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Technology Commercialization, Free Web Tools & Process, New FDA Guidances, IVD Regulatory Tips, MDSAP Faster Market Access

Message from the President


We love entrepreneurs, robot building, free stuff, and innovation.  This issue kicks off summer with a bit of all the above.  Our lead story shows how a clever Father-Daughter start-up is using our process and free online tools to help pivot from consumer to medical products.

July's video is the first of a series highlighting our approach, experience and expertise in Cardiovascular, Digital Health, IVD, Ophthalmology, Optics, QA/RA- QMS-in-a-Box, Technology Commercialization, and Ultrasound specialities.

Two minutes and four StarFish Medical employees will give you a feel for the StarFish experience and our Technology Commercialization Expertise.  We hope the videos prompt you to give us a call, send an email, or share our work with colleagues.

  As always, thanks for reading.
 

Scott Phillips, President

StarFish Process & Free Web Tools Help Start-Up


Medinovel, a medical innovation start-up, is using free tools from StarFish Medical’s website to help them develop Quickie-Prep-- an easy and fast skin prep applicator for the operating room—and make a smoother transition from consumer to medical device products.  

“For new medical product developers, Starfish’s tools provides a sanity check as we move through the product development process”, explains Ola Kowalewski, CEO and Co-founder of Medinovel.

- READ MORE ->

 

StarFish Joins 2014 PROFIT 500 Fastest Growing Companies

StarFish Medical joined the 2014 PROFIT 500 annual ranking of Canada’s fastest-growing companies on June 12, 2014.

“It’s exciting to help Medical Device innovators and entrepreneurs. We owe this honor to our clients-- who span North America and beyond– and to a team that combines innovation and expertise to bring out the best in medical devices”, notes Scott Phillips, StarFish Medical President and Founder.

 - READ MORE ->

 
Participate with Scott Phillips on the Pipeline Innovations Startup Panel Discussion at MEDevice San Diego on September 11!  Please contact Mike Camplin for details.
FDA News

New Guidances
 
VIATeC Awards

We Make a Mean Robot
 
Medical Industry News

What We're Talking About at the Espresso Bar



The FDA was busy in June, issuing two Guidances that may impact readers. We are including links to RAPS analysis and the FDA Guidances. 

FDA Global Unique Device Identification Database (GUDID) Guidance for Industry and FDA staff. Considering that UDI will be mandatory for all but class I medical  devices, this guidance is a must read for all manufacturers who intend to market products in US.

RAPS Analysis by Alexander Gaffney, RAC: FDA Unveils Final Details about Medical Device Tracking System 
 


FDA DRAFT GUIDANCE: Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.

RAPS Analysis by Alexander Gaffney, RAC: How Can Pharma and Device Companies Use Twitter? Not Easily. 

 
 

StarFish Medical and ViVitro Labs staff members rocked the team robot building challenge on June 20 at the 2014 VIATeC Awards.  You may not recognize the robot because he`s wearing a jacket and tie.  But the team spirit is clearly a winner.


Annelies, Henning and Trevor

StarFish was a finalist for the Employer of the Year award.  We congratulate the winner, KANO/APPS, as well as the entire VIATeC team on a great event.
 

 
 


The Summer 2014 issue of Vnews from ViVitro Labs includes updates and video of an Ex-Vivo Simulator Based on the Principle of a Passive Beating Heart.  We were intrigued to see a video of a human heart beating in a Biopta lab.



Surgical Body Surface Imaging Projector for Spinal
 


The importance of Measurements in Medical Device Manufacturing