Medical Device Design & Engineering Since 1999
Medical device development studies take place over specific phases, each intended to accomplish specific goals. Let’s take an in-depth look at the purpose and function of these phases and their different names throughout the entire medical device development process. Reasons for Phases There are a few reasons why studies are divided into phases. Perhaps the […]
Like all products in the medical field, medical devices undergo intense scrutiny and clinical trials before they’re given the ok. In general, the process of approval for medical devices is similar to that of new drugs produced by pharmaceutical companies. Hospitals, the FDA, and other medical institutions simply cannot risk using unproven or unsafe medical […]
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 […]
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 […]
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 […]
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 […]
The Medical Device Product Design Process 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 of most […]
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 […]
