What do EMC testing, changing from Alarp to AFAP, medical device colors and the pros and cons of two popular ultrasound signal processing techniques have in common? If you guessed they were among the Top 10 most read medical device blogs of 2015, you’re probably an engineer, a QA/RA professional, or subscribe to StarFish Medical blogs.
For those just joining our weekly share-a-thon of medical device information, tips, and tools, here’s the official 2015 countdown with a brief summary of each blog:
10. 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.
9. Proposed ISO 10993-1 Change Could Significantly Impact your Biocompatibility Plans The FDA released a proposal to change the guidance document for ISO 10993-1 in April 2013. 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 way down into Attachment A, it reveals some significant changes to the standard. Mark Drlik, a Mechanical Engineer and Project Manager at StarFish Medical. Wrote this blog, it’s been a well-read winner ever since.
8. Unleashing the impact of colour in medical device design: usability Part of a top read three part series from Christine Park, an Industrial Designer at StarFish Medical who uses her knowledge of colour, material, and finish to design innovative medical devices for clients. In this blog, she explores how colour in medical device design is used to increase usability and influence user/patient emotional response.
7. Unleashing the impact of colour in medical device design: trends and branding During Christine’s employment at Belkin, she had the opportunity to work closely with CMF (color, material, and finish or sometimes known as color, material, and trend forecasting) specialists to create CMF solutions for iPod/iPhone accessories. This blog explores colour design’s effect on medical device trends and branding.
6. 4 Strategies for engineering students to gain quality, hands-on experience Matthieu Lemay wrote this article (his first blog) as a StarFish Medical Mechanical Engineer Co-op (round 1). His blog resonates with students and employers because Matthieu speaks from personal experience. He graduated from the University of Waterloo with an architectural degree in 2011 before enrolling in the Biomedical Mechanical Engineering program at the University of Ottawa. Matt has 3.5 years of co-op work experience, and doesn’t regret a single second of it.
5. Core competencies of a medical device project manager We use Topgrading hiring methodology in our search and hiring process. Heidi Giesbrecht, MEng is a StarFish Medical Project Manager, PMO and cross-functional leader in medical device development. She wrote this blog after searching for more medical device Project Managers at StarFish– talented folks that thrive in challenging, high-paced, and innovative environments. In preparation for interviewing candidates, she prepared the Topgrading Job Scorecard.
4. Unleashing the impact of colour in medical device design: The right colours This article offers a process for those involved in developing medical products without a design background or colour training. Christine Park’s series on Color and Medical Devices concludes with a process readers can apply to their own work needs.
3. Toyota, SOUP, and Medical Device Development Kenneth MacCallum’s second top 10 blog has been on the charts since 2013. Perhaps because it’s pretty much impossible to write software without some third party code creeping in. IEC62304:2006 calls this “Software of Unknown Provenance” or SOUP, referring to software with unknown safety-related characteristics, or developed under an unknown methodology. Operating Systems, code libraries supporting the CPU, or even artifacts created by the compiler can all leave chunks of code in medical device applications that don’t write and don’t know for certain are safe. Kenneth explains all.
2. 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.
1. Inexpensive prescreening strategies for medical device EMC compliance should have its own fan club. Bjarne Hansen is an Electrical Engineer at StarFish Medical. Bjarne has been contributing to novel medical products at StarFish for 12 years, and particularly enjoys designing embedded systems. This article includes steps one can take during product development to ease the task of medical device EMC compliance. As a bonus, Bjarne has included lots of images to help illustrate his points.