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






Connected devices are key to advancing remote patient monitoring. While medical technology devices can be great for collecting data, many other steps are required to break down silos, convert, and analyze that data into a format that can generate insights 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. This is just as true for small and medium-sized medical technology companies as it is for medical device giants.

In some context, 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 device efficiency. By demonstrating how a real population will benefit from using a specific product, manufacturers can use RWE to help them advocate with regulators to add new indications for their devices. Through the use of devices to support decentralized clinical trials, RWE also has an important role to play in decentralized clinical trials, to verify the effectiveness of medtech devices and drug treatments.

Another reason medical device manufacturers value RWE is because it’s critical to patient engagement. The insights from the patient-generated data it enables to help patients track their progress and get a window into their condition, compelling the patients and their clinicians to further enhance the device. RWE is also an essential element in supporting personalized medicine.

The 21st Century Cures Act of 2016 had a transformative effect on the medtech industry in a number of ways. The 2016 law directed the FDA to develop a framework for including RWE in applications for approval of new drugs and devices and expanded indication labeling. In 2018, the FDA released its RWE framework. This has led to regulators around the world wanting to incorporate RWE into their regulatory review process, highlighting the value for medical technology manufacturers to work with a digital health collaborator to produce RWE, as it represents the new benchmark for product submissions.

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

The process involves generating, collecting, analyzing and evaluating clinical data for an SaMD to produce clinical evidence to verify the clinical association and performance measures of an SaMD, according to the FDA website. The objective is to evaluate the RWE generated by the SaMD to determine if it is of high quality, relevant and compatible with the intended use of the SaMD.

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

“I cannot participate in a conversation with a CIO. It’s just not our comfort zone. You need a trusted partner who can do it for you and someone who will speak the right language and deliver a value proposition for that IT CIO. »

Dr. Erika Ross, Director of Clinical and Applied Research in Abbott’s Neuromodulation Division, noted that the “software/computing knowledge gap is real” in medical technology and acknowledged that the device maker needs to hire talent from top IT companies to get the support they need. .

RWE is beginning to be an integral part of what medical device companies need to gain continued regulatory approval. In Europe, changes are being made to medical device regulations that will require medical technology companies to supply RWE and show how their products work long term. This means companies now need to put teams and processes in place to do this heavy lifting. It’s just too hard to live without a reliable digital health partner like Huma.

Rudolf Wagner, Huma’s Global Director of Quality Assurance and Regulatory Affairs, discussed how Huma can help medtech companies navigate the cumbersome regulatory road with their team of experienced SaMD quality and regulatory specialists.

“With the EU MDR, we are seeing a huge trend that device manufacturers not only need RWE to improve patient outcomes, but also to improve the [device] performance,” Wagner said. “We can also help manufacturers by performing clinical studies and generating the RWE they need. This is very easily done with remote patient monitoring software like Huma’s, where you can provide the clinical data in a very simple, sophisticated and safe way.

Wagner observed that not all patient-generated data (from medical devices) is equal. For example, app stores are filled with digital health apps that are not clinically validated or FDA approved. This is why it is essential that the applications used for patient-generated data are credible. Huma is one of the leaders in quality management systems that can provide this type of monitoring.

Archana Dubey, clinical director at AliveCor, noted that RWE’s submission enabled the cardiology medical technology company to improve arrhythmia management to impact patient care delivery. The partnership with Mayo and Cleveland Clinics has allowed AliveCor to generate clinical evidence that can be submitted to the FDA. In doing so, he received authorizations for his devices, allowing patients to use the devices at home to better manage their arrhythmia events.

Medical technology companies are well positioned to reap the benefits of remote patient monitoring from a clinical and pharmaceutical perspective, while continuing to validate their own devices. Their competitiveness depends on having a competent partner to navigate the requirements of regulatory bodies on a global scale. Collecting and analyzing data from these devices in a consistent manner and being able to knowingly answer questions from regulators is critical to detecting potential issues with product submissions, dosages, use of devices and the overall health of patients.

Photo: 9amstock, Getty Images