Choosing a medical device contractor is one of the most important decisions a medical device start-up can make. In today’s distributed workforce environment, finding a medical device development partner that will enable collaboration and innovation without actually physically being together is possible if you know what questions to ask.
When thinking about the roles of Quality Assurance (QA) and Regulatory Affairs (RA), I like to use the metaphor of the trail blazer and the guide, RA is there to blaze the trail and find the path, QA is there to keep the team on that path and away from pitfalls and hazards. RA does […]
Our employee experts share their best tips and examples for each phase of the commercialization process in a four-part series on Medical Device Commercialization. This blog covers Medical Device Phase One Product Development engineering, design and development. For Phase Zero tips, check out our blog on Product Definition. Medical device commercialization is typically broken into Four Phases: […]
Human factors validation testing is the final usability testing to be completed prior to regulatory submission. A mistake or an omission may result in follow-up testing being required if you uncover unanticipated use errors during testing. Careful planning is highly recommended. The following aspects should be considered for human factors validation planning. Each topic could […]
Patient-centered design is designing healthcare with the patient in mind, a methodology that prioritizes the patient’s desires and requirements. This encompasses constructing medical facilities, procedures, and systems to enhance patient care. The concept of patient-centered has gained considerable traction in recent years as healthcare organizations worldwide strive to improve their quality of care. In this […]
Color plays an important role in a product. It can define a brand identity and help usability of a product. When it comes to medical devices, the role of color becomes even more critical, guided by safety standards and regulatory requirements. When we are describing color, we merely state them as “white”, “red”, “gray”, etc. […]
Medical devices play a vital role in modern healthcare, aiding in the diagnosis, treatment, and management of various medical conditions. However, the effectiveness and safety of these devices rely not only on technological advancements but also on their usability and compatibility with human factors.
Microfluidic point-of-care assays are a hot topic nowadays and there’s lots of buzz surrounding how to make inexpensive, quick and reliable cartridges. One area that gets less focus is how to design the actuation and quantification mechanisms within the instrument or reader.
Medical device commercialization is typically broken into Four Phases: Phase Zero Product Definition, Phase One Engineering Design and Development, Phase Two Transfer, and Phase Three Manufacturing. Our employee experts share their best tips and examples for each phase of the commercialization process in a four-part series. This blog covers Medical Device Phase Zero Product Definition […]
Company culture and values have a huge impact on our client relationships and work designing, developing, and manufacturing innovative medical devices. We asked employees to share the StarFish Medical value they use most and how it makes a difference.
Recommendations to Avoid Non-Functional Cartridges The popular Netflix series “The Walking Dead” is all about “Zombies” – people that look normal but lack the ability to function as normal. In microfluidics, there are cartridges that seem perfectly normal and functional but are not due to internal defects. They are “the walking dead“ or “Zombie cartridges” destined […]
“AI seems to be a thing. Everybody’s excited about ChatGPT.” Asking ChatGPT to list current medical device trends as preparation for our monthly content meeting has turned into our latest group blog. Not surprisingly, the StarFish team identified the same trends proposed by ChatGPT- and more – with six of the most interesting trends making […]
