product definition chapter 4. what is a medical device? fda: “an instrument, apparatus, implement,...
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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
MarketCompetition
(Internal look)
Competition (External 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 Designing Constructing Consistently constructing
Distinguishes between customer attributes and technical characteristics
Yes, this guy again!
QFD Process
The wants of the customer Companies
Begins with…..Then it links………
and assists with the planning process
-Matrix format is essential to this process
with
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
Easy to put on
C om fortable w hen hanging
F its over d ifferent c lothes
Accessib le gear loops
D oes not restrict m ovem ent
Lightw eight
Safe
A ttractive
TEC HN IC AL PR IO R ITIES
PER C EN TAG E O F TO TAL
54 81.2 63 23.4 70.2 191.6 98.6 30
9 13 10 4 12 31 16 5
O ur product
C om petitor A 's product
C om petitor B 's product
D ESIG N TAR G ETS
Y
Y
Y
174g
193g
157g
250
321
198
5
3
6
4
5
4
4m m
8m m
3m m
1
4
1
4
5
3
Y 160g 250 8 6 4m m 2 4
Perform ancem easures
S ize ofrange
Technicaldeta ils
D IR EC TIO N O F IM PRO VEM EN T
C U STO M ERR EQ UIR EM EN TS
TEC HN IC ALR EQ UIR EM EN TS
2
5
1
3
5
3
5
2
+
-
+ +-
--Key to roof / corre lation
m atrix sym bols+ Positive / Supporting- N egative / Tradeoff
S trong in terre lationship
M edium interre ltionship
W eak interre lationship
Key to in terre lationship m atrix sym bols
PLAN N IN G M ATR IX
3
1
2
3
1
2
4
5
3
4
2
5
1.2
1.2
1.6
1.1
1.0
1.4
2.6
1.2
11.2
4
3
3
4
2
4
4
2
3
2
2
1
5
3
5
5
3
3
4
3
1.2
1.0
1.0
1.0
1.2
1.2
1.0
1.1
1.0
1.4 8.4
3.0
3.0
6.0
2.6
7
22
3
8
29
8
16
7
Example House of Quality Matrix(Mountaineering Climbing Harness)
© Dr. A. J. Lowe 2000
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).
In short, QFD process….
9 Easy Steps
Determining voice of the customer
Customer Surveys
Customer portion of the matrix
Technical portion of the
matrix
Matrix analysis and selection
of priority items
Proposed design comparison and synthesis of the
best
Part planning matrix
development
Process planning
matrix development
Manufacturing planning chart development
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.
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