SOFTWARE AS A MEDICAL DEVICE (SaMD). Part 2: Platforms that change the face of the digital health industry

In the first part, we have already examined the concept of SOFTWARE AS A MEDICAL DEVICE (SAMD), and also talked about its significance in the field of MedTech. In the second part of the article, we will use specific examples to explain why SaMD is a driver for the development of not only classical medicine, providing a wide range of approaches to patient treatment, but also a driver for the development of startups in the field of MedTech. 

As noted in the first part of the article, Software as a medical device (SaMD) is a separate class of software products designed to perform medical functions, which may interact with other hardened medical equipment or devices, but which exist independently of them. 

Note some features of SaMD:

1. SaMD makes it possible to improve the efficiency of medical devices and existing treatment methods, as it can easily and quickly collect high-quality patient health data, leading to better health outcomes.

2. Improving the quality of medical care: SaMD allows the integration and sharing of medical data on various platforms, including clouds, connected medical devices, thus improving medical practice.

SaMD platforms improve the administration and delivery of medical services, while reducing costs and improving the results of medical care. The information provided by the software can help diagnose and treat patients, as well as inform and manage staff. 

SOFTWARE AS A MEDICAL DEVICE (SaMD) has potential in the following fields of medicine:  

1. Screening and diagnostics: 

SaMD makes it possible to predict the risk of chronic diseases using algorithms; it provides personalized treatment plans for patients and reduces the time from diagnosis to prescription. This gives practitioners improved patient treatment results due to the early verification of the diagnosis and, as a result, the prescribed correct treatment. 

2. Monitoring, reporting and routing: 

SaMD solutions are used in combination with wearable sensors to collect essential health indicators. This enables patients to better control their condition, identify triggers and receive recommendations, as well as adjust the dosage of medications.

3. Chronic conditions and treatment of diseases: 

SaMD enables the tracking of health status data and treatment adjustments, allowing physicians to develop more personalized treatments. This is particularly relevant  in the treatment of diseases such as diabetes mellitus, arterial hypertension, oncological diseases and many others.  

4. Digital therapy (you can read more about this direction in a series of articles —   here and here ): 

Digital therapy solutions give an opportunity to meet the needs for the prevention and treatment of adverse events in patients with various diseases, including: receiving feedback and direct contact between patients and their attending physicians; raising awareness and training of patients and caregivers; integration of clinical assessment techniques used in the course of common  clinical practice; assistance and tips to patients, as well as monitoring patients condition. 

It is relevant  to underline the fact that digital therapy is a separate area of SaMD due to its features and clinical significance in medicine, which is a scientifically proven therapeutic technology that supports clinicians in providing high-quality care to patients.They take into account a number of painful conditions and provide a wide range of software solutions.

Benefits for the patient:

SaMD  can help provide personalized treatment plans, as well as reduce the time from diagnosis to treatment of patients with serious illnesses. For example, it is extremely complicated to diagnose oncological diseases and often, when they are detected, many types of cancer are at a late stage. SaMD devices can use algorithms capable of detecting anomalies that may go unnoticed in normal diagnostics.

Benefits for doctors:

Using sophisticated algorithms, programs can accurately predict the risk of chronic diseases and assist in making clinical decisions. Using SaMD, clinicians can get a more coherent picture of the patient's health status in real time, which allows them to make more accurate recommendations for diagnosis and treatment.

Example:

The Genetesis visualization device can evaluate electromagnetic activity in the body at a deeper level. His SaMD uses machine learning capabilities to extract multiple functions from the collected data. This allows radiologists to detect anomalies missed by other diagnostic tools.

Benefits for the patient:

SaMD can help patients better control their condition by detecting triggers and providing real-time advice ranging from drug doses to physical activity and environmental conditions. It can also help to improve patients' overall commitment to treatment and, as a result, lead to better clinical outcomes.

Benefits for doctors:

SaMD systems allow for outpatient monitoring of patients. They can collect and process data from wearable devices and identify minor deviations that may signal major health problems. Using this information, doctors can specify their treatment regimens. 

Example:

Propeller Health is a digital therapeutic company working on the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) using hardware and software that supports Bluetooth technology. Small sensors are easily attached to the patient's inhalator to track triggers and symptoms. The inhalator, which is connected to a Bluetooth transmitter, transmits data to the patient's smartphone and can send personalized feedback, updates to both patients and doctors.Doctors can view this data and see not only how often the patient suffers from attacks, but also the trigger environmental factors that caused distress.

Benefits for the patient:

Connected care systems encourage patients to be more accountable for their decisions to follow doctor’s orders and treatment. SaMD enables patients to monitor their activity or state of health in real time and to seek treatment if necessary.

Benefits for doctors:

SaMD tools help physicians develop personalized treatment plans for patients with chronic diseases based on data collected by software, such as blood glucose levels or heart enzymes.

Example:

Eli Lilly’s Go Dose is a mobile application for managing diabetes that can be used in home and clinical settings with the purpose to treat type 2 diabetes mellitus. Eli Lilly’s Go Dose provides nutritional advice based on blood glucose levels to help patients and doctors better manage their disease.

It should be noted that SaMD in Digital Therapy plays a vital role in the treatment or mitigation of the consequences of critical diseases due to its ability to generate and transmit very crucial clinical data.

Benefits for the patient:

SaMD is often used as an aid in the treatment of chronic conditions or illnesses. For example,  let’s take sleep apnea. According to a decision made at the International Medical Device Regulators Forum in 2014, SaMD can use the microphone of a device to detect respiratory failure while sleeping to wake up a sleeper, in order to prevent potentially serious health consequences.

Benefits for doctors:

SaMD allows clinicians to provide innovative treatment for patients with complex diseases such as cancer. For example, SaMD can act as an auxiliary tool in the radiotherapy planning system, collecting data from the patient and providing specific parameters adapted to the patient's tumor.

Example:

Pearl Therapeutics develops software-based treatment methods for patients suffering from severe mental and neurological illnesses. ReSET’s leading product provides cognitive behavioural therapy to help patients refrain from using alcohol or drugs during treatment. Moreover, reSET allows doctors to analyze the use of psychoactive substances, triggers, to provide more effective treatment options.

Currently, more than 250 digital therapeutic (DTx) and digital care products and tools (DC) have been identified that use software as a means to treat, prevent or control certain diseases or conditions. About 150 such products are already on the market. 

For more information, please refer to the IQVIA Institute for Human Studies study of digital health care (a pharmaceutical, biopharmaceuticals and corporate outsourcing service company comprising a network of units in about hundred countries — Startup Jedi) and covering trends in four areas: innovation, evidence, regulation and implementation —  to assess how these new tools and products are becoming an entirely new therapeutic method alongside traditional medicines and medical devices.

In the third part of the article, we will get acquainted with MedTech startups based on artificial intelligence that have already been certified and approved by the US Food and Drug Administration (FDA).