Early reimbursement strategy on medical devices - What startups should know

1. What is the biggest barrier startups face when implementing reimbursement strategy early?

The largest barrier remains the intersection of complex, prolonged reimbursement processes that demand substantial payer evidence generation and clinical validation while startups also face funding challenges and misaligned incentives within constrained healthcare budgets. Successfully overcoming these requires early integration of reimbursement planning, strategic evidence development, stakeholder engagement, and securing alignment between innovation value and payment structures in evolving healthcare environments.

2.    What are some tips for managing implementation challenges?

·       Check the Reimbursement Landscape

Find out if devices like yours already have billing codes or coverage from payers. For example, see if a cardiac stent has a CPT code and Medicare coverage—if yes, you can use this existing pathway instead of creating a new one.

·       Plan for Reimbursement Early

Make reimbursement milestones part of your project timeline alongside regulatory approvals. Get your business and clinical teams working together on reimbursement goals from the start.

·       Provide Clinical Data with Payers in Mind

Include outcomes that matter to payers, like fewer hospital readmissions or cost. For example, when testing a remote monitoring device, measure how many hospital stays are avoided and the associated cost benefits.

·       Secure Billing Codes and Coverage

Work with experts and professional societies to get existing codes or apply for new billing codes early—ideally right after FDA clearance.

·       Build Relationships with Key Stakeholders

Get hospital billing managers, clinicians, and local payers involved early to understand patient eligibility, coding types (inpatient/outpatients), and reimbursement criteria.

·       Develop Health Economic Models

Show how your device helps save money and improves patient health outcomes by building budgeting impact or cost effectiveness models. Example: Model how a diabetes management device reduces complications and cuts healthcare costs.

·       Start Small with Pilot Programs

Work with select clinics reimbursed on a fee-for-service or via grants to collect early evidence of benefit before negotiating with wider payers.

·       Keep Up with Policy Changes and Adapt

Watch for changes in reimbursement rules, like CMS updates, and adjust your pricing and evidence strategy accordingly.

3.    What is reimbursement?

Reimbursement is defined as the process of a public or private third-party payers compensating a provider for the costs of a treatment. Depends on the country healthcare, the payer could be the ministry of health (usually in national healthcare systems, like NHS), or private insurers (usually in private, like the US or social private healthcare systems, like Switzerland). We always recommend our startup clients to think on reimbursement planning in parallel to developing the regulatory strategy, some even earlier. Considering financial return options early in the development process will influence the early lifecycle stages of a medical device to meet criteria for reimbursement.

4.    What are the key components when building reimbursement files?

• Early Integration of Reimbursement Planning

Don’t wait until the product is almost ready or cleared by regulators—start considering reimbursement as soon as you kick off product development and regulatory planning.

This means designing your clinical trials and collecting the kind of evidence payers want to see, not just focusing on safety and effectiveness. Doing this early saves you from costly last-minute changes that can slow down getting your device covered and paid for.

• Comprehensive and Targeted Evidence Generation

  To get payers on board, you need solid proof that your device actually helps patients and saves money. This means collecting clinical data showing better patient outcomes, economic data demonstrating cost savings, and real-world data on how it works in everyday use.

For example, in your clinical data, add measures like how much your device cuts down hospital stays or improves patients’ quality of life—things payers really care about. This kind of evidence is what’ll help you get the right billing codes, coverage decisions, and payment approvals from payers around the world.

• Proactive Stakeholder Engagement and Coding Strategy

Start connecting early with payers, clinical champions, coding experts, and regulators. These folks help you navigate the tricky process of getting your device properly coded (think CPT, DRG, or local codes) and covered by insurance.

5.    Which three types of medical devices are most demanded nowadays by regulatory and healthcare providers?

• Wearable Health Monitoring Devices

  Wearables like continuous glucose monitors, digital blood pressure trackers, and ECG patches are in high demand right now. Why? Because they let doctors keep an eye on patients remotely, help manage chronic diseases, and support personalized care plans.

• AI-Enabled Diagnostic and Imaging Devices

  Devices that use artificial intelligence to help with diagnostics, interpreting images, and guiding treatment decisions are gaining huge attention. They’re popular because they help doctors be more accurate, make workflows smoother, and spot diseases earlier—especially in tough areas like cancer, heart disease, and brain disorders.

• Robotic Surgical and Intervention Systems

  Medical robots for soft-tissue surgery, orthopedics, and minimally invasive interventions are in growing demand, driven by their precision, ability to reduce complications, and expanding indications supported by clinical evidence.

6.    Is the reimbursement strategy country specific?

Reimbursement is country-specific and can be complex for startups. In the US, you navigate multiple payers like Medicare, Medicaid, and private insurers, each with their own rules and coding systems (e.g., CPT codes). This process can be long and costly, requiring strong clinical and economic evidence. In the EU, CE marking allows product sales, but each country has its own reimbursement system and health assessments. For example, Germany uses the NUB program for hospital reimbursement, while France follows different HTA rules. Startups must tailor strategies and evidence for each market to succeed.

7.   Why is early reimbursement planning essential amid growing cost pressures and value-based pricing demands?

Early reimbursement planning is key because it helps startups make sure their device meets what payers want right from the start — not just proving it's safe and works, but also showing it saves money or improves care. This avoids delays and extra costs later by aligning clinical  evidence with what payers need to decide on coverage and payment. It also makes the startup more attractive to investors by showing a clear path to getting paid and entering the market, which is critical as healthcare budgets tighten and payers focus on value, not just price.

8.    These days, what  is the range of startups that plan for reimbursement before clinical validation in the last five years?

Over the last five years, there has been a clear shift among medical device startups toward considering reimbursement earlier in development, though exact numbers vary by region. Currently, about 60-70% of startups actively incorporate reimbursement planning before clinical validation. In contrast, five years ago, this percentage was much lower, around 30-40%, as many startups focused primarily on regulatory approval first and saw reimbursement as a later step. This change stems from growing payer demands for economic evidence and tighter healthcare budgets, prompting startups and investors to de-risk by integrating reimbursement strategy early-designing clinical trials to generate both safety/efficacy and payer-relevant evidence upfront.

9.    How does early reimbursement strategy influence market access, adoption, and investor trust?

·       Faster Market Access

Planning reimbursement early ensures the device meets payer requirements from the start, avoiding costly redesigns or delays later. This helps get the product covered faster, so healthcare providers can use it and get paid sooner.

·       Better Adoption

When payers reimburse a device, providers are more willing to adopt and use it because they get compensated. Early reimbursement planning aligns clinical evidence with payer needs, increasing confidence among hospitals and doctors.

·       Stronger Investor Confidence

Investors see early reimbursement strategy as a sign of lower risk and clearer revenue potential. Showing an early plan for coding, coverage, and payment reassures investors that the startup understands the market and can achieve commercial success.

10. What's the key to nailing reimbursement success for new medical technologies these days?

·       Plan Reimbursement with Product Design from Day One

For example, if you’re developing a new heart monitor, design clinical trials to include outcomes that payers care about—like reducing hospital visits—right from the start, not as an afterthought. This shapes your entire product and data collection process to meet payer needs early.

·       Create a Clear Value Story That Shows Real Impact

Focus on what matters to payers: better patient outcomes, cost savings, or filling unmet needs. For instance, demonstrate how your device can shorten treatment time or lower long-term costs. Let this story guide what clinical and economic data you collect.

·       Collect Strong Clinical and Cost-Effectiveness Data

Don’t just prove safety and efficacy for regulators. Also design studies to show that your device reduces costs or improves quality of life, using metrics payers recognize. For example, track hospital stay length or readmission rates.

·       Secure or Develop the Right Billing Codes Early

Find out if there’s an existing billing code (like CPT or DRG) for your device. If not, prepare to apply for a new code well before launch, as this process can take years. Without a code, reimbursement and adoption can be delayed.

·       Engage Key Stakeholders Continuously

Communicate early and often with payers, clinicians, health economists, and procurement decision-makers to get feedback on your value story and evidence plan. This helps avoid surprises and aligns your strategy with real-world reimbursement processes.

·       Stay Flexible and Keep Updating Your Strategy

Payer requirements and coding systems change quickly. Successful startups regularly update their evidence, pricing, and value messaging to stay competitive and keep reimbursement pathways clear.