The global market for interventional cardiology devices, including stents, valves and balloons is expected to reach $26.06 billion by 2020, according to latest reports. The continued rise in the interventional cardiology device segment can be attributed to aging populations and the increasing prevalence of heart disease, stroke and diabetes, particularly in highly developed nations.
Bringing interventional cardiology devices to market is no easy task and is only increasing in complexity. Designing and executing successful clinical trials for such devices that will result in regulatory approval, reimbursement and clinical adoption is challenging and requires a detailed, long-term clinical strategy. Here are three key elements to consider when companies are developing and commercializing implantable, interventional cardiology devices.
The majority of such device trials include a strong FDA focus in their development strategy but the size and duration of these trials and lengthy FDA review cycles is a challenge. This has led developers to also look at geographically diverse areas in which to conduct trials. Beginning clinical testing with a safety and efficacy pilot trial in the European Union (EU) can be useful in identifying issues that then can be addressed before a pivotal clinical study protocol is submitted to the FDA and executed in the US.
When implementing a clinical strategy that utilizes global data, carefully account for the standards of care that will vary from country to country. These differences will impact data acceptance in both the FDA’s and subsequent regulatory reviews.
Become familiar with the regulations and requirements of each regulatory jurisdiction in which you plan to commercialize a device. One of the first documents written for the Design Control process should be a detailed regulatory assessment for each agency that must be specific to the device type and its intended use. The FDA requirements are generally the most stringent globally, so following the agency’s assessment project plan should work well for most other jurisdictions.
Sponsors must start including the collection of health economic data and its assessment in earlier stages of the clinical program. In the past, companies could get by with focusing on only safety and efficacy data at the pivotal study stage and follow-up, as needed, with postmarket studies to establish cost efficiency and general health economic measures. Due to escalating healthcare costs, public and private payors as well as hospital purchasing departments are increasingly scrutinizing device costs. As such, achieving market release of a new product does not guarantee adoption from operators or their purchasing departments. This is also reflective in a report that outlined that reimbursement trumps regulatory and raising capital as the industry’s top concern, as reported in MDDI.
Specific to interventional cardiology device trials, planning must factor in protocols for measuring value beyond just the cost of manufacturing and implanting a device. This includes measuring formal health economic measures such as quality-adjusted life-years. But even informal health economic measures can be helpful such as duration of procedure, blood loss, time to discharge and similar outcomes to characterize the economic impact of the device and therapy.
Don’t assume board certification and expertise with one type of device will translate to a different technology. An interventional cardiologist may be an expert in angioplasty or mitral valve repair, but not both. Be sure to choose investigators that understand how your device works.
In site selection, it’s important to explore your options and not limit yourself to only working with sites and physicians that enjoy top-tier reputations. Sites with less extensive clinical research portfolios can offer shorter start-up times, less trial competition, and a great enthusiasm for performing the study. Particularly with the lesser “known” sites, including a performance-based publication strategy can significantly increase enrollment, quality of data and overall study compliance.
In patient selection, an interventional cardiology device is seldom the only medical treatment used. Data collection must carefully account for all therapies, whether investigational or not. With sites and teams identified, involve your key opinion leader in the design of the trial, particularly as it relates to comorbities, inclusion/exclusion criteria and, of course, in the development of clinical endpoints in order to ensure they are clinically meaningful. It can also be useful to include any experienced clinical research coordinators to review the protocol as they often have the best idea of patient flow through the clinic and potential issues with Case Report Forms.
To speed clinical adoption, a best practice is to consider how other medical professionals and researchers define and use information, whether for clinical practice or research settings. Planning for such complex data collection and analyses require that all involved agree on the markers, measures and methods that will precisely define the trial endpoints and assure those assessments are uniformly available at each trial site.
As the global regulatory landscape changes and payers seek more comparative data for new interventions, developers need to rethink the manner in which they design trials. Working with a specialty medical device CRO with first-hand regulatory and interventional cardiology-specific trial knowledge can help ensure these new challenges are met with success.
-- By Eric Distad, Director of Project Management, Medical Device and Diagnostics, at Novella Clinical, a full-service clinical research organization specializing in medical device trials.