Category: UDI Compliance

There’s a new sheriff in town. His name is Jeffrey Shuren, Director for the FDA’s Center for Devices and Radiological Health (CDRH)

And he has set new strategic priorities for 2010 and beyond for all companies who manufacture, repackage, relabel, and/or import medical devices. The deadline: September 30th, 2013. His goal is to implement a total product lifecycle approach, enhance communication and transparency, strengthen its workforce to implement this strategy and provide agile feedback and innovation on unmet public health needs.

If you’re involved in labeling, this is very important Continue reading


Now before I offer an answer to my eleventh hour hype, let me summarize what Jay Crowley, senior advisor for patient safety for the FDA, has outlined for all medical device manufacturers who want to ship or export to the United States.

As you are aware, the Unique Device Identification (UDI) system is the FDA’s proposed system for identifying medical devices in a standardized way. This will help any recall efforts, post market surveillance and adverse event reporting, and electronic health record documentation. Another bonus is for the supply chain management to help improve it’s ordering and distribution of products. At the end of the day, though, the main driver is patient safety.

The FDA will be publishing the proposed UDI system regulations in 2010 for all medical devices. This will create an analogous, standardized identification system for all medical devices and promote the use of data that can help manufacturers manage their products.

For those manufacturers of medical devices in the Class 3 category, you will have one year after the final ruling, Continue reading

This step is in every major software implementation methodology. However, what is often missing are the software services experts who can quickly and reliably perform the validation and have years of experience as well as thousands of validation events from which to draw upon. During this phase, manufacturers need Installation Quality, Operational Quality, and Product Quality (IQ,OQ,PQ) experts who are knowledgeable about how new software must be implemented Continue reading

In addition to application integration at the CMS level, the forward-looking solution in healthcare products labeling looks to all major enterprise applications to drive label printing. All of these major and widely-installed enterprise applications, from providers such as Oracle, SAP, and others, are considered ‘a single source of truth.’ As such, if they are leveraged to drive label printing and label data, then the practice of manual label data entry, which is super error-prone, is eliminated.

This approach is a super win for healthcare IT professionals for a variety of reasons. Automating enterprise wide on existing business applications is less costly. Instead of fifteen departments Continue reading

Healthcare products manufacturers today know they need – and they have – systems for version control. They have solutions in place to manage the approval process for every label. These are not new requirements. This means manufacturers have systems in place for workflow; they have the right people already in place who are familiar with these systems. With this in mind, it isn’t practical to buy new or redundant applications. Instead, it makes significantly greater sense to simply add the label data in these existing applications. Most notably, this refers to integration with Content Management Systems (CMS) such as PLM, Continue reading

Step 1: Consolidation
Medical products manufacturers with dispersed, departmental, standalone and multi-regional labeling systems face a daunting task of meeting UDI compliance enterprise-wide if the decision is made to sustain these systems. Reprogramming all of these separate solutions over many departments and across all labeling geographies is a time-intensive initiative that in the end, does nothing to fix the underlying problems of a decentralized labeling approach. Therefore, bringing your enterprise labeling solution up to speed for UDI compliance could be a significant overhaul and manual intensive. A major medical devices manufacturer that attempted Continue reading

The FDA has finally set a solid date for the expected implementation of a Unique Device Identification (UDI) implementation for medical devices and other healthcare products:  September 30, 2013.

Haven’t started yet? — you’ll need to. Much of the healthcare products and services world, including many GPOs, are ahead of the curve already and demanding that their manufacturers adopt Continue reading

There has never been a better or more urgent time for manufacturers of healthcare products to make a close examination of their product labeling systems. Why? Because in most cases, existing solutions were developed over time, usually organically and often departmentally, individually and separately by each manufacturing entity to a labeling standard of their own choice. This approach has mostly worked, albeit at great expense, with much inefficiency, and at the tremendous risk of error, manufacturing interruptions, counterfeit labels and a host of other problems. But in addition to these well-known limitations, there is one additional major reason why now is a good time to explore labeling solution alternatives. New labeling mandates Continue reading

Forging a Real Solution, in Partnership, for the Real World

The following is derived from more than 26 years experience in product marking with more than 25,000 customers, most of which are global enterprises, and from our more recent work with some of the world’s most significant and forward-thinking healthcare products companies currently adopting GS1. The five leading Group Purchasing Organizations in the U.S. and Canada alone – who are mandating GS1 compliance – represent $63.4 billion in sales. But while approximately 70% of all major GPOs everywhere have announced their support of GS1, 50% of manufactures have signed on. The healthcare products companies we’re working with Continue reading

Probing Questions Every Undecided Healthcare Products Manufacturer Should Ask

Three questions come immediately to mind:

1. Which class of company do you think has the better chance for global market share gains in the coming 12 to 24 months as GS1 standards meet their sunrise dates worldwide?

2.  How does the cost of compliance now compare to the cost of compliance later and lost market opportunities between now and then?

3. What are the early adopters doing, and how are they doing it, to implement their solutions at the lowest possible cost, in the shortest period of time, and while optimizing what is currently in place?

Survey respondents listed no fewer than 814 distinct items as the most significant barrier that inhibits the adoption of data standards in their organization. These items include Continue reading