All posts by Todd Simons

Have you started planning for UDI compliance?

Class II and Class I UDI compliance deadlines are rapidly approaching. Does your strategy enable your business for long-term success? As a 1WorldSync customer you can add easily add UDI compliance to your existing subscription. You’re already exchanging trusted, accurate product information with your trading partners – why not use that process to send UDI compliance product information to the FDA?

Join the ranks of leading medical device manufacturers that are leveraging 1WorldSync to implement product information strategies for UDI compliance and beyond. Want to learn more?

Attend our informative webinar, How to Turn UDI into a Competitive Advantage, hosted by 1WorldSync Healthcare Industry Expert Todd Simons and Nada Savatic of Abbott Laboratories. Ready to get started today? Sign up for the 1WorldSync UDI solution or come visit us at Booth #6 at the FDA UDI Conference April 18-19 in Baltimore, MD.

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.

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The FDA wants YOU – to be compliant

September 24th 2015 is upon us, thus the second deadline for UDI compliance has arrived. As a quick recap, the FDA is requiring all medical device product information to be submitted to their Global Unique Device Identification Database (GUDID) in order to more easily and accurately identify and trace medical devices along the supply chain. (You can find out more about the regulation and compliance deadlines here.) Continue reading

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.