Project Management in Medical Device Development

Project management of a medical device development starts with defining the project scope, selecting the team, identifying the value, and then launching the project. Agile and lean development methods are used to manage large and complex medical device development projects. 1. Kanban Kanban is a lean concept which helps in visualizing the workflow. Here is […]

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Lean and Agile Principles in Medical Product Development

Lean philosophy has the following 5 aspects to it. Value: Precisely specify the value of the new productValue Stream: Identify the value stream in each productFlow: Allow the values to flow without interruptionsPull: Let the customer pull value from the design teamPerfection: Continuously pursue economical perfection How can wastes be eliminated in the Product Development […]

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Lesson V: Six Sigma Measure Phase

This chapter is about the ‘Measure’ phase of the DMAIC. Contents Types of Process MapsSampling in Data CollectedDescriptive StatisticsMeasurement System Analysis (MSA)Process Performance Measures 5. Process Performance Measures Some of the commonly used Process Performance Metrics are: Defects per Unit (DPU): Defects per Opportunity (DPO): Defects per Million Opportunities (DPMO)Rolled Throughput Yield (RTY): It’s a […]

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Lesson VI: Six Sigma Analyze Phase

The steps in the analyze phase are: Determine which factors impact the performance, i.e. X’s in Y=f(X)Organize the potential X’sShortlist the key X’sDevelop a data collection plan for the analysisProve the key X’s for Y=f(X) The possible X’s are determined by brainstorming. The potential X’s are organized using a cause-effect diagram or fishbone diagram. The […]

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