Complete support from concept to clinical trial

Unitron as a one-stop shop

A strong idea has the potential to make healthcare better, smarter, and more accessible. Think of an innovative ventilator or advanced measurement technologies. But the journey from concept to functional medical device requires deep technical expertise and structured guidance. What can customers expect from Unitron throughout this process? Senior R&D Engineer Marco van der Kelen explains from his day-to-day experience.

Integrated involvement throughout the entire process

Marco joined Unitron in 2020 . No coincidence, as the COVID-19 pandemic significantly increased the demand for medical devices. “I built up years of experience in electronics at a smaller company, where I handled a wide variety of tasks. That broad background is incredibly valuable today. At Unitron, I’m involved in the entire development cycle and keep oversight of the full system, ensuring that every component ultimately forms a reliable, high-performing medical product.”

Support across the full development lifecycle

Unitron works with a wide range of clients who may enter the process at different stages. Marco explains:

“Physicians and researchers often come to us with an idea grounded in scientific work. They bring deep subject-matter knowledge, and we help translate that idea into a tangible product. We start with a brief exploration and feasibility check to determine the technical direction.”

Marco serves as the link between the client and the engineering teams, working closely with the project manager. “My main responsibility is translating customer needs into clear requirements. From that foundation, we develop a well-defined concept, followed by development, proofs-of-concept and prototypes, verification, and finally production.”

A key part of the process is design transfer:  the careful handover of the design to the manufacturing organization to ensure a smooth and compliant transition to production.

Improving and advancing existing designs

In some cases, Unitron becomes involved when a customer already has a nearly complete design.

“With organizations that have a mature development process, we often step in when the product is almost ready for production. From that point, we take ownership of realization and continue working on optimizations or next-step enhancements.”

Timelines vary depending on where a client enters the product lifecycle and on the complexity of the device. Support doesn’t end when production starts: Service & Repair provides valuable insights that inform continuous improvements and next-generation versions.

Advancing together

Unitron works not only on products, but also on the processes required to bring them to market. Marco explains:

“Our Unitron Regulatory department was created in response to growing client demand for support with regulatory requirements and documentation during medical device development. Regulatory support has since become a core service and is integrated into nearly every project. Some clients have in-house expertise; in other cases, we take over that role. This helps ensure that decisions made early in the process are not only technically sound but also compliant.”

Innovative products to be proud of

Developing medical devices means contributing to solutions that directly impact people’s lives. Marco shares an example:

“I’ve been involved from the beginning in developing a smart inhalation device that delivers medication precisely into the lungs. We are building it together with partners, combining advanced electrospray technology with intelligent software. It enables patients to administer treatment at home while giving healthcare providers real-time insight into therapy adherence. This reduces the burden on both patients and the healthcare system.”

Read more about the smart inhalation device here.

Always looking ahead

Innovation naturally requires a forward-looking mindset. What trends does Marco see that will influence patients, customers, and Unitron’s own work?

“Regulation for medical devices is becoming increasingly strict and complex. That’s exactly where we can add significant value by guiding clients through the full regulatory process.”

“We’re also seeing rapid developments in machine learning and AI. At the same time, devices are becoming smaller and smarter, and more care is shifting into the home environment. Equipment that once only existed in hospitals must now operate safely in everyday household settings. That introduces new requirements for design, documentation, and usability.”

Within Unitron, teams continually invest in expanding knowledge, sharing insights, organizing internal sessions, and collaborating closely to stay ahead in a fast-evolving healthcare landscape.

Ultimately, Marco believes innovation is about more than technology:
“It’s about the people at Unitron. They bring the expertise and serve as a consistent point of contact for the customer throughout the entire journey. Together, we build solutions that truly make an impact; on patients striving to feel better, and on healthcare professionals who rely on well-designed tools to deliver the best care.”