New Acronyms from the FDA: UDI and GUDID

UDIOn September 24, 2013, the FDA established a Unique Device Identification (UDI) system to identify all medical devices sold in the U.S. starting from the point of manufacture, through all distribution channels, and to the eventual sale to the consumer.

The FDA’s UDI system requires medical device manufacturers to include a simple to read text version of the required identification information as well as a machine-readable version encoded using Automatic Identification Data Capture (AIDC) technology. AIDC refers to the various methods of electronically identifying and collecting data. AIDC typically includes bar codes, Radio Frequency Identification (RFID) tags, Optical Character Recognition (OCR), smart cards, and voice recognition technology.

At a minimum, the UDI label will contain the specific version or model number of the device, as well as the device’s lot/batch number, serial number, expiration date and date of manufacturing.

The UDI system will be phased in over the next several years. The exact timeframe depends upon if the manufacturer produces Class I, II, or III devices. Lifesaving Class III devices must meet all requirements by September 2015, while Class I devices have until 2020.

In addition to the physical label, the device manufacturer is required to submit specific information about their device to GUDID, the FDA’s Global Unique Device Identification Database. The public will be able to use AccessGUDID to look up their specific medical device and download all GUDID data available to their PC, smartphone or other electronic devices.

Similar to the UPC codes for the food and beverage industry, the medical device manufacturer will not be the one assigning the unique device identifier; instead, UDI codes will be provided by FDA-certified organizations.

On the surface the UDI concept appears to be as simple and straight forward as this:

(1) Put the required information on the label

(2) Make sure the format is correct

(3) Make the label both people friendly and machine-readable

(4) Update their quality system with all the required information (see 21 CFR 820.30(j))

(5) Upload the data into GUDID’s database

Unfortunately, it’s more cumbersome than you think when you start applying it to your actual medical devices or equipment. For example, one of our customers who sells blood glucose monitoring equipment might think it’s simple and straight forward to add one label to one piece of equipment. But they will realize that for their test strips that come in various size bottles, they are required to issue a Unique Device Identification label for each bottle size. Also for that one bottle which contains 25 strips, the manufacturer needs to assign a “unit of use” code that gets added to the label.

They also have to think about the bottles that are sold in a convenience kit with the blood glucose monitor at a bundled price. The convenience kit requires a UCI label of its own, but the items in the kit do not require a label, unless the items in the kit are to be sold separately. In addition, new labels are required every year when they introduce their new and improved models, even if they only changed the box the unit comes in.

Here are some other things I have noticed about the UDI system:

  • Items that have National Drug Code (NDC) numbers on its label do not require a UDI unless it is packaged with other items that require UDI’s, then the package requires a UDI.
  • Implantable and other devices that remain in use for an extended period of time, certain sterilized items, items that can be used more than once, or any device that may become separated from their original label, requires the UDI be etched on the device.
  • The FDA has not mandated what format the machine-readable label needs to be in. So what happens if the manufacturer uses a 3D bar code and my cell phone cannot read it because I don’t have the 3D app? Are they in violation of FDA rules?

The good news is that the UDI implementation should dramatically improve patient safety and post-sale surveillance of any type of medical device equipment. Manufacturers and the FDA will be able to rapidly collect and analyze reports about all their devices, allowing for faster identification of problems and putting patients at less risk.

One thing is clear from all of the confusion that comes with this new regulation. In order to be successful in today’s FDA regulated world requires a good quality management solution that enables rigid record-keeping and bi-directional traceability that helps manufacturers streamline their operations and handle their UDI requirements. Having an effective enterprise quality management solution is a sure way to maintain your manufacturing quality assurance.

Top 5 Risks You Need to Know Before Selecting a Manufacturing Execution System

5 Risks for MESWhen selecting a Manufacturing Execution System, there are two broad types of Manufacturing Execution System (MES) implementations:

  • A custom-built MES configuration based on an MES tool kit
  • A Commercial-Off-The-Shelf (COTS) configuration of MES software

These two flavors of MES implementations come with different variations of risk.

Taking the time to do proper risk management, identifying and mitigating risks, can protect the organization from unnecessary costs and heartache. Below you will find key manufacturing risk factors that you must understand in both approaches to ensure a smooth path to implementation.


With companies operating with tighter budgets, it is becoming more critical to manage costs throughout the entire implementation, not just the cost of the software licenses. Buying a software can be an expensive proposition if you underestimate the actual work required in services to make the software operational.

Custom built MES configurations based on MES tool kits can run high ratios of license-to-service dollars, often times upwards of 1:5. That means for every $10,000 spent on licenses, you may actually be spending $50,000 in services. With a COTS MES solution, the ratio can drop dramatically to the range of 1:2. It is important that the comparison of various solutions includes both expected license and service costs to get a more accurate pricing estimate. And don’t forget to account for the additional cost of managing the software production lifecycle for the custom solution as the toolkit and platforms require more upgrades.


Configured and COTS MES solutions always have some kind of failure risk. The reasons could be inherent, including insufficient hardware, lack of training, and/or other improper implementation processes. Validation is an extremely important exercise when custom building a solution to know how your company’s data and process flows will react in the software system. The one major benefit of looking at a COTS MES solution is that you can conduct a small project up front to test and validate data in a sandbox or emulated environment before making a bigger purchasing decision to rollout. Testing with a small sample of your data and processes in your own environment is one way to mitigate your operational risk.


Old processes and habits are often hard to change. Changing an organization to move from legacy processes to new ones or to invest in a new software adoption requires heavy commitment from the management and the entire team company wide. Implementing new solutions can be a scary undertaking for anybody and can create fear of change in the organization. Implementing change management procedures combined with executive sponsorship and ample product training are the keys to providing an entire organization the confidence it needs to change.


Technical risks can cause a sacrifice in performance or a delay in schedule requirements during an MES implementation. A common cause is over configuration and scope creep during an implementation. Continuously adding and changing requirements for an implementation can cause adverse effects on relationships between the configurations in different areas of related functionality. Each change made could have a negative ripple effect and consequences. With tailored solutions, these risks can be higher because configuration is at the crux of the solution and without following or operating to a set of standards, there is more room for failure. COTS MES configurations have the advantage of foreseeing and avoiding certain risks by various testing done by the solution provider and also reviews from multiple user communities.


Every MES implementation project has some degree of program risk where unforeseen external factors can work against a successful implementation. A company could run out of funds, a division could be consolidated and moved or the company changes direction with a new strategy. These are very hard to anticipate and can often be frustrating. That is why it is best to look for solutions that have referenceable and successful implementations done in a reasonable time frame. The longer the time it takes to “go live,” the more room there is for an unforeseen circumstance to come up. Getting implemented in 4 months versus 2 years could be the difference between a successful transformation of your manufacturing environment and a project with unfinished implementation that yielded minor improvements. Only bite off as much as you can chew in a reasonable time frame, even if it means giving up a few things to achieve that first project milestone successfully.

5 Risks for MES

At the end of the day, your company must carefully evaluate the pros and cons for both types of implementations in order to make an informed decision. To get started, download our free eBook, “What is MES?” and gain a better understanding of what Manufacturing Execution Systems can do in complex discrete manufacturing.


iBase-t Discusses Digital Thread to Manufacturing at AeroDef 2016

Foothill Ranch, Calif., January 12, 2016 – iBase-t, the creators of the Solumina software suite, a fully integrated manufacturing process planning, execution and enterprise quality management system, announced today the company will exhibit at AeroDef Manufacturing with Composites Manufacturing Conference (booth #513) on February 9-10, 2016 at the Long Beach Convention Center in Long Beach, California.

“For aerospace and defense manufacturers to stay competitive in the 21st century, the urgency of enabling the digital thread, incorporating new processes, consolidating disparate systems and technologies are critical to their continued growth and scalability,” said Vic Sial, President, iBase-t. “We have worked closely with our CAD/PLM partners and Solumina G8 closes the loop between engineering and the production shop floor.”

Solumina is built specifically to handle the complex requirements in Aerospace and Defense manufacturing and complete the digital thread from engineering design into manufacturing processes. Managing product configurations and change management across the entire value chain and product lifecycle is where iBase-t delivers exceptional value to complex manufacturers. These capabilities allow companies to efficiently meet and exceed regulatory compliance, time-to-market, and quality requirements. We specialize in breaking down barriers that hold manufacturers back from obtaining their goals.

To learn more about how your organization can better connect engineering and manufacturing processes, reduce the costs of compliance, time-to-market, and increase your manufacturing competitiveness, stop by booth #513. For a more in-depth look at the Solumina software suite set up a one-on-one introduction with iBase-t to learn more about the value in implementing Solumina and giving your organization the control and visibility of your manufacturing processes.

About iBase-t

iBase-t is a leading provider of software solutions to complex, highly regulated industries, like Aerospace and Defense, Medical Devices, Nuclear, Industrial Equipment, Electronics, and Shipbuilding. iBase-t’s Solumina software streamlines and integrates Manufacturing Execution System and Operations Management (MES/MOM), Maintenance, Repair and Overhaul (MRO)and Enterprise Quality Management System (EQMS) for operations and Supplier Quality Management. Solumina is implemented by industry leaders, including BAE Systems, Airbus Space & Defense, General Dynamics, Lockheed Martin, NASA, Northrop Grumman, Textron and United Technologies.

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