Module 14 2022

14/03/2022

Device Form Development

Output: •

Output: •

Output: •

Handling Study

Summative HF Study

Preference Study

Function Requirement: • Selected functions • Mimic final finish

Function Requirement: • Fully functional • Mechanical operation

Function Requirement:

Mimic final form

•

Life Requirements:

Short term

Life Requirements: • Medium term

Life Requirements: • Long term

•

Quantity:

1-2 components

Quantity: •

Quantity: •

•

~10 components

100+ components

SLA

IM Prototype Tooling

FDM

Vacuum Casting

The Organisation for Professionals in Regulatory Affairs

21

Cup Seal Development

Output: •

Output: •

Output: •

Ease of Assembly

OD Knowledge Space

Empirical Testing

Function Requirement:

Function Requirement: • Smooth sealing face • Varied diameter sizes

Function Requirement: • Friction Characteristics • Mechanical operation

Illustrate overall size

•

Life Requirements:

Life Requirements: • Medium term

Life Requirements: • Long term

Short term

•

Quantity:

Quantity: •

Quantity: •

1-2 components

•

~100 components

1000+ components

IM Prototype Tooling

IM Prototype Tooling

SLA

Vacuum Casting

The Organisation for Professionals in Regulatory Affairs

22

11