Software for medical devices is a crucial part of the healthcare industry, providing efficiency and accuracy in diagnosis, treatment, and patient condition monitoring. It enables medical professionals to manage large amounts of data quickly, control patients with chronic diseases remotely, and improve outcomes.
As one of the most popular types of these solutions, SaMD (software as a medical device) helps revolutionize patient care while providing significant cost savings to healthcare providers. Process automation, data collecting, processing, visualization, and storage are among the capabilities of these solutions today.
At Surf, we’ve been developing software for various niches, including medicine, since 2011. We know everything about large business specific requirements and we’re ready to share our expertise and vision.
In this article, we’ll explain how digital solutions can help doctors save lives, what types of it exist, and offer a step-by-step development plan, focusing on the main things to know before you start a new project.
How medical device software saves lives
SaMD, or software as a medical device, is designed to be used in combination with medical hardware, enabling healthcare providers to track and monitor patients’ health more accurately. SaMD utilizes a variety of data sources, such as patient records, sensors, and other devices connected to the internet of things (IoT) to provide healthcare professionals with real-time insights into their patients.
How can it help save lives?
These solutions enable health professionals to quickly assess a patient’s condition for making timely, accurate interventions. With its sophisticated algorithms, it can detect subtle changes in vital signs that may indicate a serious health issue and alert medical staff immediately. The software is designed to be intuitive and user-friendly, making it easy for healthcare providers to utilize its full capabilities. By relying on these powerful tools, medical companies are able to offer the best possible care for their patients.
In addition to its life-saving capabilities, the solutions can also be used to streamline processes within a health institution. By automating various tasks such as data entry and analysis, it allows healthcare providers to spend more time focusing on patient care.
It can be used to generate real-time reports that provide doctors with an in-depth look at a patient’s condition and enable them to make informed decisions quickly. While implementing these technological tools into their workflow, healthcare providers are able to ensure the highest quality of care for their patients and reduce errors.
These solutions eliminate many of the tedious manual processes involved in medical care, allowing healthcare practitioners to focus more on providing quality care.
5 factors to consider while planning your product development
Below, you’ll find general tips on medical device software development and learn about its types.
Requirements gathering and specification approval
For both engineers creating the IT solutions and healthcare companies using them, following technical and regulatory requirements is extremely important. It helps identify and proactively address potential risks associated with their devices and provide better treatment for patients. The right approach to requirements gathering and further product development should include identifying safety hazards, conducting robust testing, and tracking of usage information in order to reduce errors or malfunctions.
Medical device software architecture design
The IT product architecture will vary depending on the complexity of the device and its intended use. Generally speaking, developers should focus on four main elements: interface design, exact feature set, data management, security and scalability. Every element needs to be carefully planned in order to ensure that users have safe experience and efficient patient care as a result.
UX/UI design of medical device software
Investing in UX/UI design will provide an optimal user experience for medical device software. By creating engaging visuals that are easy to understand, people can quickly and effectively use the solution with minimal training or instruction.
For example, if you’re planning to add charts and graphs to your digital products, prototype them based on your target audience’s specifics needs and avoid details that can make the information difficult for perception and interpreting.
A well-designed interface helps reduce confusion and promote successful use of the product by doctors and patients of different ages.
In a new diabetes management app for an American startup, we developed and graphs so that a patient could monitor their CGM (Continuous Glucose Monitoring) data changes within a long-term period and correct a treatment plan with their doctor.
Medical device software development
A developer team usually consists of frontend and backend engineers experienced in medical IT products. Depending on the tech stack and other engineering solutions you choose, the amount of specialists, hours that would be spent on the product MVP development, and costs will vary.
For example, we at Surf often use the Flutter framework when building apps for different platforms, thus helping our clients save up to 40–60% of the project budget as compared to native technologies.
When developing medical device software, engineers should take into account the specific requirements for their product. Adherence to standards such as IEC 62304 or ISO 13485 is essential in order to produce a safe and effective solution approved by FDA.
Robust design principles should be applied during development to ensure that the digital product has appropriate levels of reliability and performance. Furthermore, developers should be aware of the risks associated with creating the product and take appropriate measures to mitigate them.
Quality assurance processes should be continuously implemented throughout the development process to guarantee that the solution meets safety, performance, and reliability requirements. Finally, regular testing of all components of the product should be conducted in order to identify any issues before it is released.
To sum up
- Medical device software helps healthcare professionals offer a better service to patients and improve outcomes.
- There are different types of digital solutions for healthcare companies and patients. They vary depending on its intent, complexity of the tasks to be solved, and possible risks for patients’ health.
- FDA regulations for SaMD cover the full development process.
- The right tech stack can save you up to 60% on the project budget.
- Choosing engineers for your project, give your preference to those who have experience in healthcare software building and follow all the regulations important for your country.