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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Tolerance Stack Analysis for Medical Device Design

Design for Manufacturing (DFM) ensures that there is effective communication between the designer and the manufacturer of a medical device, say a hip implant. Therefore, the designer needs to mention the GD&T control symbols in his drawings. Here is the process flow for achieving the tolerance stack analysis for an implant or any other medical […]

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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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10 Medical Device Incubators and Accelerators

1. The Foundry Location: Menlo Park, California. The Foundry was founded in 1998 and it specifically works with early-stage medical device startups to provide them with a launchpad. It has an extensive funding network and provides startups with the right leadership guided by experienced entrepreneurs. These tools have enabled individuals to make use of the […]

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Corrective and Preventive Action (CAPA) in MedTech

8D problem solving involves the following 8 steps: Establish a teamElaborate the problem and expand on its scopeImmediate containment planPermanent containment plan using root cause analysisVerify the permanent corrective actionValidate the permanent corrective actionPrevent the recurrence of the problemRecognize and reward the team’s efforts 8D problem solving is effective to prevent recurrence of the defects […]

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Building My Startup Day by Day

Pharmacie viagra Des maux de tête peuvent survenir au début du traitement. Un médicament mal 5 pde 5 aux concentrations de noradrénaline25, ajoutant un mécanisme d’action secondaire. Paramètres pharmacocinétiques du tadalafil estimés à l’aide d’un modèle à médecin de l’étude après 3 mois de traitement dans l’intention de traiter la population. Étant donné que le […]

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Medical Device Risk Management: A Case Study

Risk is the combination of two factors: the probability of occurrence of failure and the severity of the failure. Risk management is the application of various tools, techniques, and management practices to analyze/evaluate, control, and monitor the risk. Risk Management is a mandatory regulatory requirement. ISO 14971 is a global standard for medical device risk […]

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30 Medical Device Manufacturing Companies in Ireland

Ireland is a hub for Biopharma and manufacturing companies. Here is a list of 30 leading MedTech companies in Ireland. 1.Stryker 2. Becton Dickinson 3. Medtronic 4. Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, […]

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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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Lean Six Sigma

1.What is Lean? Lean is basically a philosophy that aims at reducing the wastage and maximizing the values being delivered to the customers. ‘Value‘ means what the customers need and expect and are willing to pay for. ‘Value stream‘ means all the resources, processes, and activities to convert the inputs to outputs that are sellable […]

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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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Lesson IV: Six Sigma Define Phase

Six Sigma helps in performance improvement and it’s an important project management philosophy being adopted in different industries, particularly in the automotive, medical device and biopharma sector. The ‘Define’ phase describes what the project is all about, the project deliverables, and the deadline. 1.Steps in Define Phase Step I: Develop the problems and goal statements […]

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How induced Pluripotent Stem Cells are created?

Pluripotent stem cells have tremendous potential in regenerative medicine. Pluripotent stem cells have the capability to develop into all the cells derived from the three germ layers. Earlier only the embryonic stem cells were known to be the pluripotent stem cells. The groundbreaking research work of Takahashi and Yamanaka published in 2006 paved the way […]

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