The Medical Device Development Process At Devicelab Part 1

Blog Archive

Jul
2020

The Design Process of Medical Devices at DeviceLab | Part 9


Part 9: When to Invoke Design Controls in a Medical Device Project Many medical device executives bemoan the burdens of Design Controls, claiming that they stifle creativity and drive up costs. That may be so, but we’re stuck with them. Given their unavoidability, we’re left to find ways to make these controls less burdensome and […]

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Jun
2020

The Design Process of Medical Devices at DeviceLab | Part 8


Part 8: Tips for Outsourcing Medical Device Development DeviceLab has been doing medical device projects for 20 years, with over 100 major programs completed. Our team also includes members who have worked at other design firms, and have seen lots of different approaches to program management. As a result, we have developed a set of […]

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Jun
2020

The Design Process of Medical Devices at DeviceLab | Part 7


Part 7: Leveraging Prototypes in Medical Device Development There’s a long list of reasons why we believe it’s wise to build prototypes when you’re developing a medical device, but the overriding reason is to facilitate learning. Even experienced designers, aided by powerful design and analysis tools, learn a lot by building prototypes. Predicting things like […]

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Jun
2020

The Design Process of Medical Devices at DeviceLab | Part 6


Part 6: The Project Management Process at DeviceLab Because we’ve done so many projects in our 20 years, we have developed a process for managing projects that establish needed controls, allows our teams to work effectively, and provides visibility to the client. This process is in compliance with regulations for outsourced development work and embraces […]

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May
2020

COVID-19 Will Make Telemedicine a New Normal


The COVID 19 pandemic has changed the world forever. As America enters into its third month of stay at home orders we have learned many things and adapted to physical distancing. Americans have learned to work, teach, meet, get services, and shop for everything from home. For those Americans needing non-serious medical attention, they very […]

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May
2020

The Design Process of Medical Devices at DeviceLab | Part 5


Part 5: Agile Hardware Development – Why It’s Important to Iterate a Design In the Agile Manifesto, Agile Values are defined by a series of preferences: Individuals and interactions over processes and tools Working software over comprehensive documentation  Customer collaboration over contract negotiation Responding to change over following a plan All of these values can […]

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Apr
2020

The Design Process of Medical Devices at DeviceLab | Part 4


Part 4: The 6 Development Tracks – Design in Parallel Medical device development is an interdisciplinary task. Designers, engineers, scientists, manufacturing, regulatory, medical, legal, and business specialists all work together toward a common goal but have distinct contributions to medical device development. At DeviceLab, we’ve organized these efforts into six tracks, which cover the needs […]

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Apr
2020

The Design Process of Medical Devices at DeviceLab | Part 3 | The FDA Waterfall


Part 3 of DeviceLab’s 6 Phase Medical Device Design Process You’ve all seen it. It’s one of the first slides in the Design Controls training class deck: FDA Waterfall Image Credit It’s a description of the interactions between certain factors and processes in the development of medical devices. In the white boxes are a series […]

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Apr
2020

The Design Process of Medical Devices at DeviceLab | Part 2


The 6 Phases of a Medical Device Development Project In the second part of this series, we explore the temporal aspect of projects. What follows is a description of how DeviceLab organizes the sequence of events in a project into distinct phases.  We typically employ six phases for every project. Sometimes we participate in all […]

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Mar
2020

The Medical Device Development Process at DeviceLab | Part 1


In this nine-part series of blog posts, we’ll be talking about the process of medical device development practiced at DeviceLab.  Some of the information discussed will be the implementation of internationally recognized standards for quality systems, and the distillation of 20 years’ experience in project management, design, and engineering. You’ll learn how we organize our […]

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