^{Published on 11.3.2026}

Being able to offer a strong regulatory support calls for contribution from someone who can see both the technical depth of a device and the broader strategic landscape shaping its road to market. Annika Astola, Innokas’ new Head of QA/RA, is that kind of expert. Her career has been defined by early experience in chemistry and later close work with medical devices, quality systems, clinical investigations, and global regulation. Here is how she found her way to Innokas and towards varied customer projects.

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Chemistry, Medtech and IVD

When Annika began studying chemistry in Otaniemi just across the street from Innokas Medical’s Espoo office back in the day, she didn’t yet know that the path would eventually lead her deep into the jungle of quality and regulatory affairs, but her mind was open to possibility. “As a chemist, you can influence the world in countless ways. Everything is chemistry,” she reflects. That mindset opened doors early on, from academic research to hands‑on work with quality systems.

At Helsinki University of Technology, Annika worked briefly with development of a microfluidic chip designed to measure thyroid hormone levels. This was an early exposure to IVD analytics that, in hindsight, foreshadowed her future career direction. “It showed me how many dimensions there are in regulated health technologies. All innovations directed to healthcare require structured and intricate systems behind them.”

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From pharma to devices

The first industry experiences led Annika into the pharmaceutical sector, before she transitioned to an innovative company developing IVD devices. This marked her shift from pharma to medical devices, which she describes as eye‑opening. “Pharmaceutical Good Manufacturing Practice (GMP) is product‑centric, even when medicinal products and their manufacturing processes are highly complex,” she describes. “But with medical devices, you suddenly have chemistry, software and hardware. All those components must work with each other as an interwoven system, and this means that the regulatory landscape becomes far more intricate all at once.”

Recently, the rise of AI has added layers to regulatory expectations as well. “The biggest challenge with AI often isn’t the technology itself, but that innovators don't always understand the full scope of documentation and processes required to bring an AI enabled device to market. That’s where my team and I want to offer clarity in the future.”

This complexity defines much of her future work at Innokas, where Annika sees the QA/RA team navigating highly varied products and supporting customers across development and manufacturing. When asked what drew her to Innokas specifically, she explains: “I was already familiar with Innokas through colleagues and industry networks, and when opportunity presented itself, I knew I had the knowhow their customers need, from QA/RA to clinical affairs.”

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Clinical strategy expertise

Annika has accumulated extensive experience in global market registrations and in major corporations with their own internal medical device development teams. Eventually she found her way to the consulting side of the industry. “Even though my background is stronger in QA/RA, a knowledge of clinical investigation process is important for a QA/RA professional as well, to be able to shape realistic timelines, budgets and collaborate effectively with CRO's (Contract Research Organizations),” she explains.

She emphasizes that clinical investigations are massive investments, comparable to full product development cycles. “For manufacturers and their QA/RA teams, understanding the clinical strategy is crucial. CROs execute studies, but a strong study design is a necessary prerequisite to a successful outcome. Careful consideration of clinical benefits, available clinical evidence, data gaps, comparator choices, and measurable outcomes take place before anything starts. That’s where a skilled clinical affairs team that is familiar with the device and its technical documentation adds real value.”

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Customer-centric approach

Annika highlighted the chance to work closely with customers was one of the main reasons she ended up at Innokas. “I love interacting with the customer base, meeting different manufacturers and helping them move forward. Clinical study planning  and interaction with CRO’s is a strength of mine, and those discussions often become central while we navigate MDR and other legislations together.”

So far, the experience at Innokas has met her expectations. The road has been paved with active QARA projects, continuous customer contact, and plenty of meaningful impact. But what she values most is the depth and breadth of expertise around her. “Here, the software engineers and electronics experts are just next door, I can hear them testing things in the lab through the wall,” he laughs. “It’s all very hands‑on, not just paperwork. Having real specialists in‑house means we can genuinely help our customers and learn from each other every day. I find being part of such a broad internal network incredibly fun,” she concludes with a smile.