Unlocking Design Inputs: The Foundation of Exceptional Product Development

Here is the official FDA regulation for design controls relating to design inputs, as found in Part 820.30(c):

Each manufacturer shall establish and maintain procedures to ensure that 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 13485:2016 also addresses this topic in section 7.3.3 Design and Development Inputs:

Inputs relating to product requirements shall be determined and records maintained. These inputs shall include:

a) functional, performance, and safety requirements, according to the intended use,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs,
d) other requirements essential for design and development, and
e) output(s) of risk management

These inputs shall be reviewed and approved.

Requirements shall be complete, unambiguous, and not in conflict with each other.

Several terms are used interchangeably for design inputs:

• Design inputs
• Design requirements
• Design input requirements
• Design and development requirements
• Product requirements

Medical device product development should be a holistic process that builds upon itself as the project progresses.

Rushing a product to market is not recommended. Investing time in design inputs can benefit the entire project; establishing them may occupy up to 20 % of the project timeline.

Writing design inputs takes practice and dedication. The task should not rest with one person; a team approach leverages diverse experience and perspectives.

Consider a range of sources when defining design inputs:

• Industry standards
• Regulations
• Previous projects/products
• Competitor products
• End-users
• Prototypes

Establish user needs first so they can inform design inputs. Your goals when defining inputs include:

• Capturing all functional, performance, safety, and regulatory requirements.
• Building upon user needs and intended use.
• Ensuring inputs are clear and objective.
• Stating inputs in a way that allows them to be verified or refuted.

Draw on all relevant sources to create comprehensive design inputs that cover every aspect of the device.

Further reading: FDA overview | ISO standards