UDI Implementations In Full Swing With Innovatum

UDI Implementations

So far this summer is off to a sizzling start with Innovatum managing seven global labeling UDI implementation projects concurrently. Four of these projects had their go live take place in the month of June 2015 alone! In conjunction with successfully submitting significant amounts of product UDI attribute information to the FDA Production Global UDI Database (GUDID) via Innovatum’s ROBAR Master Data Manager (ROBAR MDM) and ROBAR Communication Manager (ROBAR COM) products, Innovatum’s customers are taking advantage of Innovatum’s intensive experience with UDI implementation management. An extension of this for two major Medical Device Manufacturers is that they are now relying upon Innovatum’s expertise as a validation services provider to manage their complete validation processes.

Innovatum customers are fully exploiting the efficiencies of using ROBAR MDM and ROBAR Labeling along with ROBAR COM to deliver a system that uses one database to coalesce regulatory device and device production data throughout the enterprise and use the very same data for multiple purposes. The ROBAR product family does this while tightly managing security permissions and data access to various business departments. It makes the same data available for product labeling, can convert the data into Health Level 7 Structured Product Label (HL7 SPL) for regulatory data upload to the GUDID, and can supply product attribute data via a Global Data Synchronization Network (GDSN) certified data pool, a combination of data pools and other trading partners including “GUDID like variants” that will be required by other regulatory bodies.

According to Innovatum’s President Ardi Batmanghelidj, “Word is getting out. We have the only complete UDI management offering in the industry which includes a Master Data Management database that is the single source of truth or can get to the single source of truth. New fields can be added as requirements advance without a need for programming changes or validation. All of this data is easily tied to our industry leading medical device labeling system and/or our integrated regulatory data submissions and communication system though a few simple configuration changes. This greatly improves efficiency and reduces complexity by eliminating any requirements for duplicate approvals on the same data since one set of data is approved and then used for several purposes.” Innovatum has also announced its plans to integrate eIFU management starting in 2016 which further exploits the efficient use of this data. One of the overarching goals of Innovatum’s product set design is to minimize the involvement of IT resources required for implementation and on-going management.

The ROBAR Labeling, ROBAR MDM and ROBAR COM products maintain full audibility and are fully validatable in Medical Device Manufacturers environments with 21 CFR Part 11, 820, 830 and others. ROBAR Labeling is available separately or it can be used in conjunction with ROBAR MDM and ROBAR COM.


2015 UDI Conference Highlights

2015 UDI ConferenceAlthough the 2015 UDI Conference had record participation, many Medical Device Manufacturers were not able to attend, consequently this summarization of highlights from the sessions should be of value.

FDA kicked the first session off with an overview of UDI, a review of compliance dates, a listing of benefits derived from UDI and an update on GUDID status. Biggest achievements since the conference last year: Brookings Institution to create a “roadmap” for provider systems, patients, payers, supply chain personnel, and many others, to adopt and utilize UDIs. Another major achievement noted during the 2015 UDI Conference was the announcement of AccessGUDID. Challenges either addressed or being addressed: Managing input to the UDI helpdesk through implementation of tracking software, software labeling guidance, Contact Lens labeling guidance and UPC for retail guidance. A challenge that FDA is calling upon the Medical Device Manufacturing industry to address is ensuring data quality, such as product codes matching pre-market information.

FDA went on to lay out plans for the future including: working with SMI (strategic market initiative), working with standards organizations, expanding capabilities within AccessGUDID such as moving from basic search capabilities to advanced search capabilities and adding web services capabilities. Also announced were Direct Marking guidance (which incidentally was released during the conference), and the opening of the GUDID after January 1, 2016 to Class II products that are not implantable, life-supporting, and life-sustaining devices. The biggest news from FDA is that Terrie Reed is coming back.

AIM (Global trade association for the Automatic Identification and Data Capture (AIDC) industry) presented a session demonstrating the way that technologies using unique device identification (UDI) are being employed to meet recent U.S. compliance rules. The takeaways from the 2015 UDI Conference are that: various types of direct marking technologies are available and some are a better fit than others depending upon the particular medical device, vision inspection is a very useful tool to help with addressing the accuracy required for the new data elements on the labels, and software was demonstrated that can handle master data management (using information pulled from other systems in real-time), regulatory data upload, label management and printing anywhere in the world via browser using a single solution.

The key takeaway from the track concerning UDI in the supply chain is that medical device manufacturers need to be concerned with getting data all of the way through to the providers. The important thing about GMDN is that terms will change and it is up to you as labeler to make sure you keep pace and keep the GMDN information in your GUDID records up to date. The most salient point from the session on understanding efforts that are similar to UDI around the globe is that harmonization is not taking place to the extent that one might hope. Surmise that there may be some challenges and budget accordingly.


Enterprise Life Sciences Labeling (Cloud Based)

Enterprise Life Sciences LabelingEnterprise Life Sciences Labeling in the cloud.  It seems as if everyone wants to move to the cloud. The cloud promises many great things such as, flexibility, minimized infrastructure costs, lower maintenance costs, always being on the latest version of the software, etc. But when it comes to the labeling of highly regulated data such as within the Life Sciences (Enterprise Life Sciences Labeling), cloud based technologies can fall short in several important ways. In other words, depending upon the specific usage of cloud technology, there can be too much or too little cloud.

Enterprise Life Sciences Labeling Design

At its simplest level, labeling begins with label design. A very small ratio of people in a life sciences company have the responsibility of label design. Software products that deliver cloud based label design capabilities are inherently inferior to client computer based label design software packages. They are inferior for one simple reason. It all comes down to a lack of product maturity due to a lack of maturity of available cloud based software development and delivery mechanisms. The Internet can be used very efficiently to move graphics. However, Internet based technologies are very poor when manipulating graphics. When large manufacturers often have as few as four or five persons who need access to label design capabilities, why should they tolerate second rate cloud based label design software capabilities when it is so easy to use an industry leading label design product on the workstations of the few who need it? But as we all know there is more to enterprise life sciences labeling design than label design and design management.

Compliance Requirements

Having part of your labeling data stored in the cloud and part of it stored in your enterprise systems constitutes the definition of information siloing. Since data is stored in several different places, the goal of having a single source of truth in actuality becomes having a complex understanding of the various data sources that comprise an elaborate and involved single source of truth. While complex interconnectivity between cloud and enterprise system driven data sources can be built, such systems do not offer a great deal of flexibility for the rapid changes that are required when compliance requirements change. Using the same regulatory data for multiple purposes such as product labeling, regulatory data upload to various trading partners such as the FDA GUDID, GS1 Data Pools and other trading partners as they arise offers maximum flexibility. The addition of new product attributes or the accessing of this information is much easier when you own your own data, know where it is and can get to it yourself.

Larger Life Sciences companies often have manufacturing locations in various parts of the World. Depending upon the physical location of a manufacturing plant, network connectivity, (including Internet) can be unreliable. If the data that is used for Enterprise Life Sciences labeling is stored in the cloud, and is not available at the time of production and labeling, line production comes to a screeching halt until connectivity issues can be resolved. As any of us who have experienced connectivity outages know, this is a major weakness of a cloud based label production approach.

The Hybrid Cloud

Innovatum delivers a flexible hybrid cloud model to maximize all of the benefits of cloud capabilities while minimizing the drawbacks. Enterprise Life Sciences Labeling design is client based and is built around the industry leading label design software known as BarTender by Seagull Scientific. Label approval management is accomplished through a combination of email and network technologies including options such as use of a browser through the Internet and or private networks. Label printing is accomplished anywhere in the World through the use of a browser without the need to load any software. Labeling data can easily be made highly available and is synchronized with other servers in real-time. This architecture makes it possible for manufacturing plants to print labels even while network connectivity to the outside world has been compromised. The system automatically synchronizes itself when connectivity is restored. This hybrid combination of architectures provides an ability to capitalize upon strengths and minimize weaknesses found within pure cloud based architectures.

 

 


Comparing GUDID Submission Options

GUDID Submission OptionsPulling information out of the FDA GUDID is simple. The public can access information contained in the GUDID through AccessGUDID. The FDA, in partnership with the National Library of Medicine (NLM) has announced that through AccessGUDID, anyone can search or download information that device labelers have submitted to the GUDID about their medical devices. GUDID submission options, however, is an area in which a few options present themselves.

GUDID Submission Options

#1 – GUDID Web Interface

A free secure online portal known as the GUDID Web Interface is provided by the FDA and it enables medical device labelers to enter UDI data directly into the GUDID database. Device labelers may submit, search and retrieve information about their devices via the GUDID Web Interface, which enables structured input of information one DI record at a time. A few caveats though, if data is entered using the GUDID Web Interface, it must be managed using the GUDID Web Interface. This portal is most practical for companies with <100 different SKUs or catalogue items. A number higher than that requires a more robust approach.

#2 – Software as a Service (SaaS)

The vast majority of GUDID submission offerings that are available in the market today, fall into this category. These cloud based offerings create data silos between your enterprise based systems and a third party. They also create a need for setting up and maintaining multiple connections between your enterprise systems and your product labeling systems. Introduction of errors caused by data getting out of sync between labeling and upload systems is a very real possibility. Proving auditable history for 21 CFR Part 11 compliance and potential trace history is more complex when some of the history resides in the cloud and some of it resides in other systems. In many cases, cloud based technologies have the capacity to reduce complexity. However, when it comes to regulated data upload and management, SaaS greatly compounds complexity. The outsourced service model offered by some SaaS providers is merely a way to pay a third party for some of the increased complexity that their business model creates.

#3 – Licensing A System

Systems are available from a few providers and Innovatum provides the most complete, end to end UDI solution in the industry. Although the complete suite of Innovatum’s ROBAR product line includes the option of labeling design and print management capabilities we are limiting this article to a focus on regulatory data upload. Suffice it to say that with this solution, the same database and corresponding connections to existing production and business systems (PLM, MDM, ERP, RA, etc.) can be used for both labeling data and the upload and management of regulatory data. This also means that one approval management system can be used for both labeling data approval and regulatory upload data approval. This remarkably reduces approval management overhead for medical device manufacturers and relabelers such as 3PLs and contract manufacturers. The ROBAR master data management and communication components are intended to be licensed as an on-premise solution for companies that desire tight control of their data. However, the solution can also be deployed in the cloud very easily. ROBAR MDM is a focused master data management database that is specifically designed for regulatory data. It serves as a real-time conduit for regulatory data that coalesces information from various sources and maintains the history of that data in a 21 CFR Part 11 compliant manner. The one-time licensing fee and annual maintenance costs for this technology winds up being much more cost effective than SaaS or service based per transaction, per item, per company revenue models.


Ardi Batmanghelidj, Chairman of the AIM NA Healthcare Committee and President & CEO of Innovatum, Inc., to Speak at UDI Conference 2015

Cranberry Township, PA – May 21, 2015 – AIM North America (AIM NA), the industry association and authority on barcode, RFID, RTLS, NFC and mobile computing, has announced that representatives of the AIM NA Healthcare Committee were chosen to be featured in a general session for the upcoming 7th Annual UDI Conference in Baltimore, Maryland, June 24th – 25th.

Representatives from the AIM NA Healthcare Committee will present Auto ID Technologies & In-House Systems for UDI Compliance during the first day of the Conference, which highlights The Reach of UDI. The session has been designed to showcase the automatic identification technology options which enable compliance with the UDI Regulation issued by the Federal Drug Administration (FDA) in the U.S. It will provide not only live demonstrations of the technologies at work, but discuss how to make the best choices which will most benefit a specific business.

Speaking on behalf of fellow colleagues and presenters, Ardi Batmanghelidj, Chairman of the AIM NA Healthcare Committee and President & CEO of Innovatum, Inc., said,”The opportunity to present live technology demonstrations while also delivering valuable information on how to best use and implement these various technologies, will not only help in UDI compliance for the FDA, but offer valuable insight on how automatic identification technologies can benefit businesses beyond compliance. Our presentation team will certainly represent a unique perspective to the audience at the Conference and show how the adoption of automatic identification is evolving.

In addition to the general session at the UDI Conference, AIM NA and its Healthcare Committee will have a significant presence throughout the event. Many of the exhibitors available to attendees during the conference will be showcasing their respective services and products. AIM North America will also host the AIM Resource Station featuring industry information and demonstrations of a variety of automatic identification innovations and technologies.

For more details on AIM North America at the 7th Annual UDI Conference, or to register, visit UDI Conference 2015 today. Special early registration rates are available through May 24th.

About AIM North America

AIM North America is the industry trade association that represents the Automatic Identification and Mobility industry in the US, Canada and Mexico. AIM North America provides education, news and information, legislative affairs, and marketing resources to grow the businesses of the industry’s resellers, systems integrators, solutions providers, manufacturers, and distributors. AIM North America is a chapter of AIM, Inc., the worldwide authority on automatic identification and mobility for more than 40 years.

For more information, contact the AIM North America office.

20399 Route 19, Suite 203, Cranberry Twp., PA 16066 |+1 724 742 4473(Phone) | +1 724 742 4476(Fax)

Visit us at  AIM North America


Top 5 Trends in Enterprise Labeling

Labeling requirements are more complex than ever. These days, labeling within the life sciences industry needs to be data driven and dynamic to keep up with changing client needs and regulatory standards. Here’s a rundown on the top 5 trends in enterprise labeling.

labeling

  1. Regulations – Changing regulations are having an impact across all industries, particularly those in which package labeling affects customer safety, such as pharmaceutical and medical device labeling. Regulatory standards include ePedigree, UDI, DQSA as well as many new International standards that are on the horizon.
  1. Centralization—More and more companies are centralizing bar code labeling across multiple geographical locations. The three most important factors in centralization are: enabling labeling consistency, reducing IT maintenance costs and ensuring business continuity.
  1. Customer responsiveness – Customers are demanding adherence to labeling requirements, which is leading to a supply chain that is directly intersecting with labeling. This development is largely in response to the clients’ own desire to maintain efficiency by having their providers stick to their individual labeling standards.
  1. Integrated and data driven labeling – Although this concept is not a new one the growing demand for label accuracy is pushing the importance of data driven labeling. The data-driven approach enables the pulling in of dynamic data at label print time.
  1. Supplier’s increasing role in labeling –Partners’ and suppliers’ expectations are reaching beyond meeting internal needs and becoming much more globally interconnected. The most important consideration in this regard are: cost of relabeling, reducing labeling errors and successful supply chain collaboration. Requirements for compliance with UDI make this more complex.

If you have any questions about these top five trends in Enterprise Labeling, contact our experts at Innovatum today.

 


Enterprise Labeling – Cost Reduction Capability

These days, life sciences businesses dealing with global supply chains face an increasing number of important challenges. These include:

  • the need to increase supply chain transparency
  • the need to centralize label printing and have multiple remote printers at different geographic locations
  • label printerusing automation to reduce the number of label templates
  • language translation
  • changing labels rapidly to suit customer needs
  • providing labeling solutions in high volume
  • reducing the risk of counterfeit labels
  • reducing manufacturing costs

This last challenge is possibly one of the most important and an appropriate enterprise labeling is a great way to meet this challenge. An Enterprise Labeling Management System provides an enterprise class level of functionality and robustness, yet it can be scaled down to fit the smallest of organizations. Over time, you will begin to feel the pull of your growing supply chain, changing client demands and tightening government regulations. If you want to adapt to these changes with the most cost-effective solution, enterprise labeling is the way to go.

What is Enterprise Labeling?

Enterprise labeling for the life sciences industry centers around a database driven, and fully configurable computer system which tightly controls label design, rework, language translation, print and reprint and all of this can be done per 21 CFR Part 11 requirements. An enterprise labeling can save you money by reducing the waste of unnecessary stock by supporting on-demand printing as well as custom label design. The validated and automated nature of the system helps to eliminate labeling related errors that can result in expensive recalls.

Call our expert team at Innovatum today, and let’s discuss how we can help you reduce your enterprise labeling costs. We can configure a labeling solution that’s just right for your company’s needs. Let’s work together to take your enterprise labeling capabilities to the next level.



Ardi Batmanghelidj, AIM North America Professional of the Year

Ardi Batmanghelidj, President & CEO of Innovatum, Inc., headquartered in Sugar Hill, Georgia was selected as AIM North America Professional of the Year. Mr. Batmanghelidj has been a significant contributor to AIM’s work in healthcare and regulatory compliance, most recently serving as Chairman of the AIM NA Healthcare Committee. He is a published author and renowned industry speaker, providing expert guidance to the FDA and manufacturers in the area of master data management, labeling and barcoding. As one of the authors of the AIM white paper on UDI, he has been immersed in gauging the impact of serialization and UDI and has been assisting the industry toward compliance.

Established in 2007, the AIM North America Professional of the Year is presented annually to an individual in recognition of innovative and exceptional contributions to the development of the Automatic Identification and Mobility industry through their work as a contributor, collaborator, or mentor.