To thrive in the healthcare environment of tomorrow, orthopaedic device companies will need to operate within a greater portion of the supply chain by assisting upstream and downstream customers in finding operational value. For this to be achieved, it is imperative that you understand the forces driving these changes to improve your own likelihood for success.
Passage of the "Defend Trade Secrets Act" (DTSA) federalized the trade secret law that was previously governed by individual states. In one of the key aspects, companies are now allowed to file civil lawsuits in Federal court if their trade secrets have been stolen, possibly creating a new level of consistency in the way that trade secret law is prosecuted. 
Third Party Reviews - Is This the Real Deal?
Orthopaedic device companies with simpler products like arthroscopes, bone fixation fasteners and surgical instruments could consider a regulatory route that doesn't start with FDA, and instead utilize the Third Party Review program. Benefits to doing so include speeding time to market and saving time and resources for more complex 510(k) products. 

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