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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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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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 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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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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Essential Skillsets Required for Your First Biotech Job

The biotech sector mainly includes MedTech and Biopharmaceutical companies. Biotech companies hire graduates in manufacturing, engineering (maintenance), quality, operations, Research & Development (R&D) and Supply Chain. Are you a recent graduate looking to get into a biopharmaceutical company or medical device development company? This article will not only give you an insight into the biotech […]

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Good Manufacturing Practices (GMP): User Requirement Specifications

FDA Design Control Guidance for Medical Device Manufacturers US FDA 21 CFR 820.30 Design Control Requirements. At the design stage, an outline of the design control process should be actualized. Here is a diagram describing the Design and Development Planning. Medical Device Design and Development Planning Design Input There are several parameters which contribute to […]

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MedTech Skill II: Classification of Medical Devices

Classification of medical devices based on the risk involved is an important step in medical device approval process. While the medical devices are classified into 3 categories in the US, they are classified into 4 categories in the European Union (EU). 1. FDA Medical Device Classification FDA 21 CFR Part 860 classifies devices based on […]

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Applications of Mechanical Engineering in Biomedical Engineering

Have you heard of complex brain surgeries performed by robots in 20 minutes which once demanded 2 hours of dedicated efforts by surgeons? Today mechanical engineering has made inroads to the surgical beds. Are you surprised when I say that mechanical engineers are fighting cancers? Biomedical Engineering is an interdisciplinary field of study. Mechanical Engineering […]

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10 Exoskeletons to Suit Up

Tony Stark’s J.A.R.V.I.S. (Just A Rather Very Intelligent System) brings home the possibility of designing an intelligent exoskeleton. The latest advances in virtual reality, artificial intelligence, neurosensing technologies have shown promises of achieving this in the near future. Most existing exoskeletons are designed to serve two broad ranges of use, human strength augmentation and human […]

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Phineas Gage: A Classic Case in Neuroscience

The human brain is like a Pandora Box. Despite the advances in Medical Imaging techniques like fMRI, the functions of different regions of the brain is still a mystery in neuroscience. In the 19th century when medical imaging techniques were at an embryonic stage, understanding brain functionalities was a nightmare for scientists. Studying the brain […]

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7 Applications of Artificial Intelligence in Healthcare

There is hardly an industry today that has been left out from the Midas touch of the Artificial Intelligence Revolution. Modern healthcare is not just about eradicating diseases. The Transhumanist Movement is a philosophy that seeks the evolution of human life beyond its current form. Transhumanists are working to get rid of human limitations like our […]

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Ultimate Guide To Tissue Engineering Master’s

I am pursuing a Common European Joint Master’s Degree in Biomedical Engineering with specialization in Tissue Engineering at RWTH Aachen Germany and Trinity College Dublin. Transitioning from Mechanical Engineering to Tissue Engineering has not been an easy ride for me, but it was something I had anticipated before delving into it. When I was a […]

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The Future Of Stem Cell Research In India

“You may call those scientists ‘crazy’ when they claim to have found the panacea for the treatment of autism, diabetes and even genetic diseases like Thalassemia which don’t have an established cure until now.” In the last decade of the twentiesth century (1998) when stem cells were successfully derieved from a human embryo by James […]

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