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Integrating HALT with the
Medical Product Life Cycle


        Mike Silverman, C.R.E.
      Managing Partner, Ops A La Carte
         mikes@opsalacarte.com
HALT
Highly Accelerated Life Testing
 used in DESIGN for Product Ruggedization
RELIABILITY INTEGRATION




     “the process of seamlessly
  cohesively integrating reliability
     tools together to maximize
    reliability and at the lowest
            possible cost”
Reliability vs. Cost
 Intuitively, one recognizes that there is some minimum total
 cost that will be achieved when an emphasis in reliability
 increases development and manufacturing costs while
 reducing warranty and in-service costs. Use of the proper
 tools during the proper life cycle phase will help to
 minimize total Life Cycle Cost (LCC).




CRE Primer by QCI, 1998
Reliability vs. Cost, continued
                             TOTAL
                             COST
              OPTIMUM        CURVE
               COST
               POINT         RELIABILITY
                             PROGRAM
                             COSTS
COST




                              WARRANTY
                              COSTS




            RELIABILITY
Reliability vs. Cost, continued


In order to minimize total Life Cycle Costs (LCC),
a Reliability Engineer must do two things:
choose the best tools from all of the tools available
and must apply these tools at the proper phases of a
product life cycle.
properly integrate these tools together to assure that
the proper information is fed forward and backwards
at the proper times.
Reliability vs. Cost, continued



As part of the integration process, we must choose a
set of tools at the heart of our program in which all
other tools feed to and are fed from. The tools we
have chosen for this are:


                 HALT and HASS
HALT and HASS Summary
Highly Accelerated Life Testing (HALT) and Highly
Accelerated Stress Screening (HASS) are two of the best
reliability tools developed to date, and every year engineers
are turning to HALT and HASS to help them achieve high
reliability.
HALT and HASS Summary,
                   continued
In HALT, a product is introduced to progressively higher
stress levels in order to quickly uncover design weaknesses,
thereby increasing the operating margins of the product,
translating to higher reliability.
In HASS, a product is “screened” at stress levels above
specification levels in order to quickly uncover process
weaknesses, thereby reducing the infant mortalities,
translating to higher quality.
HALT
Highly Accelerated
   Life Testing
HALT - Highly Accelerated
        Life Test
   Quickly discover design issues.
   Evaluate & improve design margins.
   Release mature product at market introduction.
   Reduce development time & cost.
   Eliminate design problems before release.
   Evaluate cost reductions made to product.

 Developmental HALT is not really a test you pass or fail,
 it is a process tool for the design engineers.

 There are no pre-established limits.
HALT, How It Works


   ss
 re
St


        Start low and step up the
        stress, testing the product
        during the stressing
HALT, How It Works
         Fa
            ilu
   ss          re
 re
St



          Gradually increase
          stress level until a
          failure occurs
HALT, How It Works
         Fa
            ilu
   ss          re
 re
St




               s is
            aly
          An
                      Analyze
                      the failure
HALT, How It Works
                      Fa
                         ilu
       ss                   re
     re
    St




                            s is
      Im
                         aly
           pr
                ov
                       An
Make
temporary         e
improvements
HALT, How It Works
Increase
stress and                   Fa
start
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         re s s
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          re                       re
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  Fundamental
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 Technological


                       s is
 Im Limit
                    aly
       pr
            ov
                  An
              e
HALT, Why It Works
       Classic S-N Diagram
      (stress vs. number of cycles)



                      S0= Normal Stress conditions
 S2
                      N0= Projected Normal Life

 S1

 S0



            N2       N1       N0
HALT, Why It Works
       Classic S-N Diagram
      (stress vs. number of cycles)


            Point at which failures become non-relevant

                        S0= Normal Stress conditions
 S2
                        N0= Projected Normal Life

 S1

 S0



            N2         N1        N0
Margin Improvement Process

   Lower     Lower                 Upper    Upper
  Destruct   Oper.    Product      Oper.   Destruct
   Limit     Limit   Operational   Limit    Limit
                       Specs




                      Stress
Margin Improvement Process

   Lower     Lower                 Upper    Upper
  Destruct   Oper.    Product      Oper.   Destruct
   Limit     Limit   Operational   Limit    Limit
                       Specs




                      Stress
Margin Improvement Process

   Lower     Lower                 Upper    Upper
  Destruct   Oper.    Product      Oper.   Destruct
   Limit     Limit   Operational   Limit    Limit
                       Specs




                      Stress
Margin Improvement Process

  Lower     Lower                 Upper    Upper
 Destruct   Oper.    Product      Oper.   Destruct
  Limit     Limit   Operational   Limit    Limit
                      Specs




                     Stress
Margin Improvement Process

  Lower     Lower                 Upper    Upper
 Destruct   Oper.    Product      Oper.   Destruct
  Limit     Limit   Operational   Limit    Limit
                      Specs




                     Stress
Margin Improvement Process

  Lower     Lower                 Upper    Upper
 Destruct   Oper.    Product      Oper.   Destruct
  Limit     Limit   Operational   Limit    Limit
                      Specs




                     Stress
Margin Improvement Process

 Lower     Lower                 Upper    Upper
Destruct   Oper.    Product      Oper.   Destruct
 Limit     Limit   Operational   Limit    Limit
                     Specs




                    Stress
Margin Improvement Process

 Lower     Lower    Product      Upper    Upper
Destruct   Oper.   Operational   Oper.   Destruct
 Limit     Limit     Specs       Limit    Limit

                    Destruct
                    Margin

                   Operating
                    Margin




                    Stress
Developmental HALT Process
  Planning a HALT
  Setting up for a HALT
  Executing a HALT
  Post Testing
Developmental HALT Process
 STEP 1: Planning a HALT

 Meet with design engineers to discuss product.
    – Determine stresses to apply.
    – Determine number of samples available.
    – Determine functional tests to run during Dev. HALT.
            It is essential that the product being tested be fully exercised
            and monitored throughout HALT for problem detection.

    – Determine what parameters to monitor.
    – Determine what constitutes a failure.

 Develop Test Plan
Developmental HALT Process
     For each stress, we use the
       Step Stress Approach

      Stimuli

                 Continue until operating & destruct limits
                 of UUT are found or until test equipment
                 limits are reached.

      D
      C
      B
      A

          0:00            0:10             0:20               0:30
                             Time (hour:minute)
Developmental HALT Process
    STIMULI VIBRATION          HIGH TEMP        LOW TEMP
     START    3-5 G’s             +20° C            +20° C
 INCREMENT    3-5 G’s          5 to 10° C       5 to 10° C
 DWELL TIME   10 min*          10 min*          10 min*
        END Destruct Limit or Test Equipment Limitation

          * In addition to functional test time
 OTHER STIMULI:
   • Voltage/frequency margining
   • Power cycling
   • Combined environment (Temp/Vib)
   • Rapid transitions up to 60oC/min on the product
Developmental HALT Process
 STEP 2: Setting up for HALT

 Setup
    – Design vibration fixture to ensure energy transmission to the
    product (different from electrodynamic vibration fixtures).
    – Design air ducting to ensure maximum thermal transitions on the
    product.

    – Tune chamber for product to be tested.

    – Apply thermocouples to product to be tested.

    – Setup all functional test equipment and cabling.
Developmental HALT Process
 STEP 3: Executing a HALT
 - Perform Step Stress on each individual stress
 - Then Combine Stresses together
Developmental HALT Process
 STEP 4: Post Testing

   – Determine root cause of all failures that occurred.

   – Meet with design engineers to discuss results of Developmental
   HALT and root cause analysis.

   – Determine and implement corrective action.

   – Perform Verification HALT to ensure problems fixed and new
   problems not introduced.

   – Periodically evaluate product as it is subjected to engineering
   changes.
When to Perform HALT?
Feasibility       Development          Qualification      Launch
P1- P2 →          Late P2 →            P3 →


Perform HALT      Perform HALT         ♦Demonstrate       ♦Tracking
on 1 to 2 early   on more              100% reliability   reliability
prototypes.       samples.             target @ 80%       through field
These samples     These samples        C.L.               data
may be hand-      will be closer to    ♦Shipping /
made and test     final product        Packaging test
coverage may      and functional       ♦Validation
be low, but we    tests will be        HALT can be
can still get     more refined         performed here
clues as to       with higher test
gross design      coverage.
issues.
                      Lessons learned feedback to next
                            generation product
When to Perform HALT?
Some would say that you must do in P1 in order to affect the
design.

Others would say that you cannot perform HALT until P2
when the design is more mature and functional tests are more
complete.

Still others would argue that we cannot perform HALT until
P3 during device qual.

Which is correct?
When to Perform HALT?
Both and Neither, really!

Best solution is really to do both to get the benefits of early
testing (P1) but also to test later in the design (P2) when test
coverage is higher and samples are cleaner and then use
Verification HALT to validate the design (P3).

And if we are working with a modular design, we should be
testing the subassemblies as they become ready (P1) rather
than waiting for system test at the end – may be too late.
HALT Equipment Commonly
          Used
             Combined
             Temperature/Vibration
             Equipment
             Pneumatic Vibration (to
             provide the random
             vibration) with Wide
             Frequency Spectrum
             Fast Thermal Rates of
             Change and Wide
             Thermal Range
HALT
         Cost Benefits
Reduced product time to market
Lowered warranty cost through higher MTBF
Faster DVT with fewer product samples
Accelerated screening (HASS) allowed
Words of Wisdom From IVAC...
In order to see the failure modes that
must be eliminated, we can,
Test 100 units for one
year under normal
conditions

           OR

Perform HALT on six
units for one week!      From IVAC Tympanic Thermometer Model 2090 pamphlet
Case Study: HALT on a
    Medical Infusion Pump




An infusion pump company was developing an n+1 design (they
had a product in the marketplace and this project was to upgrade
the present design, correct issues that had been discovered, and
add new features). Early in the program we determined what
was different from the previous design.
Case Study: HALT on a
        Medical Infusion Pump
We determined that the main differences between the two product
   iterations were the following:
1. A new motor technology. The previous design had one motor –
   for infusing; the new design was to have three – one for the
   infusing, one for the cassette insertion and removal, and one for
   the air sensor to pinch the tubing in order to detect air bubbles
   in the line
2. A new power supply
3. A touch screen
4. An 802.11 wireless feature
5. A new battery design to allow for longer total life
6. New software to handle all of these new features
Case Study: HALT on a
     Medical Infusion Pump
We then performed an FMEA on each of these subsystems and
determined which testing method was most appropriate for
proving the new subsystem.
For items 1, 3, and 5, we felt that ALT was the best approach
and for items 2 and 4, we felt that HALT was a better test
vehicle. For item 6, we decided that the best approach was to
perform a Software FMEA followed by a rigorous review of the
requirements followed by development of test cases to exercise
the requirements.
Thank You for Listening !

Mike’s book on reliability titled
  “50 Ways to Improve Your
      Product Reliability”
   is due out in the spring.
               CONTACT INFO:
            Mike Silverman, C.R.E.
          Managing Partner, Ops A La Carte
             mikes@opsalacarte.com
                  (408) 472-3889

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Integrating HALT with Medical Product Life Cycle

  • 1. Integrating HALT with the Medical Product Life Cycle Mike Silverman, C.R.E. Managing Partner, Ops A La Carte mikes@opsalacarte.com
  • 2. HALT Highly Accelerated Life Testing used in DESIGN for Product Ruggedization
  • 3. RELIABILITY INTEGRATION “the process of seamlessly cohesively integrating reliability tools together to maximize reliability and at the lowest possible cost”
  • 4. Reliability vs. Cost Intuitively, one recognizes that there is some minimum total cost that will be achieved when an emphasis in reliability increases development and manufacturing costs while reducing warranty and in-service costs. Use of the proper tools during the proper life cycle phase will help to minimize total Life Cycle Cost (LCC). CRE Primer by QCI, 1998
  • 5. Reliability vs. Cost, continued TOTAL COST OPTIMUM CURVE COST POINT RELIABILITY PROGRAM COSTS COST WARRANTY COSTS RELIABILITY
  • 6. Reliability vs. Cost, continued In order to minimize total Life Cycle Costs (LCC), a Reliability Engineer must do two things: choose the best tools from all of the tools available and must apply these tools at the proper phases of a product life cycle. properly integrate these tools together to assure that the proper information is fed forward and backwards at the proper times.
  • 7. Reliability vs. Cost, continued As part of the integration process, we must choose a set of tools at the heart of our program in which all other tools feed to and are fed from. The tools we have chosen for this are: HALT and HASS
  • 8. HALT and HASS Summary Highly Accelerated Life Testing (HALT) and Highly Accelerated Stress Screening (HASS) are two of the best reliability tools developed to date, and every year engineers are turning to HALT and HASS to help them achieve high reliability.
  • 9. HALT and HASS Summary, continued In HALT, a product is introduced to progressively higher stress levels in order to quickly uncover design weaknesses, thereby increasing the operating margins of the product, translating to higher reliability. In HASS, a product is “screened” at stress levels above specification levels in order to quickly uncover process weaknesses, thereby reducing the infant mortalities, translating to higher quality.
  • 10. HALT Highly Accelerated Life Testing
  • 11. HALT - Highly Accelerated Life Test Quickly discover design issues. Evaluate & improve design margins. Release mature product at market introduction. Reduce development time & cost. Eliminate design problems before release. Evaluate cost reductions made to product. Developmental HALT is not really a test you pass or fail, it is a process tool for the design engineers. There are no pre-established limits.
  • 12. HALT, How It Works ss re St Start low and step up the stress, testing the product during the stressing
  • 13. HALT, How It Works Fa ilu ss re re St Gradually increase stress level until a failure occurs
  • 14. HALT, How It Works Fa ilu ss re re St s is aly An Analyze the failure
  • 15. HALT, How It Works Fa ilu ss re re St s is Im aly pr ov An Make temporary e improvements
  • 16. HALT, How It Works Increase stress and Fa start ilu re s s process e) re re as over St ( inc s is Im aly pr ov An e
  • 17. HALT, How It Works Fa ilu re s s e) re re as St ( inc s is Im aly pr ov An e
  • 18. HALT, How It Works Fa ilu re s s e) re re as St ( inc s is Im aly pr ov An e
  • 19. HALT, How It Works Fa ilu re s s e) re re as St ( inc s is Im aly pr ov An e
  • 20. HALT, How It Works Fa ilu re s s e) re re as St ( inc s is Im aly pr ov An e
  • 21. HALT, How It Works Fa ilu re s s e) re re as St ( inc s is Im aly pr ov An e
  • 22. HALT, How It Works Fa ilu re s s e) re re as St ( inc s is Im aly pr ov An e
  • 23. HALT, How It Works Fa ilu re s s e) re re as St ( inc s is Im aly pr ov An e
  • 24. HALT, How It Works Fa ilu re s s e) re re as St inc Fundamental ( Technological s is Im Limit aly pr ov An e
  • 25. HALT, Why It Works Classic S-N Diagram (stress vs. number of cycles) S0= Normal Stress conditions S2 N0= Projected Normal Life S1 S0 N2 N1 N0
  • 26. HALT, Why It Works Classic S-N Diagram (stress vs. number of cycles) Point at which failures become non-relevant S0= Normal Stress conditions S2 N0= Projected Normal Life S1 S0 N2 N1 N0
  • 27. Margin Improvement Process Lower Lower Upper Upper Destruct Oper. Product Oper. Destruct Limit Limit Operational Limit Limit Specs Stress
  • 28. Margin Improvement Process Lower Lower Upper Upper Destruct Oper. Product Oper. Destruct Limit Limit Operational Limit Limit Specs Stress
  • 29. Margin Improvement Process Lower Lower Upper Upper Destruct Oper. Product Oper. Destruct Limit Limit Operational Limit Limit Specs Stress
  • 30. Margin Improvement Process Lower Lower Upper Upper Destruct Oper. Product Oper. Destruct Limit Limit Operational Limit Limit Specs Stress
  • 31. Margin Improvement Process Lower Lower Upper Upper Destruct Oper. Product Oper. Destruct Limit Limit Operational Limit Limit Specs Stress
  • 32. Margin Improvement Process Lower Lower Upper Upper Destruct Oper. Product Oper. Destruct Limit Limit Operational Limit Limit Specs Stress
  • 33. Margin Improvement Process Lower Lower Upper Upper Destruct Oper. Product Oper. Destruct Limit Limit Operational Limit Limit Specs Stress
  • 34. Margin Improvement Process Lower Lower Product Upper Upper Destruct Oper. Operational Oper. Destruct Limit Limit Specs Limit Limit Destruct Margin Operating Margin Stress
  • 35. Developmental HALT Process Planning a HALT Setting up for a HALT Executing a HALT Post Testing
  • 36. Developmental HALT Process STEP 1: Planning a HALT Meet with design engineers to discuss product. – Determine stresses to apply. – Determine number of samples available. – Determine functional tests to run during Dev. HALT. It is essential that the product being tested be fully exercised and monitored throughout HALT for problem detection. – Determine what parameters to monitor. – Determine what constitutes a failure. Develop Test Plan
  • 37. Developmental HALT Process For each stress, we use the Step Stress Approach Stimuli Continue until operating & destruct limits of UUT are found or until test equipment limits are reached. D C B A 0:00 0:10 0:20 0:30 Time (hour:minute)
  • 38. Developmental HALT Process STIMULI VIBRATION HIGH TEMP LOW TEMP START 3-5 G’s +20° C +20° C INCREMENT 3-5 G’s 5 to 10° C 5 to 10° C DWELL TIME 10 min* 10 min* 10 min* END Destruct Limit or Test Equipment Limitation * In addition to functional test time OTHER STIMULI: • Voltage/frequency margining • Power cycling • Combined environment (Temp/Vib) • Rapid transitions up to 60oC/min on the product
  • 39. Developmental HALT Process STEP 2: Setting up for HALT Setup – Design vibration fixture to ensure energy transmission to the product (different from electrodynamic vibration fixtures). – Design air ducting to ensure maximum thermal transitions on the product. – Tune chamber for product to be tested. – Apply thermocouples to product to be tested. – Setup all functional test equipment and cabling.
  • 40. Developmental HALT Process STEP 3: Executing a HALT - Perform Step Stress on each individual stress - Then Combine Stresses together
  • 41. Developmental HALT Process STEP 4: Post Testing – Determine root cause of all failures that occurred. – Meet with design engineers to discuss results of Developmental HALT and root cause analysis. – Determine and implement corrective action. – Perform Verification HALT to ensure problems fixed and new problems not introduced. – Periodically evaluate product as it is subjected to engineering changes.
  • 42. When to Perform HALT? Feasibility Development Qualification Launch P1- P2 → Late P2 → P3 → Perform HALT Perform HALT ♦Demonstrate ♦Tracking on 1 to 2 early on more 100% reliability reliability prototypes. samples. target @ 80% through field These samples These samples C.L. data may be hand- will be closer to ♦Shipping / made and test final product Packaging test coverage may and functional ♦Validation be low, but we tests will be HALT can be can still get more refined performed here clues as to with higher test gross design coverage. issues. Lessons learned feedback to next generation product
  • 43. When to Perform HALT? Some would say that you must do in P1 in order to affect the design. Others would say that you cannot perform HALT until P2 when the design is more mature and functional tests are more complete. Still others would argue that we cannot perform HALT until P3 during device qual. Which is correct?
  • 44. When to Perform HALT? Both and Neither, really! Best solution is really to do both to get the benefits of early testing (P1) but also to test later in the design (P2) when test coverage is higher and samples are cleaner and then use Verification HALT to validate the design (P3). And if we are working with a modular design, we should be testing the subassemblies as they become ready (P1) rather than waiting for system test at the end – may be too late.
  • 45. HALT Equipment Commonly Used Combined Temperature/Vibration Equipment Pneumatic Vibration (to provide the random vibration) with Wide Frequency Spectrum Fast Thermal Rates of Change and Wide Thermal Range
  • 46. HALT Cost Benefits Reduced product time to market Lowered warranty cost through higher MTBF Faster DVT with fewer product samples Accelerated screening (HASS) allowed
  • 47. Words of Wisdom From IVAC... In order to see the failure modes that must be eliminated, we can, Test 100 units for one year under normal conditions OR Perform HALT on six units for one week! From IVAC Tympanic Thermometer Model 2090 pamphlet
  • 48. Case Study: HALT on a Medical Infusion Pump An infusion pump company was developing an n+1 design (they had a product in the marketplace and this project was to upgrade the present design, correct issues that had been discovered, and add new features). Early in the program we determined what was different from the previous design.
  • 49. Case Study: HALT on a Medical Infusion Pump We determined that the main differences between the two product iterations were the following: 1. A new motor technology. The previous design had one motor – for infusing; the new design was to have three – one for the infusing, one for the cassette insertion and removal, and one for the air sensor to pinch the tubing in order to detect air bubbles in the line 2. A new power supply 3. A touch screen 4. An 802.11 wireless feature 5. A new battery design to allow for longer total life 6. New software to handle all of these new features
  • 50. Case Study: HALT on a Medical Infusion Pump We then performed an FMEA on each of these subsystems and determined which testing method was most appropriate for proving the new subsystem. For items 1, 3, and 5, we felt that ALT was the best approach and for items 2 and 4, we felt that HALT was a better test vehicle. For item 6, we decided that the best approach was to perform a Software FMEA followed by a rigorous review of the requirements followed by development of test cases to exercise the requirements.
  • 51. Thank You for Listening ! Mike’s book on reliability titled “50 Ways to Improve Your Product Reliability” is due out in the spring. CONTACT INFO: Mike Silverman, C.R.E. Managing Partner, Ops A La Carte mikes@opsalacarte.com (408) 472-3889