Getting Additive Manufacturing ready for large … Additive...Getting Additive Manufacturing Ready...

Getting Additive Manufacturing Ready for Large Volumes Peter Hoogerhuis Philips Healthtech March 4th, 2015

March 4th, 2015 Philips Healthtech

• Introduction

• Tungsten 3D printing

• Application meets technology

• Large volumes

• Process

• Lean Manufacturing

• Practices

2

Philips Healthtech

34% Imaging Systems

28% Customer Services

6% Healthcare Informatics, Solutions &

Services

32% Patient Care &

Monitoring Solutions

37,000+ people worldwide in 100+ countries

€ 9.2 billion sales in 2014

450+ products and services in 100+ countries

9% of sales invested in R&D in 2014

1 Based on sales last 12 months December 2014

3 March 4th, 2015 Philips Healthtech

Making a difference in health

1,000,000 patients monitored in their homes every day

in emerging markets around the world now have access to Philips diagnostic imaging

190 million patients tracked with our patient monitors last year

100+ years of listening deeply to customers to understand what really matters

4 million+ people sleep and breathe easier using our sleep aids

+970 million people 10 petabytes of data managed for health care providers

Present in

100 countries with 450+ products and services

4 March 4th, 2015 Philips Healthtech

March 4th, 2015 Philips Healthtech

Smit Röntgen • Part of Philips Healthtech Business Unit Generators, Tubes & Components

• Leading OEM grid supplier • Founded in 1930’s • R&D – Manufacturing – Sales • Located at Healthtech Campus in

Best, The Netherlands • Serving both healthcare and

non-healthcare customers.

5

www.smitroentgen.com

March 4th, 2015 Philips Healthtech

Tungsten 3D printing

History • Started in 2007

– Joint development with EOS

• Post processing development

– Platform separation

– Surface treatment

• Product verification & qualification

equipment

Equipment • 2 Tungsten Laser Powder Bed Fusion

printers

• Platform separation equipment

• Laser marking

• Optical, tactile and X-ray quality

inspection tooling

6

Tungsten service provider

March 4th, 2015 Philips Healthtech

Laser Powder Bed Fusion process

Laser Powder Bed Fusion

Post Processing Quality

Assurance

Powder Recycling

3D CAD File

7

Separation

March 4th, 2015 Philips Healthtech

Impression of facility and process (shots van movie: this powerpoint version does not contain the movie)

Tungsten Additive Manufacturing (Movie)

8

March 4th, 2015 Philips Healthtech 9

Application meets technology

March 4th, 2015 Philips Healthtech

Cross-section

Scattered x-ray

10

X-Ray Physics

March 4th, 2015 Philips Healthtech 11

Real World Requirements

March 4th, 2015 Philips Healthtech

Capabilities

• Material: Pure tungsten (melting temperature 3420oC)

• Thinnest Wall thickness < 100mu

• Dimensional accuracy < 25mu

• Density up to 97-98%

• Build platform 23x23x20cm

• ISO 13485 certified

• Prepared for large volume manufacturing

10000-40000 pc/yr

12

March 4th, 2015 Philips Healthtech

Large volumes

Robust processes:

• 3D printing

• Metrology

• Post Processing

Lean manufacturing (ORP):

13

Layout

Process

Takt Time

Work Sequence

SOP

Sustain

1

2

4 4

5

6

Balance

Kaizen 7

3

7 steps to standard work

Compliancy

March 4th, 2015 Philips Healthtech

Robust processes: 3D printing

• Powder development

• Optics and mechanics

• Process settings

• Long term behavior

• Material characteristics

14

March 4th, 2015 Philips Healthtech

Robust processes: Metrology

• Tactile

• Optical

• X-ray

15

March 4th, 2015 Philips Healthtech

Robust processes: Post Processing

• Platform separation

• Surface treatment

• Heat treatment

• Machining

16

March 4th, 2015 Philips Healthtech

Compliancy - Quality System Requirements ISO13485 – FDA 21 CFR Part 820

17

Master Validation Plan

Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.

Identification and traceability

Calibration

Process Validation

March 4th, 2015 Philips Healthtech

Lean manufacturing: Process – Takt Time

18

• Takt Time: – Customer demand production rhythm

Available production time Customer demand

Layout

Process

Takt Time

Work Sequence

SOP

Sustain

1

2

4 4

5

6

Balance

Kaizen 7

3

7 steps to standard work

TT TT TT TT TT

TT =

March 4th, 2015 Philips Healthtech

Lean manufacturing: Layout – Balance – Work sequence

19

• Layout: U-shaped process/product flow

– Cell design (multiple work spots within short distances) – Still room for growth

March 4th, 2015 Philips Healthtech

Lean manufacturing: Layout – Balance – Work sequence

20

• Balancing: – Long Cycle Times (CT) towards short Takt Time (TT)

– Operator availability ▪ Short process-operator interval ▪ Handling multiple workspots in balance

0

10

20

30

40

50

60

70

EOS Laser Marking EDM Inspection

Min

utes

Yamazumi - balancing

CT

TT

One piece flow impossible Batch production

March 4th, 2015 Philips Healthtech

Lean manufacturing: Layout – Balance – Work sequence

21

• Work sequence: – Device Master Record (DMR) – Customer specific

– Manufacturing Execution System (ORP) ▪ Work sequence based on part number ▪ Identification, Tracking & Tracing of parts ▪ Reporting

Multiple customers Multiple parts Multiple machines

March 4th, 2015 Philips Healthtech

Lean manufacturing: SOP – Sustain - Kaizen

22

• SOP - Standard Operating Procedures – Describes the best practice – Starting point for continuous improvement

• Sustain & Kaizen ▪ Kamishibai ▪ DMAIC

Layout

Process

Takt Time

Work Sequence

SOP

Sustain

1

2

4 4

5

6

Balance

Kaizen 7

3

7 steps to standard work

March 4th, 2015 Philips Healthtech

Robust processes & Lean Manufacturing: Enablers for short design cycles

Customer CAD drawing

Manufacturing CAD drawing

Slicing and verification

Job preparation and building

23

Measurement and evaluation

March 4th, 2015 Philips Healthtech 24

March 4th, 2015 Philips Healthtech 25

March 4th, 2015 Philips Healthtech

26

March 4th, 2015 Philips Healthtech 27

March 4th, 2015 Philips Healthtech

Take-aways

• Additive metal manufacturing .... beyond the stage of rapid prototyping

…. prepared for large volumes

• Lean manufacturing …. principles are directly embedded during production ramp-up …. standard work for large volumes …. eliminate waste and optimize added value

• In-house inspection tooling, measurement equipment

…. needed for fast feedback, short design cycle

• Monitor your business case …. impact of post-processing

28

March 4th, 2015 Philips Healthtech 29

www.smitroentgen.com

Thanks for your attention

www.philips.com www.smitroentgen.com

p.hoogerhuis@philips.com