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PulmoTech Success Story

PulmoTech drives down risk of lung injury for ventilated patients in intensive care

Start-up speeds through regulatory reviews with integrated solutions for requirements and quality management.

ChallengeWith its team fully focused on developing its innovative medical technologies, how could PulmoTech simultaneously manage the complex regulatory approval process?
SolutionPulmoTech chose integrated MatrixALM and MatrixQMS solutions to deliver simple, efficient, and agile requirements and quality management.

Results

0major non-conformities on initial ISO and MDR audits
Enhancedcollaboration on development and quality activities
Lean teamenablement to complete a high-quality MDR submission on time
Device Type:Software, Medical equipment
Device class:Class IIb
Medical Speciality:Anesthesiology
Geography:Netherlands
Soluntion components:MatrixALM, MatrixQMS

Improving outcomes in the ICU

For ventilated patients in intensive care units (ICU), maintaining optimal lung pressure is vital. Overinflating the lungs carries the risk of barotrauma and lung inflammation, which increases the chances of infection and may impede recovery.

Traditional sensor technologies such as spirometry rely on measurements taken outside the body, and physicians can find it difficult to determine the optimal pressure for each patient. Start-up company PulmoTech aims to solve the pressure measurement challenge with its intelligent Esophageal Pressure Catheter (iEPC).

Rutger Flink, CEO and Founder at PulmoTech, explains: “The iEPC combines esophageal pressure measurements and enteral feeding in a single device. Because our solution measures pressure inside the human body, it delivers far more accurate data than traditional systems, and enables ICU physicians to make better-informed decisions for their ventilated patients.”

Satisfying complex requirements

To move from an initial proof-of-concept developed at the University of Groningen in the Netherlands to a product ready for use in hospitals across Europe, PulmoTech must also achieve regulatory approval.

The iEPC solution must satisfy a wide range of requirements around biocompatibility, electromagnetic compatibility, electrical safety and more. With a lean development team of just four full-time equivalents (FTEs), PulmoTech recognized that an automated approach to requirements management would be crucial.

“Notified bodies demand strict traceability for all stages of the medical device development lifecycle,” says Flink. “From the outset, I realized that a manual process would prevent us from delivering the level of control we needed over requirements, specifications, risks, and test cases—there are simply not enough hours in the day for us to perform that work by hand. Instead, we looked for an efficient way to define our regulatory and user requirements, and link them with other design objects such as risks, bills of materials and test cases.”

Deploying integrated solutions

Initially, PulmoTech relied on a paper-based approach to quality management, delivered as a service by third-party consultants. Weighed down by complex paperwork, PulmoTech soon began exploring the capabilities of MatrixALM and MatrixQMS—integrated, ISO 13485 certified solutions that enable simple, efficient, and agile processes for requirements and quality management.

“Our demo accounts from Matrix Requirements soon grew into fully fledged production deployments of MatrixALM and MatrixQMS,” recalls Flink. “Using MatrixALM, it’s easy for us to keep track of the complex relationships between our requirements and ensure that there are no gaps in our verification and validation activities. And with MatrixQMS, we can maintain a single source of truth for best practices, as well as audit-ready records for corrective and preventive actions [CAPAs], supplier management, and production traceability.”

Promoting quality, reducing risk

By digitalizing the quality management process using MatrixQMS, the company has significantly boosted the efficiency of making updates to its standard operating procedures.

Flink confirms: “By using MatrixQMS with MatrixALM, we have all the information we need right at our fingertips. For example, if we update a procedure, we can see all the design objects linked to that procedure in just a few clicks.”

Integration between the Matrix Requirements solutions also enhances PulmoTech’s risk management capabilities. Every production step, process sheet, purchase order, and batch of raw materials is recorded, enabling the company to drill down into a final batch release and create a specific bill of materials for each individual product within minutes.

Flink elaborates: “One big practical advantage of using MatrixQMS and MatrixALM is that if we were ever to have a field safety corrective action—for example, because of a non-compliant raw material—we would immediately be able to see the customers or distributors affected and execute a product recall in a targeted way.”

Focusing product development

By developing iEPC using an ISO 13485 certified solution, PulmoTech enables its lean team to avoid manual regulatory compliance tasks and focus their full attention on product development.

“Our Matrix Requirements solutions are truly at the heart of everything that we do,” says Flink. “Whether we are working on non-conformities, submitting engineering change requests, reviewing procedures or updating clinical trial reports, we rely on MatrixALM and MatrixQMS to support us—not a day goes by that we don’t log in.”

Facilitating IEC 62304 compliance

PulmoTech is leveraging the Matrix Requirements solutions to unlock additional efficiencies. For example, the company uses native APIs to allow software engineers to upload hundreds of software unit test results to MatrixALM automatically. This allows the company to prove it has performed software quality management processes in accordance with IEC 62304, and to ensure that its research and development personnel have access to accurate, high-quality data.

“Our entire IEC 62304 process is integrated into the Matrix Requirements solution,” confirms Flink. “Being able to push unit test results into MatrixALM via API is a big advantage—it saves us days of manual work each time we do it. Even more importantly, automation reduces the risk of human errors creeping in, which helps us to maintain high levels of quality.”

Creating compliant documentation

Automation is also a key benefit for PulmoTech during the regulatory approval process. Within a few clicks, the company can output complete documentation in the format that regulators require, including a full audit trail of all tests, reviews, and approvals.

“For our initial Medical Device Regulation, audit we relied fully on the Matrix Requirements solutions, and the process went very smoothly,” says Flink. “In fact, we went through the process with no major and only seven minor non-conformities, which was the best result our auditor had seen up to that time.”

Flink adds: “We are the only small start-up registered with our notified body at the moment. The fact that we out-performed so many large enterprises in the first stage of the audit process is a testament to the power of the Matrix Requirements solutions.”

Preparing for the next phase

As it moves into the next phase of the approval process, PulmoTech is confident that the ability to rapidly find information in its searchable, well-structured documentation will contribute to significantly reduced reviewer costs. Looking further ahead, the Matrix Requirements solutions will provide a solid foundation for securing approval from the U.S. Food and Drug Administration as well as global distribution partners.

“Once we have approval for iEPC and we approach distributors to take our product to market, we need to be ready for new audits—and knowing that everything is traceable in MatrixALM and MatrixQMS gives us great peace of mind,” concludes Flink.

“As we move into the next phase of the regulatory approval journey, we’re very pleased to have Matrix Requirements as our technology partner. The quality and responsiveness of their technical support is second to none, and we couldn’t ask for better solutions to bring the benefits of iEPC to ICU patients around the world.”

We are the only small start-up registered with our notified body at the moment. The fact that we out-performed so many large enterprises in the first stage of the audit process is a testament to the power of the Matrix Requirements solutions.”

Rutger Flink, CEO and Founder, PulmoTech