Erik van der Heide, Quality Assurance and Regulatory Affairs (QA-RA) Manager of Gilbert

Erik van der Heide has a remarkable background. He started his career as an aerospace engineer from Delft University of Technology in the Netherlands, with a major in orbital dynamics. Early on in his career Erik co-founded a company to develop research and development satellites; one satellite managed to get a place in the Guinness book of records with the longest space tether ever (31.7 km). His entrepreneurial mindset and need for challenge didn’t only show in aerospace engineering, he also started companies in renewable energy and in the medical device industry, setting up his own quality system along the way and successfully bringing his product to market. Through the latter company he got to know Maurits Huigen, who contacted Erik when a position was vacant for a QA-RA manager. So after successfully selling his medical device company, he initially joined Gilbert in 2022 as a consultant, but transferred soon into a full-time employee.

What does a QA-RA officer do on a daily basis?

As a QA-RA manager, I have the opportunity to be involved in all aspects of the organization. It is the role of the QA-RA manager to oversee all elements of quality and to make sure that the company adheres to the relevant quality standards and regulations. The medical device industry is highly regulated, and for good reason, so as a company we need to make sure that we and our suppliers comply. We are legally responsible as the manufacturer of the device, so even if we outsource part of the design or development of our liquid inhaler to partners, we need to ensure we are in control. I have learned throughout my diverse career that one shouldn’t fight quality, one should embrace it! As a QA-RA manager I can show the team through ‘real-world’, or allow me to say ‘out-of-this-world’, examples that good quality pays off. Moreover, I try to be a pro-active QA-RA manager, not only pointing out what’s wrong or not allowed, but also providing compliant alternatives and therewith contribute to solving the problem.

What are the regulatory affairs challenges for medical device companies?

When I worked in the space industry, there was a confined set of standards and regulations to follow, that in hindsight made things relatively easy. But in the medical device industry, you have to work with a diverse set of ISO and IEC standards. And when you open one standard, you get references to about three or four other standards. So it’s like unravelling a ball of yarn and as a result it quickly becomes quite complex. What makes it one level more complex, is that in our case, we are developing a medical device for respiratory drug delivery and the final drug device combination will need to also comply with the regulations governing drug device combination products. Now fortunately for Gilbert, we work with very experienced partners that also have quality and regulatory affairs departments to support and do checks and balances.

Where is Gilbert in the process?

For us there are two important regulatory milestones. First there is the ISO-13485 certification of our quality management system for the medical device industry. The second one will be the CE-marking according to the MDR, which stands for Medical Device Regulations.