal, our executive team looked for a way to automate as much of the requirements management process as possible.”

Embracing an all-in-one solution

To solve the challenge, IDMED selected MatrixALM, an agile, all-in-one solution that enables medical device manufacturers to manage technical documents, tests and risks easily. Developed by medical device experts, MatrixALM helps IDMED to drive down the risk of errors in its documentation and to ensure audit readiness.

“One of the big difficulties with our previous approach was that a significant portion of the team’s working week was spent manually tracing requirements and updating documents,” explains Gruener. “Because we were performing this work by hand, there was also an ever-present risk of human error creeping into our documents. With MatrixALM, we input our requirements, specifications and risks, and the solution manages the complex relationships between them automatically, saving us time and reducing errors.”

Putting MatrixALM to the test

IDMED deployed MatrixALM to support the development of its newest medical device, CuffGuard®, which monitors and maintains the pressure of the cuff surrounding an endotracheal tube. CuffGuard® is designed to help prevent the risk of tracheal lesions and ventilator-associated pneumonia.

Sanchez says: “The software component of CuffGuard® is defined as Class C under IEC 62304, as risks associated with potential software errors in the device are likely to cause major harm to a patient. As a consequence, the compliance to IEC 62304 requires us to produce extremely deep documentation around the software design and testing process.”

Replacing manual processes

Today, research and development teams, software and hardware engineers, and quality and regulatory experts at IDMED rely on MatrixALM to support their day-to-day activities.

“MatrixALM makes it very straightforward to write requirements and link them to specifications, risks and test cases,” explains Sanchez. “With the Matrix Requirements solution, we can visualize these relationships from a single point of control, eliminating the need for manual, spreadsheet-based processes.”

In addition, with MatrixALM, IDMED can do much more than streamline traceability analysis. IDMED uses clean, accurate data in the Matrix Requirements solution to generate technical and design history documentation with a single click, allowing it to rapidly prepare information for audits and regulatory submissions.

Meeting stringent regulatory requirements

By harnessing MatrixALM to help manage its requirements and create its documentation, IDMED has achieved its goal of streamlining the requirements management process.

“Without MatrixALM, assembling all the documentation required to meet the regulatory reporting standards for Class C software would have been a big challenge,” says Gruener. “Thanks to automated traceability and document creation, Matrix Requirements made it much easier for us to follow the IEC 62304 standard while developing CuffGuard®.”

Sanchez adds: “From a software development point of view, another major advantage of MatrixALM is the speed with which we can deploy code documentation—including release notes, verification plans and reports, software requirements specifications, and more. Previously, we edited documents individually, spending perhaps 5 minutes on each one. With MatrixALM, document editing is effectively immediate across all items.”

Gaining certification in Europe and beyond

Backed by accurate data and efficient digital workflows, MatrixALM enables IDMED to deliver information to auditors significantly faster. Crucially, the solution has helped the company prepare its regulatory submissions and gain a CE marking for CuffGuard®.

“Each time we’ve been audited, the auditors have commented on how impressed they are with our approach to requirements management,” Gruener comments. “MatrixALM played an important role in submitting to our Notified Body, and we have now received approval to market CuffGuard® in Europe. Looking ahead, we think the solution will also be extremely helpful with our forthcoming submission to the FDA.”

Accelerating future projects by 20%

Based on the success of the MatrixALM solution in its latest development project, IDMED is now gradually moving the documentation for its existing products into the solution. The aim is to make MatrixALM the single repository for all compliance-related information, and leverage the solution for all net-new product development projects.

“In using MatrixALM to support the development of CuffGuard®, we’ve created perhaps 30 document and workflow templates that we will be able to re-use in future projects,” adds Sanchez. “It's extremely difficult to meet the standards for complex Class C projects. With MatrixALM, traceability, testing and specifications are all much simpler, and in future I don't see how I can do without it .When we start our next new product development project in MatrixALM, we should be able to reduce our setup time by 20%.”

Planning for the future

IDMED is planning to utilize additional capabilities of MatrixALM to further streamline its development of CuffGuard® and other solutions. For example, by using built-in integration between MatrixALM and Jira, the company will make it easier for developers to track defects and access the latest requirements and specifications from the Matrix Requirements solution.

Gruener concludes: “One of the best things about MatrixALM is how flexible it is, allowing us to adapt the solution to our preferred ways of working, not the other way around. As a company, Matrix Requirements is a pleasure to work with. Whenever we reach out with a question, we get an answer in hours. MatrixALM is going to be the foundation for all our requirements management processes, and we’re looking forward to unlocking the full potential of automation.”

Each time we’ve been audited, the auditors have commented on how impressed they are with our approach to requirements management.

Aurélie Gruener, Quality and Regulatory Affairs Director