Three new medical device development blogs and two new authors joined our 2020 “most read” list. Regulatory edged out electrical engineering articles as the most popular topic. Many thanks to our employee authors past and present for sharing their insights and experience with medical device colleagues.

1. How to identify a Conformité Européenne mark vs a China Export mark 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 similarityhas been acknowledged by the EU parliament. Ashwin Sira’s blog climbed to the top in April due to confusion around marks on PPE masks in Spain
2. An electrical engineer’s overview of IEC 60601-1 Terminology & Definitions through Annexes Part 2 of Bjarne Hansen’s Electrical Engineer’s overview of one of the more important standards for medical devices: IEC 60601-1.  IEC 60601-1 is not just an electrical safety standard. At StarFish we use several checklists and templates to ensure we address all of its comprehensive requirements.
3. Pros and cons of two popular Ultrasound signal processing techniques There are a number of methods of demodulation in ultrasound although two ultrasound signal processing techniques are used predominately nowadays. Kenneth MacCallum, PEng, Principal Engineering Physicist at Starfish Medical offers the pros and cons of both methods and concurs they will both likely be used for the foreseeable future.
4. Why an electrical isolation diagram improves your medical device design 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 that Christian Proch-McMechan covers in his blog are in addition to the standard risk management, requirements, specification, and architecture documents.
5. Are you getting the most of your decision matrix? A Decision Matrix is a decision making technique used when a number of candidate solutions exist and one or more must be chosen for further development. It was proposed by Kepner and Tregoe in 1965 as part of the Kepner-Tregoe methodology. Written by Vinnie Moraes, this blog builds upon a great post by Mark Drlik. Mark focused on a specific application of the technique introduced by Stuart Pugh in his masterpiece “Concept Selection – A Method that Works.”
6. Big changes in ISO 14971:2019 Changes in ISO 14971:2019 mean a big change to the medical device industry. ISO 14971:2019 was released mid-December, and the EN version was released on December 18, 2019. The last time this standard was released was 2012, so buckle up folks because this new Risk Management Standard is going to be one roller-coaster ride. Azra Rajwani outlines a few of the changes in ISO 14971:2019.
7. Unit testing in embedded systems: 3 myths and an automated tip 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.
8. RoHS 2 vs RoHS 3 impact on medical devices RoHS 3 – The Trilogy is Complete. 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 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.
9. How to Handle Medical Device Risk Management and the change from ALARP to AFAP As part of design and development at StarFish, we undertake Risk Engagements with key Stakeholders, and create a Medical Device Risk Management file, which demonstrates that risks are controlled.  This blog provides details on the Directive and Standard, examines implications for the recent changes, and explains how we handle the situation. Vincent Crabtree, PhD wrote this while a Regulatory Advisor and Project Manager at StarFish Medical.
10. Understanding the UOUP (User Interface of Unknown Provenance) section of IEC 62366 -1:2015 From a regulatory standpoint the differences between IEC 62366:2007and IEC 62366 -1:2015 are minimal, with all the same boxes needing to be ticked. However, it is clear from reading the documentation that the whole process has been streamlined, using more familiar language and on the whole a more usable standard. Author Niall Redmond notes, “Probably a good thing from a usability document, I guess!” The biggest unknown was User Interface of Unknown Provenance (UOUP).

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