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 Many
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.
Written by Ron Sully, with technical
assistance from our Design Control Specialist, Kathryn
Kukulka.
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