Tag Archives: United States Food and Drug Administration

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.

The Power of 1WorldSync Product Information Cloud

As an avid reader of Bloomberg Businessweek, I was excited to see cloud technology, code, data management, everything that we, 1WorldSync, live and breathe, dominating the June 2015 issue. It got me thinking, how do we as a world, as an industry, as a business, educate decision makers on:

  • ‘Understanding and unlocking’ the value of the cloud?
  • Understanding the power and presence of data?

It is a new frontier, a ‘Data Revolution’, and the healthcare industry, specifically, is on the proverbial cliff ready to jump in head first. With the ongoing transformation of the U.S. healthcare delivery system, supply chain has become a key component to meeting organizational goals by driving clinical value, implementing innovation, and delivering operational efficiency. In order to fulfil its multifaceted objectives, supply chain is engaging with various stakeholders in pursuit of a common mission to foster a coordinated healthcare delivery system. Specifically, the impact of the ‘Data Revolution’ and the ‘Big Data’ explosion on the healthcare industry has spurred the creation of governmental and regulatory mandates, such as the Unique Device Identification (UDI) regulation set forth by the FDA. The UDI regulation require all medical device manufacturers to publish complete and accurate product information to the Global UDI Database (GUDID). To comply with the regulation, all medical device manufacturers must publish all required medical device product attributes to the GUDID by the specified time or face strong consequences.

Whether it’s in the form of regulatory compliance, seamless deployment along the supply chain, expanded storage, or collaborative networks or solutions, companies and businesses are looking to improve their top and bottom lines, and trusted product information is proving itself as a time and cost saver with the ability to help businesses grow. This is the core of 1WorldSync services and solutions. By building genuine business relationships and developing detailed strategic solutions 1WorldSync services address the most critical challenges within organizations in support of supply chain efficiency and regulatory compliance.

Join 1WorldSync at AHRMM15 to explore key ideas, trends, and best practices around building strategic stakeholder engagement, with an emphasis on supply chain perspective. Visit 1WorldSync at booth 924 and learn how the leaders in data pool management solutions and services can support your business for trusted product information exchange.

We look forward to seeing you there!

 

OUR Mission:

To be the Healthcare industry leader in product information exchange and the change agent that drives the industry forward through global regulatory compliance and improving healthcare standards.

I’m not sure what UDI stands for, how will my Organization be ready for compliance?

A recent United States Food and Drug Administration (FDA) regulation, issued on September 24, 2014 has medical device manufacturers on a global basis, readying their organizations for compliance. The new regulation requires most medical devices to be marked and labeled with a unique device identifier (UDI) and then entered into the FDA’s Global Unique Device Identification Database (GUDID) with a set of FDA-specified attributes.  Compliance dates are driven by the class of medical device. Continue reading