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Compliance In Focus
Posted by John Lehmann on Mon, Nov 11, 2013

3-D Printed Implants Pave the Way for Personalized Devices

I ran across an article in “The Gray Sheet” that caught my attention.  The whole concept of 3-D3 D Printed Implants Pave the Way for Personalized Devices printing fascinates me and the medical device industry is fully embracing this new technology.  3-D printing, employs computer models to build three-dimensional objects by printing layers of material (plastics, polymers, metals, powder and liquids) on top of each other.

Several medical device companies are using 3-D printing to make implantable devices that are customized to specific patients or to improve manufacturing precision and efficiency.  With this activity, we could be seeing a new paradigm of personalized implants.  The benefits of the 3-D printing process include:

  • Constructing devices that meet the specific needs and dimensions of specific patients
  • Provides a more cost-effective approach than conventional manufacturing

The FDA has publically praised 3-D printing.  In its efforts to support personalized medicine, which also includes genomic testing and stem cells.  “3-D printing is transforming our concept of personalized medicine and medical interventional opportunities” FDA Commissioner Margaret Hamburg said during an October 29th AdvaMedDx and American Association for Cancer Research meeting on personalized medical held in Washington, D.C.

Beyond a reduction in costs, 3-D printing allows for flexibility in design and manufacturing, which could lead to a reduced time to market.  Tissue Regeneration Systems gain 510(k) clearance in August for the first of several planned products – its cranial bone void filler used to repair neurosurgical burr holes.  In a recent interview TRS President and CEO Jim Fitzsimons said “To our knowledge, this is the first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3-D printing.”

3-D printing technology is exciting and could represent a new opportunity for the medical device industry.  What are your thoughts on the potential impact on the medical device industry?  Please share your thoughts below.

Photo Credit: devopstom

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Topics: 3-D Printed Implants, Personalized Devices, FDA


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