The essential link between ethnographic research, human factors engineering and risk management in injection device development' by Alun Wilcox

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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


© PDD 2011. ISO 9001 & ISO 13485

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


© PDD 2011. ISO 9001 & ISO 13485

Integrated processKey skill sets involved throughout

Human Factors Engineering

Research

Risk management

Design & engineering

Concepts ValidationDesign output

Design input

VerificationResearch

Regulatory submission


© PDD 2011. ISO 9001 & ISO 13485

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


© PDD 2011. ISO 9001 & ISO 13485

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


© PDD 2011. ISO 9001 & ISO 13485

How do they interact?ISO 62366 has a complex flowchartshowing how.


© PDD 2011. ISO 9001 & ISO 13485

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


© PDD 2011. ISO 9001 & ISO 13485

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”.


© PDD 2011. ISO 9001 & ISO 13485

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?


Design input



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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


© PDD 2011. ISO 9001 & ISO 13485

DifferentiationDevices must add real value to all stakeholders

Merck Serono - easypod™ UCB - Cimzia®

“Ease-of-Use Commendation” from the Arthritis Foundation

http://www.metropolismag.com/cda/popup_image.php?image_id=19111&slideshow_speed=


© PDD 2011. ISO 9001 & ISO 13485

products people context culturessystemstechnology

ResearchNeeds to gain a holistic understanding of the challenge.

Challenges are opportunities!


© PDD 2011. ISO 9001 & ISO 13485

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


© PDD 2011. ISO 9001 & ISO 13485

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


© PDD 2011. ISO 9001 & ISO 13485

Process mappingMap the process and identify the stakeholders


© PDD 2011. ISO 9001 & ISO 13485

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!


© PDD 2011. ISO 9001 & ISO 13485

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?


© PDD 2011. ISO 9001 & ISO 13485

Emotional mappingUnderstand what it is like to live with the condition. Engage participants to uncover more of the emotional drivers behind attitudes and behaviour.


© PDD 2011. ISO 9001 & ISO 13485

Identify opportunities Analyse research and evaluate opportunities


© PDD 2011. ISO 9001 & ISO 13485

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


Design input



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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


Design input



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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


Design input



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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?


Design input



© PDD 2011. ISO 9001 & ISO 13485

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


© PDD 2011. ISO 9001 & ISO 13485

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


Design input



© PDD 2011. ISO 9001 & ISO 13485

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.


© PDD 2011. ISO 9001 & ISO 13485

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.


© PDD 2011. ISO 9001 & ISO 13485

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.


© PDD 2011. ISO 9001 & ISO 13485

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.


© PDD 2011. ISO 9001 & ISO 13485

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.

Health & Medicine

The essential link between ethnographic research, human factors engineering and risk management in injection device development' by Alun Wilcox