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Medical Device Innovation: Improving Patient Safety One Device at a Time
Mary Beth Privitera, M. DesignSeptember 22, 2006
Dept. of Biomedical Engineering
a medical device is...
any tool used for diagnosis and therapeutic treatment
over 1800 categories which vary in complexity & riskbandages to implanted heart valves
Dept. of Biomedical Engineering
medical devices help to..alleviate painovercome disabilitysustain life
Dept. of Biomedical Engineering
medical devices also …
sometimes fail.
Dept. of Biomedical Engineering
problem scope
over 1/3 of medical device (incident) reports mention errors.
about 44% of product recalls involve design
literature cites errors as a prominent problem
Dept. of Biomedical Engineering
as the healthcare system..increases in complexityopportunities for use error
increase
Dept. of Biomedical Engineering
technical efficacy & reliabilityare the foundation…while usability is the
differentiating factor & must be taken in to consideration
Dept. of Biomedical Engineering
new devices result from…the knowledge that our world is
not perfectthat there may just be a better
way/method/path
Dept. of Biomedical Engineering
good medical device design…requires an understanding and
prioritization of feature options and potential design paths by users.
needswantsnice to haves
Dept. of Biomedical Engineering
safety and ease of use
do not just happen…
Dept. of Biomedical Engineering
safety and ease of use
rather…are the result of a user-
centered design processthe application of human
factors
Dept. of Biomedical Engineering
what are human factors?an understanding of
interactions of humans & other elements within a system.
Dept. of Biomedical Engineering
HF evaluations are required byFDA requirement per QSR
820.30HE 48HE 74HE 7514971 Risk
Dept. of Biomedical Engineering
healthcare is a system
with many subsystemsproven facility design
improves patient safety and the overall experience of healthcare delivery
Dept. of Biomedical Engineering
….but what about device design?
Dept. of Biomedical Engineering
where do new ideas begin?scientific discoverytechnology advancementsociological idealswarpoint of care
Dept. of Biomedical Engineering
innovation requires…
a balanced attitudea knowledge of science coupled
with a strong desire to explore
Dept. of Biomedical Engineering
2 types of innovation:
disruptive innovations evolution of existing practices
and tools
Dept. of Biomedical Engineering
most importantly…partnerships
medicine/clinical practice& experience
medicine/clinical practice& experience
engineeringtechnology& design
engineeringtechnology& design
market &business
requirements
market &business
requirements
innovativedevicedesign
innovativedevicedesign
Dept. of Biomedical Engineering
who are the strategic partners?healthcare professionalsengineersbusiness design
Dept. of Biomedical Engineering
HC professionals are a
driving force in successevaluate proven clinical efficacy
but also the “intuitiveness” and “feel”
mentorship
Dept. of Biomedical Engineering
They also…
prove usability of a device.
Dept. of Biomedical Engineering
long term adoption…
relies on the user’s belief that they can readily perform the procedure.
confidence for 100%-100%
expectations consideredseamless performancesafety in use
Dept. of Biomedical Engineering
safe devices accommodatethe users need for consistency
device behaves as expected
extension of the user
Dept. of Biomedical Engineering
safe devices do not tax users memoryendoscope change in viewpoints 0
degrees vs. 30 degrees
Dept. of Biomedical Engineering
safe devices are not ambiguousplacement & correct size as
critical as decision of porcine vs. mechanical
Dept. of Biomedical Engineering
safe devices provide adequate feedback
ex. AtriCure generator/handle prevents injury
Dept. of Biomedical Engineering
small changes impact usabilityex. endoscopic grasper & jaw
movement
Dept. of Biomedical Engineering
cognitive & tactile considerationscognitive interface
form of handle & recognition
tactile interfaceallow for easy control accessforces acting on control should be minimaladequate surface purchase and contoursprovide feedback where possible
Dept. of Biomedical Engineering
control relationships
end effector to handle
Dept. of Biomedical Engineering
HF thought of as a bridgetechnical capabilityencouraging correct user
performancediscourages or prevents
incorrect performance
Dept. of Biomedical Engineering
Physicians have an….
Immediate response when introduced to a new device
Inquisitive and judgmental. Drastic change from traditional product
configurations may be resisted. Upon first sight, users may be able to
intuitively detect challenges
Dept. of Biomedical Engineering
For success, device innovators must…
understand the target user, their expectations, current practices and use environment.
Dept. of Biomedical Engineering
For success, device innovators must…
reconcile engineering requirements, usability requirements, and market perceptions.
Dept. of Biomedical Engineering
Thank You!
