FDA and other governing bodies controlling the standards of medical devices are reaching deeper into the supply chains that support OEMs. As a result, OEMs are now re-evaluating their supplier quality strategies to ensure that every machined component and piece of raw material entering their production floor is 100 percent validated – making quality management a more complex undertaking. Evaluating material suppliers from a risk mitigation standpoint has become a challenging, and somewhat elusive, undertaking for manufacturers of medical devices. The session will answer the questions: What is risk mitigation as it applies to raw material suppliers in the medical device industry? How can orthopaedic device companies combat it?

2. Risk Mitigation
Medical Device Supplier Quality
Presented by:
David Mersereau
General Manager, Boston Centerless

3. What we will cover today…
Risk mitigation as it applies to raw material suppliers in the Medical Device industry and how
you combat it
• Material Identity, Material Integrity and Process Validation
• Supply Chain Management
• Catastrophic Event Recovery
• Material Quality and Consistency
• Quality Systems and Control Processes
• Employee training requirements to support these needs

4. What is supply chain risk?
As defined at various layers of the supply chain
• OEMs/Subcontractors
• Mid Process Material Converters
• Raw Material Distribution
• Originating Melt Source
Mitigation
• Quality and Reliability
• Lead time and availability
• Regulatory Compliance
• Price/Cost Benefits

5. What is supply chain risk?
• Guaranteed availability
• Regulatory compliance
• Protection against catastrophic interruptions
• Supplier performance and service level
• Inventory costs vs. availability
• Material cost vs. regulatory pressure
on consumer pricing
How does supply chain risk affect you?

6. What is supply chain risk?
An ever changing balancing act between costs, availability, performance and risk.
Small quantity immediate availability vs. Long term high volume cost benefits
Reduce supply chain, vendor management vs. Supply chain diversity and catastrophic event
Lowers cost providers vs. High vendor performance levels
Best material pricing vs. Elaborate regulatory compliance requirements
Managing/reducing inventory costs vs. Real time material availability
Process and material validation vs. Supply chain qualifications
Traceability and quality systems vs. Diverse material selection
Employee training and certification vs. Ever changing product types & regulatory requirements

7. What is supply chain risk?
1. Consumer Risk
2. Legal Ramifications
3. Healthcare Regulations
4. Consumer Cost Reduction Demands
5. Regulatory Approval Requirements
Supply chain requirements and regulatory concerns driven upstream into the
supply chain:
1. Design/Product Liability
2. Validated/Frozen Processes
3. Identification/Serialization
4. Material Validation
5. Traceability
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8. Supply Chain Requirements/Demands
OEM/Sub-Contract Manufacturers

9. Supply Chain Requirements/Demands
1. Quality/Reliability
i. Product consistency
1. Base material defects/Material Validation
2. Consistent component reliability
3. Device design/liability
ii. Process consistency
1. Process validation
2. Equipment validation
3. Product validation
iii. Traceability throughout the Supply Chain
1. Certifications
2. Document retention
3. Validated supply chain
4. Process and material traceability
5. Documented regulatory requirements
OEM/Sub-Contract Manufacturers

10. Supply Chain Requirements/Demands
2. Lead Time/Availability
i. Lead Time
1. Development material requirements
2. Short term availability vs. production volume lead time
3. Validate the supply chain from design to production ramp
ii. Availability
1. Short term demand vs. long term production demands
a. Sourcing specialty alloys
b. Consistent availability from the supply chain
for the life of the product
2. Reduced AVLs vs.:
a. product availability
b. supply chain diversity
c. sole source
d. supplier management
e. critical mass of supply chain
i. manage higher volumes
ii. national/international manufacturing support
OEM/Sub-Contract Manufacturers

11. Supply Chain Requirements/Demands
3. Reduced inventory vs. supply chain gaps
a. Inventory positions at key steps in the supply chain
b. Multiple suppliers
c. Risk of catastrophic event
iii. Supplier performance risk
1. Consistent performance (on time delivery and quality)
2. Broad range of capabilities
3. Broad product range
iv. Unforeseen impact on supply chain
1. International Issues
a. Natural disasters
b. Political events
c. Swings in exchange rates
2. Major interruptions in key supply chain
a. Sole source
b. Financial stability
c. Inadequate capacity to support increased demand
OEM/Sub-Contract Manufacturers

12. Supply Chain Requirements/Demands
3. Regulatory Compliance
i. Accurate document retention/life of the device
ii. Revision and liability control
iii. Appropriate mineral sourcing
4. Price/Cost Benefits
i. Product liability
1. Liability protection
2. Legal defense costs
3. Consumer risk
4. Long term health issues
OEM/Sub-Contract Manufacturers

13. Supply Chain Requirements/Demands
ii. Healthcare regulations
iii. Regulatory approval requirements
1. Identification/Serialization
2. Validated/Frozen Process
3. Qualification of replacement or added suppliers
iv. Corporate consolidation
1. Supply base consolidation vs. cost benefits
2. Suppliers critical mass to meet capacity
3. Regional support capability
4. Product diversity
OEM/Sub-Contract Manufacturers

14. Supply Chain Requirements/Demands
Mid-Process Material Converters

15. Supply Chain Requirements/Demands
1. Quality/Reliability
a. Material condition reducing downstream mfg. costs
i. Tighter finished tolerances
1. Final OD
2. Optimized machining process
3. Minimize material removal
4. Optimize process efficiency
ii. Surface finishes
1. Ability to use OD finish on finished parts
2. Part finishing considerations
iii. Material validation (NDT)
1. Internal defects prior to machining
2. Mechanical/material reliability
3. Material defect recall concerns
Mid-Process Material Converters (Raw material preparation/refining)

16. Supply Chain Requirements/Demands
b. Process Consistency
i. Operator training/certification
ii. Process validation
iii. Equipment validation
iv. Consistent supply chain capability
Mid-Process Material Converters (Raw material preparation/refining)

17. Supply Chain Requirements/Demands
2. Lead Time/Availability
a. Draw, Cut and Straighten
i. Custom diameters
ii. Mid-range tolerances
b. Mechanical Properties
i. Device specific mechanic requirements
ii. Specialized material specifications
c. Sub-Contract Services
i. Heat treat
ii. Cutting
iii. NDT
d. Less Than Mill Min. Quantities
i. Smaller quantities to meet demand
ii. Shorter lead time
iii. Inventory reduction VMI services
Mid-Process Material Converters (Raw material preparation/refining)

18. Supply Chain Requirements/Demands
3. Regulatory Compliance
a. Material Sourcing Restrictions
i. Chemical composition
1. REECH, RoHS
ii. Element Sourcing
1. Conflict minerals
iii. DFARs
1. Country of origin
b. Process Controls
i. Frozen/mature processes
ii. Defined/consistent supply chain
iii. Implant NDT requirements (i.e. F136/F138 requirements)
iv. FDA compliant
v. Appropriate ISO certifications
Mid-Process Material Converters (Raw material preparation/refining)

19. Supply Chain Requirements/Demands
4. Price, Volume, Benefit
a. Cold Draw
i. Typical coil volumes
ii. 500-1,000 lbs.
iii. Some volume and diameter flexibility
iv. Mid-range material tolerances
b. Material Preparation (i.e. grinding/subsequent processing)
i. Maximum flexibility
ii. Price vs. total cost benefits
iii. Few minimum quantity demands
iv. Cost benefit:
1. Exact quantity vs. minimums
2. Tighter tolerances for production yields
3. Surface finish vs. material removal
Mid-Process Material Converters (Raw material preparation/refining)

20. Supply Chain Requirements/Demands
c. Inventory
i. VMI (Vendor Manager Inventory)
1. Local availability
a. Benefits of distribution
b. Benefits of at/near final tolerances
2. Guaranteed supply chain
a. Supply chain inventory position
b. Minimum stock programs
c. Reduction of in-house inventory costs
ii. Reduced supply base mitigation
1. Sole source vs. key supplier diversification
2. Single site vs. inventory positions
3. Specialty material supply chain guarantee
Mid-Process Material Converters (Raw material preparation/refining)

21. Supply Chain Requirements/Demands
iii. Product availability
1. Local inventory
2. Supply chain inventory position
a. Converter inventory base
b. Coil to bar inventory base
c. Consignment position at key stages of
supply chain
Mid-Process Material Converters (Raw material preparation/refining)

22. Supply Chain Requirements/Demands
Raw Material Distribution

23. Supply Chain Requirements/Demands
1. Quality/Reliability
a. Material condition as received
i. Mill tolerances
ii. Mill variations
iii. Added material traceability step
2. Lead Time/Availability
a. Nominal diameters typical
i. Some custom availability
b. Sub-Contract service logistics
i. Heat treat
ii. Cutting
iii. NDT
iv. Grinding
Raw Material Distribution

24. Supply Chain Requirements/Demands
c. Less than mill quantities
i. Smaller quantities to meet early demand
ii. Shorter lead time
iii. Re-source material to ramp to production demands
d. Responsiveness
i. Standard requirements
1. Certification review prior to purchase
ii. Material issues
1. Middle man back to mill delays (adds a layer)
Raw Material Distribution

25. Supply Chain Requirements/Demands
3. Regulatory Compliance
a. Material sourcing restrictions
i. Chemical composition
1. REECH, RoHS
ii. Element sourcing
1. Conflict minerals
iii. DFARs
1. Country of origin
b. Mill certifications only/pass through
i. Part specific chemical/mechanical properties
ii. Certification review to meet requirements
Raw Material Distribution

26. Supply Chain Requirements/Demands
4. Price, Volume, Benefit
a. Inventory
i. VMI (Vendor Managed Inventory)
1. Local availability
2. Inventory dictates supply chain
ii. Product availability
1. Alloy product group selection
2. Reduced lead time if available
3. Off the shelf inventory
4. Limited technical service
b. Cost vs.
i. Small quantity
ii. Regional availability
Raw Material Distribution

27. Supply Chain Requirements/Demands
Originating Melting Source

28. Supply Chain Requirements/Demands
1. Quality/Reliability
a. Tolerances
i. Wide tolerances
ii. Typical nominal diameters
b. Surface quality
i. Mill surface quality
ii. Increase removal
iii. Greater potential for surface imperfections
c. Yield Impact
i. High volume lots
ii. Scrap impact down the supply chain
iii. Slower response
Originating Melting Source

29. Supply Chain Requirements/Demands
2. Lead Time/Availability
a. Lead Time
i. Long - weeks to months
ii. Fluctuate routinely
iii. Slower response time
iv. Drives inventory positions down the supply chain
b. Mill Minimums
i. Typically mill/heat volume minimums
ii. 2-5 thousand lbs.
iii. Least flexible on demand quantities
Originating Melting Source

30. Supply Chain Requirements/Demands
c. Alloy selection
i. Limited sources
1. OEM specification limits
ii. Tend to specialize in specific alloy groups
1. Stainless steel
2. Aluminum
3. Titanium
4. Red metals
d. Responsiveness
i. On time delivery
ii. Limited custom specifications
iii. Limited expedite capability
Originating Melting Source

31. Supply Chain Requirements/Demands
3. Regulatory Compliance
a. Documentation/certification
b. Mineral/raw material source control
4. Price/Cost Benefits
a. Price vs. volume benefit
i. Commodity pricing
ii. High volume
iii. Best linear price vs. high minimums
1. Volume required vs. cost
iv. Total process cost vs. commodity pricing
Originating Melting Source

32. In Conclusion…
• Material Identity, Material Integrity and Process Validation
• Supply Chain Management
• Protection Against Catastrophic Event
• Material Quality and Consistency
• Quality Systems and Control Processes
• Employee training requirements to support these needs
• Total Cost =
Liability Coverage + Material Availability + Process Efficiency + Traceability
Throughout the Supply Chain
Risk mitigation = balanced approach to:

34. THANK YOU