Category Archives: USA

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!

UDI for 2020: Why You Should Start Now!

September 24th, 2020 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.

The Struggle to Overcome Cross-Channel Commerce Challenges is Real

1WorldSync Omni-Channel Data Study: Charting Course for Global Commerce

A new data study commissioned by 1WorldSync highlighted some of the key challenges suppliers and retailers face when trying to achieve true cross-commerce capabilities.  The study surveyed 400 merchants and suppliers from Europe and the U.S. with more than $500 million in annual revenue, and uncovered key insights into the struggles that are faced in today’s omni-channel world.

As the global $1.9 trillion e-commerce landscape continues to expand, companies are facing difficulties successfully managing cross-channel commerce across continents, supply chains, and software systems, and are losing revenue as a result. Some even doubt the value of investing in these capabilities. In a key finding nearly half of global merchants and suppliers report having lost at least a million dollars in revenue to cross-channel commerce challenges.

The study sheds light on the apparent struggles both ends of the supply chain face in a fast paced market places where Artificial Intelligence, and online/mobile commerce emerge as top trends for consumers.

Merchants and Suppliers Face Significant Roadblocks in Navigating Cross-Channel Commerce

Key findings suggest that a majority of merchants and suppliers are not fully prepared to meet the varied demands of modern customers. Channel readiness is a significant struggle throughout the supply chain as e-commerce continues to evolve. Other data highlights include:

  • Future investment plans don’t address current e-commerce weakness: Forty-five percent of merchants and suppliers have lost more than $1 million in revenue due to cross-channel commerce challenges, and more than one in ten (13 percent) have lost more than $3 million.
  • Lack of content solutions hamper success: Half of merchants and suppliers do not use a third-party content provider, which hinders their ability to syndicate product content across channels and platforms.
  • Merchants lag when it comes to cross-channel commerce: Fifty-one percent of merchants cannot support mobile commerce, and 80 percent don’t integrate product information management across web, mobile, applications, and physical stores.

Market Leaders Show the Path Forward

While many merchants and suppliers surveyed struggle with different aspects of the retail experience, there are clear lessons to be learned from market leaders (defined as companies that complete 51 percent or more of sales online). For companies looking to learn from these market leaders and upgrade their e-commerce capabilities, top action items include:

  • Invest now in cross-channel capabilities: Sixty-five percent of market leaders have dedicated more than 30 percent of their commerce budget to digital and mobile commerce expansion in the last year. Today, 73 percent of merchant market leaders can fully execute mobile commerce, nearly 20 percent more than market laggards. Investments here help in the short and long term.
  • Engage with a third-party content provider: Eighty percent of market leaders use a third-party content provider, which is undoubtedly one reason this group reports greater visibility between trading partners.
  • Migrate to the cloud: Ninety-five percent of supplier market leaders use a cloud-based product information system, which simplifies the online sales process and enhances supply chain efficiency.

Blurred Lines & Blended Commerce – The Changing Face of Retail

“The shift in retail to the Internet is a huge change… every retail company is trying to manage the transition. It’s not well defined or understood and there’s no road map” said Simeon Gutman, a retailing analyst for Morgan Stanley (New York Times 2015).

Download a copy of our full data study here.

Win Consumers On Their Path To Purchase With Trusted Product Content

88% of consumers say that detailed product content is extremely or very important to their purchasing decision. (Google Shopping Guide, 2016).

Consumers expect rich and trusted product content on all channels: desktop to mobile.  Accurate, rich and timely product content is critical in the path to purchase from discovery to delight.

One may think that managing product content and data is easy, but the challenges include:

  • 10’s enterprise systems in typical back end to manage product data.
  • 100’s people sourcing, aggregating, cleansing data needed for commerce.
  • 1000’s trading partners requiring exchange data with in a variety of formats.
  • 10,000’s of websites, apps and 3rd parties, representing your product/brand to the consumer.

1WorldSync Omni-Channel Data Study: Charting Course for Connected Commerce

A new data study commissioned by 1WorldSync highlighted many of the key challenges suppliers and retailers face when trying to achieve true cross-commerce capabilities.  The study surveyed 400 merchants and suppliers from Europe and the U.S. with more than $500 million in annual revenue, and uncovered key insights into the struggles that are faced in today’s omni-channel world.

Key findings suggest that a majority of merchants and suppliers are not fully prepared to meet the varied demands of modern customers. One major data highlight emerged:

Lack of content solutions hamper success: Half of merchants and suppliers do not use a third-party content provider, which hinders their ability to syndicate product content across channels and platforms.

Trusted Content, Everytime, Everywhere

Brands and retailers need trusted, experienced experts to help them on their product content journey towards a single source of truth!

On May 24, 1WorldSync is pleased to partner with Progressive Grocer and GMA and host a webinar on how to “Win Consumers On Their Path To Purchase With Trusted Product Content”.

Join industry leaders from Tyson, Mondelez and 1WorldSync for a compelling discussion and Q&A on:

  • The evolution of the product content journey from supply chain to cross-channel commerce
  • How trusted content is curated and delivered anytime, everywhere
  • How to influence consumers with trusted product content strategies on the path to purchase
  • How to effectively navigate hurdles encountered while integrating cross-channel capabilities

Register Today!

 

Enabling Trusted Content Everytime in Every Channel

The majority of consumers (88%) say that detailed product content is extremely or very important to their purchasing decision (Google Shopping Guide, 2016).

Accurate and timely product content is critical in the path to purchase from discovery to delight. As digital pre-shopping, such as product research and comparative reviews, increasingly influence the shopping journey, so too increases consumer reliance on consumable content.

EnterWorks & 1WorldSync Q&A

This week, 1WorldSync’s Director of Professional Services, Data Source Solutions, Vanessa Lin, and EnterWorks CEO Rick Chavie joined for a Q&A. Together, they discussed the drivers of cross channel commerce and how EnterWorks and 1WorldSync are joining forces to pave the path for trusted content.

Vanessa Lin:

How is EnterWorks seeing new regulations and data requirements changing the way businesses must manage/distribute data?

Rick Chavie:

We have entered a new era of data standards. Whether it is the Google GTIN update last year which mandated that all brand-name products include the manufacturer-assigned GTIN number or the FDA regulations on nutritional content effective in May 2017, the growing insistence on data quality means online sellers including retailers, brands, and distributors must invest more in time, resources, and digital competencies to update product feeds continuously.

But the imposition of a single view of standard content across channels, while being pushed by the industry and government, pales in comparison to the role that the consumer is playing in driving the expectations for content to a new level.  Fickle or not, loyal or opportunistic, the consumer is now accustomed to having content that they need regarding their preferred products at their fingertips.  Correspondingly, the cost of poor and inconsistent content mounts as sellers increasingly realize that they now compete on content for share of mind and wallet.

Vanessa Lin:

Agreed! Competing with trusted product content consumers can rely on is critical. Consumers expect rich and trusted product content on all channels: desktop to mobile. What areas has EnterWorks observed where consumers are driving change?

Rick Chavie:

This is the age of content enthusiasts. Forrester Analyst Carlton Doty recently described our post-digital world, saying “customers aren’t just empowered by digital technology – they’re actually entitled. They think they deserve something, they want it now, and if you can’t provide it, they will quickly find it somewhere else.”  

Retailers, manufacturers and distributors must consider not only the effectiveness of product data, but how their content tells a story and creates differentiated experiences. Compelling, trusted product information that is consistent across channels is key. That’s where Product Information Management (PIM) and Master Data Management (MDM) solutions can help, by enabling companies to acquire, manage and transform product information into persuasive content. This content then drives higher sales and new competitive strengths through e-commerce Web, mobile, print and in-store digital channels.

Vanessa Lin:

Indeed, today’s shopping experience is driven by ‘I need to know’ moments for consumers. Given the consumer’s lofty expectations for an integrated cross-channel shopping experience, there is a steady race to remain relevant in a hyper-competitive retail environment.

A new data study commissioned by 1WorldSync highlighted some of the key challenges suppliers and retailers face when trying to achieve true cross-commerce capabilities.  For example, over half (53 percent) of merchants and suppliers experience a knowledge gap internally when it comes to understanding the value of cross-channel capabilities.

Let’s talk about how 1WorldSync and EnterWorks are working together to provide an end-to-end solution.

Rick Chavie:

The successful partnership between EnterWorks and 1WorldSync continues to hit exciting milestones, ushering in new clients, opportunities, and a powerful go-to-market strategy.

This builds on our news last year that EnterWorks received certification on Major Release 3 from 1WorldSync. The MjR3 certification expands the functionality for EnterWorks customers already connected to GDSN, and offers new users of EnterWorks’ PIM and MDM solutions the most advanced bi-directional data publishing and synchronization tools available.

Vanessa Lin:

Thanks, Rick! Overall, the EnterWorks/1WorldSync partnership brings enhanced access to richer, trusted product content to clients around the globe. We invite readers to learn more about the benefits of our partnership here.

1WorldSync and EnterWorks will both be exhibiting at GS1Connect on June 20-22 in Las Vegas. Visit EnterWorks booth #5 or 1WorldSync booth #17 to learn how the joint PIM solution can help your business.

Learn more about EnterWorks Enable GDSN Solution utilizing the 1WorldSync connector.

References

Have What It Takes To Win In A Post-Digital World? Forrester 2016 http://blogs.forrester.com/carlton_doty/16-05-04-have_what_it_takes_to_win_in_a_post_digital_world

 

Digital Catalogs Drive Conversions

Are you at risk of losing share of the $23.4 trillion in worldwide e-commerce sales predicted for 2017? (Source: eMarketer)  

Today’s buyers and modern-day voyagers are tasked with navigating an ever-evolving e-commerce landscape. Companies are investigating newer and better strategies to meet the evolving demands of partners and consumers.

There’s huge opportunity for merchants and suppliers to use the digital channel to reach shoppers in a new way.

  • Have you ever wanted to send over your seasonal product collection to your buyers?
  • Would a mobile-friendly catalog with information enable your business to train your sales team more effectively?
  • Do you have the ability to give your smaller retailers a place to get your latest, up-to-date product information?
  • Are you ready to go digital, sell everywhere and deliver content efficiently?

Enter the Sales Kit App!

The 1WorldSync Sales Kit App, part of our Product Information Cloud, is a digital catalog that provides businesses with the ability to render their own Digital Catalog(s). Sales Kit mobilizes product content and enables the easy creation of selling sheets, catalogs, slicks and other digital sales aids.

Leveraging your company’s product data that’s been loaded into the 1WorldSync Product Information Cloud Sales Kit enables:

  • Creation of a public or private online catalog with complete product details
  • Delivery of field selling sheets, spec sheets, product slicks and other digital sales aids to help drive global sales
  • Power and drive sales through eCommerce, global websites and other digital applications

Are you ready to go digital, sell everywhere and deliver content efficiently? Digital Catalogs clearly help drive online sales for large and small brands. To learn more about the 1WorldSync Sales Kit, visit here.

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.

March Madness Hangover

So it’s April… but at 1WorldSync, we are experiencing nostalgia or better yet a March Madness Hangover!

March Madness is all about constantly checking your bracket, placing bets, arguing with friends, and of course now believing you can now play in the NBA. The American Gaming Association predicts that more than 40 million Americans wager $10.4 billion on March Madness, a 13 percent increase over 2016. They also predict the madness will cost employers $2.1 billion in lost productivity (American Gaming Association 2017).

Brands and retailers, while taking advantage of the consumer’s need for related product, battle the loss of productivity. In effect, they create their own strange connection to the tournament.  Many historic brands are not having their best year ( Macy’s, Sears, KMart, Sports Authority) and even simply the old mom and pop store) are falling off our bracket.

March Madness = Marketing Magic

March is a slow time in the sports advertising world with little competition, creating a retail season of its own. Tapping into the fans’ feelings and providing a personalized experience will help produce brand loyalty.

Not only are consumers socially active via mobile, they show high engagement with the companies that speak to them during the games. Food and beverage are obviously big buyers for advertising in the tournament. Yahoo Data showed that in 2016 ad purchases paid off heavily (Yahoo Data, 2017):

  • Wing orders were up 24%
  • Pizza orders were up 17%
  • Sponsored apparel site searches were up 33%

Generating this excitement can be easy for companies of all sizes. There is enough room for smaller players as well.  Thinking local, social and timely can help revolutionize your customer experience, turning fans, into customers.

Win Consumers on Their Path To Purchase With 1WorldSync

Clearly, today’s world of commerce is ever changing and there is no perfect bracket. Why else would Warren Buffet give up $1 million to anyone who had one?

Similarly, trying to match the convenience and needs of consumers with personalized and trusted product content is no easy feat.

Looking for a whitepaper to help equip your organization with strategies that set you apart? 

Download our latest whitepaper to learn more about connected commerce and see how your organization can develop an operational backbone to support your e-commerce investments.

March Madness has become an annual event all consumers and retailers get caught up in. Whether it is the gut wrenching emotional pull,  money on the line, the right for office bragging rights or the excitement of seeing a Cinderella story,  it has created a month of madness that cannot be missed!

 

References

March Madness Betting to Top $10 Billion. March 13, 2017. https://www.americangaming.org/newsroom/press-releasess/march-madness-betting-top-10-billion

How bracket time can be a slam dunk for marketers. Feb 17, 2017.
https://advertising.yahoo.com/insights/how-bracket-time-can-be-slam-dunk-marketers?soc_src=mail&soc_trk=ma

Shoptalk 2017 Recap

It was a great week at Shoptalk 2017.  Connected Commerce is the name of the game…companies are mobilizing behind mobile and beyond!  From sessions on how online is going offline to rising mobile commerce in China;  with major retail and brand speakers like eBay, Nordstrom, Walmart, Kimberly-Clark, Mondelez, Samsung, HSN, Apple, Lowe’s and on and on and on….the discussions were insightful and engaging.  Not to mention the appearance of the Bumby’s for fair and honest appraisals of attendee appearances.

So for our loyal 1WorldSync followers, let’s boil it down on a few key insights relative to product content.

  • Shoppers will start and end their purchase journey in different places.  It’s a fact.  Brands and retailers alike must make their cross-channel commerce capabilities and content in those channels consistent, authentic and engaging.
  • Omni = Om-need…one speaker coined a phrased that omni really means om-need.  As a brand, you need to have your product content available when the shopper wants it, needs it, and when they ask for it.  Is it a Dash button?  Store Display? Alexa? Challenges abound!
  • Content is global, distribution is local.  Content is not “one-size-fits-all;” yet, brand reputation, recognition and market position has to be consistent globally.  However, consumers around the world consume that information differently – it must be tailored for local markets.  Product content strategies are following global commerce strategies and no longer siloed within channels.
  • The “connectivity of things” means product content is traveling and traversing mediums in exponential fashion.  Voice search to physical outcome is not easy.  Natural processing language and search context are just the start of challenges (or opportunities) facing retailers and brands on the consumer path to purchase.

All this points to the fact that connected commerce is growing, changing, evolving, iterating, exploding and imploding…all at once. Product content in this environment must be trustworthy, authentic, consistent, relevant and timely.  Brands and retailers need partners to help them in this quest for delivering frictionless commerce.  The eco-system is growing, these global power houses are choosing trusted, experienced experts to help them on their journey!

 

Thank you Shoptalk for another great year of rewriting the commerce blueprint!