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Give your medical device a proper FDA submission with these 3 keys

It's stressful. If you're a startup, your company depends on it: it's your FDA panel meeting. And, as Michael C. Morton, the vice president of global regulatory affairs at Medtronic (MDT), said, "It's kinda culminated with throwing the dice."

Posted by: MedCityNews .com
on September 25, 2013
Category:  Execution  Creation 
Entrepreneurs explain what medical device startups should avoid

A lively conversation has ensued over at the Medical Devices LinkedIn group in response to a member who posed the question: What are the three mistakes startups make that could act as advice for the industry moving forward?

Posted by: MedCityNews .com
on August 19, 2013
Category:  Creation  Execution 
Med device entrepreneurs share which startup costs were unexpected

In the startup world, where every dollar counts, spending too many dollars on expenses you weren't prepared for can quickly put a company in a tough spot. In a 2011 survey, one in three small business owners reported that underestimating monthly expenses was their biggest mistake.

Posted by: MedCityNews .com
on July 31, 2013
Category:  Creation  Growth 
Get angel and VC interest in your medical device startup

Paul Hartung, CEO of Cognoptix, Inc., a startup that has created a drug-device that could diagnose Alzheimer's earlier in patients, is also the first person to have a syndicated angel deal in the Northeast. He's raised more than $20 million for Cognoptix, and worked on the LASIK team at Summit until it was brought through to IPO. Here are six strategies that helped Hartung attract investors.

Posted by: MedCityNews .com
on July 22, 2013
Category:  Ideation  Growth  Creation 
Improving medical devices through real-world testing

When WiFi-enabled medical devices first came on the scene, there were relatively few of them. But as these devices have proven their worth, they have exploded in growth from hundreds to thousands in hospital environments. There are so many wireless devices competing on hospitals' WiFi systems and its increasing the risk that the devices will malfunction.

Posted by: MedCityNews .com
on June 26, 2013
Category:  Execution 
eMed's 6 to follow in entrepreneurship
  Join the conversation this week with eMed's entrepreneurs to follow on twitter. [More]
Posted by: Chris Seper
on 4/12/03
Category:  Creation 
What are the rules when physicians become medical device developers?

In today’s healthcare business landscape, support from doctors is part of many company’s medical device development business plan. Read more on when conflict of interest becomes a problem for physicians doubling as medical device developers.

Posted by: Healing Innovation
on August 22, 2011
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