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
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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
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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
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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.
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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
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Tungsten service provider
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Laser Powder Bed Fusion process
Laser Powder Bed Fusion
Post Processing Quality
Assurance
Powder Recycling
3D CAD File
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Separation
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Impression of facility and process (shots van movie: this powerpoint version does not contain the movie)
Tungsten Additive Manufacturing (Movie)
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Application meets technology
March 4th, 2015 Philips Healthtech
Cross-section
Scattered x-ray
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X-Ray Physics
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Real World Requirements
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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
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Large volumes
Robust processes:
• 3D printing
• Metrology
• Post Processing
Lean manufacturing (ORP):
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Layout
Process
Takt Time
Work Sequence
SOP
Sustain
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2
4 4
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Balance
Kaizen 7
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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
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March 4th, 2015 Philips Healthtech
Robust processes: Metrology
• Tactile
• Optical
• X-ray
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Robust processes: Post Processing
• Platform separation
• Surface treatment
• Heat treatment
• Machining
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Compliancy - Quality System Requirements ISO13485 – FDA 21 CFR Part 820
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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
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• Takt Time: – Customer demand production rhythm
Available production time Customer demand
Layout
Process
Takt Time
Work Sequence
SOP
Sustain
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2
4 4
5
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Balance
Kaizen 7
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7 steps to standard work
TT TT TT TT TT
TT =
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Lean manufacturing: Layout – Balance – Work sequence
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• 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
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• Balancing: – Long Cycle Times (CT) towards short Takt Time (TT)
– Operator availability ▪ Short process-operator interval ▪ Handling multiple workspots in balance
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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
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• 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
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Lean manufacturing: SOP – Sustain - Kaizen
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• 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
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Robust processes & Lean Manufacturing: Enablers for short design cycles
Customer CAD drawing
Manufacturing CAD drawing
Slicing and verification
Job preparation and building
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Measurement and evaluation
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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
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www.smitroentgen.com