Is this email not displaying correctly?
Click here to view it in your browser.

StarFish Medical logo
Medical Device Expertise saves time to market: 510(k) vs. CE Mark - Which is right for you?; Medical Device Ideas Concept to Design, 4 QFD Tips; FDA MDDS and mobile app guidelines; Free BIOMEDevice San Jose passes; Natus Medical Launches Echo-Screen III

Message from the President

Congratulations to our client, Natus Medical, on the launch of its newest hearing screening product, the Echo-Screen® III hearing screener.  The innovative product was launched outside the United States in the summer with FDA clearance expected later this year.

Our lead article explores the similartities and differences between launching in the U.S. or Europe.  Vincent Crabtree brings particular insight based upon his experiences as a UK-based medical device company CTO. 

We speak and write frequently to help medical device entrepreneurs succeed.  2 of our 3  blogs this month are from first-time StarFish bloggers--  and all have been well received and  highly shared.  Recent guest article links are included below as well as upcoming speaking engagements.  

It is a special pleasure to see our May 2013 RoHS article for Medical Device Summit  is still among their most popular reads.

As always, we thank you for reading.

Scott Phillips

Similarities and Differences between Medical Device 510(k) and CE Marking

     By Vincent Crabtree       


Many clients who approach StarFish have already identified 510(k) as their preferred regulatory pathway to reach the market in the US.

The reasons are clear: Large single market with a transparent regulatory body and minimal costs (compared to PMA). Clients sometimes assume that, once the 510(k) is in place, it will be trivial to obtain a CE mark and start exporting to Europe.

This article attempts to highlight 5 similarities and differences in order help those unfamiliar with CE marking effectively prioritize their regulatory efforts.



17 months and StarFish RoHS article is still on The SUMMIT'S charts

Scott Phillips is a panelist on the value of advisory Boards for smaller companies.  Institute of Corporate Directors, Victoria,  November 5, 2014 
StarFish Medical exhibits at BIOMEDevice San Jose (Booth 633), December 3-4, 2014.
Free expo admission and 20% off of conference & seminar rates.

Scott Phillips will present: How to launch a successful spinout company at the Schulich Seminar Series on December 10th, 2014, Sunnybrook Research Institute.
Client News

Natus Medical

New Hearing Screener

StarFish in the Media

Global Certifications eBook, Guest Blogs

Medical Industry News

What We're Discussing Over Cider

Natus Medical launched its newest hearing screening product, the Echo-Screen® III hearing screener.

Combining new advanced capabilities, with its proven and trusted screening technologies, this next generation Echo-Screen III handheld device comes in any combination of modalities: TEOAE, DPOAE, and ABR.

"I am very pleased to see the impressive results and unique design of this product development effort, building upon our reputation as the global pioneer and worldwide leader in newborn hearing screening," said Jim Hawkins, President and Chief Executive Officer of the Company. "We believe this next generation product will be well received by our International customers as hearing screening adoption continues to grow worldwide."

The new Echo-Screen III is being launched outside the United States with FDA clearance expected later this year.


StarFish Medical RA Specialist, Rob Keur, provided the Medical Devices chapter for the EMC FastPass eBook, Global Certifications for Makers and Hardware Startups released October 30, 2014.  Featured on TechCrunch, the eBook  aims to provide readers a clear regulatory path to market.

5 Benefits of Best-Sourcing Medical Device Teams by Martine Janicki PhD, PEng and a PMP appears in the October 2, 2014 edition of  The article is based upon an original StarFish Medical blog. October 22, 2014 edition published a Guest Blog by Mechanical Engineer and Project Manager, Mark Drlik, titled: 4 QFD Tips for Emerging Medical Device Technology.