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 May 08, 2012

New Free Report Available: 28 pages on Oracle’s Enterprise PLM Solution

Featuring seven customer case studies and enriched with industry-specific best practices throughout, this Oracle Enterprise PLM Report is most definitely a “one-stop-shop” for anyone looking for a solid overview of Oracle’s Agile PLM and complementary solutions.

Here’s a brief summary of the almost 30 pages of content:

The Origins: From Agile Software to Oracle

As part of its commitment to providing the most complete, most integrated and most industry-oriented range of applications available, Oracle in 2007 acquired Agile Software Corp., a leading provider of Product Lifecycle Management (PLM) software solutions worldwide.  Since that date, Oracle has extended and further developed its PLM applications portfolio to create the industry’s most comprehensive suite of applications for full, enterprise-scale PLM throughout the product value chain.

The Challenges for Product-Oriented Businesses

From industrial manufacturing to pharmaceuticals and retail, today’s product-oriented industries face a unique set of challenges such as complex design and supply chains, increased global competition, market demand for customized products, economic uncertainty, and industry regulations.  To thrive in these conditions, product businesses need to be efficient, agile and innovative while ensuring quality, traceability and safety.  But this difficult to achieve for many businesses, which are often plagued by delays and failures due to disjointed and inefficient product development and commercialization processes. 

The Oracle Solution

Drawing on our extensive work with product-oriented businesses across multiple industry sectors, Oracle has developed the expertise and the technology solutions to enable a new streamlined approach to managing the product lifecycle: managing the entire product value chain with Enterprise PLM solutions.  Enterprise PLM is much more than just a technology solution.  It represents a new, strategic approach to the product value chain that emphasizes process efficiency, cross-functional collaboration in the extended enterprise, rapid innovation, rigorous quality control, risk mitigation and cost effectiveness.

The Industries

Recognizing that different industry sectors have unique pressures and concerns, Oracle has developed dedicated Enterprise PLM solutions for a range of industries, including Pharmaceuticals, Medical Devices, Retail, Industrial Manufacturing, High Tech Electronics, Consumer Packaged Goods and Food & Beverage.

Pharmaceuticals: Enabling Business Transformation
With a case study on
Bayer Healthcare

Medical Devices: Supporting Innovation, Accelerating Compliance
With a case study on
Stryker

Retail: Get Control of Product Information
With a case study on
7-Eleven

High Tech Electronics: Accelerate Innovation in a Fast-Moving Industry
With a case study on
Sun Microsystems

Consumer Packaged Goods: More Efficient, More Competitive
With a case study on
Herbalife

Industrial Manufacturing: Bring Better Products to Market, Faster
With a case study on
ZF Friedrichshafen AG

Food and Beverage: Improve Compliance at Lower Cost
With a case study on
Tyson Foods

The Recommendations

Oracle recommends that in order to start taking advantage of the benefits of Enterprise PLM, supply chain technology leaders and CIOs should undertake a few key actions:

  1. Take a purposeful, thoughtful and honest inventory of existing IT product value chain operations and opportunities.
  2. Develop a complete understanding of Oracle’s Enterprise PLM capabilities and how they may be deployed to fulfill specific operational product value chain priorities.
  3. Develop short-term and long-term roadmaps for Oracle strategy and deployment to optimize product value chain impact.
This summary features just a few highlights from the full report, so please read it today!

Thursday Aug 04, 2011

Agile in the News: a Recap of Recent Customer Announcements

If it seems like you've seen more of Oracle's Agile PLM in the news recently, you're right.  We've had several interesting stories in the past month or so to announce, particularly around customer momentum.  Here's a recap:

Kroger generated plenty of buzz when it was announced the company selected Oracle's Agile PLM for Process solution to improve customer experience.  Chris Hjelm, Chief Information Officer, Kroger, is quoted in the Oracle Press Release saying, "We look forward to leveraging Oracle's Agile PLM for Process solution as we further streamline operations, improve the customer experience, and lead the grocery market through innovation and a commitment to excellence."

In Life Sciences industry news, Stryker released a case study about how they established an Enterprisewide Quality Management System with Agile PLM applications.  The story details how Stryker used the product quality management tools to cut change cycle time by 50% and improve first-pass yield of change by 90%.  They've also increased transparency to reduce the average number of corrective and preventative actions (CAPA) open at any time by more than 40% and accelerate resolutions.  AGA Medical (acquired by St. Jude Medical in 2010) also participated in a case study about drastically improving productivity and creating an enterprisewide integrated quality system with Agile PLM.  AGA Medical was able to reduce change order times from 26 days to just 4.5 days, an 83% time reduction, while including more information under appropriate controls.  The Agile solution also controls the item master for the company's JD Edwards EnterpriseOne implementation, allowing Agile to manage the approved as-designed item configuration and JD Edwards to manage the as-built device, allowing significant flexibility in managing change and complexity of the product, reducing cost and time to implement changes and speeding system business process changes.

In the High Technology arena, Secure Meters Limited announced in a case study their work with Oracle Consulting to replace ten legacy engineering systems with Oracle's Agile PLM applications.  There are several impressive results, including reduced engineering change order turnaround-time by 50%, reduced defects per software build by 40%, improved potential earnings before interest and taxes per product developer by 40%, and accelerated time-to-market for utility meters by reducing product development cycle time by more than 25%.  And in a video interview, John Hitchcock of Pace (formerly 2Wire), explained to me, Oracle's PLM Product Marketing Manager, Kerrie Foy, how they saved $4 million dollars by adding the Agile Product Cost Management application to their footprint!

Check back often for more stories, and feel free to join the discussion here, on Facebook or Twitter.

About

Hear from the community that's pioneering PLM's critical role in transforming supply chains into sustainable value chains that power profitable innovation and competitive advantage.

Search

Archives
« April 2014
SunMonTueWedThuFriSat
  
1
2
3
4
5
6
7
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
   
       
Today