Medical devices, especially complex ones with electronics, almost always undergo shipping testing before they are considered safe enough for market. We use 3rd party testing services to run typical load profiles on devices in their packaging. These usually include impact, drop and vibration testing, amongst others. Vibration testing is a particularly interesting subject, which we’ll […]
Let’s talk about what an anodized finish actually is. A core finishing technique around the world, anodizing is highly valued in the medical industry to promote longevity of devices. It is a finishing process that can be applied to a few different materials, the most common being aluminum (in fact, this blog will only discuss […]
Recently we conducted pre-testing (testing done in-house to increase confidence before undertaking more expensive formal testing) for ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter is an ISO standard for particulate testing in breathing gas pathways. This is a sub-standard of the larger […]
Medical Device Drop Test Per IEC 60601-1 Ed 3.2 Clause 15.3.4 Medical Device Drop Test and Push Test are part of IEC 60601-1. This blog describes two of the most common mechanical tests that medical device designers may want to perform in-house before sending a device for third party testing.
StarFish Medical hires many engineering students for medtech co-op positions in our product design department. A question I get asked a lot is: “what does the ideal medtech co-op look like to you?” The answer is complex and can vary. Everyone has their own strengths, but there are some general things that we look for […]
Note: RoHS 3 is a colloquial term referring to Delegated Directive (EU) 2015/863, which is actually an amendment to RoHS 2 (Directive 2011/65/EU) rather than a standalone Directive. Though this terminology has become somewhat common (common enough to keep using the term here), it’s technically inaccurate. Originally published in April 2016, the article is updated […]
Modern education seems to be leaving behind a crucial lesson: Tolerancing After speaking recently with budding young engineering students, I was pleased to hear that many get consistent access to engineering technology in their high school and undergraduate programs. It’s fantastic that hands-on exposure to tools such as 3D printers are becoming more common. That […]
One response to possible COVID-19 medical device shortages is to try to hack DIY COVID-19 medical devices together. It’s very empowering to see open-source communities come together to try to turn out a workable design to help avoid dire shortages for those in need. However, development of medical devices is far more nuanced than it […]
Sheet metal fabrication is an excellent method of making mechanical parts, especially support brackets. They tend to be cheap, light, strong, and easy to pack and ship. In this article, I explain how to avoid hole distortion in sheet metal parts.
Diseases of the eye affect the majority of the general population at some point throughout their lifetime, significantly affecting quality of life, especially if access to treatment is not available. They are so prevalent they account for the most common surgical procedure worldwide (cataract surgery), drive an industry for one of the most common medical […]
Comparing novel drug delivery systems to the traditional needle Injection devices have been around for centuries, and though the ubiquitous needle-tipped plastic syringe hasn’t changed much in the 60+ years of its existence, other technologies have been developed with significant advantages. Though it’s tough to compete with a disposable product that costs just pennies to […]
Prototype Sheet Metal Parts in 4 steps Sheet metal fabrication is an excellent method of making mechanical parts, especially support brackets. They tend to be cheap, light, strong, and easy to pack and ship. However, a major drawback to sheet metal is the setup costs in prototyping: a part might only cost $10 to make, […]