The bottom line of the article Software Development Must Be Overhauled to Drive Growth in the Medical Device Industry is summed up by this:
The power and reach of converging IT trends means that business leaders need to understand the implications of a software-driven, connected-everything world.
The context of this statement is broad (“Technology Vision”), but it is still a driving force for the Medical Device industry. Certainly connected-everything, i.e. interoperability, has been an elusive goal (I’m being kind) for medical devices and data systems.
The Accenture report notes the following three Medical Device Industry market trends:
- Complexity of medical devices and how software has become a key differentiating success factor.
- Growing demand for mobile access to patient data and clinical systems.
- The importance and complexity of global markets when creating appropriate software for medical equipment products.
The use of Waterfall vs. Agile methodologies and other software development operating models (“Software Factories”, Outsourcing, etc.) is really dependent on an organization’s culture. The biggest challenge any company has in this regard is change. Even after the business recognizes the need to “restructure” operations, this is usually easier said than done.
A good example of Medical Device Open Source software is the West Health Institute Medical Device Interoperability project which is developing Standards-based embedded software. The OSS, Cloud, and “Module Care” sections only touched briefly on regulatory issues. For FDA regulated software there are significant design, risk, testing, and validation requirements that must taken into consideration when incorporating any 3rd party software. Further discussion is here: Open Source Medical Device Connectivity.
Just like many other industries, software is a critical component in Healthcare related products. I think most Medical Device companies already know this. Making software development more efficient (cost-effective) and flexible (to meet ever-changing market needs) while maintaining quality, performance, and security requirements is a difficult balancing act.