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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 ?!?!

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Project investment

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Influence onsuccess

Project investment

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Project investment

Influence onsuccess

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Focus !! t

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Project investment

Influence onsuccess

Focus !! t

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Project investment

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Focus !! t

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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

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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