Medaffcon Makes Medtech Measurable When Data Determines Market Access

Medaffcon brings to the health technology market the kind of effectiveness and cost-conscious thinking well established in the pharmaceutical industry. Through the company’s methods, it is possible to assess whether a product truly delivers value, which patient groups it is suitable for, and what kind of data is needed to credibly demonstrate its value to regulators, payers, investors, and healthcare providers.

The evolution of EU regulation, such as the Medical Device Regulation (MDR), has tightened the requirements for health technology products. Devices are classified according to risk, and the requirements increase with the severity of use. Previously, the key focus was product safety — ensuring that the device did not cause harm. Demonstrating effectiveness or cost-effectiveness was not required.

“Today, a product receives a CE mark only if its clinical benefit can be demonstrated. It must improve health outcomes and be economically justified. Innovation alone is no longer enough,” says Pekka Männistö, Senior Consultant at Medaffcon.

According to Männistö, the change represents a major shift for many companies.

“Medaffcon can act as a guide in this new landscape. Companies often lack the expertise needed to build clinical evidence or to leverage data effectively. We have decades of experience in this,” Männistö explains.

Real-World Evidence Is Essential

Lisse-Lotte Hermansson, CEO of Medaffcon Sweden, notes that the change is particularly evident in AI-based solutions. Many promising innovations have entered the market, but evaluations have shown that technical sophistication alone is not sufficient.

The value of products must be demonstrated using real-world evidence (RWE): how the solution performs in practice, which patients benefit from it, and how it affects costs.

“Everyone understands that healthcare resources are limited. That’s why new products must deliver genuine health benefits. This needs to be understood already at an early stage,” Hermansson says.

Medaffcon Helps Demonstrate Value to Different Stakeholders

Medaffcon supports its clients in building the required evidence and communicating that value to different target audiences. For healthcare professionals, the focus is on clearly and convincingly presenting clinical benefits, while for investors and payers, evidence of cost-effectiveness and budget impact is key. In addition, the company supports market access and reimbursement processes.

In the Nordic countries, Medaffcon has established a strong position. The region is home to hundreds of medtech companies, ranging from diagnostics to implants. The market is tightly regulated under the EU MDR framework, which aims to ensure patient safety and requires that products entering the market are also clinically justified.

According to Hermansson, interest in Medaffcon’s expertise has also grown beyond the Nordics.

“We have been asked to carry out similar projects elsewhere in Europe as well. The work done in the Nordics serves as a strong reference,” she says.

This development reflects a broader shift in the medtech sector. As evidence requirements become stricter and decision-making more rigorous, the ability to demonstrate a product’s value is becoming a key competitive advantage.