2 The Design Process Overview

THE DESIGN PROCESS OVERVIEW
WHAT IS THE MECHANICAL DESIGN

PROCESS?
The application of engineering

principles towards product
design and development
2
PRODUCT DESIGN AND
DEVELOPMENT
NT
E
LO PM
EV E
T D
U C
O D
P R
MECHANICAL DESIGN PROCESS
Design and Design Sustaining Device

Feasibility Production
development transfer engineering retirement
Phase phase
phase phase phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
review review review
4
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
• Problem translated to a need statement.

• Solution evaluated (new, significant improvement, better outcome, easier…)
• Have others tried to address this problem – If so, why did they fail?
• Agrees with all stakeholders
• Device specifications identified (what are the needs?)
• Device concepts generated (brainstorming)
• Invention records documented and signed
• Market analysis (sell it before you make it)
• Competitive analysis
• Patentability search and freedom to operate
• Literature survey 5
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
6
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
Problem and need: Need:

1. hold paper together 1. hold paper together
a) without damaging paper
b) distribute securing force
Need: Need:
1. hold paper together 1. hold paper together
a) without damaging paper a) without damaging paper
c) simple
7
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
Need:
1. hold paper together
a) without damaging paper
c) simple
8
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
How to avoid problems

• Take your time
• Identify all stakeholders
• Do you research
• Informally test market
• Don’t let tentative solutions
clog your process
Problem Need Solution
9
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch

• Market analysis
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
• Agrees with stakeholders
• surgeons, physician assistant, surgical tech, nurse, sterile processing,

anesthesiologist, buyers, hospital administration, storage…
• Who ever touches the product must

be accounted for.
11
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch

• Market analysis
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
Customer and market Functional requirements Product engineering Test and verification Test by:
requirements requirements requirements Date:
1. “must be easy…” - Connector must offer two axes It is found that a offset of 40 degrees Production spec to be verified
Connector must adapt to (for connecting screw and rod) from the approximate position of 90 by prototypes and
misaligned rods and that are adjustable one relative to degrees is sufficient. To be provided functionality
receiving screws the other. by geometrical modification – not a
mechanism.
13
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch

• Market analysis
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
• Market analysis (sell it before you make it)
Break even point to cover cost of development

has to be fast.
Nobody wants to sell something if they will not

make money.
Rule of thumb is times two (for you) and then

times two again (for them).
15
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch

• Market analysis
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
Patents
Legal exchange of information for an
offensive right
Very expensive and difficult to get
Anyone can write, file and prosecute their
own patent (very dangerous)
Takes 2-4 years to issue
Many patent strategies exist and you must

chose the right one.
Public disclosure
Be careful
17
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch

Public Disclosure
Reason for rejection – Borat mankini

Requested Patent
Grace Period of 1 year in few Countries
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
0-1% 1-2% 2-3% 3-10%
Decision to proceed based on:

• Technical risks identified and reduced to acceptable levels
• Product evaluation methods

• Net Present Value (NPV)/Discounted Cash Flow (DCF)
Problem
Valuation factors:
• Patent strength • Success of related technologies
• Patent quality • Competition
• Stage of development • Profit margin95%
• Market size • Remaining life of patent
• Certainty of success
Continue
X Stop Licence Patent Sell Patent
19
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
• Stay up to date with IP

• Elaborate regulatory pathway
• Elaborate reimbursement pathway
• User needs (usability and human factors)

• Business needs
• Regulatory constraints (FDA…)
• Voluntary constraints (ISO…)
• Safety
• Error free performance
• Preliminary design
• Verified and validated design
• Prototype testing (pre-clinical trial)
• Customer sample testing
• Maintain proper design history file
• Maintain design risk analysis
• Packaging
20
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
Regulatory pathway will dictate the engineering

and performance testing required.
Correspondingly, the regulatory pathway

imposes costs.
Costs (approx.)
Class I: 10-100K
Class II : 500K-2M
Class III : 2-10M
21
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
Each country has their own distinctive manner

which they deal with reimbursement
22
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch


• Business needs
• Safety
• Packaging
23
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch


• Business needs
• Safety
• Packaging
24
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch


• Business needs
• Safety
• Packaging
25
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
0-1% 1-2% 2-3% 3-10% know-how = +1%
•
•
Review IP
Problem
Manufacturability of design (outside critical review)
• Labeling and packaging controls
• Reassessment of costs and resources based on new information
• Product evaluation methods updated and re-evaluated
80%
Continue
26
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
• Maintain procedures that respect regulatory body requirements (FDA,

Health Canada, CE…)
• Manufacturing information has been properly specified
• Updated BOM
• Supplier collaborations
• Supplier agreements in place
• Processes validated
• Employed measurement systems and tolerances (pre-quality control
guidelines)
• Maintain design history file
*note: you may devise clinical risk analyses 27

Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
Problem
• Reassessment of costs and resources based on new information

• Product evaluation methods updated and re-evaluated
• Sale of Patent may not be beneficial at this stage…
20%
Continue
28
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
• Finished device for commercialization and sale

• Must receive regulatory approval prior to launch
• Raw material supplier
• Handling
• Storage
• Distribution and sales (get ready to double the budget)
• Quality control in place
• Begin and navigate regulatory environment (clinical
trials if needed)
• Begin and navigate reimbursement environment
29
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
• Regulatory approval/clearance is obtained

• Final patent review – update if needed
• Reimbursement strategy finalized requirements
• Design history file complete
• Design risk analysis updated and reviewed
• Scale up manufacturing
• Sales training
• Clinical validation (scientific studies and publications)
• Sufficient resources (as a function of intended market value)
provided for:
• Marketing
• Sales
Phase phase
Phase Phase Phase

Device
Gate Gate Gate
launch
• Physician training
• Continued sales effort
• End user feedback is monitored
• Analyze field returns
• Technical support
• Cost reduction
• Adding additional target market
• Corrective and preventive actions
• Support of regulatory or compliance issues
• Production process improvement
• Add new features to device
• Alter intended use or claims of device
• Device history records maintained
• Continued scientific publications and studies

2 The Design Process Overview

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

2 The Design Process Overview

Uploaded by

Copyright:

Available Formats

THE DESIGN PROCESS OVERVIEW

WHAT IS THE MECHANICAL DESIGN

The application of engineering

Design and Design Sustaining Device

Phase Phase Phase

Phase Phase Phase

• Problem translated to a need statement.

Phase Phase Phase

• Problem translated to a need statement.

Phase Phase Phase

Problem and need: Need:

Phase Phase Phase

Phase Phase Phase

• Problem translated to a need statement.

How to avoid problems

Problem Need Solution

Phase Phase Phase

• Problem translated to a need statement.

Phase Phase Phase

• Agrees with stakeholders

• surgeons, physician assistant, surgical tech, nurse, sterile processing,

• Who ever touches the product must

Phase Phase Phase

• Problem translated to a need statement.

Phase Phase Phase

Phase Phase Phase

• Problem translated to a need statement.

Phase Phase Phase

• Market analysis (sell it before you make it)

Break even point to cover cost of development

Nobody wants to sell something if they will not

Rule of thumb is times two (for you) and then

Phase Phase Phase

• Problem translated to a need statement.

Phase Phase Phase

• Patentability search and freedom to operate

Many patent strategies exist and you must

Phase Phase Phase

• Patentability search and freedom to operate

Reason for rejection – Borat mankini

Phase Phase Phase

0-1% 1-2% 2-3% 3-10%

Decision to proceed based on:

• Product evaluation methods

Phase Phase Phase

• Stay up to date with IP

• User needs (usability and human factors)

Phase Phase Phase

• Elaborate regulatory pathway

Regulatory pathway will dictate the engineering

Correspondingly, the regulatory pathway

Phase Phase Phase

• Elaborate reimbursement pathway

Each country has their own distinctive manner

Phase Phase Phase

• Stay up to date with IP

• User needs (usability and human factors)

Phase Phase Phase

• Stay up to date with IP

• User needs (usability and human factors)

Phase Phase Phase

• Stay up to date with IP

• User needs (usability and human factors)