For medical device manufacturers, real-world data (RWD) and real-world evidence (RWE) are important tools for accelerating clinical research, for understanding how products perform once they reach the market, and for delivering interventions efficiently to patients who need them.
Regulators have recognized these benefits and seek to use RWE to inform decision-making, as evidenced by a 2017 guidance from the U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health. But there is still work to be done to advance RWE adoption among medical device companies.
Christian Howell, who recently joined Aetion as Vice President and General Manager of Medical Devices and Diagnostics, is committed to supporting medical device and diagnostic organizations as they leverage RWE to more quickly, accurately, and cost effectively bring interventions to the right subgroups of patients.
Christian’s career has been split between two fields: the military and the medical device industry. During his time as an officer in the U.S. Navy, Christian developed a philosophy that would guide his future endeavors: his work had to make a positive social impact. This led him, nearly 20 years ago, to medical devices, where he navigated responsibilities in business development, product management, market development, and strategy. Most recently, Christian led Medtronic’s Value-Based Health Care Partnerships organization. There, he gained an understanding of the critical role of data in the shift from volume to value in health care, so he adjusted his focus to encouraging stakeholders towards sharing data and making better decisions with accurate and high quality evidence.
Now at Aetion, Christian looks forward to working with medical device and diagnostics (MD&D) companies to accelerate the utilization of RWE in the regulatory submission process, expand its impact in reimbursement and commercialization efforts, and leverage its insights to improve patient lives. Read on to hear more from Christian on the opportunity he sees for RWE in the MD&D space.
Responses have been edited for clarity and length.
Q: How can RWE support the medical device industry?
A: Much like we’ve discovered in the biopharma product lifecycle, RWE is going to be increasingly impactful for medical devices. RWE can support and improve upon a range of processes: from determining which cohort of patients can benefit most from an intervention, to informing regulatory approvals and complementing data from randomized controlled trials, to supporting reimbursement efforts and expanding indications of use.
There’s also an opportunity with RWE to address the time sensitivities of medical device and in vitro diagnostic (IVD) development. Medical device innovation is often iterative; new products or line extensions are launched every two to three years, outpacing the time required to run full clinical trials. This forces manufacturers to evaluate whether a clinical study is worth the investment, especially if the study’s timeline may result in publications reporting outcomes on a previous generation’s technology. With RWE, medical device companies can better navigate such timeline challenges.
Modern medical devices are already largely connective, interfacing with wearables and other technologies to generate RWD. But that data is wasted unless it is turned into decision-quality evidence. I’m particularly motivated by the value RWE can have in assisting medical device companies as they work with provider health systems and their value analysis committees to deliver the right solution to the right patient at the right time.
Q: What role has RWE played in the medical device space to date?
A: The application of RWE so far has been limited in medical devices and diagnostics compared to biopharma, but is recognized as an important opportunity for the industry.
As early as 2016, Dexcom used RWE to expand the indication of its G5® Mobile Continuous Glucose Monitoring System—an encouraging sign of the FDA’s growing acceptance of RWE for medical devices. Recently, we’ve seen RWE used for a humanitarian device exemption application for a device treating adolescent idiopathic scoliosis, for an expanded indication for hemodialysis catheters, and to expand several medical devices’ indications into pediatric surgery applications.
Moving forward, RWE is going to be increasingly important to monitoring post-market, real-world performance of medical devices. A key recognition of the importance of RWE in medical devices was the development of the National Evaluation System for health Technology (NEST), a collaboration between the FDA and medical device stakeholders to generate RWE across the medical device product lifecycle and inform provider and patient decision-making.
The Aetion Evidence Platform® (AEP), in concert with NEST, will help improve the quality of RWE that medical device companies and health care providers can use to inform decisions, and to strike the right balance between assuring device safety, fostering device innovation, and improving patient access.
Q: What are regulators’ positions on using RWE to support medical device decision-making?
A: Messaging from the FDA and other global regulators has been clear: first, that regulatory processes are becoming more rigorous and new evidence requirements for medical devices are going into effect, and second, that RWE has been, and will increasingly be, expected in medical device regulatory submissions to support decision-making.
Q: What more needs to be done to facilitate the use of RWE by MD&D companies?
A: We need to continue educating MD&D companies on the value of RWE, and on its ability to deliver the right interventions to the right patients more quickly and easily, and at a lesser cost. MD&D clinical research organizations understand this value well, but leaders across the medical device and IVD lifecycles are not as well informed about RWE, and how platforms can support rigorous RWE generation.
Q: What challenges exist to using and adopting RWE across the medical device lifecycle, and how can we overcome them?
A: The most significant challenge regarding the use and adoption of RWE in the MD&D space is the quality of the data. During the medical device development process, devices go through continuous testing and several iterations to ensure the product is safe and effective. Because of this, there’s a tremendous amount to learn about a medical device once it enters the market. Capturing those learnings and measuring a device’s impact remain challenging, particularly with regard to difficulties accessing electronic health record data and the lack of device-specific unique device identifiers (UDIs). However, the FDA’s mandate regarding UDIs on medical devices means that devices are being tracked more effectively, making their impacts easier to measure with more robust RWD.
Q: How can RWE facilitate value-based agreements for medical devices?
A: There’s a tremendous opportunity for RWE to enable value-based agreements between payers, medical device manufacturers, and providers. By utilizing RWE, all of these stakeholders can more accurately assess which intervention should be used for which cohort of patients, and predict the clinical and economic outcome. High quality RWE enables stakeholders to engage in bespoke value models with a much higher degree of confidence, avoiding the generic, rebate-focused agreements of the past. Using RWE platforms, like the AEP, can also analyze a range of RWD sets to tailor value-based agreements to a stakeholder’s specific population or cohort.
Q: Now working in the RWE space, which challenges are you most eager to tackle?
A: I look forward to leading the introduction of a best-in-class technology that will further enable medical devices and diagnostics to positively impact patients’ lives. The biggest challenge will be introducing RWE clearly and efficiently to get high quality evidence in the hands of decision-makers, empowering them to make better informed decisions faster.