IS4Health

5 Reimbursement Planning Mistakes Digital Health Companies Make

Many digital health companies focus heavily on technology development but underestimate the importance of reimbursement planning. Without a clear strategy for evidence generation, target populations, and payer expectations, even strong products may struggle to achieve adoption. Understanding the most common reimbursement mistakes can help companies avoid delays, reduce risk, and improve their chances of successful market access.

Admin
2026. május 11.
4 min read

Digital health companies often bring innovative solutions to the market, from remote monitoring tools and digital therapeutics to AI-supported diagnostic platforms and patient engagement applications. However, innovation alone is rarely enough to ensure commercial success.
Many digital health products struggle not because the technology is weak, but because reimbursement planning starts too late or focuses on the wrong priorities. Payers, providers, and healthcare systems need to understand not only how a product works, but also whether it delivers measurable value.
Below are five common reimbursement planning mistakes digital health companies make.

  1. Assuming That Clinical Effectiveness Alone Is Enough
    Many companies believe that proving a product works clinically is enough to secure reimbursement. While clinical effectiveness is essential, it is only one part of the story.
    Payers also want to understand:
    • Whether the product reduces healthcare costs
    • Whether it improves efficiency
    • Whether it reduces hospitalisations or unnecessary visits
    • Whether it improves patient adherence or long-term outcomes
    • Whether it provides better value than existing alternatives
    A digital health solution may show positive clinical results, but if it cannot demonstrate economic value, reimbursement can still be difficult.
  2. Waiting Too Long to Plan Evidence Generation
    One of the most common mistakes is leaving reimbursement considerations until the product is already close to launch.
    At that stage, companies often realise they are missing key evidence such as:
    • Appropriate comparators
    • Health economic data
    • Resource use information
    • Patient-reported outcomes
    • Real-world evidence
    • Long-term follow-up data
    Generating this evidence late in development can be expensive and time-consuming.
    Companies that think about reimbursement earlier can design studies that support both regulatory approval and payer expectations. This can save significant time and reduce the risk of delays later.
  3. Targeting a Population That Is Too Broad
    Digital health companies often want to position their solution as useful for as many patients as possible. However, a broad target population is not always the best reimbursement strategy.
    Payers are often more willing to support products for:
    • High-risk patients
    • Patients with high healthcare costs
    • Populations with significant unmet need
    • Groups where the product can clearly prevent complications or hospitalisations
    For example, a remote monitoring solution may have stronger reimbursement potential in high-risk cardiac patients than in the general population.
    A narrower, higher-value target group can often create a stronger value proposition and make early reimbursement more realistic.
  4. Ignoring Existing Care Pathways and Comparators
    Some companies focus so much on the uniqueness of their technology that they forget to consider how it fits into existing clinical pathways.
    Payers and providers will compare a new digital solution with:
    • Existing standard of care
    • Alternative digital tools
    • Traditional in-person care
    • Existing reimbursement codes and care models
    If a company cannot clearly explain why its product is better, cheaper, faster, or more efficient than current options, adoption becomes more difficult.
    Choosing the wrong comparator can also weaken clinical and economic evidence.
    Understanding the current care pathway early helps companies position their product more effectively.
  5. Underestimating Differences Between Countries
    Reimbursement systems for digital health vary significantly between countries.
    A strategy that works in one market may not work in another. Some countries have dedicated reimbursement pathways for digital health, while others may require products to fit into existing payment systems.
    Companies that assume one reimbursement strategy will work everywhere often face unexpected barriers.
    Important differences may include:
    • Available reimbursement codes
    • HTA requirements
    • Pricing expectations
    • Evidence standards
    • Local payer priorities
    • Adoption pathways within hospitals or health systems
    Companies should therefore prioritise markets carefully and adapt their reimbursement strategy to local conditions.
    SUMMARY
    Digital health companies often focus heavily on product development and technical performance. However, reimbursement planning is equally important for long-term success.
    The companies that succeed are often the ones that begin early, understand payer expectations, generate the right evidence, and target the right populations.
    By avoiding these common mistakes, digital health innovators can reduce delays, improve market access, and increase the likelihood that their products will achieve meaningful adoption.