2015 innovation day_how does human factor engineering relate to the sweet spot of...
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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
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2CONFIDENTIAL
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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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TECHNOLOGY IS THE CATALYST
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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TECHNOLOGY IS THE CATALYST
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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
5
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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