The document discusses the FDA's requirements for medical device manufacturers to implement a quality system, specifically focusing on design controls. It introduces Quality Function Deployment (QFD) as a methodology to convert customer needs into technical requirements during product development. The paper emphasizes the importance of considering user interactions and environments in the design process to achieve compliance and improve product quality.

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Quality Function Deployment (QFD) for Design Controls
Introduction
The Food and Drug Administration (FDA) has requirements for medical device manufacturers to
establish and maintain a quality system for their medical device(s). The requirement for a quality
system does not necessarily introduce new concepts, but applies existing quality concepts to
design, development, manufacturing, distribution and use of medical devices. Within the larger
quality system requirement, a methodology to control device design and development of medical
devices is required. This set of sub requirements is known as Design Controls. In this paper, the
history and evolution of quality systems and their application to medical devices will be covered.
A Quality tool that could be well applied to the specific area of design controls, Quality Function
Deployment (QFD), is a focus of this paper.
History
Medical device technology came with the emergence of the modern era in the early 1900’s.
During this same period, the field of Quality was born. For much of the 20th
century the fields of
medical device and Quality evolved on separate paths. During this time, the development of
medical device technology required evolution of corresponding regulatory requirements to assure
emerging technologies are safe and effective.
In 1976, medical device amendments to the Food, Drug and Cosmetic Act (FD&C) became law.
Good Manufacturing Practices (GMP) regulations were also authorized at that time. These are a
set of procedures to ensure that devices are manufactured to be safe and effective through quality
design, manufacture, labeling, testing, storage, and distribution for the end users. In 1997, the
FDA revised the GMP requirements incorporating them into a Quality System Regulation
(QSR). The QSR includes requirements related to the methods used by medical device
manufacturers and controls used for designing, manufacturing, packaging, labeling, storing,
installing, and servicing of medical devices intended for human use. The QSR provides a
framework for device manufacturers to follow with flexibility in how to achieve requirements for
a given device. One could consider this legislation being the initial mandate for the application of
Quality and Quality Systems to medical devices.
With compliance with QSR being required, device manufacturers must structure their quality and
engineering management systems to satisfy Quality System Requirements including many
aspects that may not normally be considered without guidance, e.g. Human Factors Engineering.
As an example, Design controls requirements demand device manufacturers to consider and
document aspects of a medical device beyond its physical attributes to include aspects of how the
end user interacts with the device. FDA guidance is that Customer Requirements, Device Users,
Use Environments and User Interface should be reviewed and documented as part of the design
history file.
• Device users; e.g.: The intended users of the device (e.g., physicians, nurses,
professional caregivers, patients, family members, installers, maintenance staff members,
reprocessors…etc.); User characteristics (e.g., functional capabilities (physical, sensory

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and cognitive), experience and knowledge levels and behaviors) that could impact the
safe and effective use of the device; The level of training users are expected to have
and/or receive.
• Device use environments; e.g.: Hospital, surgical suite, home, emergency use, public use,
etc.; or Special environments (e.g., emergency transport, mass casualty event, sterile
isolation, hospital intensive care unit).
• Device user interface; e.g.: Components and accessories, Controls, Visual displays,
auditory and tactile feedback Alarms and alerts, Logic and sequence of operation,
Labeling, Training1
Incorporating elements of the User experience into the design and development of a product is
not a new or unique approach in product development. Prior to the FDA mandating device
manufacturers to apply design controls as part of a larger QMS, several Quality systems and
Quality tools had already been developed and had been proven effective in the field of Quality.
A method in which customer needs or expectations are translated into appropriate technical
requirements for each stage of product development and production had been developed and
proven effective, the Quality Function Deployment (QFD). The QFD process is often referred to
as listening to the voice of the customer.2
What is Quality Function Deployment (QFD)
QFD was developed in Japan in the late 1960s by Professors Shigeru Mizuno and Yoji Akao. At
the time, statistical quality control, which was introduced after World War II, had taken roots in
the Japanese manufacturing industry, and the quality activities were being integrated with the
teachings of such notable scholars as Dr. Juran, Dr. Kaoru Ishikawa, and Dr. Feigenbaum who
emphasized the importance of making quality control a part of business management, which
eventually became known as TQM. QFD eventually became the comprehensive quality design
system for both product and business processes. 3
Yoji Akao defined comprehensive QFD as converting the “consumers’ demands into quality
characteristics and developing a design quality for the finished product by systematically
deploying the relationships between the demands and the characteristics, starting with the quality
of each functional component and extending the deployment to the quality of each part and
process. The overall quality of the product will be formed through this network of relationships.4
The network of relationships between customer requirements and products characteristics is
commonly termed as the House of Quality. The QFD methodology prioritizes product attributes
or qualities with corresponding customer requirements and priorities. This tool is well applied to
complex products or products with multiple competing requirements. An example of the
elements in the House of Quality Relationship matrix can be organized as shown below:

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5
Application of QFD in Design Controls
FDA requires that intended users and their needs are considered in the development of a medical
device. These requirements do not prescribe the methodology by which the requirements are to
be satisfied. It is up to each device manufacturer to determine the processes by which they will
satisfy the comprehensive design control requirements. In the development of a medical device,
considerations such as budget, schedule, technological challenges, and evolving regulatory
requirements need to be prioritized, tracked and implemented.
Without some type of format or methodology to understand the interactions and impacts of all
these types of considerations, it could be difficult to have confidence in the decisions being made
are the best possible.
Developing new medical devices that improve human lives can be an exciting and emotional
experience for the people involved. Using an established method that provides organization and a
level of objectivity to what can become large and complex lists of seemingly competing
requirements and constraints is extremely advantageous. Use of QFD provides a structure to
identify and weigh multiple customer needs and requirements to ensure that they are
incorporated into the design. This leads to design controls requirements being achieved in a
seamless way.
Beyond being a methodology for achieving compliance to design controls requirements, QFD
can be expanded to include and weigh considerations beyond the relationship between the
customer requirements and product characteristics. The House of Quality interaction matrix can
be modified to include considerations such as technical benchmarking, competitive
benchmarking and business priorities.

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Final Thoughts
Compliance to the FDA’s comprehensive design controls requirements is mandatory.
Developing and implementing business and quality systems in place to achieve these
requirements is necessary to realize compliance. There can be a lot of value, including financial,
when the processes achieve more than compliance to design controls requirements.
The house of quality appeared in 1972 in the design of an oil tanker by Mitsubishi Heavy
Industries.6
The successes of applying QFD to a variety of products with every evolving
technologies has led to a number of articles, books and was included in some academic curricula.
Application of QFD to the design & development of medical devices provides a methodology
that translates customer needs, or requirements, into appropriate product specifications. The
Quality Function Deployment (QFD) quality tool has been around for over 40 years and is
proven effective in product design and development for many products, including medical
devices.

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Bibliography
1
FDA (Feb 2016) Applying Human Factors and Usability Engineering to Medical Devices
retrieved on 08/19/2019 from https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/applying-human-factors-and-usability-engineering-medical-devices
2,5
ASQ : Quality Glossary retrieved on 08/19/2019 from https://asq.org/quality-
resources/quality-glossary/q
3
QFD Institute: History of QFD retrieved on 08/19/2019 from
http://www.qfdi.org/what_is_qfd/history_of_qfd.html
4
BS ISO 16355-1:2015 Application Of Statistical And Related Methods To New Technology
And Product Development Process -- Part 1: General Principles And Perspectives Of Quality
Function Deployment (Qfd)
6
Hauser, John R.; Clausing, Don. "The House of Quality". Harvard Business Review. No. May
1988. Archived from the original on April 16, 2016.