We spoke to four executives and surgeons about what it takes to innovate in a highly regulated, cost conscious industry. Companies large and small need to do the following to successfully meet market expectations: allocate money, leverage data and consult FDA.
FDA issued draft guidance that gives orthopaedic device manufacturers more direction on labeling device trays and kits with unique identifiers (UDIs). The proposed change would clarify the definition of convenience kit, reducing the number of accepted exemptions and requiring more individual devices to be marked with UDIs.
With more than 125 exhibitors, the Exhibit Floor over 90% reserved and the Education Lineup nearly complete, start identifying the resources you'll need in 2016. Search the Exhibitor List for partners or contact these sponsors:
Acquisition news, ISO changes, additive manufacturing updates and design controls topped the list of most-read BONEZONE articles in 2015. In the event you missed one of the major strategic announcements of the year or need a refresher on compliance initiatives and industry-shaping events, we've recapped the six most-read articles here.
Fought by the industry since its inception, the medical device tax was suspended as part of the $1.8 trillion spending and tax bill passed by Congress in the waning days of 2015.
How will the industry respond? We'll take a deeper look in the March issue of BONEZONE. Make sure you receive a copy.
