Bart Penninger talks about human factor engineering in the product innovation process. Verhaert innovation day 2015.

1. TEMP-0010-DO T-E-Verhaert presentation
HOW DOES HUMAN
FACTOR ENGINEERING
RELATE TO THE SWEET
SPOT OF INNOVATION
25.09.2015
Bart Penninger
Project Manager at Verhaert
bart.penninger@verhaert.com
MEDICAL

2. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
2
CONFIDENTIAL
2
CONFIDENTIAL
PATIENT TAKES CONTROL
OF HIS OWN DESTINY
DEMOGRAPHY EDUCATION EMPOWERMENT

3. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
3
CONFIDENTIAL
TECHNOLOGY IS THE CATALYST
3
CONFIDENTIAL
TECHNOLOGY IS THE CATALYST
CONVERGENCE

4. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
4
MEDICAL TECHNOLOGY SPECTRUM
Neurostimulators Eyeglasses Thermometers
Exclusively
professional
Primarily
professional
Primarily
consumer
Exclusively
consumer
CARE SETTING
Healthcare facility, high acuity Home
PURCHASING
AUTHORITY
Healthcare facility covers most costs
with little direct reimbursement
Consumer covers most costs
personally
USER
Exclusively used by clinics Exclusively used by patient
TECHNICAL
COMPLEXITY
Highly complex, significant training
required prior to use
Low complexity, little training required
prior to use
SAFETY RISK
High risk for injury if used improperly Low risk of injury if used improperly
CT Scanner
Adapted from ‘Where Life Science meets Lifestyle’, a Frost and Sullivan whitepaper

5. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
5
OPPORTUNITIES
Adherence
125.000
MEDICATION TECHNOLOGY
10-25%
Source: http://www.acpm.org/?MedAdherTT_ClinRef

6. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
6
CONFIDENTIAL
6
CONFIDENTIAL
50°53’22.6”N 003°36’39.5”E
GPS, Full availability of the
military's secure Precise
Positioning Service (PPS)
GPS, a mere
position on your cell
phone map
TODAYAPRIL 1995

7. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
7
CONFIDENTIAL
7
CONFIDENTIAL
44% 1/3
Source: SOH04Carstensen, ‘FDA Human Factors of Medical Devices’

8. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
8
CONFIDENTIAL
TECHNOLOGY IS THE CATALYST
8
CONFIDENTIAL
USERS WILL NOT KNOW THAT
THE PADS DO NOT WORK
Delay in therapy could result in serious injury or death.
Source: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm425608.htm

9. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
9
CONFIDENTIAL
9
CONFIDENTIAL
… RELEASE THE PATIENT CASSETTE
FROM ITS MOUNT WHEN USERS
PERFORM A CHANGE OF PATIENT
TUBINGS OR WHEN THE CO2
ABSORBER IS REPLACED
This may cause anesthesia gas to leak and could prevent the ventilator
from providing breathing support if not corrected immediately.
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm453492.htm

10. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
10
2011
ANSI/AAMI/62366-1:2015
Medical devices – Part 1:Application of usability engineering to
medical devices
ANSI/AAMI HE75, 2009(R)2013
Human Factors Engineering – Design of Medical Devices
ANSI/AAMI/IEC60878:2003
Graphical Symbols for electrical equipment in medical practice
ANSI/AAMI/ISO15223-1:2007(R)2012
Medical devices – Symbols to be used with medical device
labels, labelling and information to be supplied – Part 1: General
requirements
ANSI/AAMI/IEC 60601-1-8:2006 & A1:2012
Medical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral standard: General
requirements, test and guidance for alarm systems in medical
electrical equipment and medical electrical systems
2015
International Regulatory
Landscape
Applicable standards
If the usability engineering process detailed in
this International Standard (IEC62366) has been
complied with and the acceptance criteria
documented in usability validation plan have
been met, the residual risks, as defined in
ISO14971, associated with the usability of a
medical device are presumed to be acceptable,
unless there is objective evidence to the
contrary.
Such objective evidence can subsequently
originate from post-production surveillance.
2015

11. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
11
USABILITY VS. USER EXPERIENCE
USABILITY
is the extent to which a product
can be used by specified
users to achieve specified
goals with effectiveness,
efficiency and satisfaction
in a specific context of use.
USER
EXPERIENCE
is how a person feels when they
interact with your company,
services, and products.
ISO 9241 Part 11 Guidance
on Usability
Their emotional
connection to
the task or the
joy to use

12. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
12
SWEET SPOT OF INNOVATION
TECHNOLOGY
FEASIBLE
PEOPLE
DESIRABLE
BUSINESS
VIABLE
THE
SWEET
SPOT

13. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
13
CONFIDENTIAL
13
CONFIDENTIAL
POSTMENOPAUSAL
VAGINAL ATROPHY
Postmenopausal vaginal atrophy therapeutics market
will double from 1 billion to 2 billion.
http://www.reuters.com/article/2014/02/27/research-and-markets-idUSnBw276229a+100+BSW20140227

14. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
14
THERAPY
Reusable applicator
VAGINAL CREAM
Single use/disposable applicator
VAGINAL TABLETS

15. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
15
USER RESEARCH
Vaginal crème
Messy during, and in days after, application.
Hassle of administration and clean-up/storage.
Uncertainty about measuring correct dose.
Hygiene concerns with reusing applicators.
Inconvenience of physical positioning and time needed.
I always wash the applicator of course.
It would be better if it was disposable …
It would be more sterile I believe.
Maintaining the applicator is a bit tough.
You have to pull the plunger out,
separate into the two pieces and wash it.
Shame and embarrassment
associated with thinking about condition.
Would minimize time spent thinking
about condition, not necessarily the
feelings themselves.

16. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
16
EVALUATION OF TREATMENT
1 2 3
4
5
Commercial
Product
Improved
Offering

17. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
17
MAIN DRIVERS
Single use applicator
• Current product is a cream in a tube, to
be filled into the applicator by the user
• Typical dosage scheme is twice weekly
or 21 days on and 7 days off
• Benefits of single use applicator
• Improved overall patient experience
• Product differentiation
• Improve patient adherence
• Patient experience will lead to vaginal health
EMOTIONAL BENEFITS
+
BETTER DOSAGE
=
BETTER PATIENT
EXPERIENCE
=
IMPROVEMENT
OF HEALTH

18. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
18
TECHNOLOGY & BUSINESS IN PARALLEL
Elec & SW ...
PRODUCT INNOVATION
Mech Eng ...
Marketing …
BUSINESS INNOVATION
User ...
Business
modelling …
STAGE 1
STAGE 2
STAGE 3
STAGE 4
Design ...
New value
proposition
Increase the likelihood of success,
avoiding “added value erosion”
OPTIONS
OPTIONS
OPTIONS
OPTIONS

19. Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015
19
HUMAN FACTOR INNOVATION PROCESS
Verhaert
Pressure cooker©
© VERHAERT
iteration validationinsights
1 2 30
QUALITATIVE
RESEARCH CONCEPTUALIZATION ACCEPTANCEQUICK DESIGNS
Usability and
value focus

20. Kruibeke
Belgium
Verhaert New Products & Services
Hogenakkerhoekstraat 21
B-9150 Kruibeke
T +32 3 250 19 00
E info@verhaert.com
www.verhaert.com
Nivelles
Belgium
Noordwijk
Netherlands
Lambda-X
Avenue Robert Schuman 102
B-1400 Nivelles
T +32 67 47 57 10
E info@lambda-x.com
www.lambda-x.com
Verhaert Netherlands
Kapteynstraat 1
2201 BB Noordwijk
T +31 71 760 05 50
E info@verhaert.com
connect.verhaert.com
INDUSTRYFMCGCONNECT
MEDICAL TECHXFER
MEDICALAEROSPACE
TECHXFER
FMCGCONNECT
TECHXFER
Aveiro
Portugal
Load Interactive
Av. Dr. Lourenço Peixinho 15
3800-159 Aveiro
T +351 234 604 088
E info@load-interactive.com
www.load-interactive.com
CONNECT
Masters in Innovation is the innovation platform of Verhaert
to inspire and coach professionals on product and business
development and management.
Innovation Day is an initiative of Verhaert Masters in Innovation.