Posts Tagged ‘healthcare providers’



Marketing 101 Revived: A New Healthcare Consumer Report

April 25th, 2012
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In my previous post, I discussed the need for healthcare companies to take a more market-focused approach to the healthcare consumer, including a more concentrated effort to segment the market and tailor strategies to different consumer groups.
 
Today, I’d like to explore the growing power of the healthcare consumer.
 
Overall, healthcare costs – both on the societal and the individual level – are increasing. Consumers are required, one way or another, to pay a greater share. So they are starting, albeit slowly, to ask questions about value. And they are interested in the value to themselves, individually, not to the population as a whole. How the consumer perceives healthcare value is an area that needs a lot of further exploration.

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Upcoming 510(k) Improvements: FDA’s Tall Order

February 9th, 2011
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On January 19, the FDA’s Center for Devices and Radiological Health (CDRH) announced its action plan to address deficiencies of the 510(k) program. As the program exists today, some have argued that there’s a lack of clarity, efficiency and speed in the process. With that in mind, there’s been a push by industry, patient advocates and other critical stakeholders for significant change. Needless to say, the FDA has a tough balancing act to perform in this space.
 
For context, here’s a current definition of the 510(k) program from the FDA website:
 
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.” Read the rest of this entry »

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