Innovatum Announces Cloud-Based Solutions for Regulated Labeling and Unique Device Identification Compliance

~ROBAR Online Provides Unparalleled, Scalable Security and Accessibility Capabilities~

Innovatum, Inc. has announced the availability of its highly vaunted ROBAR family of solutions for regulated labeling and UDI Compliance as a cloud based “hosted” service called “ROBAR online.” The expansion of services resets the bar for enterprise labeling capabilities and support in the life sciences industry.

The ROBAR family of products includes label design, management and printing, regulatory data management and submissions, and eIFU capabilities. Available as a single tenant solution, the ROBAR online solution includes all the capabilities and associated services that are expected from on-premise software. This includes expert consultation, implementation, integration, as well as validation assistance and on-going support.

ROBAR Online

Innovatum President and CEO Ardi Batmanghelidj said, “Through 15 years of acid testing by our customers, and as a result of our continuous improvement based on their feedback, the ROBAR on premise solution has become the leading enterprise labeling and UDI compliance software in the world. This expansion of services was made possible through diligent and dedicated efforts in managing the on premise solution for many of our customers. Along the way we embraced the growing need for cloud-based and online services, honing our skills for delivering a hosted solution regardless of its physical location. Our customer feedback has been key in providing this in-demand capability for Innovatum.”

He continued, “We are excited to bring this service to smaller companies without IT departments, and to industry leaders who feel comfortable having a world-class hosted solution.”
Innovatum is partnering with one of the world’s leading cloud based hosting companies to deliver

“ROBAR Online” in the most highly available and secure means possible. Integration with other systems such as ERP, MES and PLM remain as flexible and reliable as ever; customers always maintain access to their own data, which are not commingled with other data on the same server.

Headquartered in Atlanta, Georgia, Innovatum is a leading software and regulatory consulting company that specializes in life sciences labeling and UDI Compliance.


Real Benefits of UDI in the Operating Room and Beyond

benefits of udiLet’s face it, there are still those amongst us who grumble at the mention of having to comply with the UDI regulations. To them, it’s simply a matter of having to comply to stay in business. There are those of us however, who are advocates of the regulation and appreciate the benefits of UDI. We believe in its overall benefit for patient health and safety, and also as a means of facilitating business and reducing cost and errors.

The AIM North America Healthcare Committee recently presented a webinar to investigate the functionality of a system which makes extensive use of the UDI as a means of identifying medical devices in the operating room and associating those devices with patients’ medical health records. Through the use of in-line scanning technology during production, each device is entered into the chain of custody process where it is controlled throughout the supply chain from production to patient implantation. Part of this control includes anti-counterfeiting through confirmation of the pedigree at multiple checkpoints. Combatting counterfeit product is one of the benefits of UDI as counterfeit medical devices have wreaked havoc in the lives of patients, caregivers and others in the medical device community. Although the challenge in UDI is that multiple agencies and multiple barcodes can be used, there are differentiators that can allow a scanning device to be pointed at any barcode and in turn determine the agency and barcode type.

NOTE: The presentation below does contain some product marketing from the company which created the software however, it is a good demonstration of what a central device database can provide to the entire medical device industry. Capabilities include the ability to:

  • Identify which items are used and generate an invoice, thereby eliminating manual data entry
  • Compare costs, revisions, waste, and recalls, by manufacturer device, hospital and/or surgeon through real-time analytics
  • Identify and measure outcomes by physician, hospital and/or implants
  • Cross-reference devices, allowing stakeholders to alert patients when a recall occurs.
  • Deliver access to member information by recalled device
  • Provide member access to master implant database
  • Identify prior implantations by member/surgeon/payer
  • Eliminate overbilling by ensuring accurate device utilization by case
  • Identify actual device implants as opposed to paying for wasted or defective implants
  • Know exactly where each implant has been placed, targeting devices that need to be replaced because of a recall
  • Identify the responsible party when a revision or replacement is required

With AIM focused on AIDC matters, about 30 minutes into the presentation, focus shifts to the AIDC implications and the use of bar codes and issuing agencies and complexities that go along with it. You can view the presentation at this location: https://youtu.be/VaPZPVYI_cg. This is not an endorsement of the company or product, just a means of whetting the appetite for all of the possibilities that UDI provides.


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.


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