November 2021

Operating Safely: Patient Well-being The safe and effective operation of medical devices, instrumentation and related technologies are critical to ensuring satisfactory patient outcomes and maintaining healthcare worker safety through the product life cycle. To reduce the impact of potential risks associated with the use of any new medical device or technology, regulatory bodies such as […]

Making it Work: Manufacturing Technology Once a functional product design has demonstrated the ability to meet the technical and market needs, developers must turn their attention to manufacturing the product with the required degree of precision, reliability and cost. Simulation of all or part of the manufacturing process can be both informative as well as

Getting to Market: Product Design and Development After providing proof of concept for a new medical technology, device or development of second-generation devices, the next step is finalizing the product design. This is one of the most important stages in the development of a successful medical device since a flawed design may lead to it being

Proof-of-Concept: In the Beginning There Was… Innovative product concepts and technologies invariably need to provide some level of Proof of Concept before an organization or agency will commit significant investment in money and/or resources to support continued development and commercialization. PCM&S is being increasingly used during the proof-of-concept phase to demonstrate technical feasibility, identify critical

Introduction Medical devices continue to provide a crucial component in the diagnosis, prevention, monitoring, and treatment for diseases. Unlike drugs or biologics, a medical device can vary from the simple, which poses little or no risk to the user such as a tongue depressor or toothbrush, to the life-sustaining such as a pacemaker or medical