Payers Expect Clearer Demonstration of Health Technology Benefits

Sweden and Finland are leaders in developing and applying health technology and provide ideal environments for conducting Health Technology Assessments (HTA) for medical devices.

The Nordic countries, particularly Finland and Sweden, are at the forefront of health technology advancement and application. Sweden stands out with several innovative, well-funded health technology companies.

Sweden’s strengths in health technology lie especially in preventive healthcare and digital health

Lisse-Lotte Hermansson, Country Director for Medaffcon Sweden.

Hermansson cites Swedish company Natural Cycles as an example, which developed the world’s first contraceptive app. It was the first digital contraceptive method to be approved in the European Union in 2017 and by the U.S. Food and Drug Administration (FDA) in 2018. Natural Cycles raised nearly 60 million USD in its latest funding round in May 2024.

According to Hermansson, Natural Cycles’ app illustrates how health technology makes health care increasingly patient-centered.

When alternatives are available, people can decide whether to replace medications with a digital option. New opportunities are also emerging in areas like women’s health, mental health treatment and psychiatry.

Medical Device Approval Processes Are Rigorous in the EU

Bringing new medical devices to market and navigating the approval processes can be challenging. The EU’s Medical Device Regulation (MDR), implemented in 2021, has further slowed the approval process. This regulation aims to ensure the safety of medical devices.

Many companies developing innovative digital solutions feel the European market is overregulated and more challenging than the U.S., so they often prefer to enter the U.S. market first, Hermansson notes.

Cost awareness is also high in Europe and the Nordics. This is especially evident with new medications, where conditional reimbursement or risk-sharing agreements often secure cost-effectiveness.

Health technology companies are similarly expected to demonstrate the benefits of their solutions. Additionally, they must understand the various national systems and procurement processes to facilitate product adoption.

Medaffcon’s Expertise Supports Health Technology Companies

A skilled, experienced partner can be invaluable for a health technology company looking to demonstrate product benefits or understand market dynamics. Medaffcon has over 15 years of experience in complex research projects.

Our expertise from the pharmaceutical sector is also applicable to health technology. We are accustomed to handling demanding projects with large global companies. Our scientific standards are high, and we have a thorough understanding of the Nordic healthcare sector in the pharmaceutical and health technology fields, Hermansson says.

According to Hermansson, well-executed research using high-quality healthcare data from Sweden or Finland produces reliable results that can also be applied in other countries.

Nordic Collaboration in Health Technology Assessment (HTA)

The Nordics are enhancing their collaboration in health technology assessment. The FINOSE HTA (Health Technology Assessment) —a joint effort between Finland, Norway, and Sweden— aims to make the Nordic region more attractive to health technology companies.

Overall, the Nordic market is competitive with countries like Germany and other large European markets.

The region’s strengths include a high level of digitalization in health care, extensive patient registries, universal health care, and a unique social security identification system that facilitates data linkage across registries, states Medaffcon’s Scientific Advisor Johan Rehnberg, who works in Sweden.