Medical Device Design & Engineering Since 1999
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 […]
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 […]
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 […]
Part 4: The 6 Development Tracks – Medical Device 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 […]
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 […]
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 […]
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 […]
Despite Some Doubts, There are Plenty of Reasons to Believe Healthcare IoT is Making Significant Impacts. Here are 20! Although grossly incorrect, some might find it pointless to discuss how the Internet of Things is revolutionizing healthcare—especially for those that believe reports about how IoT (in general) and healthcare IoT (in particular) don’t even have […]
Using SEO Keyword Analysis to Find the “Best” Description of These Emerging Medical Device Design & Development Segments For the past few years, we’ve been writing about medical devices as they relate to the Internet of Things, which, of course, is also known as an acronym: IoT. Likewise, during that time, we also written about […]
How are Value-Based Care, CJR, BPCI and Other Medicare Reimbursement Models Increasing Demand for Wearable Medical Devices? IT Pro Portal recently published “Five Big Data Trends in Healthcare,” a headline that may not immediately seem relevant to medical device design and development. However, it illuminates some crucial insights into both where the medical device industry […]
