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Medical Device Expertise to reduce risk and foster innovation: Mat Ras joins California team; New Pathfinder™ product definition whitepaper; Free BIOMEDevice San Jose passes; QMS-in-a-Box; Micropharma; Otoharmonics; Sunnybrook Research Intitute; The Sensor Project; Festival of Trees; New Blogs
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 Message from the President
Jim Collins talks about ‘return on luck’ in Great by Choice. All companies face good and bad surprises. The great ones make the best of favourable conditions and grind it out in slow times.
We've made fundamental improvements in our business by growing and developing our project management team, adding project reporting and management tools, and adding functional managers.
One such development is Dr. Mat Ras joining us in Irvine, California. As a focal point for client relationships in Southern California we are delighted to have someone of Mat’s calibre on our team. Read his announcement to my right.
I'm also pleased to share recent comments from Michael Baker and Mitchell Jones in this issue. They embody exciting companies, breakthrough products, and industry leadership.
Tis the season and our entries in the annual Festival of Trees charity event for BC Children Hospital are becoming a local legend. We hope they raise both spirits and donations for a worthy cause.
As always, thanks for reading and see you in 2015!
 Scott Phillips
President
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Mat Ras Ph.D., joins StarFish Medical as our Regional Business Development Manager based in Irvine California. Mat brings over 20 years of experience in the Diagnostics, Life Sciences, and Drug Discovery markets.
Mat has held hands-on product development positions as Vice-President of product development at ThermoFisher, Senior Scientist at Johnston & Johnston, Principal Investigator and Deputy Director at Lawrence Livermore National Laboratories, and Senior Advisor at Carl Zeiss & Roper Scientific.
- READ MORE ->
New Pathfinder™ whitepaper helps optimize product definition
 Building upon the popular Pathfinder™ Sanity Check, StarFish Medical introduces its first whitepaper: Optimizing Medical Device Product Definition.
The new whitepaper helps entrepreneurs gauge technology commercialization readiness during the Product Definition phase. It draws on Starfish Medical experiences and methodologies. Download Here.
"Encouraging a company to go down a development path that is realistic from a design, regulatory, and indication for use perspective is really important. StarFish Medical identified major risks in developing the medical device and made sure we tackled those first. They understand small details which go into developing a medical device that a first time research team wouldn’t consider.
Our microbiome sampling project and prototype had been going on for 2 years. We handed the project to StarFish and have made great progress since. They took a very methodical approach based on determining indication for use that helped us identify new peripherals, add functionality and enable manufacturability. "
Mitchell Lawrence Jones MD, PhD
CSO, Co-Founder
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Client Testimonial
Otoharmonics
QMS-in-a-Box Support
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StarFish and the Holidays
Sensor Project,
Festival of Trees
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Regulatory News
FDA Guidance Update
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Did you know that StarFish offers a standalone Quality Management System (QMS) solution?
Get a head start using a QMS customized by medical device engineers and QA/RA who work with medical devices every day-- even if you are not a client of our design and development services.
“I am extremely happy with StarFish support while setting up a QMS for Otoharmonics and the Levo System tinnitus sound therapy device. I’ve worked with a lot of QMS people in my life and the StarFish team are the most helpful and easy to work with.
Their knowledge is outstanding; A lot of other QA people simply pretend to know regulatory details and implications while the StarFish team really does. And they are not afraid to admit when additional research is needed.”
Michael Baker
President & CEO
Tinnitus Relief Through Sound Stimulation
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The Sensor Project is a non-profit effort that brings new and innovative global health delivery models to optimize the use of medical sensors attached to mobile phones.
StarFish client, LionsGate Technologies, is the commercialization partner. We are proud to support The Sensor Project and encourage readers to learn more.
The 2014 joint StarFish Medical-ViVitro Labs Festival of Trees entry raises funds for BC Children’s Hospital and celebrates two Christmas holiday icons while adding a medical engineering twist for kids of all ages.
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On November 24th 2014, the FDA issued a new version of their guidance document “Design Considerations for Devices Intended for Home Use”.
The new version supersedes the previous version issued earlier in August. It is intended to clarify the use of standards applicable to devices intended for home use with respect to supply mains and electromagnetic compatibility. In the new version, the guidance indicates that designers should consider using applicable specifications outlined in the latest edition of IEC 60601-1:2012 (ed. 3.1) and its various collateral standards.
In particular, the FDA recommends considering Edition 4 of IEC 60601-1-2 and notes that electromagnetic disturbance in the home healthcare environment can exceed the default test levels for the hospital environment specified in Edition 3.
Also highlighted is IEC 60601-1-11:2011 which specifies voltage ranges for mains powered devices intended for use in the home healthcare environment which may have unreliable sources of electricity and poor grounding, unlike most hospital environments.
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© 2014 StarFish Medical Inc.
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All Rights Reserved
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