Have you read these medical device blogs?

It’s List-making time.  Review the old year or Predict the new.  Here are our “Most Popular” medical device blogs of 2013 list for readers who like to keep current with colleagues and peers.    Although “hot off the press” is perhaps not the most accurate way to label our top 2 most read blogs of 2013.  Evergreen may be a better way to describe them.  But you’ll have to skim to the bottom of this blog to find out what I’m talking about.  And you are way too precise and methodical to do that if you’re reading medical device blogs…

10. FDA Recognition Standard List Number 30 for Medical Devices by Vesna Janic, gets straight to the point.  On January 15, 2013 the Food and Drug Administration (FDA) published an updated list of standards the Agency recognizes for use in premarket reviews of medical devices.  Vesna provides a quick review of highlights and areas that warrant close attention.

9. 5 Tips for FDA 510(k) Medical Device Regulatory Clearance by Vincent Crabtree, stresses the importance of considering Regulatory all the way through the development process, and not try to ‘bolt on’ compliance at the end.    It also includes great tips and advice developed over the years for efficient 510(k) submission.

8. Medical Device Internal Auditing – Making Friends with “Bad News” by Annelies Tjebbes,  knows an internal audit will help you pay closer attention to detail in your project organization in future, and will hopefully open your eyes to the benefits of documentation.  She dispels three popular myths and suggests an equal number of tips to get the most out of an internal audit.

7. The True Cost of Medical Device Product Development by Vincent Crabtree, explores two different strategies for developing medical devices – the Smart-Way and the LeapFrog way.  This entry covers the stages in-between proof of concept and units out the door – how many steps to a final product?

6. Winning Project Management Practices for Medical Device Development by Martine Janicki, shares best practices learned medical device risk planning, risk engagement itself and mitigation implementation. “Managing the expectations of all involved is now very high on my list of project priorities.”  Martine discusses the need to communicate to team members, the project owner and any other important stakeholders.

5. 7 Tips for Efficient Medical Device Submissions to IEC 60601 Edition 3  by Vincent Crabtree, draws upon experiences working for clients submitting their electrical devices for IEC60601 Edition 3 electrical safety testing. 60601 Edition 3 takes mandatory electrical safety testing to a new level as many of the risk management requirements specified in ISO14971 are reviewed as part of the test.   This blog includes Vincent’s top tips for preparing documentation for 3rd edition 60601 testing for Legacy products.

4. How a Project Management Office (PMO) Helps Effective Medical Device Development by Martine Janicki, tackles the role of a “PMO” (Project Management Office).  The term appears ever more frequently in engineering firms, but is still not well understood. Martine explains what a PMO does, how they impact medical device development, and what the PMO looks like at StarFish Medical.

3. Inexpensive prescreening strategies for medical device EMC compliance by Bjarne Hansen, 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 Electromagnetic Compatibility (EMC) testing to ensure they can be used in the intended environment without causing other equipment to fail nor failing themselves.

2. Margin Matters by Scott Phillips, remains near the top of reader clicks two years after posting for its succinct examination of medical device margins.  Scott explains: “As part of our initial dialog we ask a bunch of clarifying questions to get under the hood and understand how potential partners and clients have addressed the main influencers on product definition.  Often we find an area that could be strengthened and one of the most common is in design for margin.”

1. Date Format Quandary for FDA UDI for Medical Devices by Vesna Janic tops our 2013 reader list.  Published in August 2012, perhaps the reason for its popularity is summed up in her opening sentences. 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.

That completes our most read StarFish medical device blogs of 2013.  What other favorites do you have from our 90 StarFish Medical blog posts?   I’ll share reader recommendations in an upcoming post.