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© PDD 2011. ISO 9001 & ISO 13485
The essential link between Ethnographic Research,
Human Factors Engineering and Risk Management
in injection device development
Presented by:Alun Wilcox
Director of Medical – The PDD Group Ltd
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PDD is a product innovation consultancy
We innovate through Insight, Creativity & Delivery
Brand strategy and product planning
Trend analysis and semiotics
People centred Research
Ergonomics and Interaction design
Industrial Design and Packaging
Engineering and Simulation
Technology and Systems Design
Model making, Prototyping and Testing
Specification for Manufacture
Production Outsourcing
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Who do we do this for?
MEDICAL / PHARMA
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Over the fence R&DLacks continuity and immersion in the challenge
MarketingDecides on the product brief
and tells Product development
MarketingCommissions
research from an external market
researchagency
Product development
Reads research report and
develops specification
Product developmentDevelops & engineers designs,
conducts Risk analysis, Usability
engineering & involves
Manufacturing
MarketingCommissions
user testing of designs from an external market
researchagency and asks
Product development to
brief them on the designs
Product developmentImplements
changes recommended in research study, completes Risk management &
transfers to Manufacturing
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Integrated processKey skill sets involved throughout
Human Factors Engineering
Research
Risk management
Design & engineering
Concepts ValidationDesign output
Design input
VerificationResearch
Regulatory submission
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Why is there value in an integrated process?Consider 2 key requirements for injection device development and approval:
ISO 14971:2009, “Application of risk management to medical devices”
The systematic application of management policies, procedures and practices to the task of analysing, evaluating and controlling risk.
ISO 62366:2007, “Medical Devices–Application of Usability Engineering to Medical Devices,”Since March 2010, compliance to this standard is now required by the European regulatory bodies. Compliance to the standard’s predecessor, ANSI/AAMI HE74:2001, “Human Factors Design Process for Medical Devices,” has been required by the FDA for more than ten years. ANSI/AAMI HE75:2009, “Human factors engineering — design of medical devices” is also now formally recognized by the FDA.
Risk management Usability engineering
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What is the difference?
Risk management
A decision makingprocess for determining
acceptable risk.
Only on risks identified as being unacceptable.
Usability engineering
A design and development process that also addresses
risks associated with usability.
On all identified risks.
Risk management Usability engineering
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How do they interact?ISO 62366 has a complex flowchartshowing how.
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Common activities
ResearchIdentify what to develop next
Usability engineeringISO 62366
Risk managementISO 14971
Define intended useIdentify characteristics related
to safety. Application specification
Identify hazardsForeseeable hazards and
situations
Usability specificationEstimate risks
Is risk reduction necessary?
Risk controlImplement measures to mitigate risk (design out, warnings etc.)
Residual riskIs it acceptable?
Risk management reportRegulatory submission
VerificationAgainst specification.
Iterative formative usability testing.
Have usability goals been met?
Validation planSpecify acceptance
criteria
Validation Summative testingNew risks?
Criteria met?NoYes
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Beyond riskRisk management and usability engineering are very well documented and formal processes necessarily focussed on risk however HE75 also states:
“Human factors are not only about safe and effective task performance, but also about user satisfaction”.
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ResearchThe starting point is not risk management but deciding what to develop in the 1st place.Why is research so key?
• How else do you identify opportunities for differentiation that adds real
value?
• How do you know what user satisfaction means to all stakeholders?
• Understand cultural differences• Understand the commercial landscape – reimbursement, competition, IP.
• The starting point of Risk management and Usability engineering is understanding the
relationship between people, products & places. How can you identify
potential hazards without this?
Concepts ValidationDesign output
Design input
VerificationResearch
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DifferentiationHow do you achieve this in a competitive and crowded market?
• Clinically proven substantially improved drug efficacy• Reduced price
• Delivery devices that:
- enhance adherence- enhance the patient experience
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DifferentiationDevices must add real value to all stakeholders
Merck Serono - easypod™ UCB - Cimzia®
“Ease-of-Use Commendation” from the Arthritis Foundation
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products people context culturessystemstechnology
ResearchNeeds to gain a holistic understanding of the challenge.
Challenges are opportunities!
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Integrate different skills to identify opportunities
Understand why people perceive things the way they do
Understand current unmet needs – practical and emotional
Understand what might drive change in the future
Opportunity areasSemiotics
Research
Trends
Understand the options
Technology Research
Research
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MappingConduct research in context to understand the therapy journey. This technique
enables:
• the process to be understood
• all stakeholders to be identified
• the emotional journey to be mapped
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Process mappingMap the process and identify the stakeholders
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StakeholdersUnderstand all stakeholder interactions, challenges and needs - clinicians, carers and patients.
• What will add value to all of their lives• What influences drug/brand preference or loyalty?• What are cognitive and dexterity challenges of the target users? This can be
interesting when developing platform devices!
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Environments of useEnvironment of use characteristics should be included in preliminary design considerations and use-error risk management assessment.
There are other, softer elements that need to be explored like storage of devices and drugs – are patients self conscious about drawing attention to their condition within their own homes?
Pharmacy storage is another important consideration for packaging design – can the pharmacist have an influence on brand selection?
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Emotional mappingUnderstand what it is like to live with the condition. Engage participants to uncover more of the emotional drivers behind attitudes and behaviour.
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Identify opportunities Analyse research and evaluate opportunities
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ConceptsDecide what to develop
• Develop a range of concepts• Test concepts with stakeholders• Evaluate against: opportunities, differentiation potential, value added, commercial
criteria, technical risk and Freedom to Operate
Concepts ValidationDesign output
Design input
VerificationResearch
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Design inputDefine design requirements
Start Usability Engineering & Risk Management process• Specify application• Define users & use environments• Conduct task analysis & define primary operating functions• Define a usability specification & set
usability goals• Define a validation plan & acceptance
criteria against usability goals• Identify and assess risks• Define risk control measures
Concepts ValidationDesign output
Design input
VerificationResearch
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Design outputSpecify and develop device
• Define product design specification• Iterative design and engineering development• Proof of Principle and prototype fabrication• Implement risk control measures
Concepts ValidationDesign output
Design input
VerificationResearch
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VerificationTest outputs against inputsConfirmation by examination and provision of objective evidence that specified requirements have been fulfilled. [21 CFR 820.3(aa)]
• Simulation and physical testing of Proof of Principle models and prototypes• Formative usability testing - has usability specification been met?
Concepts ValidationDesign output
Design input
VerificationResearch
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VerificationFormative usability studiesUsability testing should be conducted iteratively throughout the development of any device. Formative testing explores whether usability objectives are attainable, but without strict acceptance criteria. The resulting test reports become components of the usability engineering file or, for FDA, the human factors engineering file.
Sample size: 5 - 8 of each target user group (patients, nurses, doctors etc)Test environment: ideally in actual use environments but can be staged in research facilities or offices.Location: does not need to be geographically specific as long as there are no significant cultural differences in user groupsDevice fidelity: any level increasing throughout development
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ValidationTest against user needsConfirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled. [21 CFR 820.3(z)]
• Summative usability testing• Have other hazards been generated?• Assess residual risk • Is overall risk acceptable?• Complete risk management report• On-going post market risk review
Concepts ValidationDesign output
Design input
VerificationResearch
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ValidationSummative usability testing The last usability testing a medical device manufacturer completes. The goal is to validate the final design to prove that all use-related hazards have been mitigated. There are more precise requirements for conducting validation tests. It is recommended to have formal acceptance criteria (e.g., usability objectives for human performance and satisfaction ratings).
Test environment: tests must be conducted in an actual or simulated use environment. Sample size: no fixed rules but 15 – 20 are recommended. Factors to consider include: the variability of user demographics, the variability in how the device is used, the device’s complexity, and the potential risks associated with the device.Device fidelity: testing must be conducted with production equivalent units. This means the actual hardware, software, labelling, instructions-for-use, and training materials. Tasks performed: must include the primary operating functions (frequent and critical tasks) and any tasks with associated safety risks. When planning a final validation test, tasks must tie back to the hazards and risks analysis.
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Integrated skills
Researchers – skills include cognitive psychology, anthropology and ethnography. They are interested in, and develop creative methods to uncover issues and understand the interaction of people and places and what might drive change.
They analyse and make sense of data and communicate it in clear formats.
Their input is not just front end as concepts, prototypes and products need to be validated with users throughout development to ensure that they are not just safe but also offer user satisfaction.
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Integrated skills
Human Factors Engineers – their core skills are anthropometry, biomechanics, physical, emotional & cognitive ergonomics, error identification & analysis (why people make mistakes) and understanding systems and processes.
They are aware of what users can understand and physically achieve and are methodical and scientific in the application of Usability Engineering throughout the R&D process. Immersion from the outset is key to identify potential hazards.
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Integrated skills
Designers and Engineers – are good at absorbing information and translating problems into innovative solutions.
They have in depth knowledge of what materials, processes and technologies can be harnessed to solve problems and understand how to specify these to ensure robust manufacture.
They can create devices that enhance the user experience.
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ConclusionInvolving an interdisciplinary team of Researchers, Human Factors Engineers, Designers and Engineers throughout the process of device research and development offers the following advantages:
• All the team are immersed in the holistic challenge. • Continuity prevents misinterpretation of the aims and
parameters.• Real opportunities to add value and differentiate are
identified. • Comprehensive and effective risk management can be
achieved through cross disciplinary input to hazard identification, risk assessment and mitigation.
• Usability Engineering requirements are imbedded in the entire process.
• Innovative and novel ideas can be created and protected which meet real stakeholder needs on practical and emotional levels and offer commercial advantage.