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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Economic Tigers of The World

Economic power gives you the chance to dominate the world. The US, Germany, and the UK are the economic powerhouses of the world that have significant control over the global trade and hence, exercise more control over international affairs. However, this article is not about these economically powerful countries. It is about the ‘Tiger Economy’ […]

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3D Printed Medical Products: The Power of 3D Printing

3D printing heralds the possibility of rapid prototyping and production of low-volume customized products. In the last decade, additive manufacturing using 3D printing has seen a sudden boom, given the patent right expiry of Stratasys in 2009. Stratasys is the company that happens to be the brain behind 3D printing in the early 90s. A […]

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Ultimate Guide To Fundamental Analysis of A Stock

There are two kinds of analysis for a stock: Fundamental analysis and technical analysis. Technical analysis is important for daily traders and short-term investors who have to take into account the volume traded and price movements. However, fundamental analysis is important to the value investors or long-term investors. Why is fundamental analysis of stock important? […]

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32 Microfluidics and Lab-on-a-chip Startups

Microfluidics is a key technology to develop miniaturized diagnostics and analysis systems. The ‘Organ-on-a-chip’ market is estimated to reach over $6 billion by 2025 (Source: Research and Markets). Here are 32 innovative lab-on-a-chip startups making an impact in high throughput drug screening and point of care diagnostics. 1. Micronit 2. Emulate Bio 3. MIMETAS 4. […]

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Top 30 3D Bioprinting Startups

1. regenHU 2. Aspect Biosystems 3. Pandorum Technologies 4. Organovo Holdings Inc. 5. Precise Bio 6. Ourobotics 7. REGEMAT 3D 8. Cyfuse Biomedical K.K. 9. EnvisionTEC GmbH 10. Cellink AB 11. Poietis 12. Stratasys Ltd. 13. Regenovo Biotechnology Co. Ltd. 14. Next Big Innovation Labs 15. Nano3D Biosciences Inc. 16. FUJIFILM Wako Automation Corporation 17. […]

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University of Groningen Biomedical Engineering: CEMACUBE Partner University

Common European Master’s Course in Biomedical Engineering (CEMACUBE) is an EIT-label Master’s program that allows you to study in two different European universities taking leverage of the best in both universities. The University of Groningen happens to be a CEMACUBE partner university that offers excellent opportunities in medical device innovation and biomaterials research. Here is […]

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How is Academics in Foreign Universities Different from Indian Institute of Technologies (IIT)?

According to a new employability survey by Aspiring Minds in 2019, more than 80% of Indian graduates are unemployable. With the world venturing out into the Industrial Revolution 4.0, there is a huge skill gap in India. Although the education minister Prakash Javadekar has made it mandatory for Indian students to pursue at least 3 […]

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Scaffolds for Tissue Engineering

Topics: Scaffold Approaches in Tissue EngineeringScaffold Fabrication TechniquesPhysiochemical characterization of scaffolds 1. Scaffold Approaches in Tissue Engineering There are basically two scaffolding approaches which have been typically used in tissue engineering. These are: Top-down approach Bottom-up approach Tissue Engineering approaches (Nicol et al., 2009) 1.1. Top-down approach The top-down approach involves the use of a […]

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Gene Therapy

Topics: The BasicsGenetic DisordersApplications of Gene TherapyApplications of Tissue Engineering in Gene TherapyPlasmid Banks and other repositoriesResearch Methods used in Gene TherapyMethods to Analyze RNAMethods to Analyze Proteins 1.The Basics 1.1. Genes A human cell (except for Red Blood Cells) has 23 pairs of chromosomes. Each chromosome houses numerous genes. Genes are basically the sequences […]

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Working As A Biomedical Engineer in Apple

22 January 2020 I was interviewed by Apple for the Manufacturing Engineer Graduate Role in Cork, Ireland. The job profile required a Biomedical engineer graduate with experience in Computer-Aided Design (CAD), exposure to manufacturing and knowledge of lean six sigma for operational excellence. A few of my readers asked me if the technology giants like […]

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