Medical Device

Software Development

Services

Adherence to regulations is a major part of medical device software development. There are different rules for pre-market submission controlled by different regulatory bodies. For instance, medical devices in the USA need to undergo a review by the FDA, while European companies must comply with the norms issued by the European Commission. As a development provider, we know about region-specific guidance on the classification of medical devices, cybersecurity measures for medical devices, and performance criteria. For example, the FDA’s guidance divides Software as a Medical Device into three categories (minor, moderate, and major) that differ in the level of impact a software failure can make on health. The more likely failures or design flaws can result in serious injuries, the more detailed and complicated will be the approval process. In any case, you should ensure the highest level of security for your medical device software, as well as the uncompromisable stability of its performance. On top of that, you should always devise a risk management plan for your software to determine risk control measures applied in different situations. If you have questions about medical device software security, schedule a call with us, and we’ll guide you through the safety requirements we follow in different scenarios and according to different regulations.

SaMD (Software as a Medical Device) is a digital solution that acts as a device but doesn’t require an actual device. It operates on a general-purpose device (a PC or a smartphone) and can be connected to physical devices to gather health data (for instance, blood sugar levels). On the contrary, software embedded into a particular medical device is reliant on that device and developed to fit its specifications. Some examples of SaMD include:

1. Software that collects patient data to facilitate the creation of treatment plans
2. Software that analyzes mammograms to detect breast cancer
3. Software that provides real-time data on blood sugar levels by connecting to glucose meters
4. Software that gathers data from electronic blood pressure sensors to measure health vitals
5. Software that tracks sounds for sleep apnea detection and prevention
6. Software that tracks symptoms for reproductive health management
7. Software that helps users monitor health and fitness parameters such as activity levels, sleep patterns, etc.

The cost of medical device software development services depends on a variety of factors: the functional scope of the solution, required integrations with other systems, and the type of medical device it’s connected to. Besides, the cost will depend on the model of cooperation and the team that will be working on your project. In general, medical development can cost around $100,000-400,000, as it’s a highly regulated domain that requires lots of integrations and additional security measures. The cost can be lower if it’s a solution that isn’t classified at the highest level by regulatory bodies and doesn’t require complex connectivity: for instance, software with interactive exercises for cognitive behavioral therapy or medication management software that only requires input from a user.

The tech stack depends on the environment the solution will be released to and the feature set. Among programming languages, C, Python, and Java are often used for building embedded medical software. It’s also common to involve cloud computing and tools like Azure IoT Hub, as well as cross-platform development frameworks such as React Native. As a medical device app developer, we choose a tech stack for each project individually. You can schedule an introductory call to discuss the most appropriate technologies for your medical device software.