UDI Expands, Questions Roll In, And Debate Over System Adoption Continues

Jay Crowley was interviewed for an article about the current state of the Unique Device Identification (UDI) program, persistent challenges for companies and what to expect in the year ahead.

Here is a link to the article. You need to be a subscriber or register for a free trial to The Gray Sheet to view the entire article.

As Vice President of the UDI Practice at USDM Life Sciences, Crowley helps medical device manufacturers achieve regulatory compliance as well as internal benefits and competitive advantage with UDI implementation.

Is it Possible to Add Additional Product Data to What is Available Via the GUDID?

Yes, after getting UDI Connect into your Salesforce Org, go to the AppExchange and bring down the desired package. Once this happens, it is possible to add any field, pick lists, and look-ups from the Global UDI Database (GUDID) to the app. The app is highly customizable as USDM does not limiting like other managed packages. The application is flexible and designed in this way because USDM understands that all clients have different processes and practices as well as different intended uses for the application.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Can USDM Help Implement on Platforms Other than Salesforce?

USDM Life Sciences' UDI Connect platform is currently designed to work on Salesforce, and it can be ported to other backend services that support the same level of security and multi-tenancy. Porting involves adapting to the specific requirements and features of the target platform, but USDM can leverage its existing methodology and Workflows, as well as the same mobile application, and apply it to any platform.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.