Propelling Healthcare Innovation: The Crucial Role of Real-World Data for Medical Device Companies

Key takeaways:

• Real-world data is invaluable for medical device companies – enabling evidence-based decision making, continuous innovation and regulatory support.
• Medical device companies don’t have to embark on the data journey alone; the right partner can provide standardized data and analytics capabilities to help advance research goals, accelerate product development and enhance strategy development.
• Follow one medical device company’s journey with PINC AI™ Applied Sciences and its PINC AI™ Healthcare Database, leading to significant cost and time savings in research and regulatory approval of their product.

In the ever-evolving world of healthcare, medical device companies are front and center on the innovation scene, developing cutting-edge 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 the safety, efficacy and impact of medical devices has never been more critical.

Enter real-world data (RWD) – a powerful tool that provides insights beyond the controlled environments of clinical trials to help accelerate the research process and highlight product value.

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

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 gamechanger.

Identifying a strategic data and analytics partnership is necessary to accelerate RWD and RWE capabilities. The right partnership can help a medical device company achieve actionable information by connecting them with multiple health systems and patients through robust, evidence-based data and scalable solutions. Having the ability to act on the data by turning it into provider-level actions that benefit patients is critical to success.

Here are three ways medical device companies can leverage RWD and RWE to save money and time and bolster their product’s expansion.

1. RWD/RWE can support savings.

Many therapeutic devices can 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 resources required for post-market surveillance studies.

One medical device company partnered with PINC AI™ Applied Sciences (PAS) to streamline their 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. Understanding these factors would allow the medical device company to expand indications to align with outcomes and generate RWE to enhance its device utilization.

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

The medical device company worked with the PAS team to utilize the PINC AI™ Healthcare Database (PHD) to inform their efforts. The company used a robust and standardized PHD dataset to help confirm that the use of their device with expanded indications could have similar safety and positive patient outcomes. They were able to leverage PHD data to help inform their regulatory filing, ensuring that the right patients could benefit from their device.

The PAS impact: By using RWE to support their device’s expanded indications for use, the company was able to avoid additional randomized clinical trials and reduced their launch research spend by up to $3 million.

2. RWD/RWE can help reduce time to market.

Filing for expanded indications or regulatory approval takes time. Over the last few decades, inefficiencies in medical solution development have amounted to not only money spent by the medical device industry (from research to launch), but also in poorer overall outcomes for patients who experienced a rigid clinical trial environment. Incorporating RWD/RWE helps bind clinical development with the realities of healthcare ranging from comorbidities to complexities.

The company leveraged the PHD to help accelerate new indications on their older device that saved them time and investment in a traditional RCT. They were able to utilize the monetary and time savings achieved to invest in new innovative opportunities.

RWD/RWE offers the speed needed to help rebuild medical device pipelines. In the last few years, new device development has 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, 41 in 2022 and 41 in 2023 compared to 54 in 2018, 46 in 2019 and 63 in 2020.

The PAS impact: This medical device company used the PHD dataset to help support their device’s expanded indications for use and reduce their time to market by approximately 18 months.

3. 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 the 21^st Century Cures Act, more regulatory agencies are recognizing the promise of RWD/RWE. When combined with clinical trial research, it can shorten the regulatory approval process and increase the chances of U.S. Food and Drug Administration (FDA) and European Union Medical Device Regulation approvals.

The medical device company gathered insights from the PHD dataset to help support their 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 about to come to market is substantially equivalent to another legally marketed device. During this process, the device needs to meet specific criteria set by the FDA such as:

• The device has the same intended use and technological characteristics as the predicate device.
• The product has the same intended use as the predicate device yet has different technological characteristics and does not raise new questions regarding safety and effectiveness.
• The data submitted to the FDA can demonstrate that the device is at least as safe and effective for use in patients as the marketed device.

The PAS impact: The PHD dataset and RWD/RWE helped the medical device company prove that its device, with expanded indications, was substantially equivalent to using the predicate device, thus clearing their 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 the efficacy, safety and cost while supporting regulatory requirements needed for existing or potential new treatment options.

Data is a powerful and necessary tool to provide a more representative view of medical solution development, healthcare costs, resource utilization and clinical performance enhancement.

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

Want more? See how PINC AI™ Applied Sciences can help your organization drive medical device innovation with RWD/RWE.

The insights you need to stay ahead in healthcare: Subscribe to Premier’s Power Rankings newsletter and get our experts’ original content delivered to your inbox once a month.