The MAUDE (Manufacturer and User Facility Device Experience Database) reporting system is administered by the FDA to record adverse effects resulting from the use of a medical device.
– An Engineer’s Perspective of human eye physiology It is shocking to me how much we have discovered — and yet how little we still know — about the human body. At times, this makes it hard to design products to solve a problem. A great example of this is the human eye. Experts can […]
Knowing when to use simulation versus when to physically build a device depends on the problem and what you are trying to do. Computational Fluid Dynamics (CFD) is a powerful tool for predicting and optimizing fluid and thermal paths. Medical device CFD simulations offer the added benefit of being able to generate images and videos with […]
As an engineer, I enjoy quantifying parameters, documenting requirements, and understanding problems at a deeper level; but before delving into the details it’s important to take a step back and ensure your company is taking on the appropriate level of risk and reward with its emerging medical device technology.
Your medical device development engineering team has developed a number of compelling solutions to a problem – now what? If you pursue all of them, you may be wasting resources. If you don’t pursue enough, you may not capture the best idea or encompass the available IP landscape.
The key to developing, innovating and refining your microfluidic system is to generate accurate information to validate your assumptions and models. Choosing the correct tools to do so is critical to the short and long term goals of your company.
The scope of work required to make a medical device manufacturable varies significantly, and will depend on technology maturity, cost targets, and company strategy relating to ongoing manufacturing. This blog expands on 5 identified themes that precipitate from inquiries related to the genre of ‘making it manufacturable’.
The FDA released a proposal to change the guidance document for ISO 10993-1 in April of this year. Most of document UCM348890 seems straight forward – things like implementation details associated with genotoxicity, how to go about labeling your device as BPA-free, and a logical workflow diagram, were updated… However, once you work all the […]
Sometimes radiopacity is required to visualize the location of your device during a procedure, or perhaps to make sure it’s where you left it. When x-rays are utilized with metallic objects, the image can suffer from shadowing effects due to the strong contrast with the surrounding tissue or bone. An ideal radiopaque solution is a […]
The Industrial Revolution was, at least partly, funded by the Spanish pillaging the new world of gold and silver. Fortunately, since then we have found more controlled and focused programs to assist smart, capable people to achieve their goals. This is especially true in the medical field, where the final product has a direct impact […]
First principles calculations are the best way to give a design concept a reality check and worthy fluid dynamics books have a wealth of reference information on drag coefficients, major/minor losses, hydraulic diameter calculations, and a trusty Moody diagram. However, sometimes the problem is less intuitive… For example, non-Newtonian fluid flow, actual flow from a fan, […]
Many of us understand the benefits provided by workflow investigation, procedural observation, literature searches, and contextual research – and another piece of the product development puzzle is hands on exploration. This often requires getting your hands bloody, slimy, or sometimes worse. There are a few avenues to explore – but, when appropriate, my favorite is […]