Product Definition
Chapter 4
What is a Medical Device? FDA:
“an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or
related article, including any component, part, or
accessory, which is:
- recognized in the official National Formulary,
or the United States Pharmacopeia, or any supplement
to them
- intended for use in the diagnosis of disease
or other conditions, or in the cure, mitigation, treatment,
or prevention of disease, in man or other animals, or
- intended to affect the structure
or any function of the body of man or other
animals, and
which does not achieve any of
its principal intended purposes through
chemical action within or in the body of man
or other animals and which is not
dependent upon being metabolized for the
achievement of any of its principal intended
purposes.”
1976: The Medical Device
Amendments expansion:
- devices intended for use in the diagnosis
of conditions other than disease, such as
pregnancy, and

- in vitro diagnostic products,
including those previously regulated as
drugs.
 & “significant risk” device definition

Medical Device Directives:
any instrument, appliance, apparatus, material
or other article, whether used alone or in
combination, including the software necessary
for its proper application, intended by the
manufacturer to be used for human beings for
the purpose of:
- diagnosis, prevention, monitoring, treatment or
alleviation of disease;
- diagnosis, monitoring, alleviation of or
compensation for an injury or handicap;
- investigation, replacement or
modification of the anatomy or of a
physiological process;
- control of conception;
and which does not achieve its
principal intended action in or on the human
body by pharmacological, immunological or
metabolic means, but which may be assisted
in its function by such means.
These definitions are critical to this course and
to the following definition & design text…
Product Definition Process
Where are we in the market now?
 Where do we want to go?
 How big is the potential market?
 What does the customer really want?
 How feasible is technical development?
 How do we get where we want to go?
 What are the chances of success?

Surveying the Customer





Very important!
Match customer needs
with product concept
Quality product meets
customer needs
Identify segments of a
population with similar
needs
Target marketing to that
group
Defining Company Needs




Increases scope of consumers
Takes into account market analysis to take a
broader look at potential customers
Includes market sizes and trends
Reviews competitive and regulatory environment
Company Competencies
Determine how to get ahead of competitors
 Examine company using same level of
objectivity used when viewing competitors
 Examine core competencies/weaknesses
 Capitalize on strengths

Outside Competencies
Examine strengths/weaknesses of
competition
 Identify resources of the competition
 Study market shares of industry players

Completing Product Definition


Consider the marketing mix of products,
distribution networks, pricing structure, and
overall economics
Examine company issues with potential
product- technologies, company fit, life cycle,
differentiation
Customer
Market
Competition
(External look)
Competition
(Internal look)
Final Company
Issues
Definition Complete!
Quality Function Deployment
Process in which ‘voice of the customer’ is
heard and deployed
 Orderly, four-phase process:

 Planning
Yes, this guy
again!
 Designing
 Constructing
 Consistently

constructing
Distinguishes between customer attributes and
technical characteristics
QFD Process
Then itwith…..
links………
Begins
The wants of
the customer with
Companies
and assists with the planning process
-Matrix format is essential to this process
Voice of the Customer
Basic input required to begin QFD
 Relative importance of each voice is
measured by importance rating
 Competitive evaluation of products or
services permit company to observe how
its products rate on a numerical scale
 Customer complaints serve as an
indication of dissatisfaction

Technical Information
Determine how company will respond to
customer voice
 Technical or design requirements placed
on top of the matrix
 Center of matrix records presence and
strength of relationship between customer
wants and technical requirements
 Goals can be established for technical
requirements

Example House of Quality Matrix
(Mountaineering Climbing Harness)
Key to roof / correlation
matrix symbols
+ Positive / Supporting
- Negative / Tradeoff
© Dr. A. J. Lowe 2000
-
+
-
+
+
DIRECTION OF IMPROVEMENT
Performance
measures
TECHNICAL
REQUIREMENTS
Size of
range
Technical
details
PLANNING MATRIX
CUSTOMER
REQUIREMENTS
Easy to put on
2
3
3
4
4
1.2 1.1 2.6
Comfortable when hanging
5
4
4
2
5
1.2 1.4 8.4 22
Fits over different clothes
1
1
1
5
2
1.2 1.0 1.2
3
Accessible gear loops
3
3
4
1
3
1.0 1.0 3.0
8
Does not restrict movement
5
2
2
3
5
1.6 1.4 11.2 29
Lightweight
3
3
2
5
3
1.0 1.0 3.0
Safe
5
4
3
3
4
1.0 1.2 6.0 16
Attractive
2
2
2
5
3
1.2 1.1 2.6
TECHNICAL PRIORITIES
54 81.2 63 23.4 70.2 191.6 98.6 30
PERCENTAGE OF TOTAL
9
10
4
12
Our product
Y 174g 250
5
Competitor A's product
Y 193g 321
Competitor B's product
DESIGN TARGETS
13
31
7
8
7
Key to interrelationship matrix symbols
16
5
Strong interrelationship
4 4mm
1
4
Medium interreltionship
3
5 8mm
4
5
Weak interrelationship
Y 157g 198
6
4 3mm
1
3
Y 160g 250
8
6 4mm
2
4
Best tutorial is at:

http://www.webducate.net/qfd/

Before embarking on the tutorial you are
encouraged to print a hardcopy of an
example completed matrix and the blank
matrix template (MS Word doc).
Manufacturing
Technical
In short,
QFD
process….
planning chart
portion of the
development
Proposed design
comparison and
synthesis of the
best
matrix
Customer
portion of
the matrix
9 Easy
Process
Stepsplanning
matrix
Matrix analysis
and selection
of priority
items
development
Determining
voice of the
customer
Part planning
matrix
development
Customer
Surveys
Some final notes:

QFD should be used, especially in the
layout phase, to assist in the verification
and validation of the product and in the
minimization of stated requirements for the
product.
Product Specification (via QFD):
The type of product
 The market it addresses
 The function of the product
 The product parameters necessary to
function effectively
 Accuracy requirements
 Tolerances necessary for function

Product Specification, Continued







The anticipated environment for the device
Cautions for anticipated misuse
Safety issues
Human factors issues
The anticipated life of the product
The reliability goal
Requirements from applicable domestic or
international standards.