Remote Monitoring Devices - The Digital Healthcare Strategy to Combat a Pandemic

1. Remote Monitoring Devices The Digital Healthcare Strategy to Combat a Pandemic With the positive corona virus cases crossing over 1 million globally, we are at a risk of overwhelming our healthcare systems. Hospitals are stretching thin as the demand for critical care capacity surges and the supply falls short against the total projected number of cases. As per Mckinsey, the critical care capacity of the hospitals needs to be increased by four to five times in the coming weeks for offering the required assistance to the patients and reducing the mortality rates. More importantly, the centralized care delivery model in hospitals present increased risks of exposure and contraction vulnerabilities to the non-coronavirus patients. According to the McKinsey report, ceasing all non-emergent care across hospitals and other sites of care would free up to 30 percent bed capacity, caregiver capacity, and a portion of ventilator and personal protective equipment (PPE) capacity almost immediately. As the expansion of critical care capacity & a decentralized healthcare strategy are vital to saving lives and deal with this pandemic, we will need to move beyond the traditional methods of healthcare delivery. “We have to use a health care strategy that deploys resources throughout an entire community, and that’s where remote monitoring comes in” says Raj Khandwalla, a physician and director of digital therapeutics for the Smidt Heart Institute at Cedars-Sinai Medical Center in Los Angeles. Remote medical assistance can not only free up beds and vital equipments, but also uphold the healthcare system to battle the outbreak efficiently. Recently, the U.S. Food and Drug Administration agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so

2. that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate, and blood pressure. Implementing remote monitoring systems While remote care delivery assumes great importance in the present dynamics, implementing and switching to such methods at such a scale is an enormous task for the healthcare providers. Digital epidemiology tools, wearable tech, AI-based chatbots, and other similar tools are seeing a sudden surge in demand. However, before implementing a remote monitoring care model, it is imperative that the healthcare providers formulate an effective strategy. • The manufacturers of remote monitoring devices such as wearable technology and telehealth platforms should be able to scale up for meeting the exponential demand. • It is important that both patients and healthcare professionals are trained adequately to use the digital tools. • The data obtained from the remote monitoring devices should integrate seamlessly with the hospital infrastructure and Electronic Health Record Systems (EHRs). • As incidents of breaches increase amid the pandemic, the remote healthcare monitoring systems & digital platforms should be secured and protected against cyber-risks. Dr. Betty Rabinowitz, Chief Medical Officer of NextGen Healthcare, says, “Rapid integration of telehealth visits into a practice’s workflow is a complex task and requires clinical and administrative leaders to develop an effective strategy for implementation of this modality. Assuming a practice has not had prior experience with telehealth, selecting the telehealth platform is one of the first decisions the practice will face. In making this decision, it is important to recognize that the technology selected will likely need to serve the practice after the current crisis subsides and that a long-term view is necessary.” Real-life examples of remote monitoring amid COVID-19 outbreak Telehealth platforms and other remote monitoring devices not only offer cost-effective & convenient medical assistance but also prevent physician burnouts in a time when they are needed to be available at all times. Here are some real-life examples where remote monitoring devices have been deployed to monitor COVID-19 patients: • Not-for-profit Catholic health system, Providence, is using Remote Patient Monitoring for 700+ COVID-19 Patients. They are using a pathway solution from Twistle to connect automatically with at-risk patients. Up-to-date information about symptoms is gathered via secure text messaging, phone, or smart phone apps. If the symptoms require attention, an alert is sent to the care team.

3. For automation and integration of the data into the EMR workflow, Providence is using Xhealth’s digital health platform. Dr. Todd Czartoski, Chief Medical Technology Officer for Providence, talks about their digital strategy –“In the current environment, we have a large population of patients who are concerned and experiencing symptoms that may or may not be indicative of COVID- 19. Incorporating Xealth and Twistle into our clinical operations extends the reach of our front-line caregivers – enabling us to give them leverage to monitor patients effectively and efficiently – while keeping patients safely at home.” • Artificial Intelligence (AI) is being used by hospitals to flag physiological changes associated with the COVID-19 infection. Biofourmis, a Boston-based company, developed a wearable that is being used to monitor COVID-19 patients in Hong Kong. The wearable device leverages AI-based algorithms to identify and flag the symptoms that develop from the COVID-19 infection. AI-driven screening systems such as thermal-scanning face camera are deployed by hospitals to detect fevers, sweating, and discoloration to prevent symptomatic people from entering public spaces and spread the infection. Accelerating product releases & benchmarking quality In order to ‘flatten the curve’ of COVID-19 spread, isolation and distancing are critical. As the demand for remote monitoring devices surges, the manufacturers of digital health tools and platforms are required to buckle up and scale the supply. However, given the criticality of the situation, they should particularly fortify the ability of their tools to support heavy user load and function seamlessly across devices. These remote patient monitoring devices will be playing a vital role in containing the pandemic, which is why, it is essential that these devices work as efficiently as the human healthcare workforce. In order to do so, the remote health monitoring systems must be verified & validated for compliance & regulations, while delivering a safe and smooth experience to the patients. The increasing demand for scaled production of these devices may put strain on the resources and processes, leading to decreased productivity and compromised quality. In times like these especially, both quality and quantity assume equal importance. Employment of an end-to-end quality management system and automation of processes can help the remote monitoring devices manufacturers to uphold the qualitative as well as the quantitative aspects of their products. Praxia, one of the components of Cigniti’s IP – BlueSwan, is a Process Accelerator Platform that transforms medical devices testing methods by assessing processes, practices, tools, skills and risks. It implements our process-driven IP frameworks, including ADePT (Agile DevOps Enterprise Transformation Framework) to accelerate product releases while benchmarking the quality standards. Cigniti’s Process

4. Asset Library has over 400 proven test artifacts that help medical device manufacturers save 40-80% of efforts while establishing and standardizing a Quality Management System (QMS). By leveraging Praxia, our global consulting experts deliver holistic & outcome-based solutions. Schedule a discussion with us to talk to one of our experts on how we can help you scale up your production while meeting the quality standards.