2015 innovation day_how does human factor engineering relate to the sweet spot of innovation_verhaert_bart penninger

TEMP-0010-DO T-E-Verhaert presentation

HOW DOES HUMAN FACTOR ENGINEERING RELATE TO THE SWEET SPOT OF INNOVATION

25.09.2015

Bart PenningerProject Manager at [email protected]

MEDICAL

Ref: <doclog>-Adraft (change text in slide master)How does human factor engineering relate to the sweet spot of innovation • 22.10.2015

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PATIENT TAKES CONTROL OF HIS OWN DESTINY

DEMOGRAPHY EDUCATION EMPOWERMENT


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TECHNOLOGY IS THE CATALYST

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CONVERGENCE


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MEDICAL TECHNOLOGY SPECTRUM

Neurostimulators Eyeglasses Thermometers

Exclusivelyprofessional

Primarily professional

Primarily consumer

Exclusively consumer

CARE SETTINGHealthcare facility, high acuity Home

PURCHASING AUTHORITY

Healthcare facility covers most costs with little direct reimbursement

Consumer covers most costs personally

USERExclusively 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 RISKHigh 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


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OPPORTUNITIES

Adherence

125.000

MEDICATION TECHNOLOGY

10-25%

Source: http://www.acpm.org/?MedAdherTT_ClinRef


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50°53’22.6”N 003°36’39.5”E

GPS, Full availability of the military's secure Precise Positioning Service (PPS)

GPS, a mereposition on your cell

phone map

TODAYAPRIL 1995


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44% 1/3Source: SOH04Carstensen, ‘FDA Human Factors of Medical Devices’


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USERS WILL NOT KNOW THATTHE PADS DO NOT WORKDelay in therapy could result in serious injury or death.

Source: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm425608.htm


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… RELEASE THE PATIENT CASSETTE FROM ITS MOUNT WHEN USERS PERFORM A CHANGE OF PATIENT TUBINGS OR WHEN THE CO2ABSORBER IS REPLACEDThis 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


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2011

ANSI/AAMI/62366-1:2015Medical devices – Part 1:Application of usability engineering to medical devices

ANSI/AAMI HE75, 2009(R)2013Human Factors Engineering – Design of Medical Devices

ANSI/AAMI/IEC60878:2003Graphical Symbols for electrical equipment in medical practice

ANSI/AAMI/ISO15223-1:2007(R)2012Medical 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 & A1:2012Medical 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


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USABILITY VS. USER EXPERIENCE

USABILITYis 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 EXPERIENCEis 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


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SWEET SPOT OF INNOVATION

TECHNOLOGYFEASIBLE

PEOPLEDESIRABLE

BUSINESSVIABLE

THESWEET SPOT


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POSTMENOPAUSAL VAGINAL ATROPHYPostmenopausal 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


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THERAPY

Reusable applicator

VAGINAL CREAM

Single use/disposable applicator

VAGINAL TABLETS


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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.


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EVALUATION OF TREATMENT

1 2 34

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CommercialProduct

ImprovedOffering


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MAIN DRIVERSSingle 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


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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”

OPT

ION

S

OPT

ION

S

OPT

ION

S

OPT

ION

S


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HUMAN FACTOR INNOVATION PROCESS

VerhaertPressure cooker©

© VERHAERT

iteration validationinsights

1 2 30

QUALITATIVE RESEARCH CONCEPTUALIZATION ACCEPTANCEQUICK DESIGNS

Usability and value focus

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