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Compliance In Focus
Posted by John Lehmann on Mon, May 21, 2012

Five Concerns for Medical Device Industry

5 medical device challengesA recent Medcity News article caught my attention. The title reads, “What is the biggest challenge facing medical device manufacturers today?” The challenges seem endless! We recently wrote a blog dealing with money saving tactics for the device industry, since this is an ever present issue. However, the article in the online news site focuses on a different area of hardship.

As the article points out, a poll was recently launched asking the “challenging” question to a LinkedIn group. The poll included five choices:

  1. Reducing the cost of compliance
  2. Bringing new devices to market quicker
  3. Improving customer supply and satisfaction
  4. Reducing overall cost of goods
  5. Other

The responses have been quite interesting thus far. Most are selecting the second poll choice, “Bringing new devices to market quicker.” Which makes sense as the longer it takes to bring a useful innovative device to the market, the longer it takes for patients to receive life-saving treatments, and the more money it can cost manufactures.   The old statement holds true- time is money!

A few months ago survey results were published that focused the questioning on Medical Device Professionals. The question asked, “What process garners the most concerns during an investigational device’s product lifecycle?” The top answers included:

  • FDA 510(K) Submissions
  • FDA pre-submission process

We are interested in hearing what you think in response to either question. Do you have any challenges or concerns you’re currently facing? Share them with us!

Photo Credit: Dricker94


Topics: LinkedIn Group, FDA, Medical Device Industry


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