Regulatory Open Forum

820.30(c) Design Input. 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.

I am interested in industry practice for design inputs:

How do you determine user and patient needs?

Do you maintain documentation to support patient and user needs? If so, what type of documentation?

How do you determine whether your design requirements are complete or incomplete?

What is the basis for approving the design input requirements?  (That is, what makes them approvable or not approvable?)

Are your design requirements the same as your design specifications?

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Julie Omohundro RAC
RAQA Services
Research Triangle Park NC
United States
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820.30(c) Design Input. 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.

I am interested in industry practice for design inputs:

How do you determine user and patient needs?

Do you maintain documentation to support patient and user needs? If so, what type of documentation?

How do you determine whether your design requirements are complete or incomplete?

What is the basis for approving the design input requirements?  (That is, what makes them approvable or not approvable?)

Are your design requirements the same as your design specifications?

-------------------------------------------
Julie Omohundro RAC
RAQA Services
Research Triangle Park NC
United States
-------------------------------------------

820.30(c) Design Input. 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.

I am interested in industry practice for design inputs:

How do you determine user and patient needs?

Do you maintain documentation to support patient and user needs? If so, what type of documentation?

How do you determine whether your design requirements are complete or incomplete?

What is the basis for approving the design input requirements?  (That is, what makes them approvable or not approvable?)

Are your design requirements the same as your design specifications?

-------------------------------------------
Julie Omohundro RAC
RAQA Services
Research Triangle Park NC
United States
-------------------------------------------

How do you determine user and patient needs?
We perform market (competitor) analysis and also directly contact potential users and patients for their input; this is typically done by our Marketing Team.

Do you maintain documentation to support patient and user needs?
If so, what type of documentation?
Marketing creates a Customer Requirements Document which is the cornerstone for later stage-gate or change-control Project documentation, if we pass our own feasilibity analysis and obtain business leader support.

How do you determine whether your design requirements are complete or incomplete?
We evaluate the "negative space"; that is, we ask ourselves "what if the opposite were true?".
And we also confirm we can achieve all applicable Standards and Regulations, and perform a risk-benefit analysis to confirm feasibility.

What is the basis for approving the design input requirements? 
(That is, what makes them approvable or not approvable?)
We present a charter for proposed projects to a cross-functional team of Sr leaders to obtain their blessing to go forward. The charter summarizes the likelihood of financial benefits and overall market position, risk/benefit analysis, and evidence of ability to meet our own and external Standards, and Regs, and resource needs. There is also a high-level timeline for implementation and, if the design is deemed actionable, an offline discussion of its priority with respect to other projects.

Are your design requirements the same as your design specifications?
Not always; we will sometimes design to stricter specs than our requirements indicate; we weigh the potential loss of business with our ability to reliably produce in-spec products; all requirements/specs decisions are documented and justified, whether they're a match or not.

Hope this helps.
Aimée
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Aimée Campbell
Abbott Vascular
Menlo Park CA
United States
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