Tag Archives: healthcare

From UDI to GDSN: How the Medical Device Data Landscape Keeps Evolving

Are you receiving requests for  your product data from large GPO’s and hospital networks?

Medical device manufacturers receiving these requests from buyers, often require a unique dataset to be transmitted to them by the manufacturer through the Global Data Synchronization Network (GDSN) for each product available for purchase. These companies require unique, but overlapping, datasets for every device product.

With growing demands, device manufactures are unsure where to begin.

How do you collect the data, get it into the GDSN, keep it secure and ensure it is always up-to-date?

Together, Reed Tech and 1WorldSync offer device manufacturers a solution to meet the challenges of securely managing all of this data, ensuring it is accurate and up-to-date, and sharing it with the downstream users who need it.

From UDI to GDSN

The process from UDI to GDSN, from beginning to end seems to be unclear for many organizations. This upcoming webinar gives you the chance to learn and understand this process, through the experience of an accomplished device professional who experienced this challenge at Steris and sought out solutions through Reed Tech and 1WorldSync.

Join us for a compelling webinar on Tuesday, July 24th at 11 am ET that discusses:

  • How Steris, a leader in cleaning validation and infection prevention solutions, pivoted from UDI compliance to commercial data exchange efforts
  • Who is asking for data in GDSN and why they need it
  • How the GDSN works
  • The best practices for collecting, storing, managing and syndicating device product data

The Arthrex Journey: Achieving Data Requirements For UDI And Beyond

The next UDI Compliance deadline for Class 1 is September 24, 2020.  We want to make sure you are prepared to meet those requirements and evaluate the breadth of products that impact your company.

Many medical device manufacturers, including Arthrex, have already had to prepare for FDA’s UDI and meet compliance dates for Class III and Class II devices. Many more medical device manufacturers are in the midst of preparing for the upcoming Class I compliance date in 2020.

Getting to Good Data in the GUDID*

We 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.

Recently 1WorldSync attended the UDI Conference that took place April 24 – 25 in Baltimore. Our healthcare experts were present and offered UDI implementation strategies and identify a sustainable process to successfully publish product content to the GUDID!

Are you prepared for the next FDA-UDI compliance dates?

Join us for a compelling webinar with Innovit and Arthrex on May 8th at  11 am EST.

You will learn how:

  • A ‘single source of truth’ can help you get to good data in the GUDID and generate value beyond compliance
  • Arthrex, a leading orthopedic medical device company, implemented a global strategy with Innovit PIM and 1WorldSync Data Pool to successfully comply with the UDI regulation.
  • To roll-out a global strategy for product data syndication with help from Innovit & 1WorldSync experts

*GUDID – Global Unique Device Identification Database

1WorldSync 2018 Annual User Group: Unleash The Power Of Your Product Content!

We hope that you are as excited as we are about the 1WorldSync 2018 Annual User Group at GS1 Connect, taking place on June 4 in Phoenix! With a little over a month to spare before this highly anticipated event, 1WorldSync is busy rolling out the green carpet for you.

This year, we will show you how you can unleash the power of your product content! Glean creative insights and engage in peer lead topic breakout groups that cover data quality, web ready content, digital commerce and so much more.

We have speakers from C&S Wholesale Grocers, Coke, Kroger, TOPCO and Walmart sharing insights on how they are using content beyond just publication.  

Here are some insights around the speakers, topics and collaboration sessions that will make it all the more easier for you to make your grand entrance.

11:00 – 11:15 am | Welcome

Karin Borchert, CEO of 1WorldSync, will kick off the 2018 Annual User Group with a warm welcome to all attendees, discuss hot topics on the agenda, and highlight renowned speakers.

11:15 – 11:45 am | Information in the Digital World – The Need for Web Ready Content is Now

Technology now penetrates nearly every aspect of our lives and the industry continues to shift in major ways as consumers demand more information faster. We take a deep dive into the world of today’s consumer, the evolving e-commerce landscape and game-changing industry trends that are shaping 2018.

11:45 am – Noon | 1WorldSync End to End Partner Ecosystem

This session will challenge how you think about content creation, aggregation and curation. Discover our current partnerships that will enable a seamless end-to-end content process.

Noon – 1:00 pm | Lunch

1:00 – 1:45 pm | Keynote: C & S Wholesale Grocers

Learn more about who C&S is, and how they are leveraging content coming in through the network to drive innovation with increased accuracy and efficiency.

1:45 – 2:15 pm | Keynote: Coca Cola

Gain insights into the product content journey that Coca-Cola has experienced over the past few years. Learn how they are leveraging unique processes to ensure accuracy and demonstrate the downstream impacts of content quality within their systems and processes.

2:15 – 2:30 pm | Networking Break

2:30 – 3:30 pm |  User Breakouts

We will be splitting the audience into 2 main groups.  Machine-to-Machine and GUI users. In each group we will highlight specifics around data quality, new functionality and impact to those using the systems.  

3:30 – 4:15 pm |  Panel: The Evolving World of Digital Commerce  

Are you leveraging your GDSN investment in the ever expanding and evolving world of digital commerce? Join us for this impactful and must-attend session where you can hear first-hand from our renowned practitioners on:

  • How they compete with trusted content that their consumers can count on
  • How they connect their current GDSN investments with the new requirements of e-commerce and the cloud
  • What actions they are taking to stay connected to their end consumers

4:15 pm – 4:45 pm | 1WorldSync Product Vision: Where We Are Today & Where We Are Going

Do you have the essential knowledge and skills needed to empower the success of your data sync initiatives? Review 1WorldSync’s robust capabilities and the upcoming functionalities based on the company’s roadmap. Explore where the 1WorldSync Global Platform is going and how it relates to your Web Ready Product Content.

4:45 pm – 5:00 pm | Closing Remarks

1WorldSync wraps up the 2018 Annual User Group!  Provides a recap of insights from the day with lessons learned and lasting best practices that will drive tomorrow’s results.

Are you ready to witness world class experts share their expertise in engaging consumers on the path to purchase with trusted product content anytime, anywhere? Register today and we will see you in Phoenix very soon!

1WorldSync: Trustworthy Content, Anytime, Everywhere

88% of consumers say product content is extremely important to their purchasing decision. As a result, vendors are being asked to provide accurate and complete content to trading partners in order to enhance the shopper experience.

What is the GDSN?

The Global Data Synchronization Network (GDSN) enables trading partners to globally share trusted product content.

Don’t waste countless hours uploading data to individual portals. You can benefit from:

  • Data Upload to a Single SourceEliminate duplicate efforts! You can instantly publish your data to your DIY/Hardlines, Healthcare, CPG-Retail and Foodservice industry partners across different verticals and countries.
  • Consistency via GS1 Data Standards: The GS1 data standards enable standardization and obsoletion of specific attribute profiles.
  • Central Control: Gain central control and ease over your product content updates.
  • Data Publication: Publish your data to all or specific trading partners. e.g. private labels

1WorldSync: Globally Exchange Product Content in the GDSN

1WorldSync is jointly owned by the member organizations of GS1 US and GS1 Germany, the preeminent global organization for the development of global standards, for identifying, capturing and sharing product information.

1WorldSync has the largest number of items in the Global Data Synchronization Network (GDSN) with 80% of GDSN data activity enabled by the 1WorldSync Product Information Cloud supporting more than 25,000 brands and retailers in over 60 countries.

1WorldSync is the only GDSN Data Pool for product information services with ISO certification & applied standards and we offer global scalability – multi-lingual product and customer support services, serving the CPG-Retail, Foodservice, Healthcare and Hardlines/DIY industries.

Trusted Content Matters

Do you want to learn how we enable companies to distribute trusted product content to your customers via the GDSN and beyond? 1WorldSync understands that no matter where you conduct business, trusted content matters.

Visit 1WorldSync, in Booth #310, at the 2018 50th Anniversary NETWORK Supplier Trade Show being held on April 15-18 in Las Vegas.

Empower your consumers to make data driven decisions on their path to purchase.

 

Top 6 Reasons to Attend 1WorldSync 2018 Annual User Group

Every year, 1WorldSync hosts a collaborative event that provides this platform for our customers to engage, interact and share best practices, community needs, and encourage user-lead information sharing.

We are delighted to announce that registration is now open for 1WorldSync 2018 Annual User Group (AUG), co-located with GS1 Connect*.

This highly anticipated event will be held on June 4 in Phoenix.

Who Should Attend?

This event is exclusive to 1WorldSync customers. We invite attendees that hold the following job titles and specializations to participate:

Executives, Directors, Managers, Project Leads & Analysts in:

  • Data Standards/Synchronization
  • Information Technology
  • E-Commerce/Omni-Channel
  • Marketing/Sales
  • Operations & Quality/Safety/Compliance
  • Supply Chain Management

Why Attend?

In preparation for this worthy event, below are my personal top 6 reasons to attend.

  1. Amazing City. Amazing Show Witness world class experts share their expertise in engaging consumers on the path to purchase with trusted product content anytime, anywhere in Phoenix: Valley of the Sun.
  2. World Renowned Speakers Learn hot topics and trends from prominent industry leaders (past speakers include Kroger, Target, The Kellogg Company, Walgreens).
  3. Big Commitment. Bigger Benefits It is officially the era of trusted product content! Gain knowledge on critical implementation practices and developments from the best and brightest organizations.
  4. Best Practices Glean creative insights and engage in peer-led topic breakout groups that cover data quality, web ready content, digital commerce, and so much more.
  5. Networking Ninja Each year, more than 250 community members from the CPG/Grocery, Healthcare, Hardlines and Foodservice industry come together to network, discuss industry trends and share best practices.
  6. Return To The Office Rejuvenated Are you ready to jump start new programs and initiatives? We distill highlights from the event of all sessions with integrated slides which will be made available to all attendees post event.

For more information, contact us at events@1worldsync.com.

Early Bird Discount

Register by March 30 to save 15% off your GS1 Connect conference badge and use our discount code 18EXH10-AA-1 to receive an additional 10% off.

*Registration is in conjunction with purchasing a GS1 Connect conference pass.

Best of 2017: Top 1WorldSync News Stories

2017 was a big year for news stories spanning all the industries we serve, and 2018 is sure to bring plenty of stories that will continue to shape the world of commerce globally and across all verticals.

Extra extra…read all about it! Here are a few highlights we wanted to make sure you didn’t miss:

Amazon Purchases Whole Foods

We would be amiss if we didn’t lead with this story as it is definitely one of the biggest stories of the year for not only CPG/retail and grocery, but ultimately a foundational shift in how consumers will shop in years to come.  In USA Today’s Article, Dan Wilkinson, 1WorldSync’s Chief Commercial Officer, provides commentary on what this means for the e-commerce giant.

3 Ways to Improve Your Omnichannel Commerce Strategy

Nick Manzo, 1WorldSync’s Global Omni-Channel Lead, provides important insight into how organizations can improve their Omni-Channel Commerce Strategy in this article in Total Retail.  The article highlights the importance of rich and consistent content across all commerce platforms,  providing transparency across the entire supply chain is essential in order to meet the needs of today’s consumer, and how investing in a cloud-based solution allows organizations to adapt to new challenges.

Amazon Announces Its Entry into Healthcare

Internet Health Management published an article on how Amazon’s healthcare plans impact existing healthcare players. It provides insight from 1WorldSync around how Amazon’s entry into the healthcare industry will impact the big players in an already accelerated industry.  Dan Wilkinson, 1WorldSync’s Chief Commercial Officer, describes the need for disruption that only Amazon can provide, “This venture is a logical next step as Amazon continues to involve itself in every facet of consumers’ lives and wallets.”

Home Depot Nails DIY Omnichannel Experience

This year has proven that consumers want a seamless experience from a retailer, whether they are visiting a brick and mortar store, or buying on their phone or tablet. Creating this environment for consumers proves challenging for most, but Home Depot has made great strides this year with what they call their “interconnected retail” initiative.  Nick Manzo, 1WorldSync’s Global Omni-Channel Lead, comments on how this DIY/Hardlines giant is not differentiating when it comes to omnichannel in this article from Supply Chain Executive.

Name Brands Aren’t Immune to the Demands of Today’s Consumers

Campbell’s Soup is a household name that brings a feeling of nostalgia to most, but that does not make them immune to the demands of today’s consumers in their need for an experience and not just a product. Dan Wilkinson, 1WorldSync’s Chief Commercial Officer, speaks to how Campbell’s has confronted this reality head on in this piece Campbell’s shifts their focus from product to experience for the Institute’s of Food Technologists (IFT).

How SmartLabel Delivers Product Transparency To Build Consumer Trust

Initiatives like the Grocery Manufacturing Associations’(GMA) SmartLabel, highlight the common theme across all industries, that especially with foods, consumers want the most accurate and up-to-date information available.  Dan Wilkinson, 1WorldSync’s Chief Commercial Officer, highlights how getting started with SmartLabel is the stepping stone to building consumer trust for your products in Food Manufacturing Magazine.

These few stories are just the tip of the iceberg when it comes to all of the exciting things that are happening globally that impact the future of commerce and product consumption.

To stay up-to-date on the latest news from us, be sure to follow us on Twitter, LinkedIn and Facebook.

A Joint Solution: Manage & Syndicate Medical Device Product Data with Reed Tech and 1WorldSync

Medical device professionals face an ever-growing list of demands for their product data from downstream users all over the world. Some of these demands are regulatory, such as FDA’s Unique Device Identification (UDI) submission mandate.

Others are commercial, such as hospital networks needing access to device product data electronically through the Global Data Synchronization Network (GDSN) in order to maintain a current product catalog. Still other requests may come from a governmental body, not as a regulatory mandate, but as prerequisites for doing business with that agency, such as the NHS eProcurement initiative in the U.K.

These ends users require unique, but overlapping, datasets for every device product. But treating each data submission type as a separate project and ensuring changes and updates get passed along to each recipient can quickly become an unmanageable task.  

Together, Reed Tech and 1WorldSync offer device manufacturers a solution to meet the challenges of securely managing all of this data, ensuring it is accurate and up-to-date, and sharing it with the downstream users who need it.

A combined solution from Reed Tech and 1WorldSync brings individual organizational strengths into a single, comprehensive solution bringing you benefits you wouldn’t reap from working with just one of the providers:  

  1. Secure, centralized storage of your product data in a fully validated Reed Tech environment built just for device manufacturers and conforming to 21 CFR Part 11 requirements.
  2. Transparent control over the state of each record with instant reports and a complete audit trail.
  3. Access to the GDSN through 1WorldSync, the leading provider of product content solutions and largest certified data pool provider.
  4. Support by experts from both organizations, through a single point of contact at Reed Tech.
  5. Straightforward, competitive pricing and a combined agreement for an easier purchasing process.
  6. Peace of mind with a global roadmap to meet upcoming requirements, including the UDI requirements of EU MDR.

Whether it’s the FDA, NHS in the U.K., GPOs or hospital networks, you can know that the information about your product reaching the recipient is accurate and current.

To meet the challenges of managing and syndicating your device product data, visit ReedTech.com/SingleSource or contact us today and learn more about working with Reed Tech and 1WorldSync.

 

1 Solution – Global Healthcare Compliance

The healthcare industry is evolving and the ability to control trusted quality data can be challenging.

If you manufacture or supply medical devices or pharmaceuticals, then you’ll need to comply with multiple regulations in the near future. Whether it’s for the public sector (NHS in the UK), Group Purchasing Organizations, Regulation in Europe (MDR and IVDR) or in the US (FDA GUDID) – there are strict new regulations and customer demands you must meet in order to continue to do business. Continue reading

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, 2020.  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!