satisfying us and eu human factors requirements for inhaler devices
TRANSCRIPT
6 December 2016
RDD Asia 2016
Satisfying US and EU Human Factors Requirements for Inhaler Devices
RDD Asia 201608-10 November
Suresh Gupta PhD (Cantab)
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The Human Factors Engineering (HFE) process described in the presentation is based on our extensive experience in this area and our informed interpretation of the HFE guidance and
standards
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About Cambridge Consultants
We are an end-to-end product development company with a strong emphasis on human factors engineering (HFE).
For over 55 years we have led the way in the Cambridge hi-tech cluster for innovative design & development.
Our team of ~700 human factors engineers, designers, engineers and scientists have an enviable track record of world firsts and breakthrough developments.
Human factors engineering (HFE) is an integral part of our Medical Development Process (MDP).
Our MDP is compliant to ISO 13485 and US CFR Title 21.
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NEW DELHITOKYO
SINGAPORE
CAMBRIDGE
BOSTONSAN
FRANCISCO
SEATLE
We have Global Presence
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We have many years of experience working for pharma and medtech clientsSome examples
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We have a long track record of successful inhaler device developmentSome examples of respiratory devices
Conix
High performance dry powder inhaler
Technology licensed to 3M in
2008
Tobi ® podhaler
Inhaler for CF
Launched 2012 Design award
winner
T-HalerMetered Dose
Inhaler compliance & training device
Starhaler
60-dose dry powder inhaler
Launched in India
NEXThaler
Breath actuated inhaler with
mechanical dose counter
Launched 2013
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Satisfying US and EU Human Factors Requirements for Inhaler Devices
Background
HFE regulations and their focus
HFE Process
– Fundamentals of HFE process
– FDA process
– EU (International) process
– Single process for both US and EU
Conclusion
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Definition of HFE
“Human Factors Engineering (HFE) is the application of knowledge about human behaviour, abilities, limitations, and other characteristics of users to the design of medical devices and combination products”
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Benefit of HFE
“The application of HFE helps manufacturers to develop products that reduce use errors, enhance patient and user
safety, improve product usability and
efficiency, and enhance user satisfaction”
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HFE uptake
“The uptake of HFE in product development has been slow because: traditional product developers have
often considered HFE only as a desirable aspect of the development process, or
did not know how to incorporate it into the process so as to realize its benefit.”
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Paradigm change
“The paradigm has started to change with the introduction of HFE/UE
standards and guidance, and their enforcement by regulatory
bodies such as the FDA”
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ChinaCFDA
Introduction
“HFE has become an important discipline for manufacturers around the world”
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Understanding HFE
“There are Standards and Guidance specifying the HFE process but they are not user friendly!”
“This presentation attempts to provide an overview of the HFE process in a simple schematic way, clarifying the US and EU requirements and their differences.”
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HFE Regulations and their Focus
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HFE Standards and Guidance
FDA Guidance (2016): Applying human factors and usability engineering to medical devices. Guidance for Industry and Food and Drug Administration Staff.
FDA Draft Guidance (2016): Human factors studies and related clinical study considerations in combination product design and development. Draft Guidance for Industry and FDA Staff.
FDA Draft Guidance (2016): List of highest priority devices for human factors review. Guidance for Industry and Food and Drug Administration Staff.
IEC 62366-1:2015: Application of usability engineering to medical devices. IEC/TR 62366-2:2016: Guidance on the application of usability engineering to medical devices.
MHRA Draft Guidance (2016): Human factors and usability engineering. guidance for medical devices including drug-device combination products.
ANSI/AAMI HE75:2009: Human factors engineering – design of medical devices. IEC 60601-1-6:2010: Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance. Collateral standard: Usability.
ISO 14971:2007: Medical devices – application of risk management to medical devices.
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FDA Guidance (medical devices)
FDA Guidance (2016): Applying human factors and usability engineering to medical devices. Guidance for Industry and Food and Drug Administration Staff.
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FDA Guidance (combination products)
FDA Draft Guidance (2016): Human factors studies and related clinical study considerations in combination product design and development. Draft Guidance for Industry and FDA Staff.
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IEC 62366-1:2015 (medical devices and combination products)
IEC 62366-1:2015: Application of usability engineering to medical devices.
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ISO 14971
ISO 14971:2007/2012: Medical devices – application of risk management to medical devices
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Medical Device, Combination Products and HFE Pathway
What Type of Product?
MEDICAL DEVICE
MEDICINAL PRODUCT
Compliance with Relevant Directive:
98/79/EC, 90/385/EEC, 93/42/EEC
Compliance Assessed by NB
HFE Requirements in IEC 62366-1
EU
Compliance with Relevant Parts of the
CFR Title 21 Part 200-499, 600-
680
Compliance Assessed by CDER/CBER
US
Device and Medicine
Device Only
Medicine Only
What is the Principle Mode of Action?
What Type of Medicine?
What Type of Device?
In-Vitro Diagnostic
Active Implant
(Other) Medical Device
Biologics
Drug
Compliance with Relevant Parts of CFR Title 21 Part
800-898
Compliance Assessed by
CDRH for device
HFE Requirements in FDA HF Guidance
US
Compliance with Medicinal
Products Directive
2001/83/EC
Compliance Assessed by
EMA
EU
Medicinal Product(Combination Product)
Medical Device(Ancillary Medicinal
Substance)
Device Element
Medicinal Element
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Focus of HFE Process
Freedom from unacceptable risk
Safety
SafetyResources expended in relation to effectiveness
Efficiency
User Satisfaction Freedom from discomfort and positive attitude towards product
Other Commercial Benefits For example, improved sales
If any of these affects safety or
effectiveness, then it is the focus of
HFE/UE process
Superior Usability (usability beyond safety
and effectiveness)
Generally NOT the focus of
HFE/UE Regulatory
Process
Effectiveness Accuracy and completenessFocus of HFE/UE
Regulatory Process
Usability related to safety and effectiveness
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Benefits of HFE Process
Improved sales
Effective product
Competitive advantage
Reduced time to market
Simpler training
Reduced demand for customer support
Better treatment compliance rates
Better application of currently available
technology
Increased utilization of available features
Fewer returned products
Reduced chances of product recall
Reduced chances of litigation
Safe product
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Human Factors Engineering Process
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Fundamentals of HFE processUnderstand Users and Use Characteristics
Patients, Users, Use-Environment, Operating Principles, etc.
− Contextual enquiry− Observation− Interviews− Desk-based research
Analyse Safety and Effectiveness IssuesWhat could go wrong in terms of safety and effectiveness
− Task/functional analysis− Investigating known use-related problems− Use-related risk assessment
ValidateDemonstrate that the product is safe and effective
− Simulated use testing− Actual use testing
Evaluate Residual RiskAnalyse whether residual risks are acceptable and/or outweighed by the benefits
− Risk management− Risk-benefit analysis
HFE/UE ReportSummarize all HF activities concluding safety and effectiveness
− HFE/UE Report
Design, Evaluate and OptimizeDesign
Optimize Evaluate
− Design of user-interface− Heuristic analysis− Expert review− Cognitive walk-through− Simulated use assessment
Safety
&
Effectiveness
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FDA Human Factors ProcessUnderstanding Users, Uses and Use-Environments
Identification and Categorization of Critical TasksBased on Severity of Harm
Use-Related Risk
Assessment (e.g. use FMEA)
Investigation into Known Use-Problems
Analytical Analyses and Evaluations
Empirical Analyses and Evaluations- Contextual Inquiry
- Interviews- Formative Evaluations (cognitive walk-through,
simulated use testing)
- Task Analysis - Heuristic Analysis
- Expert Review
Design and Optimization of User Interface
Device (controls, display, etc.), Packaging, Labels, IFU, Training
Materials, etc.
Develop and Implement Risk Mitigation/Control
Measures- Inherent Safety by Design
- Protective Measures- Information for Safety
Risk Management
Process
Risk Management Preliminary Analyses and Evaluations Design of User Interface
Critical Tasks to be Included in Validation Testing Optimised User Interface Representative of Final Design
Evaluate Residual Risk Validation Testing
HFE/UE ReportSummarising HFE Activities Leading to Safe and Effective Product
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If a New Problem is Identified
If Further Improvement is Practicable and
Necessary
EU Human Factors ProcessUse Specification
User Interface Characteristics Related to Safety
- Task analysis- Functional analysis
- Investigation into known use problems
Risk Management
Process
Risk Management
Design and Optimization of User Interface
Develop and Implement Risk Mitigation/Control
Measures
Design of User Interface
Hazard-Related Use Scenarios for Summative Evaluation
Optimised User Interface Representative of Final Design
Evaluate Residual Risk Summative Evaluation
Usability Engineering FileResults and Record of Usability Engineering Process / Activities
Use-Related Risk
Assessment (e.g. use FMEA)
Hazard and Hazardous Situations
Hazard and Sequence of
Events Leading to Hazardous
Situations
User Interface Evaluation Plan
Design of User Interference Hazard-Related Use Scenarios
Based on Severity of Harm
Formative Evaluation
- Cognitive Walk-Through- Expert Review- Usability Test
User Interface Specification
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Common Approach to Satisfy both US and EU Submissions
HFE/UE Report (Usability Engineering File)
Use Specification / Statement of Intended UseUnderstanding Indication, Patients, User, Use-Environment, Operating Principles, etc.
User Interface Characteristics Related to Safety/ Analytical Analyses and Evaluations
Identification of Known Use-Related Problems Task Analysis
Formative Evaluation(s)
It is an iterative process and may require more than one formative evaluations
Good HF/UE practice suggests conducting at least one formative evaluation ahead of a summative evaluation (validation testing)
Summative Evaluation / Validation TestingWith representative users, use-environment and final design
Summarising all HF activities
Concluding the product is safe and effective
DESIG
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Example of a Legacy Product (Product
with UOUP)
Tailored HFE Processes
There are situations where full-scale human factors or usability engineering process may not be required
– Legacy products (products with user-interface of unknown provenance, UOUP)
– Generic / biosimilar products
– Products for use in a clinical trial
– Products with low risks
– Products with partial or no HFE documentation (Remediation Work)
Use Specification(IEC62366-1:2015, Annex C, C.2.1)
Post-production Information(IEC62366-1:2015, Annex C, C.2.2)
Hazards and Hazardous Situations related to Usability (Risk Analysis)
(IEC62366-1:2015, Annex C, C.2.3)
Risk Control (IEC62366-1:2015, Annex C, C.2.4)
Residual Risk Evaluation(IEC62366-1:2015, Annex C, C.2.5)
Use-related Risk
Assessment
Risk Evaluation(ISO 14971:2007 Section 5)
Overall Residual Risk Acceptability(ISO 14971:2007 Section 7)
Risk Management
Report
HFE Conclusion Report
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Conclusions
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Conclusions
HFE is an essential and integral part of the inhaler device development process.
The process requirements are primarily based on the core principles of safety and effectiveness.
The HFE processes for the FDA and EU submissions are largely harmonized, but there are some minor differences.
It is important that manufacturers of inhaler devices understand the process clearly so that they can comply with the requirements.
Following the HFE process does not only fulfil the regulatory requirements but also helps you to develop better products.
This presentation provides the holistic view of the HFE process in a simple schematic way, however every project is different and the process should be tailored accordingly.
6 December 2016
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