Software development can happen very quickly. Software developers can make improvements and enhancements to software easily without the need for physical products. Medical devices have not historically been products that iterate very quickly. Largely, this is because of design controls. A manufacturer must identify the needs of their medical device and the medical device must meet those needs for a product to be considered successful. However, for software development in the tech industry, the marketed software may not meet the same needs as the original software. As medical devices begin to include more software components or software as a medical device, manufacturers must evaluate if their design process allows for the nature of software evolution but still allows for proper design control.
Design Controls and Medical Devices
As per FDA regulation, manufacturers must establish a design control process. Design controls as a useful tool for manufacturers to ensure they stay on track and are developing the right medical device. Design controls are documentation activities like specifying the treatment (i.e. cardiac or diagnostic tool), defining the conditions for use (in hospital, outpatient, at home), or identifying the user (e.g. patients, surgeons, nurses). These activities help ensure that what was the initial solution is the focus of the design activities and are periodically reviewed during the product development. If at any time during the product development, the engineers and researchers decide to go in a different direction, typically they need to start their documentation activities over again. This is useful to ensure the scope of the development activities does not unexpectedly change or grow during the project.
Manufacturers have struggled to implement design controls for software development. While it is easier to evolve and expand the scope of software development activities, manufacturers need to be cautious about practices that are against design controls. Software manufacturers need to develop design control processes that allow for flexibility but still provide the structure needed from medical device design. Below are a few tips for a software design control process.
Tips for Medical Device Software Design Controls
More Structured Formal Meetings
In the typical design control process, there are three to five formal meetings about the product development. During these meetings, cross-functional leaders are presented with updates about the project and decide if the project should continue. For software development, more formal meetings can help ensure the project goals are being met or if they need to be revised. These meetings may help slow down the development of software and ensure alignment prior to moving forward.
Evaluation of Market Needs Throughout Development
Typically in design control, the market needs are only evaluated at the beginning of the project. Because software has such a big impact on the user’s experience, the market needs should be evaluated throughout development.
Evolution of Scope and Resource Planning
It is unreasonable to expect software to develop and iterate like a medical device. Design control procedures should be more flexible and allow for an evolution of scope. However, whenever the scope is revised, the project should consider if there are enough resources to continue the project.
If you are looking to create a software design control process, reach out to DeviceLab. DeviceLab has experts who are ready to help implement the best design control structure for your organization.