Manufacturing & Supply

Medical Devices

Industry Overview

The healthcare industry is in the midst of transformation.  The adoption of global standards that aid traceability of consumables and devices across the supply chain is now critical.

As the industry moves toward accountable care and pay for performance, it's looking for ways to leverage data to support lower procurement costs on contract purchases, new reimbursement models, facilitate care coordination, and in general, foster population health.  The requirement for product data quality and governance, and the associated suppliers and customers linked to these now becomes paramount to this industry moving forward.

Federal Regulatory authorities like the US FDA and similar international organizations as represented by IMDRF are actively mandating the clear identification (usually with GS1 Standards) and registration of medical devices.  These federal registries have the power to massively impact patient safety through improved adverse impact reporting.  Sister agencies to the US FDA, like the US ONC are leveraging the standardized data to more accurately measure the quality and effectiveness of care, efficiently reimburse/pay for care.  An excellent example of this can be seen in the ONC's Meaningful Use initiatives.

Innovit's iICE solutions allow medical device manufacturers to meet Federal regulations as well as commercial GDSN requirements such as GDSN product registration and communication like those specified by the Healthcare Transformation Group (HTG).