FDA’s Unique Device Identifier: 4 Steps To Successful Implementation for Medical Device Companies

By Jennifer

The Unique Device Identifier (UDI) for medical devices was introduced by the United States Food and Drug Administration (FDA) in 2007 to improve medical device traceability and performance.  FDA published the UDI final rule detailing the regulatory requirements in September 2013 and provided further guidance in July 2014. Class III medical devices were required to have UDI compliance in September 2014, and deadlines for Class II and I will be in 2015 and 2018, respectively. It is likely that global adoption of FDA unique device identification, or similar regulatory requirements, will occur. UDI implementation may seem to be yet another “regulatory hoop” that medical device companies must support, however in our view it is an opportunity to improve the patient experience by providing a more holistic approach to launching and tracking medical technologies pre-market and post-market launch.

Unique Device Identifier

Figure 1. Unique Device Identifier Shown in the Context of a Product Label. Source: UDI Conference 2012 Jay Crowley, Senior Advisor for Patient Safety, FDA. (Click to enlarge)

Follow our 4 key steps for UDI compliance, complete with the challenges you’ll face as well as solutions provided by the Licensed to Cure for Medical Devices industry solution experience powered by the Dassault Systèmes 3DEXPERIENCE© platform.

  1. Prepare the device identification (DI, see Figures 1 and 2) records by acquiring all the relevant data from various sources and documents. Data for the DI include elements like Device Identifier Type/Code, Make/Model, Brand/Trade Name, and Clinically Relevant Size. The data needs to be validated by departmental stakeholders to ensure that the information represents the final released product for the UDI submission.
    Challenges: Data aggregation may be difficult because it is in different forms, and medical device companies need to collect between 70 and 120 different product attributes to meet regulatory requirements. Of these data attributes, 55 DI attributes are submitted to the FDA GUDID.
    Solutions: Manage DI records collection as a project, using an enterprise process workflow to assign tasks to different parties to provide information from across your organization.
  2. Submit and Publish the DI record to the U.S. FDA global unique device identifier database (GUDID). After filling out the FDA forms and submitting to the FDA GUDID, the Regulatory Manager must wait for the acknowledgement of acceptance. If the submission is not accepted, the issues identified are addressed and the DI resubmitted to the FDA GUDID.
    Challenges: The UDI labeling process, which is already lengthy due to data aggregation, formatting, and coordination of cross-functional teams, is lengthened further by this process. Waiting for acknowledgement, and the possibility of needing to resubmit, adds to time pressures to meet deadlines and to coordinate with the product launch.
    Solutions: Improve project management efficiency by maintaining a “single version of the truth” medical device database. Review and approve DI record using electronic signatures to stay compliant. Receive and record acknowledgement from FDA GUDID when a submission is successful or record rejection notices for invalid DI record submission.
  3. Maintain and Monitor the device status throughout the product lifecycle to keep the U.S. FDA product registration and GUDID up-to-date.
    Challenges: Ensuring total traceability of the UDI implementation.
    Solutions: Store all device attributes (based on a pre-formatted data model aligned with U.S. FDA guidelines) in one enterprise medical device database (device information, packaging and secondary information, and device characteristics).
  4. Bridge Information between medical device reports and DI records to build root cause analysis of data and any issues. The Regulatory Manager needs to associate device/patient issues with identified product to accelerate post-market surveillance activities (for example, adverse event reporting/aggregation, medical device recalls, tracking and tracing, and patient notification).
    Challenges: Growth of medical device companies, sometimes through acquisition, make it difficult to track and manage uniformity, accuracy, semantic persistence, stewardship, and accountability of label identifiers, as well as other device data elements needed for regulatory compliance.
    Solutions: Increase information sharing throughout the enterprise using a centralized repository of DI records. For root cause analysis, perform “where used” analysis to highlight relationships with other databases, such as complaints (internal/external).
Unique Device Identification

Figure 2. Unique Device Identification (UDI) required by the FDA for Medical Devices. The UDI is designed for electronic identification (bar code) and to provide information to consumers (bottom numerical region). In the numeric region, the left part (Global Trade Item Number or GTIN) is a static code for a product and is also referred to as the Device Identifier (also DI). The remainder of the code on the right, the Production Identifier (PI), is more dynamic and is comprised of the expiration date, lot number, and serial number. (Click to enlarge)

Medical device companies face many challenges in meeting the FDA UDI requirements. Dassault Systèmes has a long history in the Medical Device industry, helping leaders create and launch breakthrough innovations. For Class I, II, and III devices, from small organizations to global enterprises integrated with suppliers, our solutions help companies accelerate innovation to market safely, more quickly, at a lower cost while maintaining quality and reducing regulatory risk.

Listen to a recent webinar featuring former-FDA and UDI regulation author, Jay Crowley and partner Kalypso by clicking here.

See Dassault Systèmes’ life sciences solutions page and the Device Regulatory Excellence solution white paper for more details.

Open-source Thinking is Revolutionizing Medical Device Development

By Catherine

Written by Catherine Bolgar

medical deviceWhen we think about medical care in the future, we tend to think about the progress technology will bring us, with cutting-edge machines that let us see what’s happening inside our bodies in ever-greater detail.

That’s true, but there’s another aspect to technological progress. As Moore’s Law brings down the cost of computing, and as consumer electronics become more sophisticated and yet cheaper, there are opportunities to use those advances to make medical devices that can serve the bottom of the pyramid.

The global middle class is estimated at 1.8 billion people in 2009, a number expected to rise to 3.2 billion by 2020 and 4.9 billion by 2030. Years ago, many people in developing countries viewed medical care as out of reach as jetting off on vacation. Today, the new middle class in these countries is going on vacation, and it expects decent health care too.

A new breed of bioengineers sees opportunity in emerging markets for devices that deliver results without costly bells and whistles.

There are still very challenging design and engineering problems,” says Josh Kornfeld, president of Tactile Inc., a Seattle product and interaction design firm. “But until five or 10 years ago, nobody even had an interest in designing for markets like this unless it was an NGO [nongovernmental organization]. Now, they’re not just giving a gift to these countries; they’re companies that are building long-term business models around servicing the needs of these countries.”

Mr. Kornfeld’s company helped Intellectual Ventures Lab and the Gates Foundation engineer a cooler whose proprietary materials make it so efficient it can keep vaccines cold for 30 days using just ice. That’s crucial in places where electricity is at best irregular and at worst non-existent—factors that have left many people unable to get vaccinated.

In the U.S. and Europe, we relish complexity,” he says. “We see technological devices as better the more training they require. We can afford to train people and make sure things get cleaned the right way and police all that stuff. In Africa, they’re highly trained people—the WHO [World Health Organization] does a great job of that—but the facilities they have access to, clean water, the resources for cleaning equipment the right way, aren’t as good. So it requires different design for use in those areas.”

In other words, the future of medical devices will involve, to a large extent, streamlining and simplifying.

Evolving Technologies, or Evotech, of San Francisco came up with a simplified endoscope—an instrument with a camera for looking inside the body. Evotech’s endoscope, called EvoCam, is being used in Uganda and India in keyhole surgery, hysterectomy surgery, ear and nose care such as sinus operations, and complicated cases of vaginal fistulas.

The EvoCam costs about $500, versus $50,000 to $100,000 for the high-tech systems usually used in modern hospitals. These modern systems weigh about 100 pounds, and consist of several devices—an image-processing unit, a light source and other modules, which sit on a big cart. Evotech turned it into a tablet- or laptop-based system.

When modern endoscopes were developed in the mid-1970s, consumer electronics were no match—videocassette recorders were rare and camcorders were huge. Today, a person can add a high-definition camera to a mobile phone for $2.

Evotech put the EvoCam under a Creative Commons license and published a shopping list of off-the-shelf parts, along with assembly instructions, so doctors anywhere can make their own. By not using proprietary parts, repairs are cheap and easy. For example, the EvoCam uses a regular USB cable to connect the device to a laptop; modern systems have special cords that cost about $1,000 to replace and that aren’t easily available, says Moshe Zilversmit, co-founder of Evotech.

Now we want to open-source it so anybody can build it,” Mr. Zilversmit says. “We’re trying to create a community where physicians come back with different ideas about how to improve it. We can gather information on what kinds of surgeries they’re doing. A lot of them are macgyvering it,” referring to the TV character who uses resources at hand to solve difficult problems.

Open-source innovation for medical devices is a new frontier. Even in the information technology industry, open-source hardware is a new, but growing, trend.

When you think of medical devices, it’s about high margins and low-volume sales,” says Avi Latner, Evotech’s other co-founder. “When you do affordable devices, you have to go beyond product design and rethink the business model as well. We decided we wanted to make it open source. Like software—open source revolutionized software. On the common basis of free tools, why not do the same for hardware in medicine?”

The trend is likely to lead to better-designed and better-engineered products adapted to emerging markets. And as fiscally strapped developed countries re-examine health-care spending, medical devices that are cheap, solid and simple are likely to gain favor in certain cases where the benefits of fancier systems is marginal.

For more from Catherine, contributors from the Economist Intelligence Unit along with industry experts, join The Future Realities discussion.

Technology with a purpose: 3D Printing for People with Disabilities

By Aurelien

South by SouthWest Interactive (SXSWi) is a great place to hear about upcoming trends from highly influential keynote speakers. However, it is even better at revealing smaller yet not less relevant gems. Enabled by Design is probably one of them.  :-)



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