Monday Sep 30, 2013

Is product innovation working for you?

First results of the "Oracle Innovation Management Survey: Are you getting the maximum Return on Innovation?" show 80% of companies see Innovation as a Top 3 priority. 82% report needing to improve their innovation investment decision making, and 91% have too many innovation projects for the available resources. Harvard Business Review aligns with these result, and says Innovation Isn’t Just About New Products...

Tell us what you think! Participate in the ORACLE INNOVATION MANAGEMENT survey and receive a complimentary research report. All you need to do is to invest 10 minutes. As a reward, you will gain insight into:

  • Top challenges impacting return on innovation
  • How companies are looking to improve their innovation management processes
  • How your company’s experiences benchmark with those of other leading organizations

Participate in the online survey (for german version go here, and for french version go here).

survey

Monday Sep 16, 2013

Oracle's Unique Device Identifier Solution: A 3-Step Approach to FDA Compliance

By Todd Hein, Senior Director of Life Sciences, Oracle

In 2007, the Food and Drug Administration Amendments Act was signed to improve patient safety by improving the flow of information on medical devices. This legislation is anticipated to be enforced within the next 12-18 months and, at minimum, requires Class II and Class III medical devices distributed in the U.S. to carry a Unique Device Identification (UDI), a unique numeric or alphanumeric code with an identifier specific to each device or model as well as an identifier with current production information.

The FDA's vision for the UDI system is to provide global visibility and support the following improvements in the medical device processes:

  • Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
  • Reduce medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
  • Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
  • Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
  • Lead to the development of a medical device identification system that is recognized around the world.

In order to help medical device companies to streamline the process and achieve UDI compliance in the short timeline available, Oracle has announced the 3-Step UDI Solution that combines enhanced business processes with data capture to achieve UDI compliance at a low total cost of ownership. Keeping with the theme of simplicity, the comprehensive Oracle solution achieves UDI compliance in three simple steps:

  1. Source, cleanse and validate legacy UDI attributes for each shippable SKU
  2. Process and manage UDI, Global Trade Information Number (GTIN) and SKU hierarchies
  3. Extract and submit accurate data to the Global Unique Device Identification Database (GUDID) and Global Data Synchronization Networks (GDSNs)

To develop the 3-Step UDI solution, Oracle worked closely with the FDA to gain a better understanding of the requirements, and also worked directly with the several leading medical device companies to ensure specific business challenges were addressed. Through a partnership with Inspirage, an Oracle Platinum Partner; the resulting solution provides a "Rapid Start" template approach to ensure that the aggressive FDA deadlines can be met.

The value of deploying this solution is not just limited to meeting FDA compliance mandates. With the underlying technology in the Oracle UDI solution, medical device companies have a strong foundation to expand parallel business processes across the enterprise for compounding business benefit.

The 3-Step UDI Solution demonstrates Oracle's commitment to addressing the unique requirements of the medical device industry. Combining industry knowledge with a comprehensive product line and partner expertise, Oracle is well-positioned to create valuable solutions to assist all medical device companies.

To learn more about the Oracle 3-Step UDI Solution, click here.

 

Tuesday Sep 10, 2013

Oracle OpenWorld 2013 Focus on Product Value Chain Schedule Published

The buzz around Oracle OpenWorld is heating up!  Before heading to San Francisco, take a moment to read the Focus On Product Value Chain document, a list of PLM-related sessions, demos, activities and more at #oow13 available via the OpenWorld website.

https://blogs.oracle.com/PLM/resource/OOW2013PLMemailheader.jpg

Can't decide which events look right for you?  Here's my TOP 3 list of must-attend activities:

  1. Networking with PLM Partners Brunch Wednesday at 8:00 a.m. – 10:00 a.m. at B Restaurant: Agile PLM users and interested customers have the opportunity to meet with PLM partners and other Agile PLM users to discuss a PLM topic of their choosing, over delicious breakfast at the nearby B Restaurant.  This has been an OpenWorld favorite for our PLM customers the past two years, and shouldn’t be missed.  Registration is required, so please email terri.hiskey@oracle.com for more information.
  2. SCM and PLM General Sessions Monday at 10:45 a.m. for SCM and 12:15 p.m. for PLM:  So technically this is a list of Top 4 must attend activities, but believe me, with all the bustle of OpenWorld attending general sessions is the best way to hone your schedule and kickoff the week.  Hear the latest updates directly from the solution area management team, and even find out what’s in store for the upcoming Value Chain Summit 2014.
  3. SCM Networking Reception  Tuesday at 6:00 p.m. at the John Colins Restaurant: All SCM and PLM customers are welcome, so join us!  But keep in mind, drop-ins will not be admitted.  Registration is required, so please visit  http://www.oraclepartnerevent.com/2013/oow-scm-reception/email.html to make your reservation.

Have your own recommendations or interested in more info about any of the sessions?  Let us know!

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