^{Published on 12.5.2026}

The gap between a promising concept and a compliant, manufacturable product is where the risk for timeline slips and budged strain lies for medical device companies. The decisions made in the first weeks of development on design, engineering, manufacturing, and quality teams structures and when they get to talk to each other, can be the determining factor of whether a product reaches market on schedule or not.

As Director of Design Services at Innokas, Tomi Hugg is responsible for the full scope of the company’s design services operations. He brings a practical, cross-disciplinary perspective to managing complex medical device development, ensuring that design, engineering, and compliance move forward together rather than converging under pressure at the final stages. This is his interview about what that means in practice.

Concept to production, under one roof

Tomi's responsibility over the design organization spans hardware, software, and integrated QA/RA expertise. He is closely involved in daily customer work and directly responsible for the continuous development of Innokas' design services.

"In practice, this means planning, overseeing and participating in the full product design capability from early-stage concepting all the way to NPI and production," Tomi explains. "It's essential that these disciplines work in close coordination from the start."

Innokas has deep experience in designing a wide variety of demanding electromechanical medical devices, including sensor-based and optical technologies, compact wearable-sized systems, and large equipment-scale products. Navigating such a complex technological landscape requires careful balance and tight coordination between teams.

Quality as part of the process

To accommodate this, hardware and software design are tightly integrated with a multidisciplinary QA/RA team that works alongside design throughout the process rather than acting as mere review function brought in at the end. Many specialists have backgrounds in healthcare, which means vital details like clinical use scenarios are examined early, before they become expensive problems to solve.

“Often, when a product is brought before a separate QA/RA team at the end of the project with an engineering partner, the problems that are found take the team right back to the drawing board. Design that they thought was ready needs to be revamped and redesigned to accommodate compliance at the cost of both timeline and budget. We avoid this by having our quality experts by our engineers’ side from the beginning”

This approach is especially relevant in Europe, where MDR requirements shape product development decisions from the first conversation. "When quality and regulatory expertise advances alongside design, compliance becomes a built-in feature”, says Tomi. "Products reach the market faster and more predictably as a result."

“My colleague Annika Astola will join me for the upcoming European Medical Device Summit by Generis as the Head of our QA/RA operations. We collaborate closely every day to ensure Innokas’ design operations are aligned with the regulatory demands of the industry”

Experience that signals adaptability, not only longevity

According to Tomi, longevity in medical device industry reflects more than technical depth. It signals the ability to stay relevant across regulatory cycles. "Regulation, responsibility, and expectations have changed continuously over the decades. Staying relevant requires evolving without losing control of quality."

Innokas has specialized in medical devices for over 30 years, through the transition from MDD to MDR, introduction of IVDR, the shift to Software as a Medical Device (SaMD) and many other events in the European Medtechs shifting scenery with readiness to adapt further as the industry shifts.

For medical device companies evaluating long-term development partners, this history translates into predictability across extended product lifecycles, offering a different kind of reliability than newer firms could offer.

A development partner that operates at enterprise scale

As a Finnish, family-owned company working with customers across Europe, Innokas combines the structural stability of a privately held business with no short-term ownership pressures, consistent leadership, and long institutional memory, with the agility that bigger enterprises often find absent in their own organizations.

"Our largest customers are located across Europe. Efficient communication with distributed teams is part of our everyday operation that must stay consistently reliable," says Tomi.

His own background directly contributes to this capability. With over twenty years of experience in large industrial organizations, Tomi understands how global enterprises are structured, how decisions are made across functions and geographies, and what large customers need from an external partner over a multi-year relationship.

"Agility matters. Decisions move quickly, people get up to speed fast, and there's very little unnecessary process slowing projects down. Innokas grows alongside the customer and accommodates the need to scale by adding expertise and resources as the need arises."

Looking ahead to the Generis Summit

The European Medical Device Summit brings together leaders in product development, design, quality, and regulatory affairs on 9th-10th of June, at the intersection where Innokas operates every day.

"The most valuable conversations I have are about how organizations can design with genuine confidence in a highly regulated environment," Tomi reflects. "The decisions made early, technically, clinically, and regulatorily, have a vast impact on everything that follows. That's where our focus will be."

At the Summit, Innokas aims to engage with organisations looking for more than a contract manufacturer or isolated engineering resource. The goal is a conversation about what it takes to move from complex innovation to a manufacturable, compliant product, and what a long-term development partnership that supports every practicality offers strategically.