KOVE chooses Matrix Requirements

Safer fetoscopic interventions for unborn babies

KOVE, a spin-off from Zurich University and The University Hospital of Zurich, Switzerland, is dedicated to reducing the risk of preterm birth related to fetoscopic interventions.

Although fetoscopy is minimally invasive, the intervention requires amniotic sac perforation in order to access the fetus, which can lead to preterm birth. KOVE is designing the world’s smallest suturing device to approximate the perforated tissues, which helps to stabilize the membrane 3 [1] and, therefore, reduces the risk of preterm birth.

After 15 years of research, KOVE’s device has demonstrated proof-of-concept in a 50-day trial in sheep. The company is compiling the critical data and documentation needed to apply for FDA clearance and CE marking for market authorization in the US and EU, respectively.

As a start-up company with a lean structure of around four employees, KOVE made a strategic decision to introduce a certified management system soon after proof-of-concept.

Dr. Lorenz Uebersax, Chief Product & Regulatory Officer at KOVE, remarks: “We know that our product will most likely be manufactured on a license or contract basis, and our expertise lies within design and innovation.

We took the view that it was essential to keep our design and quality management, including management of suppliers, under close control, and wanted a solution targeted at the medical device sector that was easy to use and provided a clear route to approvals.”

Finding the best solution

Looking at possible electronic solutions, Dr. Uebersax quickly realized that many options provided either design control or a quality management system (eQMS), but it was rare to find a system that offered a unified approach. By contrast, MatrixQMS and MatrixALM offer an integrated solution for both elements of the innovation and approvals journey.

“Designed by medical device experts, Matrix includes a combined approach to design control and technical requirements management, which is particularly appealing for KOVE,” comments Uebersax. “Matrix is a flexible, versatile solution that can be configured to your needs. With outstanding advice and support from Matrix Requirements, it took just three months for the KOVE team to become self-sufficient in using the new solution. For a lean organization that wants to retain full control over quality management and device design, Matrix is a given.”

As a company built by people with mainly academic backgrounds, KOVE relies on the Matrix solutions to provide the core process control that will help to accelerate approvals and future commercialization. “The Matrix environment provides clear audit and responsibility tracking, is transparent, controls change documentation and approvals, and ensures that people are unable to skip process steps. We can clearly assign authority and responsibility within the system, and generate reports and documentation with full traceability, helping us to ensure compliance during highly complex development projects,” adds Uebersax. “Matrix works in a logical way to help you structure and configure your processes.”

Preparing for regulatory approval

Matrix produces reports with a full audit trail, and is ISO 13485 and ISO/IEC 27001 certified – all of increasing importance to KOVE as it moves towards product certification and production.

“KOVE is creating a truly innovative product that will not go through the ‘similar device’ process. Using Matrix during development means that 90% of the hurdle of preparing documentation for marketing approval has been overcome along the way. For KOVE, Matrix will enable us to meet the demands of each regulatory organization quickly and reliably, reducing our workload.”

As part of the certification journey, KOVE passed a mock audit with external partners, which raised only minor points, as Uebersax explains: “A start-up developing its first product needs to work in a controlled and compliant manner a long time before it can be certified by the notified body, and a system like Matrix can help to minimize the effort involved.”

Uebersax concludes, “My recommendation for all innovative medical device companies is to start using a management system early on in the development process to prevent the waste of valuable efforts due to conflicts with requirements and consequent delays in time to market. Matrix helps KOVE to mitigate development risks with fully documented, auditable, verified design control and requirements management, which will ultimately help KOVE to improve fetoscopy outcomes for thousands of patients, worldwide.”