ERNI Labs – pioneering the future of MedTech with predictive maintenance

By Ares Cabó Carrera (ERNI Spain)

The environment

From point-of-care to laboratory medical devices, the market is constantly growing, and with it comes the need to test them – not only during their on-market period but also until their end of life, especially with the entry into force of the regulation for in-vitro diagnostic medical devices (IVDR). In addition to the instrument’s performance in terms of the measurement, any additional functionality, as well as its hardware, shall be extensively tested, as decades can pass between the first software release to retiring the product.

What we offer

As part of our partnership-based technology services, we have our ERNI Laboratory in Sant Cugat del Vallès (Barcelona), which complies with the Biosafety Level 1 (BSL-1) requirements, the lowest security level for handling biological material. This means the material handled in the laboratory does not pose any risk to healthy adult humans and presents a minimal potential hazard to laboratory personnel and the environment. With our laboratory, we can support you from the software development analysis and feasibility phases until the release, including the verification of medical devices. Our laboratory is unique because we are ready for a quicker ramp-up to working with hardware. We are also ready to maintain and test specific machines such as medical devices. The whole package is then completed with software developers and testers experienced in MedTech projects, along with lab technicians and lab managers.

Case study: The customer and their challenge

One of our customers, a world-leading research focused healthcare group in the fields of pharmaceuticals and diagnostics, was looking for a provider who could support them in the software development, verification process and maintenance phase of some of their key analytical and pre-analytical devices. It was critical to maintain the existing processes to keep compliance and ensure quality. The customer also needed time to focus on core competencies and new technologies to remain competitive.

The solutions

For one of those medical devices, a system used in virology and blood screening, we started performing the Software Product Care in 2016, and it continues today. By having a laboratory with two instrument lines and subject matter experts, we were able to conduct investigations of field cases and internal customer cases as well as assisted support requests for software and hardware as if they were performed in house.

Our expertise in MedTech, highly regulated environments and testing was crucial in our customer’s decision to choose ERNI. Together with our BSL-1 laboratory, we also started a “Digital Twin” initiative to gather data and use it for scheduling predictive maintenance – which reduced service costs and downtime of systems at the end customer’s laboratories, among other benefits. Any downtime in a laboratory is critical; it means that patient measurements cannot be performed in a timely manner, and therefore it has direct consequences on patients’ health. Additionally, any malfunction of a medical device could impact the accuracy of the patient’s measurements, directly affecting the patient’s health.

In a world where the tendency is to provide more with fewer resources (in the health ecosystem) and with longer life expectancies, we need to optimise all the resources invested. Having predictive maintenance contributes to this.

At ERNI, we know our way around medical devices in and out, and we have the environment and tools to carry out development verification and product care.

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