Close-Loop Manufacturing in the Medical Device Industry Enable CLM and Rapid NPI with Camstar Enterprise Platform and TeamCenter Presenter: Sergio Bellisario, 24 th October 2017 1.30pm Room: Estrel Hall C1 Company: Siemens PLM @: sergio.bellisario@siemens.com
What we are going to see today What CLM with Camstar and TeamCenter Why The role of CLM is becoming crucial for the manufacturers Goal Understanding how Camstar enables the CLM Page 2
Presenter: Sergio Bellisario Segment HQ - MOM Industry Manager
Agenda 1 Where the Medical Device Industry is going? 2 What s Camstar? 3 Close-Loop Manufacturing and how Camstar implements it 4 Example: Typical Manufacturing Process 5 Key Takeaways and Q&A Page 4
Where the Medical Device Industry is going?
Market Trends & Challenges Reducing Time-to-Market Enhancing Flexibility Increasing Quality Increasing Efficiency Fast changing demand Individualized and customized products Raising product recalls Slow paper-based processes Rising product complexity Globalization & differentiation Increasing regulatory pressure Sustainability Increasing pressure from competitors Product changes Need for improved traceability and clearance Decreasing margins & inefficiencies Page 6
What s the effect of the regulation? Source: http://www.propharmagroup.com/blog/diffe rence-between-quality-and-compliance - Published July 9, 2014 Page 7
MES and FDA Case for Quality Page 8
MES Is key in the shift from compliance to quality Page 9
FDA expectations for High-Manufacturing Quality Source: USFDA as Presented at Siemens PLM Medtronic hosted Intelligent Design Control and Integrated Risk-Management Event, June 28, 2017 Page 10
What would help you improve Page 11
Key Concepts Compliance Quality Need to improve the product quality MES is key in the shift from compliance to quality FDA has recognized that 54% of recalls could be avoided by using an MES system Data Visibility Effective use of metrics and data analytics capabilities Remove the barriers Organizational culture change to Improve cross-functional team collaboration Page 12
What s Camstar?
Siemens continuously invests in the future which is increasingly Digital 1958 - Start of production automation: Siemens receives the patent for SIMATIC 1996 - Totally Integrated Automation (TIA) enables inter-operability between all automation components 2009 - TIA Portal provides access to all automation tasks 2013 - Siemens is currently the only company whose technologies combine the real and the virtual production world under one roof 2014 - Acquisition of Camstar expands strategy for Manufacturing Execution Systems (MES) 2015 / 16 - Siemens establishes leadership in product and process simulation to enable full digitalization 1958 Execution Domain (Siemens Automation) 1995/96 2001 2008 2009 2012 2013 2014 2012 2011 2016 Product development (Siemens PLM) 2007 $10+ billion in investments since 2007 Page 14
Closing the loop in digital enterprises Manufacturing Execution Systems (MES) as the keystone Closed Loop Manufacturing enables our customers to create an effective crossfunctional collaboration between product design, process planning, production execution and automation Page 15
Camstar Product Strategy Camstar Enterprise Platform TM INDUSTRY FOCUS ENTERPRISE-CLASS MOM Medical Device Semiconductor + 1 2 3 Global Manufacturing Change Mgt. Closed-Loop Manufacturing Global Performance Management Electronics 4 Global Quality Management 5 Global Product Pedigree Partner Ecosystem Enablement Page 16
Customers Future State Medical Device Industry s Status Customers Future State Paper Based Process Mainly manual operation, error prone process High Regulated Industry Slow Change Mgt., Slow NPI Compliance Quality Need to improve the product quality Healthcare Spending The System is under financial pressure. Paperless Manufacturing Eliminate slow and error prone paper-based processes Improve Flexibility Simplify the Change Management Reduce Compliance & Brand Risks Good product at the first time, reduce recall COGS % reduction Reduction of COGS 3% or more Page 17
Value of Paperless & Consistent Product Quality 41% decrease in production NCRs 65% reduction in Workmanship complaints 58% reduction in overall complaints 6% increase in productivity 1% Yield increase over lifetime of MES = $19M in savings 96% reduction of documentation errors 75% reduction in Final DHR review time Reduced scrap from 5% to 0.1% Increased Output per FTE 90% reduction in DHR review time Eliminated 75% of all errors 100% elimination of 1st and 2nd Manufacturing DHR reviews 82% reduction in Final DHR review time Reduced 20 FTE s in Dialyzer Dept. (1 FTE x 4 shifts x 5 lines) Reduced Dialyzer release time by 4 days $1.6 M in inventory reduction Page 18
Our Customers are Leaders in the MD&D Industry Page 19
Close-Loop Manufacturing Siemens s Full Picture
Siemens Camstar Siemens TeamCenter Siemens Polarion Siemens digital enterprise framework for Intelligent Design Control Requirements, Risk and V&V Mgmt User Needs Product Risk Mgmt & Design Inputs Mfg Process Risk Mgmt & Design Inputs Product Verification Mgmt Mfg Process Verification Mgmt Validation Mgmt Product Design: Data Mgmt, Simulation Mgmt & Output Mgmt Product + Mfg Process Design edhf, edmr, Technical File Mgmt Document & Change Control, Lifecycle Process Mgmt Mfg Process Design: Data Mgmt, Simulation Mgmt & Output Mgmt Design Transfer Production + Utilization Production edhr Service & Support Page 23
How Camstar implements the Close-Loop Manufacturing
Camstar Closed Loop Manufacturing Teamcenter + Teamcenter Manufacturing + CEP Engineering Domain Execution Domain Manufacturing Designer Quality Engineer Manufacturing Engineer Production Planner Production Supervisor Production Operator Quality Inspector NX TC Manufacturing Camstar Enterprise Platform Teamcenter Core Collaborative Change Management CEP Framework Page 25
Camstar-TeamCenter CLM Process Swim Lane Product Management Define Requirements, Risks and V&V plan Designer Engineering Create/Update Prod. Design & Drawing (configuration Mgt.) Manufacturing Engineering Create/Update Mfg. Product structure (mbom, Config. Mgt.) Define, Enrich & Verify Mfg. Process Plan Process Plan Verification (Run Simulation and Optimize) Approved Manufacturing Change Notice with DMR approval info Import and review non conformance Production Planning Create/Update Material Master and BoM for MRP Create/Update BOP for MRP edhr Generate Manufacturing Order Update Mfg. Order and Inventory Operation Management Create/Update Workflow Spec Workflow Sp. ok? N Enrich Product and Process Plan Submit Production Content for DMR Begin Manufacturing Review Non- Conformances (trigger CAPA) Y Shop-Floor Operator Execute Task Inspect and report issue, if any Order Completion Siemens Siemens Siemens Polarion Page 26 Camstar MES TeamCenter
Camstar Close-Loop Manufacturing Use Cases Collaborative BOP Cross-domain change management Collaborative approach between Engineering & Manufacturing to design a process for manufacturability Global change management & configuration management Options & Variants Shop Floor issue closed loop EWI harmonization Work Instructions & 3-D Visualization Ability to configure manufacturing process for the product family and dynamically apply the configured process requirements for appropriate orders Ability to take containment actions in the Shop Floor & escalate systemic problems to Engineering for corrective actions Provide necessary tools to author manufacturing work instructions consistent with design requirements Improved operator experience to access the right work instructions, 2-D & 3-D models Page 27
Example: Typical Manufacturing Process
Nanobox Assembling Page 29
Engineering Domain Page 30
Process Planning in TC Manufacturing The Nanobox is designed by using TC Manufacturing Process Planner Creation of mbom Creation of BOP structure 3D data associated to support planner in the BOP creation Creatio of EWI and 3D WI Master Data Conficuration Managing Variants Page 31
Master Data Exchange Page 32
Product Configuration and Master Data Exchange Page 33
Master Data Enrichment Page 34
Engineering Change Data Exchange Page 35 Video
Process Execution Page 36
Material Enforcement The Approved an released process is imported from TeamCenter Manufacturing (Camstar Workflow, Tasks step, BOM, Material Quantities, EWI, Revision,...) First step: Scanning the container/product against the imported BOM Page 37
Production Data Collection Electronic Work Instruction are linked to the specific Mfg. Step Second Step: Installing the Video port and measuring the screw gap. Data entry can be both manual or Automatic EWI / 3D WI defined in Team center are available within Camstar. Page 38 Video
Complete the Operation Last Step: Once the operation is compleated, the operator comments/saved pictures can be used to escalate the manifacturing issue to the designers (TeamCenter). Page 39
Review Non-Conformance Page 40
Non-Conformance Creation Camstar s Production Event A product related Non- Conformance is created Can be created either during the Manufacturing process or afterwards (e.g. in a dedicated Quality Assurance process). The previously created 2D document can be easily attached Page 41 Video
Non-Conformance Management Review and Escalate Typically a Supervisor or QA role employee has to review and enrich the Non-Conformance record and finally decide further Product processing, e.g. whether it goes on Hold, Rework or can be Released. Page 42 Video
Key Takeaways
Manufacturing Processes Open-Loop Manufacturing Close-Loop Manufacturing User Requirements Service & Support Risk & Design inputs User Requirements Risk & Design inputs Product Design Production Product Design Verification & Validation Design Outputs Mfg. Planning Design Transfer Final Product DHF Mfg. Planning Design Transfer Production Service & Support Verification & Validation Design Outputs Page 44
Close-Loop Manufacturing Open-Loop Manufacturing Key Takeaways to Close-Loop Manufacturing Reducing time-to-market Reduced manufacturing lead times and production enforcement Enhancing Flexibility IncreasingActionable manufacturing intelligence efficiency to avoid recall events Increasing quality Reduce cost of regulatory pressure by focusing on product quality Page 45 Gain competitive advantage by building higher quality new products, faster and at lower cost Increasing efficiency
Thanks! Sergio Bellisario Segment HQ - MOM Industry Manager : 13024 Ballantyne Corporate Pl, Charlotte, NC 28277 : +1 (704) 2080 270 : sergio.bellisario@siemens.com