SlideShare a Scribd company logo
Risk Management in
Medical Device Development
Peter Haller & Kristof Horvath
13 May 2015
2
Agenda
1. Medical device safety
2. Risks in medical devices
3. Risk management lifecycle
4. HFMEA
5. Live demonstration
3
Intland Software
Webinar info
• Live demonstration will be followed
by a Q&A session
• Webinar recording will be
• available at
http://intland.com/webinars/
• Sign up for our upcoming webinars
4
o Founded in 1998
o Headquarters in Stuttgart, Germany
o Office in Silicon Valley, USA
o Our ALM solution includes:
• Requirements Management
• Software Development Management
• QA & Test Management
• Demand Management
• IT Operations (DevOps)
Intland Software
Introduction
5
Intland Software
Automotive
High Technology
Defense
Finance
Medical
Other
Our clients
6
• Patient safety a concern
• About 10% of patients harmed by medical errors (WHO)
• Errors in medical devices harm patients and manufacturers alike
(through model recalls)
• High percentage of errors caused by software failures (24% in 2011
according to FDA research)
Risk Management in Medical Device Development
Medical device safety
7
• The later you catch issues, the more expensive it's going to be to
fix them (recalls)
• Risk mgmt could help:
o Shorten time to market
o Increase product quality
o Ensure reliability and safety
• Industry regulations, standards (ISO 14971, IEC 62304, US FDA
Title 21 CFR Part 11)
Risk Management in Medical Device Development
Risks in medical devices
8
1. Risk Identification
2. Classification and Assessment
3. Hazard Analysis
4. Risk Reduction Plan
5. Risk Mitigation Actions
6. Documentation and Reporting
Risk Management in Medical Device Development
Risk management lifecycle
9
• Designed by the VA National Center for Patient Safety (NCPS)
• Combines the detectability and criticality steps of FMEA into a process
represented by a Decision Tree
• Replaces RPN with Hazard Score
Steps:
1. Define topic
2. Assemble team
3. Describe process graphically (flowchart)
4. Hazard analysis
5. Decision tree: Proceed or Stop?
Risk Management in Medical Device Development
Healthcare Failure Mode and Effects Analysis (HFMEA®)
10
Watch our live demo now!
Thank you for your attention!
Any questions?
sales@intland.com
We are looking forward to hearing from you!

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Risk Management in Medical Device Development

  • 1. Risk Management in Medical Device Development Peter Haller & Kristof Horvath 13 May 2015
  • 2. 2 Agenda 1. Medical device safety 2. Risks in medical devices 3. Risk management lifecycle 4. HFMEA 5. Live demonstration
  • 3. 3 Intland Software Webinar info • Live demonstration will be followed by a Q&A session • Webinar recording will be • available at http://intland.com/webinars/ • Sign up for our upcoming webinars
  • 4. 4 o Founded in 1998 o Headquarters in Stuttgart, Germany o Office in Silicon Valley, USA o Our ALM solution includes: • Requirements Management • Software Development Management • QA & Test Management • Demand Management • IT Operations (DevOps) Intland Software Introduction
  • 6. 6 • Patient safety a concern • About 10% of patients harmed by medical errors (WHO) • Errors in medical devices harm patients and manufacturers alike (through model recalls) • High percentage of errors caused by software failures (24% in 2011 according to FDA research) Risk Management in Medical Device Development Medical device safety
  • 7. 7 • The later you catch issues, the more expensive it's going to be to fix them (recalls) • Risk mgmt could help: o Shorten time to market o Increase product quality o Ensure reliability and safety • Industry regulations, standards (ISO 14971, IEC 62304, US FDA Title 21 CFR Part 11) Risk Management in Medical Device Development Risks in medical devices
  • 8. 8 1. Risk Identification 2. Classification and Assessment 3. Hazard Analysis 4. Risk Reduction Plan 5. Risk Mitigation Actions 6. Documentation and Reporting Risk Management in Medical Device Development Risk management lifecycle
  • 9. 9 • Designed by the VA National Center for Patient Safety (NCPS) • Combines the detectability and criticality steps of FMEA into a process represented by a Decision Tree • Replaces RPN with Hazard Score Steps: 1. Define topic 2. Assemble team 3. Describe process graphically (flowchart) 4. Hazard analysis 5. Decision tree: Proceed or Stop? Risk Management in Medical Device Development Healthcare Failure Mode and Effects Analysis (HFMEA®)
  • 10. 10 Watch our live demo now!
  • 11. Thank you for your attention! Any questions? sales@intland.com We are looking forward to hearing from you!