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No surgeon, no sale: why clinicians decide medical device market entry in the Nordics

Writer: Mikhail Kukva
Mikhail Kukva
7 days ago
3 min read

Many manufacturers plan a Nordic launch around the buyer: the tender, the price, the distributor. All of these matter. But in orthopaedics, trauma and spine surgery, the step that comes first is a clinician deciding that a new device is worth trying. Without that decision, a product does not reach the specification. Without the specification, it does not win the tender.

The buyer signs, the clinician decides

In all five Nordic countries, clinicians help define what a device must do before a public tender is published. They sit in the product groups that write requirements, judge quality in the evaluation and report how products perform after they are in use. A procurement unit can run an excellent tender, but it cannot choose a device that the surgeons who will use it have not asked for.

This makes clinical acceptance a market access question, not only a marketing one. A company that waits for the tender to meet the clinicians has usually waited too long.

Four kinds of clinical leaders

Not every surgeon has the same influence on a launch. For a device company, four roles matter most.

  • Department and section heads. They manage budgets, approve the introduction of new methods in their unit and often nominate the clinicians who take part in procurement.

  • Registry leaders. The Nordic countries run some of the world's oldest national registries for joint replacement, spine surgery and ligament injuries. The people who lead them shape how the results of implants and techniques are reported.

  • Society and congress figures. Board members of national orthopaedic, spine and arthroscopy societies, and faculty at Nordic and European congresses, set the professional agenda and train the next generation of surgeons.

  • Research surgeons. Professors, docents and surgeons who run clinical studies produce the local evidence that hospitals and health technology assessment bodies trust most.

These roles often overlap. A professor at a university hospital may also head a section, sit on a registry steering group and chair a session at a European congress.

Registries are the Nordic difference

National quality registries record which implant was used in each operation and follow the patient for years. Some, such as the Norwegian Arthroplasty Register, compare results across implant types with the stated aim of identifying poorly performing products as early as possible. Sweden's Swedish Arthroplasty Register covers hip and knee replacements going back to the 1970s, with very high completeness.

For a manufacturer, this has two consequences. First, a new implant will be measured against established products from the first operation, in public. Second, a well-documented product with good registry results has a strong argument that is hard to match elsewhere in Europe. A launch plan that ignores the registries ignores what Nordic surgeons will look at first.

Working with clinicians the right way

Engagement with clinicians is regulated, and the rules differ between countries. Since 2018, the MedTech Europe Code of Ethical Business Practice has ended direct industry sponsorship of healthcare professionals at third-party conferences. In Denmark, doctors must notify or obtain permission from the Danish Medicines Agency before working with a medical device company (Executive Order no. 879 of 2024). The other Nordic countries rely on agreements between the public healthcare sector and the industry associations, with their own rules on meetings, consulting and transparency.

For a company new to the region, the practical lesson is simple: decide early which clinicians you need and for what, put every collaboration on a written and documented basis, and expect clinicians to check that it complies with local rules before they agree.

What HealthChain adds

Before entering a Nordic market, a manufacturer should know which hospitals perform the relevant procedures, who leads the departments, who runs the registries and research that will judge the product, and how clinicians in that country may work with industry.

We know who leads the relevant departments, registries and professional societies in each Nordic country, and we bring the right clinical experts into a project when it needs them. In our Market Entry Snapshot, this becomes a clear picture of where the clinical decisions are made for a specific device, and in which order to approach them. Through Distributor Search and Selection, we check that a partner has real relationships with the clinicians who matter, not just a list of hospital accounts.

If you are planning to bring an orthopaedic, trauma or spine device to the Nordic countries, book a 30-minute call.

 
 

Planning your next market?

Book a free 30-minute call to discuss your device, your target markets or a deal you are assessing.

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