Design

Question 1

What are the steps of the general design process?

Answer 1

Define Problem
Gather Information
Concept Generation
Concept Selection
Embodiment Design
Detail Design
Implementation

Question 2

What is involved in Defining the Problem?

Answer 2

Problem Statement
Objectives
Target Specs
Constraints/Limitations

Question 3

What is involved in Gathering Information?

Answer 3

Anatomy/Physiology
Regulatory
Current/Related Methods
Opportunities

Question 4

What are the three parts of the FDA definition of a medical device?

Answer 4

Recognized in National Formulary
or
Intended for use in diaganoses, mitigation, treatment, prevention
or
Intended to affect the structure of function of the body through non-chemical means

Question 5

What classes require design controls

Answer 5

All Class II and III, some Class I

Question 6

What are the design controls?

Answer 6

Design...
& Development Planning
Input
Output
Review
Verification
Validation
Transfer
Changes
History File

Question 7

What are the four stages of the stage gate process?

Answer 7

Feasibility and Planning
Design and Development
Verification and Validation
Design Documentation and Tranfer
\+ Commercial Manufacture

Question 8

What is Design Input?

Answer 8

User needs and market requirements

Question 9

What is design output?

Answer 9

Target specs

Question 10

What is a design review?

Answer 10

Formal process for reviewing documentation, decisions, and updating DHF

Question 11

What are Verification and Validation

Answer 11

Verification: showing that it works as intended
Validation: showing that it solves the original problem

Question 12

What is design transfer

Answer 12

Moving the design from R&D to manufacturing. 
Often require IQ, OQ, PQ
Installation Qualification
Operational Qualification
Performance Qualification

Question 13

What is in a DHF?

Answer 13

Plans
Specs
V&V test results
Design review
changes

Question 14

What are the two types of risk analysis?

Answer 14

Clinical Risk Analysis

Manufacturing Risk Analysis

Question 15

Define Harm, Hazard, Severity, Risk, Residual Risk

Answer 15

Harm: physical injury or damage
Hazard: potential for harm
Severity: Measure of consequences of risk
Risk: combination of probability of occurrence and severity
Residual Risk: Risk remaining after protective measures

Question 16

Define ALARP

Answer 16

As Low as Reasonably Practicable:

Residual Risk is reduced to an acceptable level without sacrificing patient safety or clinical utility

Question 17

What is the RPN? The Criticality?

Answer 17

SOD

S*O

Question 18

What should be included on a label?

Answer 18

Intended Use
Indications for Use
Contraindications for Use
Warnings, Cautions
Description of Device
User Instructions
Specifications
Corrective Actions

Question 19

What is the design paradox?

Answer 19

The more you know, the less freedom you have to change things, and the more costly it is to make changes.

Question 20

When is most cost committed in design? When is it incurred?

Answer 20

Cost is mostly committed in conceptual design and incurred in manufacturing.

Question 21

What are the types of concept design?

Answer 21

Original design
Adaptive design
Redesign
Selection Design