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NEUROMODULATION
Heart Valves
A medical device plant journey: from Lean-6 Sigma, through
Operational Excellence, to Industry
CARDIAC SURGERY
Operational Excellence, to Industry 4.0 vision
EMS Berlin, November 2018
Vittorio MorizioHead of cardiac Surgery Manufacturing and
Supply Chain
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Agenda
� Who we are: company focused on Head & Heart
� Mirandola site introduction
� Operational Excellence journey
� More to come
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manufacturing footprint: global presence with 9 sites
Vancouver
DenverMirandola
Munich,
Saluggia
Houston
Pittsburgh
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CARDIAC SURGERYNEUROMODULATION
São Paulo
Melbourne
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FOCUS ON:FOCUS ON:
MIRANDOLA PLANT
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Mirandola Plant Profile
Criteria KPI
ProductsOxygenators (WW), Perfusion Tubing Sets (EU&IC), ATS Disposables , Accessories,Cannulae
ProcessesInjection Molding, PVC Dipping, Assembly (830 equipments with PLC)
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Buildings (sqm) 44.000
Clean room (sqm) 5.800
Total Ops employees 729
Indirect 185
Direct 544
Warehouses / DC In the siteSterilization
FG warehouse
CR
Molding
CR
Off
ic
e
Off
ic
e
R&D
RM warehouse
CRMainten
ance
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Mirandola core products
Extracorporeal circulation circuitINSPIRE Oxygenator
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Oxygenators Perfusion Tubing Sets� 460.000 units/Y� 200 SKUS
• 500.000 units/Y• 6.000 SKUs
Mirandola Product Portfolio
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ATS KIT Cannulae• 500.000 units/Y• 80 SKUs
• 250.000 units/Y• 380 SKUs
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We started our Lean/ 6σ journey in 2010
We began with…The vision: improving Cost Quality Delivery, enhanc ing patients experience and saving lives, day by day
• Foundation was built defining Value streams and appointing dedicated interfunctional teams
• Massive training on tools and techniques was launched• Massive training on tools and techniques was launched
• Successful first pilots on single piece flow, U cells, Takt time, WIP and Lead Time reduction…
• 6σ implementation, addressing both molding and Assembly to get breakthrough FPY improvement
• While doing all that, involving continuously people at all level in the plant
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Lean Flow today
RM warehouseSupplier 2
Supplier 1
Sub-2Sub-1 Sub-3
eKB
eKB
eKB
CS
FIFO
CR4
MaterialPlanningMRP eKB
Mixed modelPush (20%)-Pull (80%)
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Molding
Supplier 3
CR1FG warehouse
sterilization
Mirandola
eKB
eKB
FIFO
Heijunka
Customers
Supplier x CS
CR2
CR3
7 Days LT
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Hoshin Kanri & Operational Excellence at work
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Some examples of the achievements in the last 2 years …the last 2 years …
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Automation : examples in assembly process
� Five separated manual steps into one
� 61” time reduction
� 5 FTE direct labor saving
� productivity increased from 35 to 29 sec/unit
� improved quality and safety� improved quality and safety
� 7 machines integrated by 3 robots
� 48“ time reduction
� 4 FTE direct labor saving
� standardized times and methods
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Automation : automatic palletizer and AGV
� reduced manual handling risk
� pallet height from 1,8 m to 2,4 m
� lower number of sterilization cycles
� productivity from 85” to 59” /unit
� SW connection with SCADA and AGV
� connecting CRs, sterilization and FG
warehouse
�continuous operation 24 h - 7/7
� 2 FTE indirect labor saving
� improved quality (handling damages red.)
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Automatic Optical Inspection
� Starting point : Several in-process visual checks (solid impurities, welding, gluing, plastic
chips, scratches, aesthetic marks) performed by operators
� Automatic visual inspection successfully implemented (water leak test , IAF gluing)
Welding defect observed duringanalysis
Bowl under analysisImage of oxy during water leaktest
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Predictive maintenance
Infrared camera- pilot project in 2018 (master thesis UNIMORE)
- Extension to electrical cabinets, drying machines, centrifugal potting
Vibration sensors connected to a supervision system
E-Maintenance Engineering with mobile devices
- real time work orders
- direct request for spare parts by maintenance technician
- enhanced fault tree analysis and preventive maintenance
Vibration sensors connected to a supervision system
- pilot project in 2018
- Extension to compressed and sterylized air systems
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Digitalization 4.0 + full traceabilityMES/SCADAANALYTICS
Future development
MACHINE SUPV
Yn = OK � proceedYn = KO � scrap Y1 …Yn
PREDICTIVE SPC
CLOSED LOOP
Future development
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Statistical process control
[Press]
Six sigma implementation to manage automatic components scrap based only on processparameters control (Zero dimensional control)
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[Press]
[Kistlersensor]
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OEE real time cockpit
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OEE real time details
Machine alarm : Pareto
OEE
Machine alarm : Pareto
CSV file
Availability
Efficiency
Qualty
Main KPIs available in real time on a web app
Cycle time
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Lean 4.0: eKanban
� From Excel based eKanban to global Ultriva SW package (paperless implementation)
� Real time collaborative platform � scheduling on shift basis
� Extension to all main suppliers and other Livanova plants planned in 2019
eKB ManagerPlanning Manager
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Driving operational and environmental inprovements through:
- 6S
- TQC and TPM
- KAIZEN
Operators engagement
Final award ceremony as a standard for
best improvement proposals
- KAIZEN
- Operators training
- Gemba walk
- Automatic ideas collection
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Achievements
7,4% 7,8% 5,2% 3,7% 2,5% 2,0%
14,6% 15,4%
10,1%
7,20%
4,70%3,80%
2,0%
4,0%
6,0%
8,0%
10,0%
12,0%
14,0%
16,0%
18,0%
Trend Scrap Inspire Trend Volumes & Cycle time Inspire
57921 178400 241761 314800 370000 407000
65
47,542,5
39,536,5
33,5
0
50000
100000
150000
200000
250000
300000
350000
400000
450000
0
10
20
30
40
50
60
70
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7,4% 7,8% 5,2% 3,7% 2,5% 2,0%0,0%
2013 2014 2015 2016 2017 2018
Scrap Inspire [%] Scrap BPU [%] Scrap HVR [%]
Area Suggested activities Completed activities
A1 35 22
A4-A5 190 143
A9 359 321
Total 584 486
% Completed activities 83%
0
50
100
150
200
250
300
350
400
A1 A4-A5 A9
Suggested activities
Completed activities
Suggestions/Ideas 2016-2017
00
2013 2014 2015 2016 2017 2018
Volumes [units] Cycle time [min]
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MIRANDOLA STERILIZATION FACILITY
The Sterilization facility, which uses Ethylene Oxide as sterilant agent, is one of the most fullyautomated and reliable in the world
• SAFETY: No one exposed to EO emissions
• ZERO products MANUAL handling : AGV moves pallet from assembly lines tosterilization and then to Finished Good warehouse
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sterilization and then to Finished Good warehouse
• TRACEABILITY : Sterilization and degassing process fully traced with RFID technology
• Parametric release : remove the biological indicators (Bis) use the process parameters
• ENVIRONMENT: Extremely low impact (EO emission lower than 10 times the limits byregulation)
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Green campus: tri-generation plant
� Concurrent production of electrical power, hot water, cold water, steam
� 30% saving of primary energy consumption
� Increase the eco-sustainability of the site (CO2 emissions)
� Remote control and supervision
elglobale EP
FQEEη ++=
(78-82 %)
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More to come soon …
What’s in the pipeline
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2018-2020 : acceleration to Smart factory 4.0
The vision
• Lean 6 Sigma as baseline for continuous improvement together with new technologies
• Enhanced automation
• Digitalization
- IoT, augmented reality, sensorized machines, M2M interconnection
- RFID technology expansion (real time control supply chain)
• Zero Handling, internal and external (AGV, automatic pallet creation)
• Zero “human controls”, HANDS OFF
• WORKFORCE 4.0
Impr
oven
ent
Time
Innovation
Innovation
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Cooperative robots application: solvent dispensingToday 2019
• - manual solvent dispensing
• - need specific DPI
• - cycle time and quantity not standardized
• - solvent dispensing by Cobot
• - operator performing other safer activities
• - 6 Sigma validation
• - real time traceability and in process control
• - Lean 4.0 automation system
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Automatic visual inspection in molding process
Automatic visual inspection replacing human control with higher accuracy and efficiency
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Automatic retrofit process
FEEDBACK
In-process total quality control (dimensional and aesthetical) and automatic retrofit actions in order to improve process capability
pressure curves
vision system
SYSTEMINPUT
OUTPUT