Glia Stethoscope 2.0: Fixing problems in an open source medical device
Here’s the TL;DR: Glia’s Stethoscope 1.0 release in March 2018 went well, but we had some problems that we worked hard to fix. Today, we’re introducing the Glia Stethoscope 2.0, which fixes these problems. We’re posting our new release to Github, Prusaprinters, Thingiverse, and MyMiniFactory if you want to make your own. Want to order a stethoscope from Glia? You can order from our store.
Issues with Stethoscope 1.0: The bench is not the real world
We knew the Stethoscope had excellent acoustics. We even published a study about it. However, with a limited pre-launch test pool, we didn’t have enough exposure to lots of head shapes and sizes and ear canals. When more people started using the stethoscope, some of them reported problems with the stethoscope’s fit. We investigated and found the spring was too tight and the earbuds fit in a way that didn’t work for about 10% of those using the stethoscope — unacceptably high numbers.
We modified the ear tubes and spring to create a more consistently comfortable fit that worked. We tested these changes across several hundred users over the past year. The stethoscope still has fit problems in about 1% of users, so we’re not fully done.
Reports also came in that in real-world conditions, the spring made from PLA plastic became brittle and broke. After extensive bench testing, we shifted production of the entire stethoscope line to PETG. This material requires more careful venting of the plastic fumes, but seems to have extended the life of the spring considerably.
Glia passes first Health Canada inspection
When we got the inspection notice from Health Canada a few months ago, the Glia team was excited and nervous. We welcomed the opportunity to figure out what we could do better, but we also fretted an unknown process with a large governmental bureaucracy.
The good news is that we passed the inspection! Health Canada issued a report with careful recommendations, and Glia resolved the outstanding issues.
Build or buy your stethoscope now!
We realize that not everybody can setup an approved manufacturing site for stethoscopes. As such, we’re helping those who are not in a position to manufacture their own stethoscopes to acquire one. You can find a stethoscope for sale on our store here. We charge $25 CAD for them, $5 is about the cost of making a stethoscope, and $20 is to support the Glia project’s work. Our budgets are openly available, so feel free to look and see where your money will go.
Next step: FDA approval
It’s time to start thinking about FDA approval for the stethoscope, so that it can be used by our colleagues in the United States and also by physicians in other countries that accept FDA approval. If you have experience in FDA licensing, please get in touch!
