Familiar but Mysterious: Understanding Software as a Medical Device

As technology continues to advance software has become an important part of most products. It has become integrated widely into medical platforms.  In 2019, the Software as a Medical Device (SaMD) market was estimated at about $18.4 million, and it is projected to reach $86 million by 2027 at an annual growth rate of 21.9%. As one of the fastest growing sectors in healthcare, we explore when software is considered a medical device and what are the implications for manufacturers.

What is Software as a Medical Device?

Software as a Medical Device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."

What does it mean?

1. The software has a medical benefit
2. There is a patient risk if it malfunctions or used incorrectly
3. It can be used to inform, prevent, diagnose, monitor, treat or alleviate disease
4. It does not achieve its primary intended by pharmacological, immunological or metabolic means 
5. It can provide patient data and inform healthcare providers of options for treating, diagnosing, preventing or mitigating a disease

SaMD provides unique features that extend beyond those of the traditional medical device or hardware. It can be launched on non-medical hardware such as smartphone, using the cloud for processing and data storage. As a medical device, it must be compliant with healthcare industry regulations and guarantee the safety and data privacy of patient information. 

Few examples of SaMD solutions:

• Applications for viewing images from radiation examinations
• Software using AI to analyzing medical test results 
• Software that uses outputs from Hardware based medical devices to assess patient’s health state
• Calculators such as BMI

Advantages of Software as Medical device

SaMD can amplify the effectiveness of medical devices and existing treatment plans, as it enables easy and fast collection of high-quality data, converting it to insights which leads to better health outcomes. It also enables faster integration of AI, as it provides a interface for the AI to run on, which increases the ability for healthcare professionals to understand patterns and predict changes.

A 2020 article in Nature’s npj Digital Medicine identified 64 FDA-approved medical devices and algorithms that utilized AI/ML, and a 2021 article in The Lancet Digital Health identified 222 AI/ML medical devices approved in the USA and 240 devices in Europe mostly through software solutions that are faster to develop. 

SaMD also utilizes the latest technologies to integrate and share health data across various platforms, including the cloud, connecting and collecting patient health data using medical devices, smartphones, and more, simplifying the collection of large amounts of data.

SaMD plays a vital role in the treatment or mitigation of critical illnesses thanks to its ability to generate and feed highly-relevant clinical data and interact with users. An example is Pear Therapeutics who develops software-based therapies for patients suffering from severe psychiatric and neurologic conditions.

Rather than swallowing a pill or taking an injection, patients with substance disorders are treated with SaMD. The company's product - reSET, delivers cognitive behavioral therapy to help patients abstain from using alcohol or drugs during treatment.

The success of treatment is depended on patient engagement and feedback. The native user interface of SaMD solicit patients to interact with the software to generate user feedback helping caregivers to gain a more holistic picture of a patient’s medical condition and adjust treatment plans to be more.

Regulation

Given the unique features of SaMD that extend beyond a traditional medical device or hardware, regulators recognized the need to converge on a common framework and principles that enables to promote safe innovation. The International Medical Device Regulators Forum (IMDRF) formed the SaMD Working Group (WG) to develop guidance for risk categorization, quality management and clinical evaluation.

The Federal law (Federal Food, Drug, and Cosmetic Act, section 513) has established three classes of risk-based device classification:

• Class I (low to moderate risk): general controls - Class I are defined as non-life sustaining. These products are least complicated and their failure possess little risk
• Class II (moderate to high risk): general controls and Special Controls - Class II are more complicated than class I, though they are also non-life sustaining. These are subject to any performance standards.
• Class III (high risk): general controls and Premarket Approval (PMA) - Class III are those that sustain or support life. Their failure is life-threatening.

The first step is to choose the correct classification, document the logic behind the decision. The additional aspects of regulations include:

• Design control which covers seven key areas: users' needs, design inputs, design process, design outputs, reviews, verifications and validations. The U.S. FDA expects a firm to maintain certain documents to understand the design, development and V&V processes.
• Cybersecurity - As part of the software validation and risk analysis required by 21 CFR 820.30(g), software device manufacturers may need to establish a cybersecurity vulnerability and management approach, where appropriate.
• Post market – define how surveillance, analysis and information sharing is done. Assess the device and clinical impact of vulnerabilities and exploits
• Mobile apps regulations – define to which of the 2 groups of mobile apps the software developed belongs to and comply with the regulatory requirements of the group.

Challenges

Like any other technology, SaMD is also facing some fundamental challenges such as continuously updating regulatory requirements, safety, security, privacy, compliance with workflows, up-to-date development methods and design standards.

Choosing to buy a Medical-Grade cloud rather than develop it, has many benefits for SaMD developers. By using an existing medical-grade cloud, software developers have a ready- made platform for their software in compliance with all  regulations and data privacy requirements. This significantly cuts down on development time as companies are able focus on their product development without needing to invest resources into also developing a medical- grade cloud. . 

BioT’s Medical-Grade cloud platform provides a secure, regulated, scalable software solution allowing SaMD companies to store, monitor, and analyze massive amounts of health information on a real-time basis. 

Book a demo of our connected care platform and experience firsthand its reliable performance and impressive array of features. 

Patients and providers are increasingly connected, both through dedicated medical devices and other hardware (such as phones and smart watches) which present a great opportunity for the development of new medical solutions using SaMD. With the many benefits to be found in using SaMD, it is encouraging to see that many of the development challenges to implementation can be overcome by using a 3rd party medical-grade cloud.