Software development for medical devices

Medical devices are tools, instruments, machines, implants, or other similar products that are intended for use in diagnosing, preventing, monitoring, treating, or alleviating various diseases and health conditions. Medical devices range from simple tools such as tongue depressors to complex machines such as MRI scanners. They are regulated by the Food and Drug Administration (FDA) in the United States, by the European Medicines Agency (EMA) in Europe, and by other regulatory bodies in other countries and regions. 

Obtaining regulatory approval typically involves demonstrating the safety and efficacy of a device through clinical trials and testing procedures. When developing software for medical devices, you must also strictly adhere to regulatory requirements. However, this is difficult to achieve without prior experience in software development for medical devices. Yalantis knows how to ensure a secure development process to help your medical practice operate efficiently and risk-free.

Medical devices are classified based on the level of risk they can cause for a patient. In the United States, there are three classes of medical devices: Class I, Class II, and Class III. Class I devices are considered low-risk devices such as wearable glucose monitors, Class II are medium-risk devices such as CT scanners, and Class III devices are high-risk devices such as deep-brain stimulators. All medical devices that enter the market must undergo rigorous testing before they can be approved for use. The testing process typically involves laboratory testing, animal testing, and clinical trials. Clinical trials are conducted on people to evaluate a device’s safety and efficacy. 

We offer customized development services depending on the class of the medical device you need to integrate with and for which you need to develop software. The more high-risk the device we have to work with, the stricter the security measures we need to take. Plus, performance and availability requirements will also differ depending on the class of device.

Digital medical devices enable efficient remote patient monitoring, improve clinical decision-making, streamline administrative tasks, and enhance the patient experience and patient engagement. Digital medical devices perform much more accurately than traditional devices, leading to better treatment outcomes. Also, software-enabled medical devices can automate certain tasks that medical staff need to perform manually when using traditional medical devices, such as writing down or printing out patients’ health metrics. With digital medical devices, you can also deliver more personalized patient care thanks to analytics of patient outcomes. As healthcare organizations continue to invest in digital medical devices, we can expect to see further improvements in healthcare service delivery and patient satisfaction.

SaMD solutions are intended for use in the diagnosis, treatment, or prevention of a medical condition or disease. These solutions include mobile health apps, clinical decision support software, and other digital health technologies. Software as a medical device differs from traditional medical devices in that it is primarily composed of software code rather than physical components. Additionally, software as a medical device is often designed to be used by patients or healthcare providers in a non-clinical setting. 

Examples of SaMD include mobile health apps for managing chronic conditions, clinical decision support software for diagnosing diseases, and remote patient monitoring systems for tracking patients’ vital signs. Software as a medical device has the potential to improve patient outcomes by providing more personalized and accurate diagnoses and treatments. It can also help healthcare providers manage patient care efficiently and cost-effectively, particularly in remote or underserved areas.

During years of experience developing healthcare products, we’ve worked on numerous projects that involved developing infrastructure for seamless integration with medical devices. We’ve integrated diverse healthcare software systems with all three classes of FDA-approved medical devices.

The Yalantis healthcare team also has experience developing software for medical devices, as some of our clients have needed a solution for displaying data aggregated from these devices. When working with us, the options are vast. You can integrate your existing healthcare systems with medical devices of any class or develop a unique software solution from scratch that integrates with the necessary devices.

We help our clients develop medical device software that speeds up diagnosis and enables accurate remote patient monitoring and chronic disease management.

If you lack time and resources for analyzing the healthcare technology market to choose the best-fit medical device vendor, we can help. At Yalantis, consulting and development services go hand in hand. Providing all-around technological support is our core responsibility as a trusted development services provider. 

First, we elicit your requirements. Then we start looking for suitable medical devices. If you need to integrate with a smart scale, pedometer, and a blood pressure monitoring device, for instance, we’ll look for a vendor that offers all three medical devices, as it’s much easier to integrate with multiple devices from a single vendor than to work with three separate vendors. When choosing the right medical devices to integrate with medical device software, we pay attention to a vendor’s years on the market, clients’ reviews, compliance with laws and regulations, and data management mechanisms. We usually provide our clients with a few providers to choose from and lay out the benefits of cooperating with each vendor, allowing the client to make the final choice.

Complexities and challenges are common when building medical device software. Mostly, these challenges appear due to lack of sufficient documentation from a medical device vendor or the necessity to integrate a single healthcare solution with many devices from different vendors.

Lack of documentation we can handle either by contacting the vendor’s team and asking them for instructions on how to work with their medical devices or by discussing changing the vendor and integrating with similar devices that have better specifications. When facing challenges with integrating a single healthcare system with several medical devices from different manufacturers, we implement techniques for merging data aggregated from these devices to make sure that your medical device software can seamlessly process data from different devices.

Still, you should keep in mind that each project is unique, and issues can differ and depend on many factors. Even tight development timeframes can cause unexpected issues.