Evidence Development for Medical Devices

Written by Jill Hagenkord, MD, Chief Medical Officer, Optum Genomics

This blog outlines the evidence and the evidence narrative needed to achieve widespread clinical adoption and reimbursement coverage for new medical devices from a private insurer’s perspective. 

Dr. Jill Hangenkord

A Long Timeframe 
On average, it takes 14–17 years for a health product to move from concept to widespread clinical adoption and reimbursement. One reason for this long timeframe is the large amount of evidence that is needed to prove that a medical device is (1) safe, (2) works reliably and reproducibly, and (3) provides a beneficial outcome based on its intended use. The time to widespread adoption can be lengthened by a medical device developer’s lack of industry experience and unfamiliarity with the complexity of market access (e.g., research scientists and physicians who have only focused on their practice and/or academic practice). 

Intended Use, Validity, and Clinical Utility 
The first step, which gets skipped more often than one might think, is important. The company must determine: What is the device’s intended use? Although it is common to develop a technology and then look for a problem to apply it to, the more successful route is identifying and characterizing a health problem and then developing a solution that best solves that problem. The next steps are proving analytical and clinical validity. The last step is proving clinical utility. Many companies waste time, money, and resources in the evidence development process by taking shortcuts, but companies that take shortcuts rarely succeed beyond some short-term wins. The clinical utility step is especially important for focused ultrasound and its specific intended uses. 

Watch a recording of this presentation from the 2022 Symposium.

Clinical validity study design and metrics are straightforward. Properly determining the positive and negative predictive values in a clinical validity study are critically important to the clinical utility study design. Unlike clinical validity, clinical utility study design will vary based on the test’s intended use. Clinical utility is determined by payers, individual physicians, and professional societies. When designing a clinical utility study, it is important to obtain feedback early and often from clinical champions and payer medical directors who can specify the right endpoints. Consulting groups like Optum can help companies obtain payer and provider feedback, potentially shorten the time to a coverage determination, and reduce the risk of being surprised that a clinical trial was not appropriately powered or did not answer a key question. 

Key Opinion Leaders and Clinical Champions 
Companies should engage with medical experts during a device’s earliest developmental stages. Engaging with technical key opinion leaders (KOLs) is crucial, even while working out the technical capability of a device and conducting validation studies. Engaged KOLs should be speaking at technical meetings, telling the story of the reliability and reproducibility of the technology. Before beginning clinical trials, companies must determine which key clinical champions and KOLs to work with and plan 2 to 3 years ahead to ensure that when the evidence is ready, the company is ready “hot off the press” to go to the right podium with the right KOL to tell the data story. Companies must start thinking about market access early in the process. They must evaluate the opportunity, the total addressable market, any competing technologies or devices that are being used at the same point in care, and the winnable market share. Data models can be used to predict whether a device is viable and worth investing time in. 

In summary, it is not enough to have evidence. Companies must be able to articulate the story of the data and support each claim with evidence. The new technology must solve a real problem in medicine, fill a significant gap in care, and effectively impact a change in care when it reaches the marketplace. Finally, at the end of the journey, companies should watch the behavior of their device in the wild, identify any implementation blockers, and put resources toward unblocking any implementation gaps. 

Watch a recording of this presentation.  

Dr. Hagenkord is a senior vice president and chief medical officer at Optum Genomics.