What MedTech investors ask after the CE mark
According to J.P. Morgan, venture investment in European MedTech has held at around two billion dollars a year since 2022, but it is spread across fewer companies each year. More of the money goes into later rounds, and fewer companies get their first one. The official Nordic figures show the same pattern. In Finland, venture funding for startups rose by 60 % in 2025 to €765 million, yet the number of seed-stage companies that received funding fell by 40 %, and about two thirds of the money came from foreign investors (Finnish Venture Capital Association). In Denmark, the national investment fund EIFO found that MedTech companies took about four and a half years on average to raise their first venture round, almost twice as long as biotech and digital health companies (EIFO).
Investors still back MedTech, but they wait until more of the risk is gone, and after the CE mark most of the remaining risk is commercial.
Public money carries the early stage
We reviewed more than 450 European MedTech and clinical AI companies that have a CE mark or FDA clearance, are close to one, or have just started selling. About 200 of them are in the Nordic countries. More than 40 % of the Nordic companies have public money among their funders: national funds and agencies such as Business Finland, Tesi, Almi, Industrifonden, EIFO or Investinor, or the European Innovation Council.
The largest of these instruments is the EIC Accelerator, which combines a grant of up to €2.5 million with an equity investment from the EIC Fund. It is also hard to get: in one 2025 round, the EIC selected 71 companies out of 1,211 applicants. The evaluation does not stop at the technology. It scores the go-to-market plan and its milestones, the evidence that customers will pay, the financial plan and the team's ability to bring the product to market.
The long road after the CE mark
A CE mark under the MDR now takes most companies one and a half to two years (MedTech Europe), and as we wrote in our article on regulatory affairs, the work does not end there. A hospital buys a new device through a tender, or through a framework agreement it has already signed (how Nordic hospitals procure medical devices), and someone has to pay for it, either the hospital from its own budget or a payer through reimbursement (who pays for your device). In the United States, a study in JAMA Health Forum found that fewer than half of 64 novel medical technologies authorised by the FDA had reached Medicare coverage within the study period, and the median time to coverage was almost six years. The level of clinical evidence did not predict which technologies would be covered. The size of the company did.
For an investor, this is the period when a portfolio company spends money on sales and clinical work before income arrives. A plan that underestimates it can lead to a missed sales target and a bridge round on worse terms.
What investors ask beyond the technology
Technical and regulatory due diligence is a standard part of a MedTech investment. It answers whether the device works and whether it can be CE-marked. The commercial case often rests on the founders' own plan. These are the questions it has to answer:
Which countries come first, and why those?
Who pays for the device in each of them, and through which budget, tender or reimbursement route?
Which hospitals and departments will buy first, and which clinicians will lead the first use?
Will the company sell directly or through distributors, and does a suitable distributor exist?
How long from the CE mark to the first tender won, and what team and budget does that take?
Is the sales forecast based on market data, or on a share of a total market?
Most of these questions can be answered before a sales forecast is written, by studying each target country in turn: how its hospitals buy, who pays, which competitors are already there and at what price, and who could sell the product. A plan built on that groundwork is easier for an investor to test.
Buyers pay for sales that work
Two large recent acquisitions by Nordic MedTech companies show what the market rewards. Coloplast bought the Icelandic wound care company Kerecis for up to $1.3 billion in 2023; 98 % of Kerecis's revenue came from the United States. Getinge bought the US company Paragonix Technologies in 2024 for up to about $477 million; almost all of its sales were also in the United States. In both cases, the buyer paid for a commercial organisation that was already selling, not only for the technology.
Many Nordic startups follow the same path and name the United States as a first market. For those that start in Europe, the commercial plan is harder to write, because each country buys and pays for devices in its own way, and the plan is only as good as what the company knows about each of them.
What HealthChain adds
A credible commercial plan starts with knowing the target markets. Our Market Entry Snapshot is that first step for any company preparing to enter a new European market: which countries to prioritise, how hospitals there buy and who pays, which competitors are present and at what prices, and whether to sell through a distributor, directly or both. These are the facts investors look at, and the Snapshot puts them on paper before the plan is written.
For startups and SMEs, our Scale-up Plan builds on that groundwork and turns a working product or early sales into a commercial plan that investors can assess: target markets and the order to enter them, the procurement and reimbursement route in each, the channel, and a sales forecast with the team and budget it needs. It is written to be used in investor materials and in applications for EIC Accelerator or Business Finland funding.
For investors, our Commercial Due Diligence applies the same market review to a startup's own plan and gives an independent view, before the investment decision, of whether its device can be sold in Europe, through whom and how fast. The scope and timing are agreed with the fund for each deal, and it complements the technical and regulatory due diligence a fund already buys.
If you are raising money for a medical device, or assessing one, book a 30-minute call.
