The SaMD and CMMD market is poised for massive growth as software plays an increasingly integral role in medical devices
Advances in medical technology, especially software, are poised to cause a seismic shift in how healthcare is administered and delivered across the world. One area where digital transformation has been particularly profound is medical devices. Broader technological trends such as the emergence of the Internet of Things (IoT) have paved the way for a new generation of mobile connected devices that are revolutionizing care delivery.
While there has been a rise in proprietary hardware devices in recent years, much of the industry’s focus has turned to a relatively new category: Software as Medical Devices (SaMD). Though many hardware devices contain software necessary to their function, SaMD is unique in that the software itself performs a medical function and in many cases can run on general use computing platforms such as smartphones or tablets. The International Medical Device Regulators Forum (IMDRF) and FDA define SaMD as software intended to be used for one or more medical purposes, either in combination with other products such as hardware devices or completely free from proprietary hardware. The line between SaMD and CMMD (connected mobile medical devices) is blurry, due in part to rapid innovation that challenges traditional regulatory boundaries.
For the purposes of this article, we will be looking at the landscape of SaMD and CMMD—devices where software plays a crucial role in delivering care—designed to treat, diagnose, cure, mitigate, or prevent medical conditions and diseases.
The connected device ecosystem is versatile and encompasses multiple segments of products along a spectrum from pure software to proprietary hardware devices where software plays a crucial role in delivering care. Medtech companies and their connected devices typically fall into four broad categories:
For decades, imaging and diagnostic technology has relied on large stationary systems in dedicated facilities or—at best—bulky, cart-based systems. That reality has shifted dramatically as more compact, portable diagnostics have entered the market. These lighter mobile technologies are enabling leaner hospital operations and new distributed care modalities. In emergency settings, these tools can reduce the time from triage, to diagnosis, to treatment. And in non-emergency cases, providers can avoid redirecting patients to other departments or facilities that house imaging equipment, which often results in long wait times for appointments and results.
Vave is a cordless, handheld ultrasound device for premium cardiac, abdominal and lung imaging, connectable to both iOS and Android devices. Radiologists can securely share, review and comment on patient exams and portfolios in real-time.
Butterfly iQ is another portable ultrasound scanner, which connects to a smartphone app that allows providers to capture images, pull patient information, and send scans to their secure Butterfly Cloud or PACS.
Similar to an MRI scanner, Genetesis’ non-invasive biomagnetic imaging system is used to measure and display the electromagnetic signals produced by a patient’s heart within minutes of scanning. Utilizing the power of machine learning, radiologists can identify anomalies that are often missed by other tools such as electrocardiograms.
Many SaMD and CMMD systems use wearable sensors to collect and monitor vital signs in order to quickly identify deviations that may point to health problems. These tools support remote patient monitoring (RPM) by sending real-time data to physicians who can intervene more quickly when an issue occurs. The automatic nature of remote patient monitoring using wearable sensors means that patients do not need to remember to log symptoms and physicians do not need to worry about bias in self-reported data. Many of these tools also provide live feedback to patients, encouraging them to take actions to prevent emergencies.
MC10 BioStamp nPoint
The BioStamp nPoint system is a wireless remote monitoring platform intended to collect physiological data. The algorithm helps deliver clinical insights into the wearer’s vital signs, activity, posture, and sleep.
Current Health’s AI-powered remote patient monitoring platform offers continuous, wireless core vitals monitoring through a wearable device. The accompanying iOS, Android and web dashboards support fast identification of health changes and opportunities for far earlier medical intervention.
Connected devices are also making inroads in the chronic condition management space. These systems help patients and health providers track and interpret health data, which serves the dual purpose of encouraging patient engagement while also allowing clinical teams to more easily adjust treatment plans when needed. Data collected by SaMD and CMMD, such as blood glucose levels, can help patients track their health in real-time and seek medical assistance when needed. Progress in this area is crucial given the increasing prevalence of chronic conditions: An estimated six in ten adults in the US have a chronic disease, and these diseases are now the leading cause of death and disability worldwide.
Further, poor medication adherence costs the US healthcare system an estimated $100 Billion annually in direct costs, as 20-30% of medication prescriptions are never filled and 50% of medications for chronic disease are not taken as prescribed. To engage in effective disease management, patients need to feel that they are part of the process. Personalized solutions based on data provide patients with ownership over their health, empowering them to take control and manage their conditions. Not only can connected devices improve health outcomes, but the broader Internet of Medical Things (IoMT) could save the industry as much as $63 Billion globally.
Hinge Health is a digital healthcare solution for chronic muscular-skeletal conditions, combining wearable sensors and an app offering health coaching to provide physical therapy remotely.
Propeller is an inhaler sensor attachment that tracks asthma and COPD medication usage and location data, and sends this information to the patient’s smartphone app. The app builds a personalized profile based on disease symptom triggers and provides management tips, medication adherence reminders, air quality forecasts, in-app medication refills, shareable progress reports, and lost inhaler locators.
Flyp by Wellinks
Flyp is a pocket-sized, portable nebulizer for COPD and asthma patients. Without tubes, plugs or compressors, treatment can be provided within minutes. This device connects to a mobile app which receives, processes, and returns data to both the patient and care team for real-time feedback on their treatment plan. The Flyp nebulizer is one component of a broader disease management service offered by Wellinks.
Quell by NeuroMetrix
Quell is a wearable pain relief technology that stimulates sensory nerves with electrical pulses to trigger the body’s natural pain relief response. Through the Quell app, chronic pain patients can personalize and manage their treatment.
The final category of devices are digital therapeutics, which provide entirely (or almost entirely) software-based therapeutic interventions. This is perhaps the least well-developed field of SaMD, but it has the potential to transform behavioral health. Digital therapeutics provide individualized, clinically-informed care to patients in the comfort of their own homes and on their own devices. These virtual care tools dramatically increase access to therapeutic interventions, particularly for those who may have reduced mobility or live in remote areas.
Pear Therapeutics develops software-based therapies for patients suffering from severe psychiatric and neurologic conditions. Their leading product, reSET, delivers cognitive behavioral therapy to recovering substance and alcohol abuse patients and enables clinicians to view their patients’ substance use, cravings, triggers, or drug screen results to provide more effective treatment options.
EndeavourRx is a prescription treatment for children with ADHD, delivered through a video game. As part of a wider treatment program, caregivers can take an active role in the child’s treatment through the ADHD Insight behavior tracking app that monitors changes in the condition.
Floreo delivers social and behavioral therapy to people with Autism Spectrum Disorder (ASD) through a virtual reality application. This immersive education platform delivers engaging lessons to young users while allowing a supervising adult to monitor progress.
Tying digital therapeutics with chronic condition management, Better’s prescription platform delivers behavioral therapy for patients with cardiometabolic diseases. A clinical study found that the Better digital intervention produced meaningful results for users with type 2 diabetes.
As advances in hardware technology have enabled smaller, lighter, more mobile hardware devices, so too have advances in virtual care paved the way for more complex, clinically-backed interventions delivered through software. The field will undoubtedly continue to grow as new products and investor dollars pour into the market. With SaMD and CMMD expanding beyond the traditional device definition, connected devices may be redefined as tools for virtual care delivery and patient engagement.