Reliability in Medical Domain
VIT Training
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Agenda
 HCL Reliability capabilities – Medical Domain
 Stages of Medical device life span
 Medical device classifications
 Risk Management
 PMS
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HCL Reliability Capabilities – Medical Domain
•
•
•
•
•
•
Reliability Plan & Approach
Reliability Allocation
Reliability Prediction / Physics of failure
Preliminary Hazard Analysis(PHA)
Fault Tree Analysis (FTA)
FMEA / FMECA
•
•
•
•
Design FMEA
Functional FMEA
Process FMEA
Application FMEA
• Reliability Estimation from Failure Data
• Warranty Analysis
• Statistical Analysis Support
• Cp & Cpk Study
• Gage R&R Study
• DoE Studies
Reliable & Safe Design
• Environmental Test
Compliance to reliability
and safety requirements
for certification
• Reliability Testing - Reliability Growth Testing,
ESS, ALT, HALT
SW
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Relex (FMEA, FTA, Prediction), Reliasoft (Bolcksim, Weibull++7, Alta Pro, MPC3), Cafta
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Global Harmonization Task Force Medical Device Definition
 “Medical device” means any instrument, apparatus, implement, machine, appliance, implant, in vitro
reagent or calibrator, software, material or other similar or related article, intended by the manufacturer
to be used, alone or in combination, for human beings for one or more of the specific purposes of:
 diagnosis, prevention, monitoring, treatment or alleviation of disease
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury
 investigation, replacement, modification, or support of the anatomy or of a
 physiological process
 supporting or sustaining life
 control of conception
 disinfection of medical devices
 providing information for medical purposes by means of in vitro examination of specimens derived from the
human body
 and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means.
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Medical Devices Life Span
Major phases in the life span of a medical device
Stages of a medical device life span (WHO, 2003)
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Ideal conditions for ensuring the safety and performance of medical devices
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Common framework for medical device regulations
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Tools and general requirements of the five members of the GHTF
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Quality system standards used by different authorities
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Medical Device Regulatory Authority
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Country
Name of Regulatory Authority
USA
Food and Drug Administration (FDA)
UK
Medicines and Healthcare Products Regulatory Agency (MHRA)
Australia
Therapeutic Goods Administration (TGA)
India
Central Drug Standard Control Organization (CDSCO)
Canada
Health Canada
Europe
European Medicines Agency (EMEA)
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Medical device regulatory requirements
FDA’s QSRs: Title 21 CFR Part 820, esp. 820.30
European Union’s MDD 93/42/EEC
ISO 13485 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO 14971 Medical Devices – Application of Risk Management to Medical Devices
ISO/TR 14969, Medical devices — Quality management systems — Guidance on the application of ISO
13485:2003
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
IEC 62304:2006 Medical Device Software – Software Life Cycle processes
IEC 62366:2007 Medical Devices – Application of Usability Engineering to Medical
Devices
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2018 HCL Technologies Limited | www.hcltech.com
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Medical Device Classification - FDA
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Device Classification / Risk Levels
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Device
classification
Risk Level
Class III
High
Class II
Moderate
Class I
Low
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Medical Device Classification in USA
 Medical devices are classified based on the risks associated with the use of the device. Devices are
classified as Class I, Class II, or Class III, with Class I being the lowest risk and Class III the highest risk.
 Class I – These are devices that present minimal potential for harm to the user. Examples include enema
kits and elastic bandages. 35% of medical device types are Class I and and 93% of these are exempt from
pre-market review.
 Class II –These are devices that generally present a moderate risk of harm to the user. Examples of Class
II devices include powered wheelchairs and some pregnancy test kits. 53% of device types are Class II,
most of which require FDA review through premarket notification (510(k)).
 Class III – These are devices that sustain or support life, are implanted, or present potential high risk of
illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 9% of
device types are Class III and require FDA review through premarket approval (PMA) or humanitarian
device exemption (HDE).
 Unclassified/Not classified – These are device types that FDA has not yet classified. 3% of device types
are unclassified/not classified..
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Medical Devices Regulated in the United States
 Premarket Notification [510(k)] – submission required to demonstrate that the device is substantially
equivalent to a device already placed into one of the three device classifications before it is marketed.
 Premarket Approval (PMA) – application required to demonstrate that the device is safe and effective
when used. It is the most stringent type of device marketing application and is required for Class III
devices.
 Humanitarian Device Exemption (HDE) – a marketing application for a Humanitarian Use Device (HUD).
An HUD is a medical device that is intended to benefit patients in the treatment or diagnosis of a disease
or condition that affects, or is manifested in not more than 8,000 individuals in the United States per
year.
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Medical Device Classification across the globe
Risk Level
India
Australia
Canada
EU
Japan
USA
Low
A
I
I
I
General
I
Low-Moderate
B
IIa
II
IIa
Controlled
II
Moderate-High C
IIb
III
IIb
High
III
IV
III
Highly
Controlled
III
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D
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Design Strategy – Waterfall model
FEASIBILITY
PHASE
Specification
DESIGN & DEVELOPMENT
Feasibility
SW & HW
Detail Design
PRODUCTION IN-SERVICE
Prototype
Development
Production
Field Use
Figure 1 – Application of Design Controls to Waterfall Design Process (figure used with
permission of Medical Devices Bureau, Health Canada)
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Why Risk Management?
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Evolution of Risk Management
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ISO 14971 - Medical devices –
Application of risk management to medical devices
Scope:
 Specifies a process for a manufacturer to identify the hazards associated with medical
devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the
associated
 risks, to control these risks, and to monitor the effectiveness of the controls.
 Applicable to all stages of the life-cycle of a medical device.
 Does not apply to clinical decision making.
 Does not specify acceptable risk levels.
 Does not require that the manufacturer have a quality management system in place.
However, risk management can be an integral part of a quality management system.
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Terms and definitions
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Terms and definitions
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Terms and definitions
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Terms and definitions
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Terms and definitions
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Terms and definitions
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Terms and definitions
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Terms and definitions
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Terms and definitions
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Risk Management Plan
 Scope of the plan
 Responsibilities and authorities
 Criteria for acceptability
 Process of collecting post production information
 Record of changes
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Risk Management File
 Risk Management file shall provide traceability for each identified hazard to:
 The risk analysis
 The risk evaluation
 The implementation and effectiveness of the risk control measures
 The evaluation of the acceptability of any residual risks
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Elements of Risk Management
4 elements of Risk Management are
⎯ risk analysis;
⎯ risk evaluation;
⎯ risk control;
⎯ production and post-production information.
Risk Management Process
Identify
hazards
Monitor the
effectiveness
of the controls
Estimate Risk
Control Risk
Evaluate Risk
Conception
Disposal
Life Cycle
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Schematic representation of the risk management process
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Hazardous Situation
Hazard
Hazard
Risk
Exposure
Hazardous Situation
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Risk Analysis Process
 Intended use / Identification of product and functional characteristics related to safety of the medical
device.
 Identification of device related hazards.
 Estimation of device related to hazards.
 First Identify the hazard (Potential source of harm).
 Next, Identify the hazardous situation (Circumstance in which people, property (or) the environment are
exposed to one (or) more hazard).
 With these information, define the foreseeable sequence of events (and their probabilities) that may
lead to harm.
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Examples of hazards – Annex E (ISO 14971)
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Examples of initiating events and circumstances - Annex E (ISO 14971)
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Relationship between hazards, foreseeable sequences of events,
hazardous situations and the harm that can occur - Annex E (ISO 14971)
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Risk
Risk = f
{P
Harm
, SHarm
}
PHarm = Probability of occurrence of Harm
SHarm = Severity of that Harm
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Qualitative Severity Level
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Semi-quantitative analysis
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Risk Evaluation & Risk Acceptability
 International Standard does not specify acceptable risk.
 Risk Acceptability criteria decided by Manufacturer.
 Criteria is defined in RM plan.
 Estimated Risk is low, Risk reduction need not be pursued.
 Else, Risk reduction shall be performed.
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Example of a three-region evaluation matrix
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Risk Evaluation
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Risk Control – Option Analysis
 Designing for inherent safety
 Protective measures in the medical device or manufacturing process
 Information for safety
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Examples of Risk control measures
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Overview of risk management activities as applied to medical devices
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Post Market Surveillance Data Analysis
Challenges:
•
Failure trend and monitoring between product variants
•
Money incurred on the products during service and warranty
•
Minimum inventory level at warehouses at different Geographical locations
•
Relationship between the product failures and trends (Geos, abnormalities,
manufacturing changes, use errors etc.,)
•
Mapping PMS trends to gage the effectiveness of risk controls
•
Calibration of product risk thresholds and risk profile
Risk Analysis
Risk
Evaluation
Risk Control
Risk Estimation
Occurrence of
Harm (P1)
Evaluation of
Overall Residual
Risk Acceptability
Risk
Management
Report
Risk Criteria –
Product Threshold
Monitor Complaint
Trends
Product
Performance
Between
Competitors
Probability
Estimation
from Clinical
Data
Severity
Occurrence
Product
Performance
Between
Variants
Vital Few
Contributors
PMS
Complaints
Violations from
Specification Limit
Severity of
Harm (P2)
Risk
Probability
Estimation
from Product
Complaint Data
Production and
Post-Production
Information
Product
Performance @
Different
Geographical
Locations
Product
Failures
@
Different
Time
period
Complaints
Violations from
Specification Limit
Post Market Surveillance Data
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Presentation prepared for
Example: Aftermarket Reliability Analysis for Insulin Pump
Business Need
• To study the field
performance of insulin
pump and reduce the field
compliance.
Project Scope
• To determine the field reliability of Insulin
Pump
• Identify field failure contributors
• Improvement suggestions
• Warranty Analysis
Output
Challenges
Weibull plot
• Availability of field data
• Time to failure.
• Limited information on field usage condition for the
failed component.
Inputs: Shipment Qty
• Understand the Field failure trend.
Areas of Work:
• Field Failure Data Analysis
Best Dist
• Field returns forecast during warranty
duration.
• Provide inputs for spares planning.
Reliability Metrics
• Identification of reliability concern.
Weibull Distribution
Parameters
• Supports rational decision making process
for design modifications or preventive
Inputs: NEVADA Format Sales Vs returns Field data
maintenance
Field
Data
Analysis
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
Determination of Failure Distribution with
mathematical analysis

Estimation of parameters of distribution
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