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

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.