Benefits of early integration of Human Factors: A BYDUREON® BCise case studyJames Meehan, Associate Principal ScientistDDF Summit Berlin March 2019

BYDUREON Products

Images: www.bydureon.com

Bydureon® Single Dose Tray

Bydureon® Pen

Bydureon® BCise

HFE Approach for BCise - Outline

• Focus of the development => improved usability

• Users involved through-out

• Target patient population: type II diabetics, adults

• User population: patients, caregivers, healthcare professionals

i.e. doctors, pharmacists, nurses etc

• Dosing: weekly either self-administered or caregiver

• Home use environment

3

Device

SelectionFormative Studies Validation

3 Key Steps

User Feedback

• Data/ feedback from marketed products to identify user needs• Periodic Reviews

• Market feedback

• Key areas of focus for device design:• Combined system – no need for separate vial

• Reduced use steps – e.g. reconstituting powder and aqueous elements

• Integrated Needle – eliminate attachment step

• Hidden Needle – reduce anxiety

• Reduce overall size – reduce anxiety/ improve mobility

Device

Selection

Device Type Selection

5

Patient

Needs

Technical

Capabilities

Financial

Concerns

Pre-filled syringe w/

sharps protection

Hidden needle

On body

Injector

Low Vol, Low

viscosity

Autoinjector

Hidden needle

Integrated needle

Combined System

Reduced Size

Integrated needle

Combined System

Reduced Size

Hidden needle

Integrated needle

Combined System

Reduced Size

Device

Selection

Device Definition - Device Activation Selection

Design Decision: Device activation option A was selected. This option minimised the

use steps while also affording the control (needle insertion) that users sought. It was

also the preferred option for patients which are the intended main users.

C: button preferred by

some – perception of

control (mainly exp

users). Others felt it

was unnecessary.

B & C: preferred by

HCPs – more

automatic

A: preferred

by patients.

Quieter &

gentler.

Device

Selection

Device Definition – Form Factor

Why Focus on this?

• First impression

• Design affordances

• Facilitates grip

7

Device

Selection

Device Definition – Form Factor

8

Cap: larger

sizes with

texture and flat

areas preferred

Window: identified as

a key element. E

preferred due to direct

view of cartridge.

Unlock Knob: larger with

flat areas preferred.

Disliked the asymmetry of

option D.

Grip & handling: cylindrical

or square shape preferred.

Convex shape (option B)

disliked due to risk of

slipping

Device

Selection

Final Design

9

Large viewing window with full

view of cartridge

Large unlock knob

with flat surfaces

Large cap with

textured ridges

Square body with rounded

edges

Front activated –

Also acts as needle

shield

Needle hidden

through-out

Colours provide

feedback

Recognisable

symbols

90° travel

between lock

& unlock

Before Use After UseVlidationDevice

Selection

Design User interface Development

10

Formative

Studies

Study 1 Study 2 Study 3 Study 4 Study 5 Study 6 Study 7

Instruction

location Chamfered edges

Instruction Layout

Finalised Design User

interface tested per

summative protocol

Timeline – HF Summative Activities Validation

FDA interaction/ discussion: During Submission

12

• Different departments within FDA (DMEPA & DMPP)

• These comments came late in the review cycle

• Required fast response in order to meet launch deadline

• Comments between departments not necessarily aligned

• Majority of HF related comments were on the IFU

• Information/ data from formative work was used to identify comments

that may have a detrimental effect on usability/ safety

• Where appropriate this data was presented to the FDA to present a

rationale or identify an alternative

• The majority of comments required discussion, agreement was

reached and launch deadline was met

Validation

Key Takeaways

• Start Human Factors activities early

• Use market knowledge to drive design

• Prototypes in the hands of target users

• Early user buy in mitigates significant design changes later

• Engage early with FDA

• Allow time for discussion

• Without engagement/ discussion the summative study would likely have had to be

re-run

• Test the summative protocol with pre-summative/ pilot studies

• Utilise data from formative work to assess comments from the FDA and

provide response

• IFU may be the area of most discussion – its important to understand the data

behind each part of the IFU

• Data from a comprehensive HF program can assist with HA responses

13

Validation

Thank You