Course Description:

In order to design safe and efficacious medical devices, many detailed design decisions will have to be made, documented and verified. The single most effective method to achieve a high level of safety and decrease the verification and testing effort is the correct decomposition and architecture of any system. Effective architectures not only allow achieving safe devices but also minimize the lifecycle cost of the device by reducing regression testing after changes. Smart allocation of user interface functions and separation of safety functionality will allow the use of graphical user interfaces without compromising safety or complexity.

This medical device design course will help attendees gain a basic understanding of failure types, failure modes and failure rates. Based on the failure behavior, different architectural approaches like redundancy, diversity and supervisory architectures will be discussed. Special emphasis is placed on risk and risk control allocation into architectural structures and the effect on overall design and lifecycle cost will be discussed.

This two day interactive course will also address the basic risk management methods and risk related methodologies like FMECA that significantly influence the architectural design.

Learning Objectives:

Upon completing this course on medical device safety design, participants will:

  • Understand failure rates, modes and types
  • Know methods to address different failure types
  • Be able to design basic architectures to address failure (single channel, multi-channel, hot-standby, control-monitoring)
  • Address user interface challenges in architecture
  • Understand risk analysis and FMECA (and why these methods are different) and their impact on safety

Seminar Fee Includes:

AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will benefit:

This course is designed for system engineers, project managers and R&D personnel tasked with developing cost effective yet safe medical devices. The following personnel will find this session valuable:

  • Senior quality managers
  • Compliance professionals
  • Project Managers
  • System architects
  • Software engineers
  • Design engineers
  • Quality engineers

Course Outline:

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Introduction
  2. What is Architecture?
  3. Failures as cause for hazards
    1. Overt failures
    2. Hidden (covert) failures
    3. Single fault model
  4. Random failures
    1. Stress / Strength models
    2. Design margins
    3. Failure rates
    4. Failure modes
    5. Detectability
  5. Systematic failure
    1. Root causes
    2. Avoidance strategies
  6. Architectural decomposition
    1. Allocation of functionality
    2. Allocation of risk mitigation
    3. Interfaces
  7. Channel Structures
    1. Single channel systems
    2. Multi (dual) channel systems
    3. Control / monitoring systems
  8. Common cause failures
    1. Common sources
    2. Impact and mitigation
  9. Diagnostics
    1. Start-up diagnostics
    2. Run-time diagnostics
    3. Diagnostic coverage
    4. Active vs. passive diagnostics
  10. Questions & answers / detailed discussion based on attendant’s examples

  1. Risk management concepts
    1. When to use
    2. Hazards and harms
    3. Time constraints
    4. Definition of risk control measures
    5. Effectiveness of risk control measures
    6. Weaknesses of the methodology
  2. Failure Mode and Criticality Analysis
    1. When to use (lifecycle)
    2. Qualitative / quantitative analysis
    3. Safety failure fraction
    4. Differences to risk analysis
    5. Weaknesses of the methodology
  3. Software architectures
    1. Documentation requirements
    2. How to verify software architecture?
    3. Interfaces and interference
  4. Risk based verification
    1. Allocation as driver for verification effort
    2. Interference and dependencies
    3. Lifecycle costing
  5. Practical tips and tricks
  6. Q&A

Meet Your Instructor

Markus Weber
Principal Consultant, System Safety, Inc.

Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. Mr. Weber graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, he has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices.

In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. He has helped multiple companies, from startups to Fortune 500 firms.

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

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