As with every aspect of clinical research, the cost of post-market surveillance and other post approval studies is rising fast – and in some cases, exceeds projected revenues. Generating and applying real-world evidence (RWE) early in the device development cycle is one way to reduce the costs and delays associated with post-marketing requirements.

RWE is derived from real world data (RWD), which includes data from sources such as electronic health records, registries, and pharmacy and insurance records. Devices are especially good candidates for early RWE use since evidence collected in the context of actual patient care from previously approved versions or similar devices often can be used to supplement findings from clinical trials of the latest version in development.

Integrating RWE and clinical trial evidence into an ongoing life cycle management strategy can greatly lessen the demand for, and cost of, post-market research. When developed to directly address known payer and regulator needs, RWE can demonstrate the practical value of medical products even before they are approved.

In this first of two blogs, we will examine why post-marketing costs are rising so quickly, and how starting RWD collection early in the device development cycle can reduce post-market delays and save money. Our second blog will assess current and future opportunities for gathering RWD and developing it into compelling RWE that supports earlier approval and coverage decisions that maximise device portfolio value.

Payer and Regulatory Complexity are Raising Costs to Unsustainable Levels

Post-marketing study growth is largely driven by increasingly complex regulator and payer demands for more RWE of device safety, efficacy and cost savings. Payer coverage standards are typically more demanding than regulators’ standards for approval, as they are increasingly requiring evidence of quantifiable improvement in patient outcomes, cost effectiveness and overall value versus alternatives.

Indirect costs can grow higher still. Each day a new medical device is delayed for marketing or coverage approval is one day less for patent-protected sales – and delays can stretch into months or years. According to one study, the average delay between marketing approval and first reimbursement in 2010 was nearly six months (See Reference 1).

Clearly, the rising cost of waiting until a medical device nears approval to begin RWE generation is not sustainable. A better approach is needed.

RWE Can Improve Efficiency Across the Development Continuum

Key stakeholders, including sponsors, patient advocates, regulators and payers, increasingly understand the value of generating RWE early in the product development process. They recognise its potential for reducing the time-to-patient for critical unmet medical needs and for minimising the costs and delays associated with post-market research requirements.

The Center for Devices and Radiological Health (CDRH), in a recent FDA draft guidance, states, “RWE may be suitable to support the expansion of the indications for use of cleared or approved devices through an appropriate premarket submission. RWE may also be suitable to augment the information needed to support clearance or approval of the next generation of a device.” (See Reference 2).

While evidentiary requirements are not changing, FDA is taking steps to evolve the regulatory decision-making process through the expanded and more efficient use of RWD, especially data on safety, expanded indications, and specific patient population outcomes gathered from hospitals, physician offices and other real-world settings.

According to the Bipartisan Policy Center, which represents researchers, sponsors, payers, regulators and public policy experts in the US, RWE offers benefits at all stages of the development spectrum (See Reference 3). For example, RWE can help expedite the generation of hypotheses to inform the design of clinical trial protocols.

Sponsors can mine RWD sources, such as patient registries, to learn more about patient needs and to validate study hypotheses accordingly. By creating more informed hypotheses at the outset, developers can collect the most critical endpoints during a prospective clinical study. This also enables them to identify and recruit the right patients, particularly those who can benefit most from the device, ultimately reducing the amount of additional data needed to support post-approval requirements.

RWE is also more likely to reveal potentially novel uses for a device, yielding hypotheses that target a broader range of indications, resulting in more efficient clinical trials that are better aligned with the needs of payers. RWE of a device’s off-label benefits, for example, can support regulatory decision-making for a wider set of indications than from data generated through traditional randomised clinical trials (RCT). This gives regulators the impetus to grant a manufacturer an expanded label without requiring additional post-market research to investigate new potential indications, which saves manufacturers time and money.

Once a device is approved, drawing RWD from established patient registries and electronic health records could provide much broader safety and efficacy evidence at a lower cost than traditional post-market studies. These data could augment risk/benefit profile information needed to support coverage decisions. Collecting RWE from early development and adding real-world claims data helps establish population health and cost benefits, cost-effectiveness and total value to payers.

A Look to the Future

Eventually, more informed integration of RWE in product development may blur the lines between clinical development and real world care delivery, allowing faster label expansion as development moves toward a more continuous improvement model.

For now, early generation of RWE can shorten development timelines, lessen the burden for RCTs, and reduce the urgency for and expense of traditional post-market surveillance, confirmatory and label-extension trials. Beyond maximising product value, it helps more patients live longer and healthier lives.

To speak with ICON’s Medical Device and Real World Evidence experts on the implications for your business, contact us.



(1) Makower, J et al. FDA Impact on US Medical Technology Innovation. Medical Device Manufacturers Association, 2010

(2) Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Draft Guidance for Industry and FDA Staff. US FDA Center for Devices and Radiological Health, and Center for Biologics Evaluation and Research, July 27, 2016, updated September 16, 2016

(3) Using Real-World Evidence to Accelerate Safe and Effective Cures: Advancing Medical Innovation for a Healthier America. Bipartisan Policy Center, June 2016 

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