Why collaboration is essential for using real world evidence in regulatory submissions underpinning remote patient monitoring


Connected devices are essential for the advancement of remote patient monitoring. Although medtech devices can be great for gathering data, there are many more steps required to de-silo, convert and analyze that data in a format that enables insights to be generated from it. Medtech and digital health are like two separate worlds that speak a different language. In order to benefit from the growing requirement to support medtech devices with real world evidence (RWE), device companies need to partner with a digital health infrastructure company that understands the needs of medtech companies and can also help them navigate the regulatory landscape. That’s just as true for small to medium-sized medtech companies as medical device giants.

For some background, Congress defines RWE as data demonstrating the potential benefits or risks of a drug or device derived from sources other than traditional clinical trials. RWE can help quantify the effectiveness of devices. By demonstrating how a real-world population will gain the benefit of using a specific product, manufacturers can use RWE to help them make a case to regulators to add new indications for their devices. Through the use of devices to support decentralized clinical trials, RWE also has a substantial role to play in de-centralized clinical trials, to ascertain the effectiveness of medtech devices and drug treatments

Another reason why medical device manufacturers value RWE is it’s crucial to patient engagement. The insights from patient-generated data that it enables help patients track their progress and gain a window into their condition, compelling patients and their clinicians to value the device even more. RWE is also a critical component to supporting personalized medicine.

The 2016 21st Century Cures Act has had a transformative effect on the medtech industry in a few different ways. The 2016 Act called upon the FDA to develop a framework for the inclusion of RWE in submissions for new drug and device approvals and expanded indication labeling. In 2018, the FDA released its RWE framework. This has led to a willingness by regulatory bodies worldwide to incorporate RWE into their regulatory review process, driving home the value for medtech manufacturers to work with a digital health collaborator to produce RWE, since this represents the new gold standard for product submissions.

The regulatory needs for software as a medical device (SaMD) stand in sharp contrast with those for medical device hardware. The most critical and perhaps obvious point is that the risk of inaccurate or incorrect output of the SaMD could impact the clinical management of a patient. 

The process involves generating, collecting, analyzing, and assessing clinical data for a SaMD to produce clinical evidence to verify the clinical association and the performance metrics of a SaMD, according to the FDA’s website. The goal is to evaluate the RWE generated by the SaMD to determine whether it is high-quality, relevant, and supportive of the SaMD’s intended use. 

Paul Trueman, vice president of market access for Smith & Nephew, acknowledged the knowledge gap between medtech and software implementation. 

“I can’t walk into a CIO conversation. It’s just not our comfort zone. You need a trusted partner who can do this for you and someone who’s going to speak in the right language and come up with a value proposition for that CIO in the IT department.” 

Dr. Erika Ross, director of clinical and applied research with Abbott’s Neuromodulation division, noted that the software/IT knowledge “gulf is real” in medtech and acknowledged that the device manufacturer needed to hire talent from top IT companies to get the support they needed.

RWE is starting to become part and parcel of what medical device companies need to have continuous regulatory approval. In Europe there are changes being made to medical device regulations that will require medtech companies to provide RWE and show how their products perform long term. That means that now businesses have to put teams and processes in place to do that heavy lifting. It’s simply too difficult to do without a reliable digital health partner like Huma

Rudolf Wagner, Huma global director quality assurance & regulatory affairs, explained how Huma can help guide medtech companies through the cumbersome regulatory pathway with their team of experienced SaMD quality and regulatory specialists.

“With the EU MDR, we see a huge trend that device manufacturers not only need RWE in order to improve patient outcomes, but also in order to improve the [device] performance,” said Wagner. “We can also support manufacturers by running clinical studies and generating the RWE they require. That is very easily done with remote patient monitoring software like Huma’s where you can provide the clinical data in a very easy and sophisticated and safe manner.”

Wagner observed that all patient-generated data (from medical devices) is not equal. For example, app stores are filled with digital health apps that are not clinically validated or cleared by the FDA. That’s why it’s critical for apps that are used for patient-generated data to have credibility. Huma is one of the leaders in quality management systems that can provide that kind of oversight.

Archana Dubey, chief clinical officer with AliveCor, noted that submitting RWE enabled the cardiology medtech company to improve arrhythmia management to impact care delivery for patients. Partnering with Mayo and Cleveland Clinics enabled AliveCor to generate clinical evidence that could be submitted to the FDA. In doing so, it received clearances for its devices, enabling patients to use the devices at home to better manage their arrhythmic events.

Medtech companies are well-positioned to reap the benefits of remote patient monitoring from a clinical and pharma perspective as well as continuing to validate their own devices. Their competitiveness depends on having a knowledgeable partner to navigate the requirements of regulatory bodies globally. Collecting and analyzing data from these devices in a consistent manner and being able to knowledgeably respond to queries from regulators is critical for spotting potential problems with product submissions, dosages, device usage and the overall health of patients.

Photo: 9amstock, Getty Images

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