Medical Device Innovation: Improving Patient Safety One Device at a Time Mary Beth Privitera, M. Design September 22, 2006.

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!