The future looks bright for medical device research: many researchers suspect a tremendous amount of growth and opportunity over the coming years. Emerging markets in India and APAC, rising health care costs, and aging populations in many countries all contribute to higher demand for innovative devices to improve the lives of those in need. And advances in real-world evidence (RWE) have added an exciting layer of sophistication to the technology behind medical devices and the research that brings them to market.
However, despite the positive outlook, the industry still faces a number of obstacles. With industry growth comes greater competition and additional pressure to create high-quality, innovative, and cost-effective products. A recent report by Infinity Research placed product quality and regulatory compliance as the top medical device challenges. The bar is now higher, and organizations working in global markets now need to meet the tightening regulatory standards of multiple countries. On top of this, IoT and data security are more important than ever as device manufacturers collect vaster amounts of sensitive data that need storage in a secure infrastructure.
Stemming from these challenges is a growing concern: the costs of medical device development are rising and achieving a return on investment is increasingly difficult. Verna Manty Rodriguez, Founder and Principal at Manty Medtech, a consulting and advising company specializing in medical device development, cites ROI as the most significant hurdle in the device industry today. However, she also discusses ways researchers can keep costs low despite the challenges of modern clinical trials.
The Promise of Real-World Evidence
According to Rodriguez, the primary way to get ROI is to get to market as fast as possible. And real-world evidence (RWE), including wearables and mHealth, are vital aids in achieving that goal. These tools decrease the burden of site visits on clinical trial patients and allow researchers to track data from a wider pool, reducing costs and timelines while improving the patient experience. In the collection of post-trial information, RWE enables researchers to identify side effects, adverse reactions, and medication errors in real time. As a result, researchers can more easily make changes to improve drug efficacy, further reducing time to market.
Beyond improving patient convenience, real-world evidence also improves data accuracy. Traditionally, it’s left to patients to self-report information on physical activity and the times when they come in for site visits. Many researchers are aware that self-reporting is prone to human error, misremembering, and incompleteness; however, wearables can make data more accurate by creating a detailed record of a patient’s physical activity between visits.
But before the game-changing potential of RWE can be fully unlocked, regulatory and practical concerns still need to be reckoned with. Wearables, smartphones, and other real-world data collection tools are not eClinical and therefore lack the edit checks, audit trails, and other regulatory requirements necessary to meet FDA standards. If RWE could be fed directly into an eClinical platform like EDC, it could be subjected to the regulatory mechanisms of eClinical technology and more widely used. It is now incumbent upon the medical device industry to bridge this regulatory gap to take advantage of all the promise RWE offers.
The Latest Regulatory Developments
The FDA has taken note of the merits of real-world evidence and is taking steps to facilitate its incorporation into clinical trials. The FDA Commissioner, Scott Gottlieb, recently stated that as more opportunities arise to gather reliable data from the real-world use of medical devices, there are more possibilities to use this data to create novel products and to inform the safe and effective use of existing ones.
While medical device researchers will always experience challenges and hurdles, both regulators and industry experts see real-world evidence as a crucial tool that will drive the future of clinical trials, cutting costs and reducing timelines while improving the patient experience and data accuracy. Greater integration with eClinical platforms is an essential next step in maximizing the potential of RWE and overcoming the challenges of modern device trials. It is with these tools that researchers can better serve patients while getting a higher return on their investment and hard work.