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Universal criteriafor the design of medical instruments
Ingeborg Griffioen
Target found!
Designers !?
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Two questions
Designers: How can we optimize design?
CSA: How can we prevent bad products?
Two questions
Designers: How can we optimize design?
CSA: How can we prevent bad products?
or howcan we combine two worlds in time
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Panton
Panton bv
Team creative experienced designersMission: solve problems in health careStrong focus on: usability & safetyHow: designProducts, process, communication
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Panton bv
Flexible team
Core Team
Expert Team
Network
Designer focus
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Designer focus
Excel onA) FunctionalityB) CostsC) Timing
Designer focus
A) Functionalitytechnical feasible, ergonomics, design
B) Costsproduct costs and investments
C) Timingproduction, marketing, approvals, trade show
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Designer focus
A) Functionalitytechnical feasible, ergonomics, design
users love itB) Costsproduct costs and investments
feasible for supplierC) Timingproduction, marketing, approvals, trade show
beat competitor
Designer focus
A) Functionalitytechnical feasible, ergonomics, design
users love itB) Costsproduct costs and investments
feasible for supplierC) Timingproduction, marketing, approvals, trade show
beat competitor
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Design criteriaforfunctionality
Design criteria
Seven groups of requirements in the PRD(Product Requirement Definition)
Legislation & marketEnvironmentMedical deviceContextUsersPatientsUse
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Design criteria
Seven groups of requirements in the PRD(Product Requirement Definition)
Legislation & marketEnvironmentMedical deviceContextUsersPatientsUse
Design process
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Design process
Universal processManaging risksAccording to standardsand quality systems
Still creative ?!?!
t
%
Project investment
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t
%
Influence onsuccess
Project investment
t
%Risks
Project investment
Influence onsuccess
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Focus !! t
%
Project investment
Influence onsuccess
Focus !! t
%
Project investment
Influence onsuccess
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Focus !! t
%
Project investment
Influence onsuccess
Design process
In the first phases:Room for creativity Feedback welcomeThere’s a lot to consider simultaneously
Make the best decisionsAs a multidisciplinary teamAt organized design reviews
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Design reviews
Design reviews
Meetings between two phases toEliminate wrong decisions ASAP Use preliminary resultsCheck with PRD
Multidisciplinary team
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Design reviewsAnalysis → PRD, FMEAIdea phase → sketchesConcept definition → early modelsTesting → test resultsDesign phase → drawingsEngineering → new modelsTesting → test resultsSourcing → BOMProduction test → FOT, SOTCertification → DHF, TCFProduction → products
AnalysisIdea phaseConcept definitionTesting Design phase Engineering Testing Sourcing Production test CertificationProduction
Design reviews
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Design reviewsAnalysis → PRD, FMEAIdea phase → sketchesConcept definition → early modelsTesting, → test resultsDesign phase → drawingsEngineering → new modelsTesting → test resultsSourcing → BOMProduction test → FOT, SOTCertification → DHF, TCFProduction → products
Focus !! t
%
Project investment
Influence onsuccess
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Bridging the gap
Bridging the gap
I] Open the closed doors of both worldsII] Improve education
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Bridging the gap
I] Open the closed doors of both worlds
Designers:Invite CSA at reviewsTeam up creativity
CSA:Make designers understand applicationScenariosOpen innovation desk
Bridging the gap
II] Improve education
Designers + CSA:Give lectures
Create manual for designers
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Conclusions
Conclusions
Improving & feedback is only feasible at startFeedback on preliminary resultsFocus on total resultOpen doorsPlan reviews togetherEducate
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Conclusions
Designers !?
Conclusions
Berwick (IHI) says improve healthcare by:Focus on the problemGain knowledgeCo-operate
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Conclusions