6 December 2016

RDD Asia 2016

Satisfying US and EU Human Factors Requirements

for Inhaler Devices

RDD Asia 2016 08-10 November

Suresh Gupta PhD (Cantab)

6 December 2016 2

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

6 December 2016 3

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.

6 December 2016 4

NEW DELHI TOKYO

SINGAPORE

CAMBRIDGE

BOSTON

SAN

FRANCISCO

SEATLE

We have Global Presence

6 December 2016 5

We have many years of experience working for pharma and medtech clients

Some examples

6 December 2016 6

We have a long track record of successful inhaler device development

Some 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-Haler

Metered Dose

Inhaler compliance

& training device

Starhaler

60-dose dry

powder inhaler

Launched in India

NEXThaler

Breath actuated

inhaler with

mechanical dose

counter

Launched 2013

6 December 2016 7

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

6 December 2016 8

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”

6 December 2016 9

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”

6 December 2016 10

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.”

6 December 2016 11

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”

6 December 2016 12

China

CFDA

Introduction

“HFE has become an

important discipline

for manufacturers

around the world”

6 December 2016 13

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.”

6 December 2016 14

HFE Regulations and their Focus

6 December 2016 15

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.

6 December 2016 16

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.

6 December 2016 17

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.

6 December 2016 18

IEC 62366-1:2015 (medical devices and combination products)

IEC 62366-1:2015: Application of

usability engineering to medical devices.

6 December 2016 19

ISO 14971

ISO 14971:2007/2012: Medical devices

– application of risk management to

medical devices

6 December 2016 20

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

6 December 2016 21

Focus of HFE Process

Freedom from unacceptable risk Safety

Safety Resources 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 completeness Focus of

HFE/UE

Regulatory

Process

Usability related to safety and effectiveness

6 December 2016 22

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

6 December 2016 23

Human Factors Engineering Process

6 December 2016 24

Fundamentals of HFE process

Understand Users and Use Characteristics

Patients, Users, Use-Environment, Operating Principles, etc.

− Contextual enquiry

− Observation

− Interviews

− Desk-based research

Analyse Safety and Effectiveness Issues

What could go wrong in terms of safety and effectiveness

− Task/functional analysis

− Investigating known use-related problems

− Use-related risk assessment

Validate

Demonstrate that the product is safe and effective

− Simulated use testing

− Actual use testing

Evaluate Residual Risk

Analyse whether residual risks are acceptable and/or outweighed by the benefits

− Risk management

− Risk-benefit analysis

HFE/UE Report

Summarize all HF activities concluding safety and effectiveness − HFE/UE Report

Design, Evaluate and Optimize

Design

Optimize

Evaluate

− Design of user-interface

− Heuristic analysis

− Expert review

− Cognitive walk-through

− Simulated use assessment

6 December 2016 25

FDA Human Factors Process

Understanding Users, Uses and Use-Environments

Identification and Categorization of Critical Tasks Based 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 Report Summarising HFE Activities Leading to Safe and Effective Product

6 December 2016 26

If a New Problem is

Identified

If Further

Improvement is

Practicable and

Necessary

EU Human Factors Process

Use 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 File Results 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

6 December 2016 27

Common Approach to Satisfy both US and EU Submissions

HFE/UE Report (Usability Engineering File)

Use Specification / Statement of Intended Use

Understanding 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 Testing

With representative users, use-environment and final design

Summarising all HF activities

Concluding the product is safe and effective

DE

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6 December 2016 28

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

6 December 2016 29

Conclusions

6 December 2016 30

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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Registered No. 1036296 England

Cambridge Consultants is part of the Altran group, a global leader

in Innovation. www.Altran.com

www.CambridgeConsultants.com The contents of this presentation are commercially confidential and the

proprietary information of Cambridge Consultants © 2016 Cambridge

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