Premier Inc.

Myla Maloney is the Chief Growth Officer for Premier Applied Sciences, the research and analytics division of Premier, Inc. With 23 years of experience in the healthcare industry, Maloney supports Premier’s mission of transforming healthcare by leading population health improvement collaboration between Premier Applied Sciences and life sciences organizations.

Denise Juliano is the Group Vice President for Premier Applied Sciences, the research and analytics division of Premier, Inc. She is responsible for developing strategic business relationships with life sciences companies and health systems and expanding the utilization of Premier’s Applied Sciences solutions. Under Denise’s leadership, the PAS team received the Biotech Week Boston Award for innovative use of technology-enabled healthcare solutions in Digital Medicine.

Through this article, Denise Juliano and Myla Maloney highlight the transformative role of real-world data (RWD) and real-world evidence (RWE) in the medical device industry. It emphasizes how leveraging RWD/RWE can significantly streamline the development and approval process for medical devices, offering substantial savings in time and costs. The authors detail how RWD/RWE supports regulatory filings, accelerates time-to-market and reduces the need for additional clinical trials. By providing actionable insights and proving product value in real-world settings, RWD/RWE is reshaping medical device development, driving innovation and facilitating faster market access.

Medical device companies are at the front and center of the innovation scene, developing cutting-edge products and technologies that have the potential to revolutionize patient care. However, the journey from conception to widespread adoption is complicated and the need for robust, real-world evidence (RWE) to support medical devices' safety, efficacy and impact is critical.

RWE is generated from real-world data (RWD) analysis—from sources including electronic health records, claims and billing data, patient registries and more—and provides insights into the benefits and risks of medical interventions in real-world settings. 

“The integration of real-world data with clinical research can enhance regulatory submissions, increasing the likelihood of FDA and European Union approvals.”

As medical device companies strive to bridge the gap between product development and real-world application, leveraging RWD for RWE generation has emerged as a game changer for accelerating clinical research, saving money and time and highlighting product value.

RWD/RWE can Support Savings.

Many devices take an average of 3-7 years and cost more than $500 million to bring to market. Using RWD/RWE can save time, provide proof of efficacy, help to enhance clinical trial design, feasibility and execution and improve life cycle management by reducing the resources required for post-market surveillance studies.

One medical device company partnered with Premier, Inc.’s Applied Sciences (PAS) division to streamline its processes, save money and avoid more randomized clinical trials (RCTs). The company wanted to better understand their device and its safety, outcomes and benefits to patients from utilization.

The research started with RWD analysis to help provide the evidence needed to support a regulatory filing for expanded device indications and identify patients who could potentially benefit. One key goal was to understand the device’s current evidence-based indications and determine potential options for label modification while maintaining device safety and effectiveness.

The company utilized a robust and standardized real-world dataset to help confirm that the use of their device with expanded indications could have similar safety and positive patient outcomes. By using RWE to support the device’s expanded indications for use, the company was able to avoid additional RCTs and reduced its launch research spend by up to $3 million.

RWD and RWE Can Help Reduce the Time to Market.

Filing for expanded indications or regulatory approval takes time. Over the last few decades, inefficiencies in solution development have amounted to significant time and money spent by the medical device industry from research to launch.

New device development has also been sluggish as companies prioritized COVID-19 response. For proof, look no further than new medical device approvals, where the U.S. Food and Drug Administration (FDA) approved just 28 in 2021 compared to 63 in 2020.

RWD/RWE offers the speed needed to help rebuild medical device pipelines.

The medical device company leveraged RWD/RWE to help accelerate new indications on its older device, saving time and investment in a traditional RCT and reducing the time to market by approximately 18 months. Additionally, the monetary and time savings achieved were utilized to invest in new innovative opportunities.

RWD/RWE Can Help Support Approvals and Regulations.

It’s prudent for medical device companies to invest in RWD/RWE as payers, regulatory bodies and health systems increasingly demand proof that a medical solution delivers real value by doing what it’s intended to do.

Thanks to heightened consideration for RWE, the FDA released new industry guidance in August 2023 and December 2023 on the use of RWD/RWE for regulatory decisions for drugs and biologics, which was originally kickstarted by the 21st Century Cures Act. When combined with clinical trial research, RWE can shorten the regulatory approval process and increase the chances of FDA and European Union Medical Device Regulation approvals.

The medical device company gathered insights from a real-world dataset to help support its Breakthrough Designation request and 510(k) regulatory filing, also known as premarket notification. When a company submits an FDA 510(k) notification, its goal is to demonstrate that the new product is substantially equivalent to another legally marketed device.

Leveraging RWD/RWE helped the medical device company prove that its device, with expanded indications, was substantially equivalent to using the predicate device—thus clearing its product of further RCTs and testing.

Shaping the Future of Medical Device Development

RWD/RWE is shifting how medical device companies discover new product targets and identify opportunities for repurposing existing medical solutions. These datasets provide the information needed to better understand product efficacy, safety and cost while supporting regulatory requirements needed for existing or potential new treatment options.

Importantly, identifying a strategic data and analytics partnership is necessary to accelerate RWD/RWE capabilities. The right partnership can help a medical device company achieve actionable information through connections with health systems and patients via robust, evidence-based data and scalable solutions.

As medical solution development and expanded indication methods evolve, the power of RWD/RWE continues to prove key in improving outcomes, generating patient-centered clinical trials, uncovering insights and expediting solution time to market.