Welcome to our most read Medical Device Development Blogs of 2014. StarFish Medical readers can’t get enough regulatory information and analysis.  They are also partial to testing, design, career path, and finances.

StarFish writers cover a lot of topics with a common goal: Share experiences and knowledge with medical device colleagues.

ICYMI, here’s a chance to catch our most popular entries over your holiday break.

10:  Kyle Cameron’s RoHS guest article for Medical Device Summit remains a hit over 18 months after publication.  His updated January 2014 RoHS blog, RoHS 2 and Medical Devices: Compliance Overview, is just as popular.  “The RoHS 2 Directive has made a huge impact on designing medical devices and other devices alike.  According to a RoHs FAQ Guidance document published by EC, from July 2014, the substance restriction will gradually be extended to new product categories. Compliance is a more substantial challenge than is often recognized.” – Kyle’s blog discusses some of the details.

9:  “Toyota’s $1.5 million jury awarded loss in an Oklahoma court illustrates 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.”  Kenneth MacCallum explores Toyota, SOUP, and Medical Device Development and the potential impact on Engineering, Product Development, Quality, Regulatory.

8:  Iterations of a Medical Device Career Path by Annelies Tjebbes, is excerpted from a UBC Engineering Co-op workshop.   It struck a chord with readers.  “We all go through many iterations of our career.  Most people these days have on average 5 different careers in their lifetime.  It’s a great way to keep rediscovering and re-branding yourself, and also a great way to get 5 retirement parties out of life!”

7:  Sorting Through New and Final FDA Guidance Documents broke the record for most-clicked link in our monthly newsletter when it debuted in August 2014. Vincent Crabtree, PhD, a Regulatory Advisor & Project Manager at StarFish Medical, spent a lot of time with some decidedly “non-beach reading” to produce a much shared resource for those eager to understand the new guidances.  “Several new and final FDA Guidance Documents were issued for Medical Devices in the past month. Why so many? As part of the Medical Device User Fee Amendments 2012 and the 510(k) Working Group committee report 2010, the FDA is working hard to improve predictability, increase transparency and raise the standard of 510(k) submission, demonstrating the agency’s commitment to reducing regulatory burden where practical, without compromising patient safety.”

6:  Proposed ISO 10993-1 Change Could Significantly Impact your Biocompatibility Plans by Mark Drlik, explores the possible impacts of a proposed ISO 10993-1 change.  “The FDA released a proposal to change the guidance document for ISO 10993-1 in April of this year (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.”

5:  Scott Phillips, President of Starfish Medical, offered timely business planning advice for readers in February with 5 Top Annual Plan Medical Device Design and Development Process Improvements.  “Over the years I’ve learned to choose a limited number of improvement efforts, apply management  resources, then measure with them regularly for progress and impact. The costs of not focusing sufficiently in a few key areas can ruin a great idea.”

4:  “In my last blog I wrote that the FDA proposed a rule that requires a unique device identifier (UDI)  to be placed on the label and packaging of a marketed and sold medical device. It turned out that internally at StarFish, the required date format caught the attention of our engineers more than any other requirement.”  More than two years later, QA/RA Director, Vesna Janic‘s blog, Date Format Quandary for FDA UDI for Medical Devices, is still catching attention.

3:  5 Tips for FDA 510(k) Medical Device Regulatory Clearance by Vincent Crabtree is another must read over a year after publication.  “Some companies experience problems getting FDA Regulatory Clearance using the 510(k) Pre-market Notification process.  As a Product Development company, StarFish Medical’s focus is more on regulatory compliance than strategy.  We believe it is important to consider Regulatory all the way through the development process, and not try to ‘bolt on’ compliance at the end.    Here are tips and advice developed over the years for efficient 510(k) submission.”

2:  Vincent Crabtree’s How to Handle Medical Device Risk Management and the change from ALARP to AFAP  blog celebrates its first birthday with plenty of fans. “The Medical Device Directive is currently under review, in part due to the French Breast Implant scandal, and there has been much critical feedback to the EU over the change from ALARP (or ‘As low as reasonably practicable’) to AFAP (“As Far As Possible’ (AFAP)).  We will have to see how this and other feedback affect the treatment of risk in the Directive, which is Law, versus the Standard, which is not.  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.

1:  Climbing two spots from 2013’s Top 10 countdown is Bjarne Hansen‘s tip-filled resource for saving money on Electromagnetic Compatibility (EMC) prescreening tests.  Inexpensive prescreening strategies for medical device EMC compliance is packed with ideas and examples of simple and inexpensive tools an electrical engineer can build to enable quick EMC prescreening.  Medical devices containing electronics require EMC testing to ensure they can be used in the intended environment without causing other equipment to fail nor failing themselves.

Next week, we debut our Top 10 Video list for 2014.  Viewing for StarFish videos were up 38% in 2014 and we can’t wait to share the results.  In the meantime, we hope you enjoy our most-read 2014 Medical Device Development blogs and encourage you to share them with colleagues.