Quality, Speed, Price:

Now Pick Three

Implementing Lean Principles

is Easier with Advanced Metrology!

We believe in using technology

to make better parts/products faster

with lower cost and higher confidence.

Situation

• FDA & EU regulation

• Supply chain validation

& verification

• Domestic & international

recalls

• If you snooze, you lose

Innovation wins

2

Introduction

• Jet Engine Engineers

Pratt & Whitney

• GD&T professionals

• Metallurgical engineers

• Over 12 years experience

Structured Light Metrology

Computer Aided Inspection

• Cross-industry precision

process expertise

• Regulatory affairs &

QSR’s

3

Master

Practitioners

• Computer Aided

Inspection (CAI) from

3D Structured Light

Metrology (SLM)

• Dimensional inspection,

FAI, CAD/BP comparison,

analysis, part-fit, tooling…

• Problem Solving

• Accelerate manufacturing

process optimization

• Product Modernization™

4

• A traditional canon of project management

• Fast delivery of top-quality product is expensive

• Cost-cutting has unfavorable consequences

either harms quality or slows delivery

The Triple Constraint Problem

5

• Cost driver in medical device development:

Time-to-Market (TTM)

• Driven by economics

• Mitigated by technological advance

• Now possible to optimize all three

The Triple Constraint Problem

6

21st

Century

Structured

Light

Metrology

(SLM)

Closer

QSR

Compliance

Improved quality*

Faster launch*

Lower cost*

Shorter

Development

Cycle

The Solution: Structured Light Metrology

*All while

increasing

confidence!

7

What Is Structured Light Metrology

(SLM)?

SLM is an optical 3D geometric measuring system …

• Based on the principle of triangulation

• Projected structured light fringe pattern

• Digital cameras capture high-resolution images

• 3D coordinates for each pixel are recorded

4 to 11 million data points per scan

• Multi-scans merged to 1 complete 3D image

• Comprehensive post-processing of scan-files 8

Broach

3D Scan

Stem

3D Scan

3D Scan Captures 100% of Part’s

Surface Geometry in an .STL file

9

Part Scan Files Are Quickly

Aligned & Compared to CAD & BP

Plus Material

Minus Material

10

Broach Stem

Within Tolerance

11

Graphic Visualization for Quick Review

& Confident Conclusions

Stem Insert

12

Vastly Superior Understanding

enhancing & complimenting

Conventional Dimensional Inspection Reports

Stem

Assembly

Comprehensive

Inspection

Results…

… with speed & accuracy

• Inspection: Compare part to CAD

• Validation: Compare part to another part

• Surface profile of articulating

• Tooling acceptance & optimization

• Part wear pattern inspection

• Assemblies & part fit resolution

• Product Modernization™ (reverse engineering) Create parametric CAD models

from/for legacy parts

• Optimize processes quickly & Reduce Time To Market

13

…Throughout

Product Life

Cycle

Sample applications:

• Investment casting

• Precision machining

• Injection molding

• Forge tooling

• Tooling inspection & digital archiving

• First article inspections

• Periodic inspections

• CNC program validation

• Assemblies part fit

…among many others

14

CAI Solution: Bone

Ingrowth

Coating

• Thickness

• Uniformity

• Cross-sections

• Roughness

15

Solution For: Temp/Press Mold

Optimization &

Poly-wear

• Reduce iterations

• Improve understanding & confidence

• Better fit to reduce wear

16

Accuracy

Superior to CMM standard

Proven by ANOVA Gauge R&R - (MSA)

Accuracy better than 2.0µm (0.000078”) overall

Standard deviation 0.30µm (0.000012”)

Routine System Calibration

NIST Traceable Artifacts

AAAM Artifacts

Perfect Correlation to Traditional Measurement Systems

17

Gage R&R Study Conclusion

18

How CAI Improves Quality DMAIC: Define Measure Analyze Improve Control

• Identify the problem clearly

Quantify the shortfall

Determine the root cause

Communicate it effectively

• Gain process understanding

Drive throughout every stage

19

How CAI Improves Quality DMAIC: Define Measure Analyze Improve Control

• CAI: The Process Engineer’s Dream Tool Comprehensive information

If you can see it, you can measure it

Non-contact, non-destructive

Fast & simple setup – results in just minutes

• Better quality (than CMM’s) at lower cost

• Full documentation for traceability QMS-compliant controls

Can be certified to AAAM standards

NIST & PTB traceable

• Solve your most vexing/expensive problems

20

How CAI Improves Quality DMAIC: Define Measure Analyze Improve Control

• Post-processing analysis yields comprehensive

inspection results

• Strong evidence of problem root cause in

process

• Full color 3D dynamic visualizations allow

engineers to understand entire geometry

• L3I has developed a proprietary,

comprehensive analysis toolset based on

years of aerospace & orthopedic experience

21

How SLM Improves Quality DMAIC: Define Measure Analyze Improve Control

• Evaluate process performance against new process benchmarks

• Understand assembly wear characteristics

• Understand manufacturing outcomes

• Progress can be readily reported to/monitored by regulators & stakeholders

• Determine where improvement is most needed

• Modify or re-design process as needed

22

How CAI Improves Quality DMAIC: Define Measure Analyze Improve Control

• Continuous improvement

• Eliminate wasteful, repetitious

iterations

• Trend insights into the control phase

• Drive measurement outcomes into

better process understanding

• Make excellence a habit!

23

Is this a

souped-up

CMM?

• NO!

• CMM’s no longer the gold standard

• CMM’s fool you; Optical Comparators lie

• CMM’s require big assumptions

• CAI is non-contact, fully automated, & repeatable

24

CAI:

Superior to

Traditional

Metrology

• Objective standard of measurement

• Comprehensive full 3D

• Millions of data points to accurately compare entire geometry

• Improved comprehension

• Greater confidence

• Traceable, trackable, trendable for SPC

• No precision fixturing needed

25

SLM: CMM Perfect Correlation Shoulder Dome

26

How CAI Reduces Cost

• Reduce or eliminate iterations

Based on 10,000-times more information

• Advanced metrology has lower labor costs

• The real story is opportunity cost

Time is a lot of money

• Every extra month’s delay cost $2-25M

In lost revenue, lost profit, lost market share

27

The Time-to-Market Advantage

Trendability Trackability Traceability

Statistical Process Control (SPC)

Improved Understanding of Design, Development & Process

Better, Faster, Cheaper Outcomes

28

Automated 21st

Century CAI

Smart Inspection Station™

• Accurate & Comprehensive

• FAST and easy

• Self-contained (single plug)

• Configurable

• Shop floor ready

• Part scan in minutes

• Analysis results in seconds

29

What Our Clients Are Saying

"Relative to the results L3I is providing, the current CMM

and optical comparator are only a small improvement

over guesswork.“

K.J., Mfg. Engineer, Orthopaedic OEM

“Studies have proved that the Level 3 Inspections system

and method of inspection for implants is as accurate, or

better than our CMMs. Since the white light scanning

processes have the required accuracy and can cover so

much more of the feature surface, their data is a more

accurate representation of the feature true size and

form.”

I.H., Metrology Director, Orthopaedic OEM

30

Keep the Competitive Edge

1. Maintain high standards

Build quality in

2. Design & manufacture

devices that are Lighter

More reliable, longer life

Less expensive

Easier to use

3. Bring innovations to

markets sooner

31

The New Triple Constraint Model

Pick All Three with

21st Century Computer Aided Inspection

32

We are here to help you with technology

to make better parts/products faster

with lower cost and higher confidence.