Two new medical device commercialization blogs, one returning champion, and two new authors join our 2021 “most read” list. Electrical engineering amd regulatory articles tie for the most popular blog topics. Many thanks to our employee authors past and present for sharing their insights and experience with medical device colleagues.
- RoHS 2 vs RoHS 3 impact on medical devices Subtitled “RoHS 3 – The Trilogy is Complete” (#8 in 2020) The Restriction of Hazardous Substances (RoHS) has had a substantial and permanent effect on the materials that go into many of the electronic products we make. Nigel Syrotuck updated his original blog in late 2020 and explains how knowing what to look for and finding good vendors with appropriate quality programs will lead to a smoother product development program and faster time to market.
- 5 gamma irradiation sterilization tips (New Top 10 entry) Gamma irradiation sterilization is performed by exposing product to a radiation source. It is one of the “big three” of processes available for sterilizing disposable medical devices. Selecting the right sterilization process for your application requires consideration at an early stage in development. Julian Grove shares 5 tips for preparing your product for gamma irradiation sterilization in ongoing production.
- Determining the best method to detect E. coli (#10 in 2020) Various methods exist to detect coli, amongst them are PCR, gold nanoparticles for a visual colour change confirmation and fluorescent labelled enzymes. Azra Rajwani outlines the detection methods mentioned above, and helps narrow down which detection method is best suited for a specific application.
- Pros and cons of two popular Ultrasound signal processing techniques (#3 in 2020) Although there are a number of methods of demodulation in ultrasound, two ultrasound signal processing techniques are used predominately nowadays. Kenneth MacCallum, PEng, offers the pros and cons of both methods and concurs they will both likely be used for the foreseeable future.
- An electrical engineer’s overview of IEC 60601-1 Terminology & Definitions through Annexes (#2 in 2020) Part 2 of Bjarne Hansen’s Electrical Engineer’s overview of IEC 60601-1 covers Sections 4-14 and the Annexes. IEC 60601-1 is one of the most important standards for medical devices. At StarFish we use several checklists and templates to ensure we address all of its comprehensive requirements.
- How to identify a Conformité Européenne mark vs a China Export mark (#1 in 2020) The Conformité Européenne (CE) mark is a common sight on products in North America, and Europe. However, the China Export mark and CE mark are easily confused, which is understandable because they look almost identical. This similarity has been acknowledged by the EU parliament. Ashwin Sira’s blog climbed to the top in April 2020 due to confusion around marks on PPE masks in Spain
- Top 10 COVID-19 Medical innovations (New to Top 10) The COVID-19 pandemic has triggered the drive for technological advancement. Scientists, engineers and innovators have risen to the challenge by doing that which they do best – designing, building and prototyping. Lorenzo Gutierrez offers his picks for top 10 COVID-19 medical innovations.
- Supplier Quality Agreement or Supply Agreement? (Returns to Top 10) Laura Meyer shares her supply chain expertise in this perennial favorite. In the early stages of medical device development, it is usually sufficient to secure pre-production quantities through a simplified procurement cycle. A specification, a quote, a purchase order and a certificate of conformance —what other paperwork is needed? Why clutter up a simple, well defined process with other documents and paperwork? Learn why Laura recommends that a Supplier Quality Agreement be launched even in the early stage development process.
- Why an electrical isolation diagram improves your medical device design. (#4 in 2020) As tempting as it is to start ordering parts and tinkering for your medical device, there are a few preliminary documents you can create to help you choose the right parts. Eventually you’ll need a design that must pass the requirements of IEC 60601-1. Drafting documents now will prompt you to ask the right questions early and hopefully solve any core technology safety related hurdles early. The documents Christian Proch-McMechan covers in his blog are in addition to the standard risk management, requirements, specification, and architecture documents.
- Unit testing in embedded systems: 3 myths and an automated tip (#7 in 2020) There are a range of modern techniques that can be used to facilitate better reliability of embedded firmware. One thing that Peter Kazakoff is a big fan of is unit testing. Embedded engineers opposed to unit testing will raise a few common objections. Peter decided to write his blog debunking three common myths and share his experience using an automated unit testing tool after seeing firsthand how unit testing can improve medical device firmware quality.
Image Credits: see individual blogs
Astero StarFish is the attributed author of StarFish Medical team blogs. We value teamwork and collaborate on all of our medical device development projects.