A Step-by-Step Guide on Developing a SaMD Product

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Software as a Medical Device (SaMD) is a medical software solution that can perform one or more medical functions without any need for a device itself. SaMD applications are intended to treat or prevent diseases and are typically used with non-medical hardware connected to virtual networks. 

SaMD popularity is now growing, and it has become widely used both for therapy and diagnostics. It has already developed into advanced technologies with the support of common operating systems, mobile devices, and cloud storage. It also must be compliant with healthcare industry regulations and guarantee the safety of patient information. 

The software must also support all the necessary infrastructure like research, testing, data collection & storage. This article will consider medical device software solutions and speak about their functionality and development process.

What is SaMD?

According to the International Medical Device Regulators Forum (IMDRF), SaMD is a piece of software that has one or several medical functions without being an integral part of a hardware medical device. This is a relatively new and revolutionary healthcare solution since it can perform complex medical manipulations like diagnosing, clinical management, and suggesting treatments. 

Here are the examples of SaMD solutions:

  • Applications for viewing images from MRI, Ultrasound, or X-Ray examinations;
  • Computer-Aided Detection software for image post-processing for detecting cancer;
  • Software using AI for analyzing the test results and detecting pathologies;
  • Software that analyzes the data from other devices for assessing the patient’s health state and calculating the risks;
  • Applications that calculate the medicine dosage based on the patient’s condition.

medical device software development

Is Your Application a SaMD?

It is easy to confuse a SaMD product with other types of medical software solutions, so we decided to provide criteria for distinguishing a SaMD application from any other ones:

  • SaMD can perform medical manipulations and directly take part in the treatment processes;
  • SaMD can be launched on generic (non-medical) hardware devices: smartphones, computers, tablets, smartwatches, etc.;
  • SaMD is not intended to manage the hardware medical device and is a standalone medical product. But it can be used in cooperation with hardware medical devices and integrated into the entire clinic ecosystem.

SaMD Intended Use Cases 

According to International Medical Device Regulation Forum (IMDRF), there are three primary ways of using the SaMD applications in clinical practice. Let’s look at them closer.

medical diagnosis software

Treating and Diagnosing

Using SaMD apps for treating and diagnosing means that the information provided by them will be used for taking immediate or near-term actions:

  • Using the application for treating or preventing a disease in connection to other medical equipment or general-purpose software and hardware;
  • Diagnosing \ screening a disease or health condition directly on the human body or using the data from other medical or general-purpose devices.

Clinical Management

SaMD in clinical management means that the information collected with their help will be used to identify early signs of disease. With SaMD data, the clinicians will guide the next steps of diagnostics and treatment:

  • Increasing the safety and efficiency of using other medical products or devices;
  • Predicting risks, helping to make a precise diagnosis;
  • Identifying early signs of disease;
  • Informing about treatment or diagnosing options;
  • Gathering clinical information by aggregating the relevant data (health records, information about drugs, allergies, population).

Health Monitoring

SaMD can be used to monitor the state of individual patients or public health in conditions with different grades of severity.

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Read about the remote patient monitoring and implementation steps.

  • Critical conditions are life-threatening or incurable states where timely diagnosis or medical intervention is vital to avoid death, serious health issue, or mitigating public health impact.  
  • Serious conditions are situations where accurate and timely actions are vital to avoid unnecessary medical interventions or long-term consequences both for individual patients and public health. Unlike critical conditions, they are curable, don’t require major or time-critical interventions.
  • Non-serious conditions are states with moderate importance of timely & accurate diagnosis and treatment: diseases with slow and predictable progression, requiring minor non-invasive interventions.

medical device software testing

SaMD Market Stats 

In 2019, the SaMD market was estimated at about $18.4 million, and it is projected to reach $86 billion by 2027, at an annual growth rate of 21.9%. The growing SaMD popularity results from effective use in clinical practice: facilitating diagnosis, treatment, and healthcare management for a particular patient and public health. 

SaMD solutions are transforming the healthcare area since they empower the patients to be involved in their treatment process more. Patients with chronic diseases can get their health data and immediately share it with other healthcare specialists. 

According to a survey conducted by Deloitte Center, 68% of medical device companies are creating the infrastructures for using SaMD devices. Since the technology becomes more affordable, it influences the entire healthcare system and allows to provide the patients with personalized treatment.

SaMD development is greatly associated with the growing adoption of IoT devices in the healthcare industry. IoT is actively integrated into independent medical devices, creating IoMT (Internet of Medical Things). IoMT helps healthcare institutions increase the efficiency of their work at all levels. 

Advanced IoMT systems help the clinics to improve patient care, reduce operational costs and improve the efficiency of cooperation between different specialists. The IoMT market is projected to reach $285.5 billion by 2029, with a CAGR of 28%.

SaMD Industry Regulation 

SaMD has unique features that make it different from traditional medical software or hardware. It means that this category requires specific regulatory principles. Their aim is to help the companies introduce innovations safely and guarantee patient’s safety. 

Compliance Guidelines

In 2013, the International Medical Device Regulators Forum (IMDRF) released SaMD compliance and quality management guidelines. 

SaMD leadership & expertise

Before coming to medical device software developers, the company should gain management support and become an expert in SaMD product design and development. The executive team should support the team compliance effort. A strategic approach and strong expertise lead help to achieve both the goals and regulatory compliance.

SaMD lifetime support

Appropriate product management at all stages of the medical device product lifecycle is key to the success of a SaMD project. Here, the organizations must pay attention to product planning, risk management, documenting, analytics, and improvement. Complying with the regulations and quality standards will help to streamline product development and automation.

The SaMD organizations follow the standard operating procedures (SOPs) to ensure the appropriate management and compliance.

SaMD product implementation

The compliance requirements force the companies to follow appropriate systems and processes of product realization. Their purpose is to define and standardize a way to handle the implementation process.

Regulatory requirements define the following aspects of product development: 

  • Design & development process
  • Deploy & delivery
  • Installation, configuration & maintenance

SaMD validation

Since SaMD is a fully-featured medical device, it adheres to clinical validation. It aims to ensure that the product meets its intended purpose. IMDRF has specific regulations for SaMD, and now we‘ll discuss how to validate medical software devices.

how to validate medical software devices

  • Valid clinical association shows the level of SaMD clinical acceptance. Its goal is to determine if SaMD’s output in a particular medical situation meets the actual clinical standard and condition.
  • Analytical validation detects if SaMD is able to generate the accurate technical output from the input data.
  • Clinical validation measures if a SaMD product is capable of providing clinically valuable output associated with the intended use case.

The ability to generate evidence of clinical validity is essential for SaMD to be a valuable part of clinical practice.

Key SaMD Functionality

The functionality of a SaMD product is highly dependent on its medical purpose and target audience. Below, we will speak about the different types of common SaMD functionality.

medical diagnosis software

Medical Functionality

Since the main goal of the SaMD product is disease treatment, diagnosing, and preventing, medical features are the most important ones. Depending on the end-user (doctor or patient), the SaMD company defines the complexity of the software itself.

Screening and medical diagnosis software — using complex algorithms, the software can accurately scan a patient’s actual health state, detect abnormalities, and predict the risk of a disease

  • For patients, SaMD can help to detect complex diseases at the earliest stages and receive timely and accurate treatment.
  • With SaMD accurate diagnostics, the doctor is able to precisely determine the patient’s condition and offer the optimal treatment at once.

Monitoring and alerting — with the help of sensors, wearable SaMD devices can be used to monitor the patient’s state and alert the doctor if anything goes wrong. 

  • For patients, this is a way to improve monitoring their condition and provide real-time treatment customization: drug dosage, physical activity, etc. It also helps the patient to be closely involved in the treatment process and improves the result. 
  • For the healthcare provider, SaMD helps to improve ambulatory patient monitoring and chronic conditions management and makes the treatment more flexible.

Digital treatment — SaMD is able to collect relevant data and send it to other medical products. This plays a vital role in treating critical or chronic conditions and adjusting the treatment scheme to the needs of a particular patient.

  • For the patients, it helps to detect abnormal conditions and give immediate reaction to prevent potentially serious consequences.
  • For clinicians, SaMD digital treatment helps the advance treatment to patients with complex illnesses and act as an assistant in gathering the patient’s data.

Medical calculations — SaMD algorithms are able to automate such things as calculating the dosage of medicine, anesthesia, and the power of medical devices. With software, it is possible to adjust these parameters in real-time, based on patient condition.

  • For the patients, it helps to get the exact number of drugs they need and to adjust the treatment in real-time.
  • For the doctors, SaMD automates the working routine and eliminates the need for manual calculations. This will give the doctor more time for direct interaction with the patient and solving complex tasks.

Advanced medical functionality

We have described the common medical manipulations SaMD is used for, but it can also have advanced algorithms for performing the following complex manipulations:

  • 3D shape reconstruction can be used for recreating a model of an organ, bone, or growth based on an ultrasound, x-ray, or endoscopy images;
  • Telemedicine — SaMD can establish remote communication between the doctor and the patient regarding software usage, the diagnosis and treatment processes, symptom control, etc.;
  • Machine Learning analytics — with the help of ML algorithms, SaMD can check doctors’ decisions, avoid medical mistakes, analyze and predict the treatment progress.

Data Storage & Compliance Features

Like any medical software, SaMD deals with a lot of patient data and must follow international regulations regarding its protection. Security and compliance features are also included in the functionality of SaMD, although they are not visible to the end-users.

medical device software developers

Cloud data storage

  • Secure collection, processing, and transmission of the information collected by SaMD;
  • Storing and sending the information according to the DICOM standard;
  • Secure download of medical data on patient’s device.

Security compliance

  • Access control: two-factor authentication for doctors and patients, access logging, identification of unauthorized sessions;
  • Data encryption;
  • Compliance with international requirements: HIPAA, HITECH, FDA, ONC.

Management Features

To improve the user-friendliness of the application, it is recommended to include the features that will help the audience use it more efficiently and increase their satisfaction rate.

In-app guidelines

  • The instructions teaching the audience to use the functionality (videos, interactive guidelines, FAQ, etc.), both for the patients and the doctors;
  • Suggestions for data input (automated filling, showing the recent entries, showing data format);
  • Notifications for the patients to take drugs, do exercises, or any other medical manipulations;
  • Notifications for doctors to check the patient’s state and customize the treatment.

Marketing

  • Customer satisfaction management;
  • Managing marketing campaigns: notifications, newsletter, promotions;
  • User feedback surveys for analyzing and improving the app.

Medical Device Software Development Process

The Jelvix team offers full-lifecycle medical device software development with professional support at all stages. Let us tell you about the development process in our team.

Gathering the Requirements

At this stage, we discuss the future software concept: help you analyze the market and come up with the desired functionality and requirements. As a result, you will have an implementation plan with the full stack of features and their prioritization.

Software as a Medical Device

Creating the Roadmap

Based on your requirements, we will create a roadmap that is a sort of detailed breakdown of all development stages. This will help to visualize the amount of work, define the tasks and area of responsibilities, and further control the development process. 

Writing the Specification

To start the development process, we create a detailed specification where step-by-step product creation is described. We will modify it according to your suggestions, and once everything is clear and agreed upon, we will proceed with product implementation.

UI\UX Design

We will start the product implementation by creating a user-friendly design that will be convenient both for the patients and the doctors. We will organize the user journey in the following way:

  • Study the logic of doctors and patients and create the design based on them;
  • Make the most important functions accessible in one click so that the doctors and patients won’t need to perform extra actions;
  • Implement the in-app hints so that it would be easy for the users to get accustomed to it.

SaMD

Product Development

Here we are coming to the development process. Our specialists will create features from scratch, integrate third-party services and implement security compliance measures.

To spot and fix the issues at the earliest stage, we cover each development stage with testing. 

Quality Assurance

To make sure that your SaMD product works in the way it should, we will assess the system using different types of medical device software testing:

  • Functional testing will make us sure that each feature works as intended;
  • Performance testing will help to determine if the software works smoothly under different conditions;
  • Integration testing will prove that the SaMD product is compatible with all other software and hardware components.

Deployment

Once the development is complete, we will deploy the application making it available to the public. If there are any performance issues on the end users’ side, our team is on guard and is ready to fix them immediately.

Support & Maintenance

Our work is not ended with the release. We will keep maintaining the smooth performance of the SaMD product and keep it updated with new features. 

medical device product lifecycle

Conclusion

Now you know everything about the functionality and use cases of SaMD products. Being implemented properly, SaMD devices become a valuable part of clinical processes and help the doctors provide better care to the patients.

Book a free consultation from the Jelvix team specialists to discuss how to implement the idea of your future SaMD project. 

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