MEDICAL DEVICE DESIGN CONTROL AND VERIFICATION

(It’s not just the law, it’s Really a Good Idea)

What is Design Control?

In simple terms, it is the complete control over the design development of your product

Design Controls designates the application

of a formal methodology to the conduct of product development activities.

What is Design Control?

Establishment of an intended use and design inputs A design plan Periodic design reviews throughout the design

process Confirmation that the design outputs conform to the

design inputs through: Design verification ("did we design the device right?") Design validation ("did we design the right device?")

Translation of the design into manufacturable specifications

Clear documentation of the entire process in a design history file or DHF.

What Design Control is NOT

Control over R&D activities Something the FDA made up because they

had nothing better to do Bad for business Something only medical device companies do Many other industries use design control

Properly applied, the use of design control will increase the quality of your products!

Need For Design Controls

Many people (and companies) see design control as just more paperwork and stress

But…a robust design control process will eliminate lots of stress post market

Need For Design Controls

Business Need Failure to establish a robust design control

system, can: Lead to the development of product which is not

“suitable for use” Inability to be able to correct issues once a product is

on market Open you up to audit observations for violations of

CFR’s and ISO standards

Need For Design Controls

Design control during development can help prevent “Feature Creep”

If all changes to a design have to be assessed and approved, maybe more thought might go into them.

Need For Design Controls

Design control and the documentation which is required: It makes it much easier to fix any issues which may

crop up after product launch. Need to be able to trace design decisions Formulation changes Vendor changes Manufacturing changes Etc.

Need For Design Controls

Remember: Fixing a product once it is on market costs money. The faster you can fix the issue, the faster the

product can be returned to market And the happier your customers will be

Design Controls also make it easier to improve a product after launch as all design decisions are documented The product support groups can find out why R&D

did what they did

Need For Design Controls

Regulatory Requirements Yes, there are regulatory requirements around

Change Control. No, you can’t get around them. Yes, they are getting tighter. No, it is not going to get easier.

What Does the FDA Say About Design Control? 21CFR, Sec. 820.30 Design controls (a) General. (1) Each manufacturer of any class III

or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met

What Does the FDA Say About Design Control? There are 9 major subparts to the regulation: (b) Design and development planning. (c) Design input (d) Design output (e) Design review (f) Design verification (g) Design validation (h) Design transfer (i) Design changes (j) Design history file

Compare 21CFR820.30 to ISO 13485 ISO 13485 has very similar requirements to

the FDA standard

Design Control Waterfall

Design Verification

What is Design Verification? Per the FDA: Sec. 820.30 Design controls (f) Design verification. Each manufacturer shall

establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

Design Verification

(Design) Verification – Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled

Elements of Design Verification Know the answer before you start!! Verification is not an experiment!

Starts with clear, well defined product requirements Product requirements MUST be measurable Otherwise they can’t be verified

Elements of Design Verification Formal Protocol Link directly to an approved product requirement Contain full methodology or reference to standard

methodology Statistical justification for number of samples,

runs, etc. Statistical plan for data analysis

Elements of Design Verification Formal Protocol (con’t) Clear acceptance criteria Procedure for what to do if verification fails Pre-approved

Elements of Design Verification Report Reference to the protocol Who performed the work Where work was performed Summary of Data Can reference location of original data as long as it is

in a controlled location (ELN)

Elements of Design Verification Report (con’t) Summary of any deviations, exceptions or invalid

results And why they are acceptable

Significant deviations to the protocol must be preapproved!

Clear statement of pass/fail Reference to what you are going to do if the

protocol fails

Results of Design Verification You Pass the Protocol You have successfully verified the stated product

requirement You have proven by objective evidence that your

product (at least in this case) meets it’s design requirements

You have built what you said you were going to build.

Results of Design Verification You Fail the Protocol You have NOT successfully verified the stated

product requirement Now what? (No, don’t do this)

Results of Design Verification Ok… so you have failed a protocol, now what First of all, if you have done a good job of writing

product requirements and characterization of your system, this should be a very rare event

You should have procedures as part of your quality system to follow

Investigate, investigate, investigate The reason might not be related to your system

Results of Design Verification If after a thorough investigation You determine that you really can’t verify a

product requirement You need to take a good look at that product

requirement It might not be achievable with your product as

designed

Can the product requirement be updated and re-verified? Without impact to the user need it is traced to

Can you make a design change and re-verify?

Final Summary of Design Verification After all your design verification studies are

complete (and hopefully successful) You should put together a full design verification

summary report A format that works well is a trace matrix This shows the full design control trace in one

place

User Need

Product Requirement

Verification Protocol

Verification Record

Result

Changes to Product Design

Any changes to product design either prior to or after market launch must be evaluated to determine if there is impact to the ability to continue to meet product requirements Changes to product design normally require

formal design verification (and possibly design validation) to ensure that the product continues to meet product requirements.

A Few Examples Of How the FDA Sees Design Verification Example 1 4. Failure to establish and maintain adequate

procedures for verifying the device design and documenting the results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, as required by 21 CFR820.30(t). For example:

a. When requested, no documentation to confirm that the finished product conformed to specified requirement as stated in the (b)(4) was provided.

A Few Examples Of How the FDA Sees Design Verification Example 2 (UK Company) Failure to establish and maintain procedures for verifying the device

design, as required by 21 CFR 820.30(f). For example: a. Procedure number 12, Issue number 2, Design Management,

embedded within the Quality Manual, Issue number 4, describes the responsibilities, methods, and records to be followed during a design project. However, the procedure does not define or refer to a process to be followed for conducting design verification of the XXXXXX device.

b. Your firm was unable to provide documentation related to the initial

design verification of the XXXXXX device. Your firm’s Managing Director/Owner, QA Manager, and Management Representative indicated that your firm has never conducted design verification activities to ensure the design outputs meet design inputs for the XXXXXX device.

And My Favorite…

Failure to establish procedures for design control which are required by 21 CFR 820.30(a). Specifically, there is no procedure established to control the design of the assembled replacement batteries in order to ensure that specified design requirements are met. In addition, there are no specifications defined for the components and assembled replacement batteries (excluding minimum voltage and battery chemistry), and no design control activities, such as design inputs, outputs, verification, validation, or changes, have been documented.

In Summary

Design Control and the Verification of Product Requirements Good Business Practice Results in increased customer satisfaction Fewer post market changes It’s the Law

That’s All Folks!

My Contact Information: Alan Golden Manager QA, Operations

Support Abbott Molecular Alan.golden@abbott.com 224-361-7159