New EU Medical Device Regulations

EU Medical Device RegulationsThe new EU Medical Device Regulations: learn more about the new MDR and its impact on your translations. Download the FREE Whitepaper from Innovatum’s Partner Argos Multilingual!

This free Whitepaper will give you information about:

  • The scope of the regulation
  • Why the changes happened
  • What happens when – dates for compliance
  • How to prepare for these upcoming changes
  • How it will impact your multilingual content

If you have further questions, please contact us at (877) 277-3016.


Innovatum Announces ISO 9001:2015 Certification and EU MDR/IVDR Solutions at the 2018 UDI Conference

Sugar Hill Ga April 11, 2018

Innovatum ISO 9001:2015 Certification Announcement

Innovatum, Inc. is pleased to announce ISO 9001:2015 Certification by an ANAB accredited body for its quality management system for software development, delivery, and support as a Life Sciences software provider. ISO 9001 is the International Standard for Quality Management Systems. Innovatum’s commitment to quality is now substantiated by ISO 9001:2015 Certification. This development demonstrates an exciting and documented level of quality assurance for Innovatum as a labeling, regulatory data management, and submissions software company. Innovatum constantly sets the bar higher for similar companies in the industry.

Innovatum and EU/MDR IVDR Solutions at 2018 UDI Conference

As a proven provider of UDI solutions, Innovatum will be discussing EU MDR/IVDR considerations based upon experience and information gained by working with leading life sciences companies and through leadership in AIM. Considerations for challenging aspects of compliance such as destination labeling, implant card, eIFU management strategies and automated label print quality management will be addressed and demonstrated. Drop by Booth #19 at the 2018 UDI Conference in Baltimore, MD on April 24-25, 2018 to join in the discussion, learn and share your experiences.

The UDI Conference allows you to hear about solutions and approaches from other companies that are similar to yours and interact directly with the FDA UDI team. Examine the agenda at www.udiconference.com/UDI_Conference/ and register at www.udiconference.com/UDI_Conference/registration/ Remember to enter “INN” in the discount field for $100 off of the published rate.


Via The BarCode News: Innovatum Integrates Microscan Barcode Inspection Solution To Ensure Life-Sciences Quality

Microscan, a global technology leader in barcoding, machine vision, verification, and lighting solutions, will partner with Innovatum, a leading regulated labeling software and consulting services company for life-sciences, to present a fully integrated label inspection technology helping life-science manufacturers assure that all product labels are correct and barcodes meet quality grading requirements. Although scanning technologies and software for barcode verification have been around for quite some time, this fully automated closed-loop solution saves set-up time, boosts productivity of label management and inspection processes, and ensures that the risks and costs associated with mistakes and poor quality of the labels are minimized.

Innovatum will be demonstrating the integration of its ROBAR Labeling system with Microscan’s LVS-7510 print quality inspection solution embedded within a Zebra printer from the Booth #7 at the Global GS1 Healthcare Conference taking place in Chicago, IL on October 17-19. This breakthrough development is a fully automated complex solution that checks the entirety of label data to ensure data on that label is based on the information received from the Automated ID and Data Capture part of the system and is a match to the ROBAR labeling database.

To read the full article, click here.


Innovatum Makes Cover Story of Major Life Sciences Industry Publication

This month, Innovatum further demonstrates its leadership role in the Life Sciences labeling nicheregulatory data management, and submissions by contributing the cover feature article in Medical Design Briefs and an article in Medical Design Technology.

life sciences labelingAs medical technology accelerates at an almost incomprehensible pace, regulations and requirements increase correspondingly. With rapid innovation and the desire to speed time to market comes more rigorous requirements for safety and effectiveness, which drives the establishment of programs such as FDA’s unique device identification (UDI) system. UDI is designed to identify medical devices through their distribution and use in their labeling and to report certain information via publicly accessible database.

Read the full article here: http://viewer.zmags.com/publication/685a60a7#/685a60a7/12


Ensuring Quality Management Amidst Regulatory and Design Technology Changes

ensuring quality managementA regulatory driven, product design tsunami is headed our way, but at least we have an awareness that it is coming and a means of preparing for it. New requirements for destination labeling, brought about by globalization, are on a collision course with the applications of technology that we have become accustomed to. Global UDI initiatives and burgeoning breakthroughs in patient-specific modalities only add to the impact by adding to the complexity of compliant distribution worldwide. It is time to embrace a new paradigm for product design and labeling to maximize efficiency, while meeting compliance requirements for the future. While just-in-time manufacturing is here to stay, on-demand localizable labeling is quickly becoming a reality for companies that wish to remain competitive in a swiftly changing world. But patient-specific product design implies a more focused level of labeling for each unit of production. To make sense of all of this, we need to think in terms of finding a common denominator to solve these challenges. The common denominator is data.

Read the full article from Advantage Business Media.


5 Unique Device Identification Challenges

Unique Device Identification ChallengesMany of FDA’s Unique Device Identification requirements have already phased in. The labels and packages of Class III and Class II medical devices, for instance, must now bear a UDI.

“But UDI is not over,” says Ardi Batmanghelidj, President and CEO of Innovatum, a software and regulatory consulting company specializing in life science labeling and Unique Device Identification (UDI) compliance. “In contrast, it is just beginning.

“Although many medical device manufacturers have complied, on-going maintenance for previously submitted UDI data will soon be enforced,” he tells PMP News. “And the regulatory requirements of UDI variants by regulatory bodies around the world will continue to make global UDI compliance a challenge for quite some time.”

Batmanghelidj explains 5 common UDI challenges and potential solutions.

Communication. One of the challenges arises from miscommunication of labeling data. “Most medical device manufacturers inexplicably approach UDI by separating it into two different projects that are managed by two different departments,” Batmanghelidj says. “The labeling team is responsible for UDI data on the label, and the UDI team is responsible for UDI data management and submissions. Yet, most of the data overlaps and must be kept in sync! Think of a row in an Excel spreadsheet that contains fields with labeling specific data for an item. Now think of adding additional columns to house regulatory data within that same row. Since some of the data within that row is placed upon sticky labels and some of that very same data is also being submitted to regulatory bodies, this data can be stored once and reused. This ensures data quality. The problem of having to prevent a likely mismatch between the information that is submitted and the information used on the label is now gone. With an extension to what is traditionally considered to be enterprise labeling software, it is now possible to bring these capabilities to life.”

Read the full article from Packaging Digest.


Innovatum Adds Cloud-Based ROBAR Service Delivery For New Customers

Keeping with Innovatum’s commitment to deliver the highest level of customer service, we have teamed with Oracle and it’s Cloud Platform to provide easy access to our labeling solutions in a highly secure, easily available cloud environment. The Oracle Cloud Platform provides customers, partners, and developers with everything they need to build, deploy, and extend applications and run business-critical workloads.

“Our market is changing, and so must our industry-leading life science labeling solutions. So we decided to start delivering our ROBAR service via the cloud to make it easier for new customers to access our world class labeling solutions. For us, high availability, reliability and security are top priorities, especially in the highly regulated industry in which we operate,” said Ardi Batmanghelidj, president and CEO, Innovatum. “We considered several solutions, including Amazon, but chose Oracle Cloud Infrastructure as a Service due to Oracle’s reputation as a leading technology provider. Oracle’s focus on security helped to tip the scales, along with the cost-effectiveness of its offerings.”

Innovatum is well-known for keeping up with significant changes in the market and ensuring that our client’s needs our met, especially as it pertains to accessing our life sciences labeling solutions. Adopting Oracle’s Cloud Platform provides Innovatum and clients with the highest level of security and availability to its market-leading life sciences labeling solutions.

Begin a no-obligation conversation by calling 877-277-3016 or clicking here.


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.


Is Life Sciences Labeling Really That Complex?

The answer to that question in a word is yes, life sciences labeling is immeasurably complex. To provide you with an illustrative contrast based upon my decade of experience within the field of information security, life sciences labeling is a far more complex subject than an area such as Cyber-security technologies. If you think my previous statement is off-base, then keep reading. In addition to being exceptionally complex, labeling within the Life Sciences is also a mission critical function that is constantly changing as regulatory requirements are increasing exponentially around the world. Since the U.S. FDA considers the label to be part of the product, if products are not being properly labeled, those products must not be shipped. A product that is incorrectly labeled has the potential of causing injury or death. Labeling systems must also be extensible to accommodate new data in a flexible way as requirements will constantly continue to change.


Medical Device Labeling/Packaging Recalls 2010-2015

Please enjoy this article in Innovatum’s continuing series containing timely content which is contributed by life sciences industry experts. Guest blog contributors will be presenting topics pertaining to labeling, regulatory management, and compliance considerations. The following article was submitted by…

Joshua R. Dix, Suraj Ramachandran, and Darin S. Oppenheimer

1. Introduction

Throughout its one hundred and ten year history, the Food and Drug Administration (FDA) has faced complex issues related to the labeling and packaging of products falling under their scope of influence. As early as 1912’s Sherley Amendment to the U.S. vs. Johnson ruling, regulations aimed at providing safe and effectively labeled products have been heavily woven into the fabric of FDA’s history. However, when compared to the extensive history of food and pharmaceutical law, legislation of labeling/packaging specific to medical devices is a relatively immature discipline.  While the Agency has made numerous strides to counteract these problems, most notably 1978’s monumental Medical Device Amendments which enacted controls for manufacturers, the persistence of complications, such as class I recalls (a reasonable probability that the use or exposure to a product will cause serious adverse health consequences or death), have produced a difficult landscape for the FDA to traverse.

A recent analysis, conducted as part of continued research on recalls, utilized the FDA’s Center for Device Evaluation and Radiological Health’s (CDRH) recall repository to collect data and evaluate trends in both voluntary and involuntary recalls established between January 2010, and May 2016. This analysis demonstrates recall issues related to the labeling and packaging of medical devices are both continual and progressive, accounting for 15% of all recalls since 2010. (See Table 1: Labeling/Packaging Recalls by Year 2010-2014 for Raw Data) (Blue Lynx Consulting, 2015). The data also specifies a progressive yearly occurrence rate with trending indicating an upward swing in the following root causes as identified by the agency; labeling errors, design, mix-ups, false or misleading labeling, and change control.

2. Labeling/packaging Recall History By the Numbers

Since 2010, recalls related to device labeling/packaging account for an average of 488 issues annually. (Blue Lynx Consulting, 2015). Alone, this number is severe enough, however when juxtaposed with the major fluctuations in year to year growth percentages, a strong case begins to emerge which demonstrates an industry unable to predict the proper solutions to mitigate or control these adverse events. The data related to labeling/packaging recalls pulls back the curtain on an industry which is lives in a perpetual state of unrest. While recalls diminished moderately in both 2011 (-23%) and 2013 (-8%) (Blue Lynx Consulting, 2015), each year was followed by a wild upward fluctuation,  +104 between FY 2011 and FY 2012 and +62% growth between FY 2013 and FY 2014 (Blue Lynx Consulting, 2015). (note: 2015 data provided by the FDA is incomplete, therefore the growth between 2013 and 2014 is the latest information available.)  Over a five year period the cumulative growth percentage of recalls related to labeling/packaging grew +132%, reaching a five year high in 2014 with a total of 800 recalls. (Blue Lynx Consulting, 2015). For a complete overview of cumulative growth by labeling/packaging recall see (See Table 2: Labeling/Packaging Recalls Cumulative Growth % by Year 2010-2014)

In addition to being one of the most prevalent causes of medical device recalls, labeling related recalls are also one of the most likely to cause serious health problems or death to the end user. As defined by the Agency, Class I recalls are ones in which “dangerous or defective products could predictably could cause serious health problems or death.”  Recalls correlated to labeling/packaging grew an average of 604% between FY 2010 and FY 2014, topping out at +1136% between FY 2013 and FY 2014. (Blue Lynx Consulting, 2015). For a complete overview of cumulative growth by labeling/packaging recall subcategory see (See Table 3: Labeling/Packaging Recalls % Growth Rate 2010-2014 (Subcategories))

3. Industry vs. the Agency?

It should come as very little surprise the FDA has begun to take notice of the unmitigated and ongoing failures related to device labeling/packaging. In fact, there is a growing recognition among FDA staff that a lack of device labeling standardization may be harming patients. (Gaffney, 2015). As the FDA noted in  a 4 January 2013 Federal Register announcement regarding device labeling, there is a growing need for medical device labeling to be delivered in a clear, concise and readily accessible format so that patients, caregivers and healthcare providers may access and utilize device labeling as efficiently and effectively as possible,. Physicians may inadvertently skip over important information or be unable to find information in an emergency.  (Federal Register, 2014)

Coupled with a 2013 public workshop the FDA held to discuss labeling issues, the Agency’s acknowledgement of the continuous and sometimes harmful events derived from device labeling represents a manner of thinking centered on the standardization of device labeling and the creation of an online labeling database.  The proposed database would provide industry a central location for standardized medical device symbols used in labeling. Despite these efforts, response from industry has been mild at best, “with some characterizing the proposed solutions as solutions in search of a problem.” (Gaffney 2013)

As recalls continue, and trends pile up supporting the FDA’s thinking regarding the need for innovative mitigations in the area of device labeling/packaging, one must wonder if the temper of industry’s reaction will be altered by evidence, or if end users will continue to suffer from events which are readily preventable.

4. Statistical Evidence- Graphs

Table 1. Labeling/Packaging Recalls by Year Raw Data 2010-2014

Medical Device Labeling

Table 2. Labeling/Packaging Recalls Cumulative Growth by Year % 2010-2014

Labeling Recalls

Table 3. Labeling/Packaging Recalls % Growth Rate 2010-2014 (Subcategories)

packaging recalls

 

Author Bios:

Joshua Dix

Joshua R. Dix is a Regulatory Affairs Specialist centered in the Western New York area.  Joshua is the Global Regulatory Lead for multiple product platforms with responsibilities including Regulatory Strategy, Submissions, Product CAPA, and Audits. With extensive experience in both Regulatory Affairs and Quality Systems, Joshua has worked diligently to bring multiple medical devices to market in over twenty different countries. Joshua holds a Bachelor’s degree in English from the State University of New York.

 

Suraj RamachandranSuraj Ramachandran, MS is a Regulatory Affairs Manager based in the Chicago Area. Suraj is involved primarily with managing the infusion pump platform and supporting all new product development and lifecycle maintenance activities including regulatory submissions, design control, audits, and CAPA’s. Suraj has also led many development efforts regarding medical device software, intended for both domestic and international markets. Suraj holds an undergraduate degree in Biomedical Engineering as well as a Master’s degree in Biomedical Engineering from the University of Michigan. In addition, Suraj holds a RAC certification from the Regulatory Affairs Professional Society.

 

Darin OppenheimerDarin Oppenheimer, MS is a Regulatory Affairs Director based in New Jersey. Darin is involved in many facets of the Product Development Lifecycle including regulatory submissions, due diligence, and active participation on industry trade organizations and standards committees. Darin leads a team of regulatory professionals focusing on electromechanical devices and software. His prior background as a Research and Development Scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery. Darin’s undergraduate degree is in Molecular Biology from the University of Tampa. He also holds two Masters Degrees from Johns Hopkins University in Biotechnology and Regulatory Science as well as a graduate Certificate in Biotechnology Enterprise.

References

Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Health Care Practitioners for Device Labeling Format and Content, 79 Federal Register. 54727 (September 12th, 2014)

Gaffney, A. (2015, April 6). How can Medical Device Labeling be Standardized? FDA Study Aims to Find Out.  Retrieved from http://www.raps.org/Regulatory-Focus/News/2015/04/06/21899/How-can-Medical-Device-Labeling-be-Standardized-FDA-Study-Aims-to-Find-Out/

Gaffney, A (2013, May 21) Industry to FDA: Give us Flexibility on Proposed Device Labeling Standards. Retrieved from http://www.raps.org/focus-online/news/news-article-view/article/3487/industry-to-fda-give-us-flexibility-on-proposed-device-labeling-standards.aspx

U.S. Food and Drug Administration, Food Drug and Cosmetic Act, July 1978

U.S. Food and Drug Administration, Sherley Amendment, 1912

Note: All supporting statistical information garnered from the FDA Recall Database in support of this article was compiled and provided by Blue Lynx Consulting.