Tolerancing is often an essential step in understanding the manufacturing/assembly requirements of an optical system designed for use in medical devices. The use of optical design software for tolerancing simulations is a valuable tool for identifying the specific manufacturing/alignment errors that can be allowed and their limits. Zemax OpticStudio® is a popular optical design software […]
Several companies offer microscopes specifically designed for microfluidic applications and cell imaging. However, they are often price prohibitive and, in most cases, do not readily fit the specific requirements for a particular microfluidic application.
Optical imaging tools can enhance the crucial role of biomedical imaging in accurately identifying diseases and monitoring their progression. Conventional medical imaging devices such as X-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, and positron emission tomography (PET) are commonly used in clinical settings (Figure 1). However, these imaging modalities are limited in their […]
The FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The document provides guidance for developing a Predetermined Change Control Plan (PCCP) for managing changes to the device software functions. The PCCP is a critical component of […]
The FDA requires a UDI in both plain text and machine-readable format (i.e., bar code) to be printed on a label that is attached to the device and the device packaging for traceability through distribution and service life of the device.
Chronic non-healing wounds cause a significant burden on the healthcare system and are the leading cause of limb amputation. Integrating smart bandages within the healthcare system can reduce hospitalization rates and in-clinic wound treatment time, hence reducing the overall burden on the healthcare system.
How VR design tools can improve product development VR is one of the hottest trending tools in Industrial Design. Whether on social media or at conferences, designers are talking about how they use VR in the design process. In fact, we wrote about how VR can change Medical Device Design – XR is about to […]
When you hear the word cancer, it conjures up sad feelings. Most patients think that if they have it, they have less chance to survive and it’s the start of a countdown to death. Most people only know of the most common treatments such as – chemotherapy, which uses drugs to kill cancer cells, radiation […]
Do you know the most overlooked step in creating a useful medical device? It might sound surprising, but if we were to look at a graveyard of failed products, more often than not they fail because, while they deliver their promise, they fail the user. Do not underestimate how critical it is to seek user […]
Extended Reality (XR) is going to fundamentally shift how medical devices are researched, designed, and promoted. In this post, we’ll discuss how XR changes the future of medical device development and the benefits of employing XR. But first, let’s clarify what XR is and why now is the time to pay attention to it. Long […]
The design process is all about making design decisions. Whether the outcome is good or bad, the faster you can validate these decisions, the better your design becomes because you are iterating and learning. My new favorite tool to iterate is our laser cutting machine. I must admit that before joining StarFish, laser cutting was […]
On June 26, 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released the Government response to consultation on the future regulation of medical devices in the United Kingdom. This response will effectively guide the UK’s post-Brexit implementation plan for medical device regulation. The following are high-level key points that are sure to be […]