Tag Archives: healthcare

UDI: Generating Value Beyond Compliance

Getting to Good Data in the GUDID*

The United States Food and Drug Administration (FDA) regulation mandates that UDI data for Class I medical devices to be submitted with an impending deadline of September 24, 2018.  This has made medical device manufacturers on a global basis, readying their organizations for compliance. As a leading healthcare provider or manufacturer, do you find yourself asking yourself the following questions?

  • What is the scope of products impacted (exempted or not)?
  • What are my obligations under FDA UDI regulation?
  • How do I transform compliance into a competitive advantage?
  • How can I source my data from multiple locations, formats and systems, controlled by different functions?
  • How can I ensure the data I provide to the FDA is complete and accurate?

1WorldSync & Innovit Join Forces

Innovit,  a global provider of software solutions for PIM (Product Information Management), MDM (Master Data Management), GDSN (Global Data Synchronization) and Enterprise Workflow Management, and 1WorldSync™, the leading provider of product content solutions, possess a collaborative agreement to enable more robust product content capabilities for the medical device industry.

Whilst manual data entry or Excel spreadsheet upload may have been a viable solution for Class II & III submission deadlines, Class I poses a much greater challenge for labelers.  The sheer volume of products in this category makes manual submission methods too slow.  High product volume increases the burden of data collection, data cleansing and data entry to the GUDID.  The risk of failing to meet FDA’s deadline increases substantially.  

Innovit’s ‘UDI Multi-Connector’ is an automated, machine-to-machine data validation and submission system designed to address today’s needs for GUDID, as well as tomorrow’s needs for other global UDI recipients such as EUDAMED, NHS, and more.    

Whether your organization relies on a HIBC or a GTIN (or you’re looking for definitions on what those terms mean), 1WorldSync offers multiple solutions to send your data to the FDA. A primary benefit of submitting data through a 1WorldSync solution is that the data collected can be easily sent to other recipients, including GPOs, distributors, and other healthcare providers.

With the 1WorldSync UDI Solution, your business can prepare and validate medical device product information before the compliance deadline, giving you more time to focus on producing the quality products your customers and patients love.

One Process, One System and One-time Investment for Compliance. Advanced Readiness

Get ahead of the game and get back the time to focus on producing quality products your customers and patients love! For organizations manufacturing medical devices, 1WorldSync & Innovit experts can help organization prepare to meet the September 24, 2018 deadline through our comprehensive solutions.

Manufacturers can create a sustainable process to collect, manage, and distribute product content to all their UDI recipients, including FDA GUDID, EUDAMED, NHS, and others.

Make plans to visit Innovit and 1WorldSync at the UDI Conference taking place June 7-8 in Baltimore. Learn UDI implementation strategies and identify a sustainable process to successfully publish product content to the GUDID from our experts first-hand!

*GUDID – Global Unique Device Identification Database

UDI: One Cost for Compliance. Advanced Readiness

1WorldSync, the leading provider of product content solutions, recently entered into a collaborative agreement with ReedTech, a provider of data management and analytics solutions for the life sciences industry, to enable more robust product content solutions for the medical device industry.

1WorldSync™ & Reed Tech® Join Forces

Through the integration of data exchange capabilities from 1WorldSync with Reed Tech medical device product data management solutions, the two organizations together are able to offer device manufacturers a single full-service approach to device product data management.

“This collaboration will allow the medical device industry to receive expanded, customizable offerings to meet current and future challenges,” said Dan Wilkinson, Chief Commercial Officer at 1WorldSync. “Our agreement benefits customers of both companies, enabling more robust product content support to meet the continually changing mandates and regulations in healthcare.”

Ethan Eisner, VP of Global Commercial Markets at Reed Tech, also indicated his enthusiasm for the project. “Reed Tech is a leader for medical device product data management solutions, including Unique Device Identifier (UDI) regulatory filings to the FDA. Our organizations are well-aligned to offer superior value to our customers through a single solution capitalizing on the strengths and expertise of both companies. We are excited about the addition of GDSN capabilities into our medical device data management solutions.”

Generating Value Beyond Compliance

With a single, full-service solution from 1WorldSync and Reed Tech, you can feel confident in your company’s product content and rededicate your time to producing the quality products your customers and patients need.

1WorldSync and Reed Tech can help your organization manage and capitalize on the value of your product content, syndicating to trading partners to fulfill requirements of governmental authorities (such as FDA UDI and UK NHS eProcurement) and buyers (such as GPOs and influential hospital networks).

Visit 1WorldSync (booth #6) and Reed Tech (booth #20) at the UDI Conference in Baltimore June 7-8. Learn UDI implementation strategies and identify a sustainable process to successfully manage your device product content from our experts first-hand!

On May 23, Reed Tech and 1WorldSync will co-present a free webinar for industry members on how to meet the UK NHS eProcurement deadline and provide product data to buyers. Register now!

UDI for 2018: Why You Should Start Now!

September 24th, 2018 for Class I UDI compliance is just a heartbeat away, particularly when evaluating the scope of the UDI initiative and the breadth of products impacting your company.

Many suppliers that have previously submitted Class III and Class II product data have already begun gathering and sending Class I data.

Key Challenges for UDI Labelers:

  1. Understanding the complexities of the UDI legislation as it applies to your organization’s products.
  2. Finding the existing data, creating data that does not exist, and organizing the data into a single point of truth for submission to the FDA GUDID.
  3. Setting up the proper data governance to ensure that the information is correct to meet the deadline and continues to stay up-to-date and accurate in the future.

How 1WorldSync Can Help You

  1. Understanding Rules – Our experts are well versed in the UDI legislation, definitions, and terminology to be able to help your organization identify attributes relevant for UDI per the legislation. Watch our latest and greatest UDI Video to see how we can set you up for success!
  2. Data Collection – Our organization has vast experience with previous UDI customers and can provide education and guidance around attribution. In addition, we can also leverage previous knowledge to directionally aid in the sourcing of attribution. Read our new case study to learn how Teleflex partnered with us to implement a data management solution to comply with the upcoming UDI regulation.
  3. Data Governance – Our team can provide the structure necessary to ensure that information stays up-to-date and accurate, integrating the data collection into day-to-day processes and reducing effort in the future.

Getting To Good Data in the GUDID With 1WorldSync

The general structure of a UDI project is very similar to a typical supplier implementation, with some key exceptions. At the end of the day, data needs to be sent by the supplier to a recipient. 1WorldSync handles this use case on a daily basis and we can provide insight as to proven best practices and strategies.

There are key differences in a UDI project that our experts are trained to guide you through. These key differences include applying for a GUDID account, testing with the FDA, and understanding FDA specific attribution.

Whether your organization relies on a HIBC or a GTIN (or you’re looking for definitions on what those terms mean), 1WorldSync offers multiple solutions to send your data to the FDA. A primary benefit of submitting data through a 1WorldSync solution is that the data collected can be easily sent to other recipients, including GPOs, distributors, and other healthcare providers.

Generating Value Beyond Compliance with 1WorldSync

The amount of time and effort to prepare for compliance with the FDA UDI regulation is frequently underestimated. Your organization may need to start sooner than you think.

If you’re like us, you like to be ahead of the game. With the 1WorldSync UDI Solution, your business can prepare and validate medical device product information before the compliance deadline, giving you more time to focus on producing the quality products your customers and patients love.

Make plans to stop by 1WorldSync (Booth # 6) at the UDI Conference taking place June 7-8 in Baltimore. Learn UDI implementation strategies and identify a sustainable process to successfully publish product content to the GUDID from our experts first-hand!

For more information around our offerings and experience, please contact us at healthcare@1worldsync.com or visit http://solutions.1worldsync.com/-unique-device-identification.

A Connected Lifestyle for 2017

We are all living a Connected Life in 2017.

Connected and mobile commerce is a way of life for us all and businesses are striving to leverage this connectivity to improve consumer safety, the customer experience and increased market penetration.   The growth of cross-channel commerce is a core component of every business plan, regardless of industry or geography.

Global market leaders embrace product content as vital to their engagement with business partners and customers.  Trusted content turns that engagement level into commitment.  Every business leader knows that more content is better, but what we have all learned is that trustworthy information is often the difference between loyal, repeat consumers and lost sales; or worse injury from lack of available product information.

The Smart Label initiative for consumer goods and EUDAMED and the FDA UDI regulations for medical device labeling initiatives, provide guidance for companies on which content is needed to aid patient safety and provide consumers with information to make health and wellness decisions.  However, in the absence of regulations, what content is needed, which channels, and how frequently?  These are problems many companies are challenged with in 2017.  Digital content is a requirement, not a luxury; and the proliferation of the content consistently remains obstacles to be overcome for all industries globally.

In the 1WorldSync data study launching in April, Charting the Course for Global Commerce, over 400 global respondents reported thirty-nine percent of merchants cannot support mobile commerce, and 68 percent have yet to integrate product information management capabilities across web, mobile apps and in store.  Establishing a connected commerce platform remains elusive for many companies.

The 1WorldSync Product Information Cloud solutions continue to evolve and leverage both industry best practices and best in breed technologies to assist our community in overcoming many of the connected commerce challenges: from UDI and Healthcare solutions in Asia, Europe & the Americas to Hazmat solutions and retail apps for increased sales and market penetration.

The Connected Life is a reality for consumers, patients, brands, suppliers, hospitals, governments, retailers and distributors….Everywhere, Every Day.

NHS continues with GDSN implementation plans

The NHS (National Health Service England) announced in their January 2017 Case Study they will continue with their Global Data Synchronization Network™ (GDSN) roll-out now.

The Case Study confirms that GDSN is the right process to deploy for manufacturers to send all their product content to 154 trusts in the UK; with official implementations deadlines as early as September 2017 for the initial product categories.  Continue reading

Summer Release Sneak Peek!

Summer Release Sneak Peek

1WorldSync will be launching our Summer release later this month. We’re excited to debut our expanded capabilities to support your Omni-Channel and Healthcare product information initiatives. The Summer Release features new apps and solutions that include:
 
  • Foodservice Product Content Marketplace that will allow foodservice manufacturers to highlight their products to the long tail of foodservice distributors.
  • Digital Catalog which allows you to take your product content in Catalog1 and create a rich online product catalog that can be used by your internal sales and customer service teams, browsed by your customers, and leveraged by your marketing teams.
  • And several new apps that allows you to get your products Google, Walmart, Amazon and beyond!

Stay tuned for more information about our Summer Release!

Are you ready for UDI compliance?

This free workshop provides insight for how your business can comply with the FDA UDI regulation. You will learn about:

  • how to transform compliance into a competitive advantage?
  • what are your obligations under the FDA UDI regulation (Class I and Class II products)?
  • how leading manufacturers successfully use 1WorldSync solutions to efficiently manage those challenges
  • Audience: Supply Chain, Data Quality and Regulatory Affairs managers
Register today

 

These workshops are free and seats are limited:

United Kingdom

Date and Time: 23rd June 2016, 10:00 a.m. to 12:30 p.m.
Location: Leicester Marriott Hotel, Smith Way, Grove Park, Enderby, Leicester, LE19 1SW UK
Register now

Germany (this workshop is held in German)

Date and Time: 23.06.2016 10:00 – 13:00 Uhr
Location: Tuttlinger Hallen – Tagungsraum 1,
Am Europaplatz – Königstraße 39, 78532 Tuttlingen
Register now

France (this workshop is held in French)

Date and Time : 28.6.2016, de 9h30 à 12h00
Location: Centre Regus Opéra, 27 avenue de l’Opéra, 75001 Paris
Register now

Streamlining the Global Healthcare Data Supply Chain to Comply with Safety and Traceability Mandates

Article originally featured in Pharmaceutical Compliance Monitor.

The demand for robust product information is pervasive. It touches every industry and comes from multiple facets – end consumers to global governments – and the healthcare industry is no exception. Patients are no longer simply recipients of care, but active participants requiring access to rich product information to make informed decisions about their health, care and wellness.

Continue reading

1WorldSync Annual User Group, Europe

The 2015 Annual User Group, Europe was a fun and informative event, bringing 184 participants from 89 companies and 18 countries together for a day of collaboration and sharing! Our key theme was: “Be efficient, Be compliant, Be transparent”.
The event kicked off with a networking boat cruise and the EMEA Power of 1 Awards.
This year’s winners include:
  • Data Quality – Dr. Oetker
  • GDSN Adoption – Robert Bosch GmbH
  • Innovation – Mars, Incorporated
  • Compass Award – David Sheldon, Nestle
The AUG agenda was packed with the first industry workshops for DIY, Healthcare and FMCG/Foodservice. Customer and partner speakers for the plenary sessions included Google, Mars, Lansa, SCA, Jorg Pretzel of GS1 Germany, The World Customs Organisation, and KPMG
PicMonkey Collage
Visit the 1WorldSync Annual User Group site to read more.

1WorldSync Annual User Group Europe is just around the corner!

This year the 2015 Annual User Group Europe will be co-located with GS1 Germany’s ECR Tag at the World Conference Center in Bonn, Germany. Join us for an evening of networking and a full day (September  21 – 22) of engagement with your trading partners and industry peers. At AUG Europe, we will help you gain knowledge on critical implementation practices and intelligence on CPG/Grocery. Hardlines and Healthcare industry insights and trends. If your role involves a focus in Master Data Quality, Regulatory Compliance, Supply Chain Processes or E-commerce, then this conference is for you!

Continue reading