July 2016 | Volume 2







FDA recommends that companies re-examine UDI basics with new guidance on how to form a proper identifier. The UDI must be present on the label and packages via easily readable plain-text and automatic identification/data capture technology.


Vagueness in standard methods and regulatory guidance on instrument testing and validation has left OEMs questioning what best practices to apply to their devices.
 
Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. This is reported to be the first synthetic cartilage device to gain FDA approval.



Infection control has been on the radar of various orthopaedic device companies, from start-up to top five. In the trauma market, technologies intended to minimize post-surgical infections are emerging as a potential solution to address rising healthcare costs. 
From the archives


Outsourcing innovation can optimize design, improve timeline performance and reduce cost. It requires collaboration between the OEM and supplier, strong internal relations at both companies and an understanding of each company's core competency.


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Here's 
why...




Q.
  Seeking new customers and partners?
A.  Search the Device Company and

Supplier/Service Provider Directories.


Q.  Looking to improve sales forecasts?
A.  Utilize revenue predictions through

2020 in THE ORTHOPAEDIC INDUSTRY

ANNUAL REPORT
.


Q.  Wanting to make meaningful

contributions at your next meeting?
A.  Access company news via ORTHOFLASH.


...and much more!

 




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