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This presentation was originally 
    conducted by Pete Davis of 
   Neomend at the MD&M West 
     Conference, Feb 11 2013.  

VISIT HERE for the full presentation.
To err is human

           Pete Davis
  VP of Research & Development
Neomend a subsidiary of Bard Davol




                1
Really – an R&D guy
  presenting risk
    analyses??



         2
Risks exist because perfection doesn’t!




                   3
Communicating to
Management the Value of
   Risk Management




           4
Risk Analysis Steps

• Why Risk Management
• Why ―Communicate‖
•   Doing a Hazard Analysis...quickly

• How to ―Communicate‖ to ―Them‖




                          5
What is important


• It’s about the Specs!
• “A problem well defined is a
 problem half solved.”
  • John Dewey




                  6
What does Quality ―control‖?




             7
Quality
• Does not Design.
• Does not Manufacture.
• Does not Distribute.
• Use? Possibly.
• Words – No.
• Control? Yes.


                         8
Again, what does quality
       ―control‖?




           9
Think about these?




        10
Any impact on

• Customers
• Patients
• Business
• Environment

                11
Thoughts?



    12
Writing Instrument Standards
     • ISO 11540:1993 - Caps for writing and marking instruments
H      intended for use by children up to 14 years of age -- Safety
i      requirements

g       • Specifies safety requirements for cap size, ventilated caps
           (vent area, air flow) and marking. Annex A describes the
h          test for air flow. Caps which do not comply should have
l          the instrument or its packaging labelled with a warning as
           to the dangers of asphyxiation from pen caps.
i
     • ASTM D4236 - 94(2005) Standard Practice for Labeling Art
g      Materials for Chronic Health Hazards
h       • Scope 1, 1.1... chronic health hazards known to be
t          associated with a product or product component(s), when
           the component(s) is present in a physical form, volume, or
e          concentration that in the opinion of a toxicologist (see
r          2.1.11) has the potential to produce a chronic adverse
           health effect(s).


                                  13
Importance of Risk Management
 •   Prepare and respond to your Customers!
 •   Business strategy
 •   Business security
 •   Provide a Competitive advantage
 •   Communicate information
     •   Good news
     •   Bad news
 • Not counting everything else
    – Regulatory requirement
                           14
Evolving Process
100%

90%

80%

70%

60%

50%

40%

30%

20%

10%

 0%
         Feasiblity Prototyping Development Clincal Trial    Distribution   Post-Market
       and Research                                                         Survellance

                                  Known     Unknown = Risk


           Risk needs a multi-functional approach!
                                       15
New requirements

• Medical Device Directive 93/42/EEC (M5)
  • Add’s Usability - See Annex I, 1st paragraph
     • Subset of Risk Management
     • EC 62366 - Medical devices -- Application
       of usability engineering to medical devices




                        16
Structure
Design (ISO     Usability (EC        Process (ISO
  14971)          62366)                14971)



                 New Risks?



                 Risk Analysis
                    process



              Mitigation & Control

                      17
This presentation was originally 
    conducted by Pete Davis of 
   Neomend at the MD&M West 
     Conference, Feb 11 2013.  

VISIT HERE for the full presentation.

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Preview medtech riskanalysis

  • 1. This presentation was originally  conducted by Pete Davis of  Neomend at the MD&M West  Conference, Feb 11 2013.   VISIT HERE for the full presentation.
  • 2. To err is human Pete Davis VP of Research & Development Neomend a subsidiary of Bard Davol 1
  • 3. Really – an R&D guy presenting risk analyses?? 2
  • 4. Risks exist because perfection doesn’t! 3
  • 5. Communicating to Management the Value of Risk Management 4
  • 6. Risk Analysis Steps • Why Risk Management • Why ―Communicate‖ • Doing a Hazard Analysis...quickly • How to ―Communicate‖ to ―Them‖ 5
  • 7. What is important • It’s about the Specs! • “A problem well defined is a problem half solved.” • John Dewey 6
  • 8. What does Quality ―control‖? 7
  • 9. Quality • Does not Design. • Does not Manufacture. • Does not Distribute. • Use? Possibly. • Words – No. • Control? Yes. 8
  • 10. Again, what does quality ―control‖? 9
  • 12. Any impact on • Customers • Patients • Business • Environment 11
  • 13. Thoughts? 12
  • 14. Writing Instrument Standards • ISO 11540:1993 - Caps for writing and marking instruments H intended for use by children up to 14 years of age -- Safety i requirements g • Specifies safety requirements for cap size, ventilated caps (vent area, air flow) and marking. Annex A describes the h test for air flow. Caps which do not comply should have l the instrument or its packaging labelled with a warning as to the dangers of asphyxiation from pen caps. i • ASTM D4236 - 94(2005) Standard Practice for Labeling Art g Materials for Chronic Health Hazards h • Scope 1, 1.1... chronic health hazards known to be t associated with a product or product component(s), when the component(s) is present in a physical form, volume, or e concentration that in the opinion of a toxicologist (see r 2.1.11) has the potential to produce a chronic adverse health effect(s). 13
  • 15. Importance of Risk Management • Prepare and respond to your Customers! • Business strategy • Business security • Provide a Competitive advantage • Communicate information • Good news • Bad news • Not counting everything else – Regulatory requirement 14
  • 16. Evolving Process 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Feasiblity Prototyping Development Clincal Trial Distribution Post-Market and Research Survellance Known Unknown = Risk Risk needs a multi-functional approach! 15
  • 17. New requirements • Medical Device Directive 93/42/EEC (M5) • Add’s Usability - See Annex I, 1st paragraph • Subset of Risk Management • EC 62366 - Medical devices -- Application of usability engineering to medical devices 16
  • 18. Structure Design (ISO Usability (EC Process (ISO 14971) 62366) 14971) New Risks? Risk Analysis process Mitigation & Control 17
  • 19. This presentation was originally  conducted by Pete Davis of  Neomend at the MD&M West  Conference, Feb 11 2013.   VISIT HERE for the full presentation.