Regardless of the size of the company and the type of device, software development is a major part of the day-to-day business of medical manufacturers. Whether we like it or not, hardware that doesn’t depend on software has no demand among buyers.
Most of the difficulties in the software development process that medical market players face are standard. Regardless of the industry, all companies in need of information solutions face these challenges. No one can do without well-established processes, good developers, experienced architects, skilled testers, and qualified managers.
Sooner or later, any medical company faces a situation where the life cycle of their products is coming to an end. For example, the production of hardware components of the product is stopped. Or an astute competitor releases a new device with a more attractive feature set. In any case, there comes a time when it is impossible to postpone the development of a new generation of the product.
The specificity of the medical industry is that the product release cycle is very long. Therefore, the importance of strategic, long-term planning cannot be underestimated. Of course, from time to time there are innovative, breakthrough solutions that form a new market segment. But in most cases, we’re talking about creating a more functional, more efficient, more user-friendly version of what already exists.
So, it’s time to share a few tips on healthcare software solutions.
- The sooner you get the development team involved, the better
Make sure that the selected team has enough experience with hardware, firmware, and operating systems. Involve the developers as early as possible. It is advisable to start already at the design stage of a new device. This will save you a lot of time and money.
As a rule, engineers create the design of the device. And developers decide which hardware is best suited for a particular operating system. Armed with this knowledge early on, your team will help you determine how many processors are needed, whether a real-time operating system is needed, what to do with the Board Support Package (BSP) and Hardware Abstraction Layer (HAL), what hardware drivers are available, and what will need to be written from scratch.
Do not neglect this advice, because mistakes in design can be fatal. Whatever solution you’re working on, don’t forget to involve developers early on!
- Your team must work in accordance with accepted standards
Train your specialists in IEC 62304 and ISO 13485 standards, as well as risk management standards. In recent years, these standards have de facto become the main set of requirements for the development of medical equipment and software. Obviously, the software development process is only part of the quality management system of a medical product. However, this is an absolutely necessary part. Therefore, it is very important to integrate the development team well into the overall quality system.
If there is one thing more important than knowing these standards, it is following them carefully. Mature teams are required to work in accordance with the standards.
- Protect your algorithms – work with reliable partners
When you manufacture a device, what do you consider your intellectual property? Most often, these are mathematical algorithms and their implementation. Experienced product teams know that algorithms are their main value.
Pay close attention to your algorithms. Collaborate with reliable teams and take measures to protect your intellectual property.
- Create a simple and reliable user interface
Usability is one of the most important qualities of a new product. However, do not overdo it! Keep in mind that your device should be simple, intuitive, and trouble-free. A new cool feature that recently appeared on your iPhone is not necessary for your medical device.
In the development of good medical software, the needs of end-users and design technologists are crucial. No matter what you do, your users are doing the most difficult job in the world – they save lives! They are already having a hard time, so you, as a software provider, should do everything possible to simplify their task.
- Plan for interoperability from the start
The vast majority of modern medical devices are complex devices with multiple layers of running software.Moreover, they must exchange data with other equipment and information systems of the hospital. And it is not necessary that these systems will be manufactured by one manufacturer. Devices from different companies must “talk to each other” using different protocols. From specialized direct serial connections, Wi-Fi or Bluetooth, to those still unknown communication methods that will be invented next year.
The interoperability of medical devices is becoming extremely important. And your development team should be able to provide it. Getting familiar with the HL7 standard can be a great starting point!
In conclusion
It is clear that all this is just the tip of the iceberg. But if this article made you think about how to better organize your medical projects, then it has achieved its goal.
Regardless of whether you decide to use your own team on the project or attract an external developer company, do not forget about the recommendations above. Remember that someone’s life depends on your medical decisions!
