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Compliance In Focus
Posted by John Lehmann on Mon, Oct 8, 2012

How Medical Device Development Is Different

medical device development is differentEach sector of the research industry faces its own unique challenges. For instance, take clinical research involving drugs versus devices. While some aspects of the research process and clinical trial are the same, their differences require special attention to have a compliant and well-controlled study. Likewise, an article titled, “Combating the challenges of medical device development,” investigates how medical device development is similar to other product development- but still faces unique challenges.

The article lists the following challenges that are specific to the medical device industry:

The amount of regulation that is involved in device development definitely sets the industry apart.  On top of this list, pile on another set of complications, including:

  • Increased competition
  • Need to sell into global markets
  • Need to shorten development time and time to market

It’s obvious the pathway to approval isn’t exactly broad and easy. Then again, the patients on the other end of approval deserve something that is proven safe and effective. While they may seem like burdens or obstacles these challenges ultimately help the people who will receive them.

What are your thoughts on device development? Can you think of any other unique challenges to add to the list? Let us know below.

Photo Credit: holeymoon

Register for IMARC & ImageIQ's Complimentary Webinar:  "Imaging in Clinical Trials – Unique Compliance Challenges" Wednesday, November 7, 2012 - 11am EST

Topics: Medical Device Development, Drugs versus Devices, Clinical Research


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