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Evidence Generation: The Key to Market Access for Your Next Medical Device

While innovation alone has the power to draw clinical interest, it takes more to show—to prove—that a medical device is truly a solution after being studied in the clinic. Real-world effectiveness has become paramount to achieve optimal market access in the current environment for 2022 and beyond. Clinicians and payers are now placing similar demands on medical device manufacturers as they do on pharmaceuticals in terms of demonstrating value for money.

Navigating the medical device landscape

Lower non-emergency procedure volume, labor shortages, and increased expenses brought by the COVID-19 pandemic have combined to cause dire financial circumstances for hospitals causing a push back on expensive innovations and investments in new technologies above and beyond the current standards of care.

Major regulatory changes in the EU, UK, and US are also creating complexities for manufacturers. Most notably, EU’s Medical Device Regulation (MDR) affects more than 500,000 device types. There are additional regulatory changes surrounding diagnostics and patient data likely on the way. Read more about these medical device regulatory changes in this blog.

Establishing value to medical device payers

How do you push a new device through the headwinds to the market?

By being vigilant and comprehensive in establishing value for money.

Payers expect robust evidence of patient benefits for coverage and commercialization models that shift cost areas with greater control, such as the pharmacy benefit for certain med tech devices; business to consumer (B2C) models for medical diagnostics; and the intersection of digital health, med tech, and payer strategy.

Ask yourself:

  • How does the device provide additional clinical value over predicate therapies?
  • How will the ultimate payer assess the value of the innovation?
  • What is the process for evaluating the clinical and financial outcomes associated with the technology?
  • How can you help your customer weigh cost against outcomes?

While answering these questions and generating evidence, keep in mind that you’re not necessarily speaking with just one payer, but perhaps many stakeholders including hospital committee members, integrated delivery networks (IDNs), and clinicians. It’s also important to understand the payment pathways for and potential hurdles to optimal reimbursement and uptake.

Meeting the needs of hospitals

Hospitals may be in a difficult position financially for the foreseeable future, but they remain key customers for many manufacturers. Hospital expectations for new products and services center increasingly on revenue generation, either by improving the patient experience or enabling more optimal operational decisions based on data.

In many ways, hospitals are becoming the battleground for innovation adoption and reimbursement. Any new medical device or technology presented going forward will almost certainly need to show meaningful revenue generation and/or a clear differentiator in patient experience to position hospitals as destination points of care.

Leveraging real-world data to drive uptake

Payers and hospitals alike are looking to data to drive decisions and support outcomes. For example:

  • The Stryker ProCuity smart hospital bed serves as a platform for better patient management by connecting collected patient data to other hospital IT systems, thereby improving patient outcomes by preventing falls and pressure injuries. It also has cost reduction potential by optimizing resource use via real-time location tracking.
  • Philips is continuing to advance a remote patient monitoring solution centered around wireless connectivity between its Biosensor BX100 product and other hospital processes. It improves patient management and outcomes by enabling early detection of patient deterioration, reducing ICU transfers and readmissions, adverse events, and length of stay.

These are just two examples of leveraging real-world data to enhance uptake. Oftentimes, that data begins with a single institution from which a manufacturer can confirm and compile succinct evidence supporting value.

We can help you generate the evidence you need

The bar for medical device evidence is arguably now as high as that of pharmaceuticals. Manufacturers must focus on enhancing their value story, working early internally with cross-functional teams on how that story is going to be told outside of the regulatory pathway, and tailoring evidence and arguments to specific payers. Certara enables this journey by assisting with value identification, creation, and communication, from assessment and evidence development to market shaping and launch excellence. To learn more and hear from our experts, watch our 2022 Medical Technology Symposium.

About the author

Lee Stern, MSc
By: Lee Stern, MSc

Lee is responsible for all health economic and market access engagements for global clients. She also oversees the full operations of the New York office. Lee is a strategic and actionable leader managing highly qualified and scientifically robust cross-functional and geographically disparate teams.

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