Note: This article is part of a series exploring how to unlock the value of remote patient monitoring
The medtech industry is at the dawn of a new era. Medical device companies, for the most part, have struggled to collect data from patients through their devices. They have lacked the knowledge and motivation to move beyond this stage, but that’s beginning to change. Regulatory shifts and technological advances have converged to support the collection of real world evidence (RWE). Collaborations between medtech and digital health companies create the potential for clinicians to make informed decisions based on RWE to improve patient outcomes. The opportunities for this new chapter of remote patient monitoring are just beginning to emerge.
In a recent webinar, executives from Huma, Abbott, Smith & Nephew and AliveCor shared how they are using RWE collection to support remote patient monitoring and improve patient outcomes in neurology, cardiology and orthopedic surgery
Alex Gilbert, digital medicine with Huma, shared how his company views its role in RWE collection. The opportunities fall into three buckets, he said.
“One is to improve prescribing confidence and being able to showcase how a real-world population will derive benefit from using a specific product,” he said. “Secondly, I think, as an add-on to that, the real-world evidence really feeds into creating novel value-based care agreements, which are now becoming a much higher interest than previously. That real-world evidence ultimately is there to be able to support those agreements in the long run.”
Gilbert noted that medical device regulatory changes in Europe mean that companies need to produce RWE that can help them quantify how their products perform over the long term. To do so, businesses have to set up teams and processes to support RWE collection that they may have previously thought were something “nice to have” rather than mandatory.
At Abbott Neuromodulation, Director of Clinical and Applied Research Dr. Erika Ross provided an overview of the company’s work in creating implanted medical devices to treat chronic nervous system disorders, such as Parkinson’s disease, chronic pain, and depression. She explained that the volume of data generated from the devices enables providers to develop a more personalized picture of each patient. That’s particularly important given the differences in how each individual experiences chronic pain. RWE also enables the medical device giant to quantify the effectiveness of new products and new indications, which helps regulators evaluate those devices.
AliveCor’s ECG device enables patients to help monitor and manage arrhythmias between physician appointments. In contrast to Smith & Nephew and Abbott, AliveCor’s devices are used by patients to share data with providers. Devices that can highlight when arrhythmias occur in a patient’s daily life are critical to providing proof of heart conditions that can be tough to diagnose.
In order to maximize the benefits of RWE in providing physicians with timely data on patient health, it’s critical to minimize the amount of time physicians must devote to analyzing the data and to ensure it easily fits into their workflows.
“It’s about taking away the role of analyzing data and creating insights, so that actually you’re providing them with insights rather than just information from a clinical perspective,” Gilbert said. “It’s [a question of] how do we get them to that high-level insight point because clinicians and, generally, clinical teams aren’t there to collect data or analyze data. They’re there to make decisions. That’s what digital technology should be doing. It should be aiding them in making those decisions.”
Dr. Archana Dubey, chief clinical officer with AliveCor, agreed and also underscored the powerful impact when medtech companies understand the needs of their provider partners.
“AliveCor and a lot of digital health companies have made data insight a priority, so it provides the data in the way that the clinician wants, in the way that it can be actionable,” Dubey said. “Just by adding remote patient monitoring, we were able to show real-world evidence of nearly 56% reduction in emergency room use and then 68% reduction in hospitalization for patients with arrhythmia. That is powerful.”
RWE collection also has led to a more dynamic relationship between medical device manufacturers and clinicians, posing a question of what each party needs to thrive.
Paul Trueman, vice president of market access for Smith & Nephew, said that as an orthopedic device company, Smith & Nephew views its role as one of making it easier for physicians to triage their patients. That’s true not just for the acute cases when a patient’s recovery suffers a setback between a procedure and follow-up appointment.
“We are very cautious about stepping over into what might be construed as medical management,” Trueman said. “So, we are trying to put in place additional data points which we think help in managing patients and an easy, intuitive interface with the surgeon or the HCP (health care provider) to actually look at that triage appropriately. … We’re about providing data, supporting the patient through that, critically, so there’s a strong patient focus, but then giving the HCP the right data to actually work out whether they need to intervene.”
He also highlighted medical device manufacturers’ responsibility to use big data generated from RWE to improve the performance of their products.
“The longer piece, I think, comes much later as we start to build big data sets. That’s where we start to get signals about overarching product performance, rare events. We know that’s occurred in orthopedics in the past, and where we haven’t had that wholesale data collection, we probably missed it as an industry at times, or we found it too late. I think as we start to get more and more data, or we recruit more patients into these kinds of services, we’ll start to get those signals a lot earlier. Hopefully we can intervene earlier. So early case, I would say it’s very much a surgeon’s responsibility. Big data, longer term outcomes, I think that’s a manufacturer’s responsibility to observe that, and that’s what the regulations are telling us to do now,” Trueman said.
Asked whether manufacturers are moving towards directly engaging with patients, AliveCor said it is. Others, such as Smith & Nephew, view the benefits of RWE collection coming just as much from highlighting improvements in a patient’s condition as from alerting physicians to a patient’s decline in health. But whether information is going to patients or doctors, partnerships between a medical device company and a trusted health technology company like Huma can make all the difference .
“One thing we’ve tried to do working with Huma is to not only escalate cases, but de-escalate cases,” Trueman said. “I think there’s both sides of the argument here. A big part of this, for me, is actually just explaining to the patient what’s normal. When you’re going through your recovery, when should you be alarmed? When is it perfectly normal? If you’re going to have seroma in the knee after knee surgery, it’s going to be stiff for a number of days. You don’t need to be doing a call out to an [Emergency] room or to your surgeon about that, but also telling them what are the parameters where you do need to do that. We’re not directly intervening, and thankfully, rarely will there be a fatal or a severe life-threatening event in an orthopedic surgery episode. But where we have signs and symptoms of an escalation of an infection, for example, we’re trying to give the patient enough insight and knowledge and education to actually know when to pick up the phone to their provider.”
Medical device companies are blazing a path forward in helping to transform patient outcomes through RWE collection. But only by collaborating with digital health companies will they be able to present this data in a format that fits neatly into clinician workflows in a timely manner without overwhelming them with data and alerts. It may also make it easier to address diverse patient populations who may not respond to treatment in the same way. These compelling examples across neurology, cardiology and orthopedic surgery offer an exciting preview of how RWE collection presents new opportunities to transform health care.
Photo: metamorworks, Getty Images
