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StarFish Medical March News:
Featuring Free Vancouver Medical Device Commercialization Seminar, New blogs and video: Digital Health and Medical Devices, RoHS Compliance Tips, Compliance Online Medical Device Summit

Message from the President


The generosity of medical device industry leaders never ceases to inspire me.  They share their time, knowledge, experiences and connections daily to help others.  

At StarFish, I encourage everyone to speak at events, participate on panels, and hold lots of conversations internally and with clients.  

Two topics dominate:  

  • What  does it take to commercialize a medical device?
  • How  will Digital Health impact traditional medical devices?  

This month's newsletter highlights both areas.

On April 1, our first StarFish Medical Seminar comes to Vancouver.  Thanks to the generosity of  our speakers and leading organizations, we've created a free half-day event that includes great minds and success stories from across the continent.  Details are in this issue. and tickets are going fast. 

The second initiative distills highlights from internal discussions on Digital Health and its implications for medical device companies.   

John Walmsley moderates a panel discussion with myself, Kenneth MacCallum, Principal Engineering Physicist, and Sal Sanci from our Software Engineering Group.   It's full of ideas that we hope will spark conversations and new solutions.

I hope to see our BC area readers on April 1, and look forward to feedback on the video. 

As always, thanks for reading.

Scott Phillips, President

2015 Medical Device Commercialization Playbook comes to Vancouver

Larry Spears, Former Deputy Director FDA/CDRH Office of Compliance and FDA Investigations, delivers the keynote speech,  How to reduce your vulnerability to an FDA audit, when StarFish Medical presents the 2015 Medical Device Commercialization Playbook on April 1, 2015 in Vancouver BC at the Terminal City Club.  

The free half day seminar is designed for Vancouver medical device company leaders who want to learn from experts and peers across North America.   BCIT, Emergo Group, Innovation Boulevard, Neovasc, and LSBC are supporting sponsor organizations. 

Michael Baker, Ramgopal Rao, Steve Arless, Awni Ayoubi, and Paul Geyer share experiences and topics critical to success in 2015.   From attributes of successful spin-out companies to inside stories from industry veterans, attendees will learn practical advice, current trends, and real examples from Southern California, Montreal, Seattle, and Vancouver.   

In the spirit of celebrating community success, the  event concludes with a networking reception where  LifeSciences BC will make an award presentation to: Kardium Inc., winner of the 17th Annual LifeSciences BC Award for Medical Technology Company of the Year in front of their peers.  

Capturing advantages and addressing challenges of Digital Health

By John Walmsley

ingestible Smart Capsule™ for sampling intraluminal contents, cells, and tissue.

I have been moderating panels on Digital Health and noticed the term can mean different things to different people.

To our clients, Digital Health generally refers to connecting a medical device to a network to capture all of the advantages that that brings. 

The advantages and opportunities cannot be ignored, yet the challenges can be both technical and, since this is we are in the world of medical devices, regulatory. I  touch on both the good and the challenging in a two blog series and video conversation.



ComplianceOnline Medical Device Summit: Scott Phillips will speak March 19-20, in San Diego CA.  
The 2015 Medical Device Commercialization Playbook, April 1, 2015 in Vancouver BC.

Presented by StarFish Medical with support from BCIT, Emergo Group and  Life Sciences BC. 
Client News

New US patent for Kenek Core™ technology

MD&M West Recap

Client products draw interest

Regulatory Analysis

11 Things to Avoid for RoHS compliance

LionsGate Technologies, Inc. (LGTmedical), a privately-held medical device company, announced February 24, 2015, that the U.S. Patent and Trademark Office (USPTO) has issued a patent for its pulse oximetry technology based on the Kenek Core™ proprietary audio waveform platform.

This innovation transforms smartphones and tablets into clinically accurate medical devices by connecting simple, inexpensive sensors to the mobile device's audio port.;

The company also announced today that its flagship medical device, the Kenek O2™ pulse oximeter, has been issued a Health Canada Class II Medical Device Licence for individuals and healthcare professionals to check blood oxygen level (SpO2) and heart rate.

The Kenek O2 pulse oximeter is available in Canada with U.S. availability anticipated in Q3 2015.



StarFish Medical client products delivered at MD&M West Expo.  

Newly launched Levo System by Otoharmonics, is a user-friendly custom sound therapy for those affected by tinnitus.

FASTResponder, the newest sternal intraosseous device from Pyng Medical, was specifically designed to be as easy to learn, simple to use, and fail-safe as possible.

Offering a glimpse of the future was a Smart Capsule™ for sampling intraluminal contents, cells, and tissue from Interactive Diagnostics.

Kojo Omtlekofer of Santa Clara CA, won the iPad Air2. Michael Naumann of San Diego CA , and Nate Elsen of Boulder CO won the KENEK Edge pulse oximeters.


RoHS is still a hot topic. Even though it has been around since 2002, RoHS is still changing to include more restrictions and more requirements. Medical devices were exempt for many years, but most are now included in the RoHS directive. 

RoHS stands for the Restriction of Hazardous Substances. It is an EU directive that came into legal effect in 2013 in an effort to reduce hazardous waste. It requires that all electronic and electrical equipment (except batteries) sold in the EU do not contain certain substances by volume.

You can find the full EU directive text here, including the inclusions and exemptions. To avoid these substances, I've put together a (non-exhaustive) list of 11 high risk parts and processes.