Introduction to Design Control

Kathryn Kukulka - Regulartory Affairs DirectorMany of our clients (about 75%) hire us to design and engineer medical devices. The companies they represent range in size from start-ups to Fortune 500 corporations. All have at least two things in common, a desire to see their ideas realized, and the necessity to implement the FDA's Quality Systems Regulations in their development process.


Kathryn Kukulka, our Regulatory Affairs Director is pictured at left. 
She can answer your questions regarding FDA-mandated Design Control.


In 1996, the Good Manufacturing Practice (cGMP) requirements were revised to include the area of Design Control. These practices assure consistency with quality system requirements worldwide, and apply to most medical devices.


It is believed that the intrinsic quality, safety, and effectiveness of a device are established during the design phase. Statistics show that 44% of all medical device recalls are a result of inadequate design control. Obviously, the consequence of a recall is not limited to the end-user. Another result is lost money for the manufacturer, and ultimately higher product development costs. Considering the relatively short market viability life span for a product, it is in everyone's interest to "do it right the first time".


Formal design control is not required for feasibility studies, but once it is decided that a design concept is feasible and will be developed, a plan must be established to determine the adequacy of the existing design elements. Some see the biggest challenge for the manufacturers of medical devices is the understanding of how to implement and integrate federal requirements with their existing systems.


The design control process is part of a larger system of checks and balances that the medical device manufacturer should already have in place as part of their overall development plan. Definition of the process is important because the Design Control Guidelines are not intended to apply to the research and feasibility stages of product development. The debate is determining when feasibility ends, and development begins. A comprehensive Product Development Process with specific milestones and development phases can alleviate any questions. Our Project Design Control team can offer guidance to help ensure that the final design (the one released to production) meets the approved guidelines.


Good design controls lay the foundation for the healthy design and development of medical devices in general. Properly instituted, these guidelines provide the manufacturer with the opportunity to address and/or correct problems early in the process. Everyone benefits. The end user is offered a safe and effective product, and the manufacturer has the best chance to secure a successful return on their investment.


These eleven requirements affect most medical device manufacturers.


Design Controls are made up of ten elements for which procedures are written. Risk Management and analysis could be considered an eleventh section. Following is a short description of the different sections of Design Controls as they relate to the regulatory requirements and the Code of Federal Regulations 820.30.


1)  Design Control – States that when manufacturers or suppliers develop a product subject to design controls, they shall establish and maintain the proper documentation to ensure that the specified design requirements are met.


2)  Design and Development Planning – Describes the overall development plan and defines design activities and responsibilities. Establishes the roles of all contributors to the development process including marketing, purchasing, manufacturing, R and D, Regulatory Affairs, etc.


3)  Design Input – Establishes the requirements that will ensure the device will meet the needs of the intended users.


4)  Design Output – Applies to all stages of the design process. These are the final technical documents that constitute the Device Master Record (DMR). This information shows that the device was developed according to the Design Plan and Design Inputs.


5)  Design Review – These ongoing meetings (minimum 2 formal meetings required) occur throughout the design process. They verify that the development of the design continues to meet the requirements outlined in the Design Input stage.


6)  Design Verification – Identifies whether or not the Output requirements continue to meet the Input requirements. This stage should ideally involve persons who are not responsible for the design under review. Results are documented in the Design History File. It verifies that the product was made correctly.


7)  Design Validation – Follows successful Verification, and is part of overall risk analysis. Includes testing of production units under actual or simulated use conditions. Validation demonstrates that all Verifications have been completed and that only safe and effective devices are produced. It confirms that the right product was made.


8)  Design Transfer – Addresses the transfer of a design to production, and review of those specifications. Ensures that the finished production devices have the same qualities established during the design phase.


9)  Design Changes – This is the documentation which shows that all modifications to the design after the Design Review have been identified, reviewed, and approved. If changes are made, they must be Verified and Validated again.


10)  Design History File – The documents that show that the device complies to the approved design plan and design control procedures. This file is the basis for the Device Master Record, which includes all specifications, drawings, outputs, and actions relating to the development of the device.


11)  Risk and Hazard Analysis activities are required during most phases of development. The extent of this testing is proportional to the risks associated with the product. If risks are unacceptable, the device may need to be redesigned, or warning labels should be attached. It is important that any changes do not introduce new risks or hazards.


When reviewing the design control requirements, FDA investigators will not determine if a design is appropriate, or safe and effective. They will evaluate the design control process, make recommendations based on whether the manufacturer has the required checks and balances in place, and verify implementation of the design control guidelines. If the Risk and Hazard Analysis procedures are found unacceptable or incomplete, however, reviewers will question the  "safety and effectiveness" of the device. Recent literature review shows that appropriate risk analysis procedures are not being addressed in more than half the cases studied. For these reasons, Omnica recommends that manufacturers establish an specific Risk Management section of their Design Control system.