December 2017 | Volume 1




In this long-awaited guidance, FDA outlines its  position on use of the technology for medical devices, from design development to final finished device testing. We highlight three elements that address questions most often posed by readers.

CM&S has the potential to revolutionize medical devices by accelerating innovation and providing comprehensive evidence of long-term safety.






Sanford Health is attempting the use of fat-based stem cell treatments to heal small and partial thickness rotator cuff tears. This is reportedly the first clinical trial in the U.S. to gain FDA approval for the use of adipose stems cells to treat this type of injury.

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The Centers for Medicare & Medicaid Services finalized cancellation of the mandatory hip fracture and cardiac bundled payment models, and implemented changes to the Comprehensive Care for Joint Replacement bundled payment model.

Study results indicate that Rotation Medical's Bioinductive Implant, a system for rotator cuff repair, may consistently heal rotator cuff tears, increase tendon thickness and prevent tear progression.
What is often overlooked during M&A projects is the identification of risks for disruption and opportunities to leverage supply chain infrastructure to ensure that, after closing, the acquirer will be able to sustain or enhance uninterrupted and efficient upstream and downstream product supply.
 
To thrive in the healthcare environment of tomorrow, orthopaedic device companies will need to operate within a greater portion of the supply chain, assisting upstream and downstream customers in finding operational value.