Bringing a medical device to market has never been simple, but over the past decade, it has become significantly more complex. What was once a more linear process has evolved into a highly interconnected system of regulatory, clinical, and technical requirements.
When Jani Virtanen founded MDS in 2015, the starting point was not a grand long-term vision, but a recurring pattern.
Companies, particularly startups, were asking the same questions: how to approach regulatory approvals, how to define indications, how to plan clinical investigations, and how all of these pieces connect when bringing a product to market.
“There was a clear gap in understanding the full picture,” Jani recalls. “Not just individual requirements, but how everything fits together when you’re actually trying to get a product to market.”
MDS was created to address that gap. Ten years later, both the company and the industry it operates in have evolved significantly.
From external support to embedded partnership
In the early years, regulatory and quality support could often be brought in as a relatively separate function. That is no longer the case.
“Earlier, it was possible to think of a consultant as a more independent role,” Jani explains. “Today, that doesn’t really work. You need continuous guidance, and you need to be integrated into the client’s team to be effective.”
This shift reflects a broader change in the industry. As regulatory, clinical, and technical requirements have become more interconnected, the role of external experts has moved closer to day-to-day operations.
For software and electronically complex devices in particular, decisions around development, cybersecurity, clinical evidence, and regulatory strategy are tightly linked — making isolated support increasingly impractical.
Over time, MDS has adapted by working more closely alongside client teams, embedding expertise where it is needed most.
A decade of increasing complexity
One of the most consistent themes over the past 10 years has been the growing complexity of the regulatory landscape. According to Jani, the shift has been significant.
“From the client perspective, the amount of work and cost has at least doubled,” he notes, pointing to the impact of MDR and the stricter approach taken by Notified Bodies.
Clinical requirements have expanded considerably, and areas such as software classification, cybersecurity, and AI-related considerations have introduced additional layers. At the same time, timelines have extended.
Market access has become slower, with longer queues and more demanding documentation requirements. Activities such as clinical evaluations now require substantially more effort than they did a decade ago.
Perhaps most importantly, regulatory considerations can no longer be postponed.
“Today, you need to take regulation into account much earlier in product development,” Jani says.
Changing expectations for medical device companies
As the regulatory environment has evolved, so have the expectations placed on companies. Manufacturers are now required to navigate multiple overlapping frameworks, from MDR and IVDR to cybersecurity and emerging AI-related regulations.
“Even for experts, combining all of these requirements is challenging,” Jani points out.
At the same time, financial pressures have increased, particularly in early-stage companies.
“The funding situation has been one of the biggest surprises,” he reflects. “There’s a clear need for expert support, but companies are not always able to allocate resources for it.”
This combination of increasing complexity and constrained resources, has made efficiency and prioritisation more critical than ever.
Broadening the scope of support
As these challenges have grown, MDS has expanded its capabilities.
While regulatory and quality expertise remain central, the company has increasingly supported areas such as clinical research, cybersecurity, intellectual property, and product development-related decision-making.
“We are not just a quality and regulatory consultancy,” Jani says. “We also support product development. From specification to partner selection and beyond.”
This broader approach reflects a practical reality: decisions made early in development have a direct impact on regulatory success later on. By connecting these areas, companies are better positioned to move forward efficiently.
What experience has reinforced
Looking back, some insights have become clearer over time. One of them is the importance of realistic expectations.
“Even seemingly simple things can take a really long time in this field,” Jani notes.
Another is the role of collaboration. A common misconception, he explains, is that external consultants can operate independently.
“In practice, that doesn’t work. To be effective, you need to integrate, understand the product, and work closely with the client.”
These lessons have shaped how MDS approaches its work, with a focus on integration, continuity, and practical execution.
Looking ahead
The next decade is likely to bring both new challenges and new opportunities. Artificial intelligence is expected to play a growing role, particularly in supporting documentation and regulatory processes. At the same time, it will introduce new expectations around data, validation, and compliance.
“AI will help in many areas, but it will also influence how regulation is interpreted and implemented,” Jani says.
Cybersecurity and AI-related regulations are also expected to become increasingly important.
At a broader level, the question remains how regulatory frameworks, particularly in Europe, will evolve to support innovation while maintaining safety.
A milestone built on long-term collaboration
For Jani, the 10-year milestone is ultimately a reflection of sustained, high-quality work. “It shows that we’ve been able to support our clients consistently over a long period of time,” he says.
Over the years, MDS has contributed to bringing numerous products to market. In some cases helping companies find alternative pathways or strategies that enabled earlier access.
The underlying goal has remained unchanged: support the development and market access of meaningful medical technologies that improve healthcare outcomes.
Should you wish to know more about how our services can support your market entry, you can contact us at Kristian@mdsdenmark.dk or schedule a consultation via Book a Meeting.