“Design Input" refers to the development specifications, and it's not just the FDA that makes concrete demands in this regard.
This article describes what content your design input should contain. You will learn how risk management interacts with the design input.
"Design input means the physical and performance requirements of a device that are used as a basis for device design."
ISO 13485 also uses this term, but without defining it.
The FDA also defines the requirements for the design input. It states:
Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.
ISO 13485 expects the following to be part of the design and development inputs:
Like the FDA, ISO 13485 also requires the product requirements to be determined, evaluated and documented.
ISO 13485:2016 has increased the design input requirements.
The design inputs must now also include the “usability requirements”. The standard does not define what “usability requirements” are. They could include:
The previous version of the standard already required the design inputs to be unambiguous, consistent, complete and appropriate/correct, and for this be verified in a review.
ISO 13485:2016 requires that the requirements must also be validatable or verifiable (i.e. testable on the product). This should be self-evident, but it is now explicitly required.
The design inputs must be part of the design and development file. This file was introduced in ISO 13485:2016 and corresponds to the FDA's “design history file”.
Read more on the subject of the design history file here.
The intended use is not part of the design input. The FDA explicitly requires a process to be documented detailing how the “design requirements” (which it uses as a synonym of “design input”) are drawn up so that this intended use can be achieved.
The user needs are not yet part of the design input according to the FDA. Instead, the design input must be suitable for meeting these needs.
ISO 13485 explicitly includes the regulatory requirements, which are part of the stakeholder requirements, as part of the design inputs.
The term system requirements specification contains two separate terms:
The system requirements should be included in the design input. Finally, the product requirements are determined and these are, by definition, part of the design input.
The system specification (above the hood) can be included in both the design input and the design output:
We recommend the second option because the UI specification is indeed a result of development.
Even if the UI specification is part of the development, it should not be the job of the developers to create it, but instead it should be the job of usability engineers, especially interaction designers.
If you don't distinguish between system requirements and system specifications, then include the system requirements and software requirements specification (SRS) in the design input.
Thanks to Dr. Markus Bentrup for his help in clarifying this.
During development, you will need to revise the design input and the design output accordingly. Make sure that all versions of these documents become part of your design history files. This is the only way to document the development history in a traceable and credible way.
We often see medical device manufacturers using the following procedure:
If you use this procedure you run the risk of wasting a lot of time and money.
The result of the risk analysis should itself become part of the design input.
We suggest the following procedure:
Only now develop your medical device according to this design input. For example, if the design input specifies a probability that a group of (electronic) components or self-written software cannot guarantee, you will have to choose a different system architecture, e.g. a diverse system architecture.
Unfortunately, we almost never see design inputs (i.e. system requirements) that are a response to specific probabilities. The consequences are costly improvements, delayed projects or/and unsafe medical devices. You can avoid these problems!