How to create the best market access and reimbursement strategy for your medical device

The medical device industry is facing increasing pressure to offer healthy returns to its investors by bringing innovative new products to market. But between fluctuations in the economy, mounting concerns over environmental sustainability, and other forces, medical device budgets are tightening.

As a result, company leaders are increasingly looking to market access teams to navigate obstacles in the ever-changing medical device landscape. Leaders rely on market access teams to get coverage from additional payors, improve reimbursement rates, and most importantly improve overall patient access to their devices.

If you’re a leader at a medical device company or a manager of a market access team, you know that developing a market access and reimbursement strategy takes careful consideration and up-to-date market intelligence. The process can take between 5-7 years, so it’s important to have your strategy locked in before FDA submission.

Because bringing a medical device to market is such a long and important process, we’ve put together this guide to help you create a more effective market access and reimbursement strategy. So, whether this is your organization’s first medical device, or you’re a part of an experienced organization, this guide is for you. Below, we’ll cover four tips we believe will elevate your market access and reimbursement strategy.

Tip #1: Start early and engage with key stakeholders

As said above, the medical device development journey can take between 5-7 years, so it’s important you start planning your market access and reimbursement strategy as early as possible. By doing so, your company can gather crucial insights, engage with key stakeholders, align your strategies with market needs, and proactively address potential challenges.

Here are three things you can do to get your strategy off to a great start:

Identify your target market

Before diving into strategy development, it is crucial to identify the target markets for your medical device. This includes determining the patient population that would benefit from your device and the healthcare providers who would use or prescribe it. You can use medical and prescription claims for insights into the patient journey and which physicians perform the highest volume of applicable procedures and their prescriber behavior.

Understand regulatory requirements

Understanding the regulatory landscape early on enables you to design your device and strategy with compliance in mind. This means researching the specific regulatory requirements, approvals, and labeling processes needed to bring your device to market. Use these resources to learn more about achieving compliancy:

• Overall FDA device development process
• FDA 510(k) guidance
• FDA PMA guidance
• FDA De Novo classification request

Engage with key stakeholders

Building relationships with stakeholders, decision makers, and key opinion leaders (KOLs) is essential throughout the medical device development process.

Collaborate with healthcare providers to understand the patient outcomes of your device and the potential impact it might have on a provider’s practice.

Patient advocacy groups can also help you adjust your strategy to better meet the perspectives and needs of your patients.

Lastly, you’ll want to stay in close contact with payors early to comprehend their reimbursement requirements, coverage policies, and evidence expectations.

Tip #2: Leverage real-world data and clinical evidence

To strengthen the value proposition of your medical device and support its market access and reimbursement, it’s essential to gather robust real-world data and clinical evidence. This data serves as a powerful tool in demonstrating the clinical and economic benefits of your device compared to existing alternatives.

Real-world data provides insights into your device’s performance and outcomes in routine clinical practice, complementing the controlled environment of clinical trials. Consider post-market surveillance studies, patient registries, or collaboration with healthcare institutions to gather data on the device’s effectiveness, safety, and real-world utilization. This data helps establish the device’s value and long-term benefits.

Before launch, clinical studies can generate rigorous scientific evidence supporting the safety and efficacy of your device. Be sure to consult with key opinion leaders, healthcare providers, and regulatory bodies to ensure your clinical trials address the most relevant and useful facets of your device and deliver the results you’re looking for.

By leveraging compelling data, you can effectively communicate your device’s value proposition to payors and differentiate it in the market, increasing the chances of reimbursement and adoption. This is especially important because payors often require more clinical evidence for medical devices than what is required by the FDA—because not all medical devices require clinical trials (e.g., 510k submissions).

Tip #3: Understanding CPT codes is essential

An understanding of common procedure terminology (CPT) codes is also important for medical device companies developing a market access strategy. These codes are used to identify and classify specific medical procedures, services, and supplies. A comprehensive understanding of these codes helps medical device companies accurately categorize their products, ensuring proper coding and billing for reimbursement purposes.

Understanding the coding system also allows you to position your device more effectively within the reimbursement landscape. Payors and insurance providers often base their coverage and reimbursement decisions on the assigned procedure codes. By aligning your medical device with the appropriate CPT (or HCPCS) codes, you increase the chances of it being eligible for coverage and reimbursement.

Robert Bargenquast, Head of U.S. Market Access Strategy and Reimbursement at Carl Zeiss Meditec Inc., stresses how important it is for medical device companies to know the ins and outs of the coding system, particularly when selling to hospitals. With so many new technologies revolutionizing healthcare, the industry is hyper-competitive. If a company does not have a coding and coverage pathway for their device, Bargenquast argues, then they lose any chance of being adopted by a facility, since the hospital won’t be appropriately reimbursed.

Tip #4: Develop a strong communication plan

Clear and effective communication helps medical device companies convey the value of their device and educate the providers and patients who may be using it. After all, a medical device likely won’t receive much adoption if its benefits are difficult to understand, or it’s hard to use.

Start by developing a comprehensive communication plan that outlines your target audiences, key messages, and communication channels. If you’ve been following along, then you’ve already taken care of a lot of the heavy lifting at this phase of the journey. Your market access team should be closely collaborating with marketing and sales to identify exactly who you need to reach and how you need to tailor your messaging for maximum impact.

If you’re selling to a hospital, for example, then consider looking into the hierarchy of their organization. This can give you insight not only into hospital leadership but also into the physicians, nurses, and healthcare workers administering care.

You may also want to diversify your outreach efforts across the communication channels your audience uses to engage with your company. Known as omnichannel marketing, this strategy aims to deliver a seamless experience to your customers as they navigate various touchpoints with your brand. Along the way, you’ll collect data to understand how, why, and when different types of customers interact with your brand. Not only does this give you a clearer picture of your audience’s interests, preferences, and pain points, but it also tells you what the most effective channels for engagement are.

What it all means

Creating effective market access and reimbursement strategies for medical device companies requires careful planning, early engagement with stakeholders, robust data collection, adaptability, and strong communication efforts. By following these tips, you can enhance your chances of securing reimbursement, driving market adoption, and ultimately improving patient outcomes.

For more information on how to create more effective market access strategies or accelerate the medical device commercialization process, check out these resources:

• Watch our on-demand webinar covering even more tips for creating successful market access and reimbursement strategies.
• Read our cross-functional guide exploring nearly every strategic consideration you need to evaluate to launch your medical device.
• These two blogs detail what you can do to accelerate FDA approval and the information you need to commercialize at the right time.