Nick Delmonico, founder and CEO of Strados Labs, examines the role of sensors in remote patient monitoring (RPM).
Over the past several years, the medtech industry has seen incredible technological advancements and opportunities to provide patient care in lower cost care settings like the home. Medical smart sensors, devices capable of collecting clinical-grade biometrics from patients and connecting to software applications like EHRs or telehealth applications, are increasing in stakeholder demand. In the last three years alone, wearable use with patients has risen from about 35% to nearly 45%. In reality, over 45% of people today are monitoring their health in some way with wearable technologies, and of the new users in the last five years, about 2/3 of those are using it to manage their chronic condition. Over 15% of clinical trials include wearables today and according to Kaiser Associates and Intel, 70% of clinical trials will incorporate sensors by 2025.
Remote and telehealth capabilities
Remote patient monitoring (RPM) is the ability to collect data from a patient after they leave a doctor's office, hospital, or skilled nursing facility and get meaningful insights that you wouldn’t otherwise have access to outside of one of the aforementioned facilities. Armed with this information, as a clinician you can either decide to change management, treatment, or recommend the patient seek care locally. Reimbursement for RPM in 2022 can be between $70-$150 per patient over the course of 30 days of management and provides significant ROI to providers when complex patients can avoid the ER or a hospital admission as a result.
Patients don’t always have convenient access to specialists like pulmonologists or cardiologists in their area, making it difficult to see the doctor without taking time off from work. RPM & telehealth provides a way to engage with the clinician via text messages and through a patient portal where you can ask questions and easily sync and provide critical physiological data from your wearable sensor, all without having to commute and take time off from work.
Strados for example has developed an FDA cleared technology called RESP, a lung sound measurement device that connects to a mobile and web application to aid in clinical assessment of a patient’s respiratory status. RESP is worn by a patient and collects recordings of lung sounds daily, for review by a clinician via its web platform. It detects and measures wheezing, coughing, rales, rhonchi, all of these different lung sound abnormalities that may not otherwise be reported by the patient subjectively. This may help doctors, nurses or therapists make treatment decisions for the patient and avoid hospital visits.
Mitigating challenges with decentralised clinical trials
Clinical trials are the cornerstone of medical advancements, but due to geographic and financial barriers, they are not accessible to all patients. Trials typically require that participating patients travel to a study site for data collection including biomarkers, creating challenges with recruitment and retention. In December, the FDA introduced a new strategic framework to advance the use of real-world evidence to support the development of drugs and biologics. Using wearable devices to collect biomarkers and electronic outcomes assessment (eCOA) like blood pressure, cough rate, activity remotely enables decentralised and hybrid trials to be successful.
Reducing patient burden to increase retention
Study sites are not always conveniently located to the general population, which can make participation impossible for patients who do not have the means to travel. These barriers can impact the diversity of patient populations, recruitment, data collection and ultimately the trial results.
Leveraging connected medical sensors and digital health applications means researchers can collect all the study data required like questionnaires, point of care diagnostics, and physiological data wherever the participant is, significantly reducing the patient burden and increasing the likelihood that they will remain enrolled. Digital biomarkers collected from wearables and sensors also help researchers effectively define the recruitment criteria and enrich enrolment of a patient subgroup who are more likely to respond to a novel therapeutic in Phase ⅔ clinical trials.
What is most exciting for the future of smart sensors and wearables in clinical trials and remote care is the rapid adoption of mobile technology and infrastructure that is now in place, pushed over the edge by COVID-19. Firms and patients are now fully enabled by telehealth and remote platforms. The integration of the right smart sensors to capture key insights into biomarkers and vitals is the clear next step.
