Consider for a moment the modern automobile. A car’s computer can pinpoint for a mechanic exactly what’s going wrong, and provide a thorough history of how things have been working (or not) in recent weeks. Data networks keep tabs on recalls and alert drivers when parts need to be replaced. In some cases, operating software can be updated wirelessly to address performance or emissions issues, without the driver lifting a finger.
Now ask: Shouldn’t my grandfather’s insulin pump do that, too? (See Figure 1)
The U.S. Food and Drug Administration (FDA) thinks someone’s replacement hip or artificial heart valve should respond in much the same fashion. So in 2013, they introduced the Unique Device Identification (UDI) requirements. These have had great bearing on the medical device industry—but they have also provided that industry great promise in terms of leveraging the emerging technology of the Internet of Things (IoT). Compliance with UDI will also provide an unprecedented level of data gathering across manufacturing, distribution and end use that will offer all stakeholders the promise of greater efficiency and other benefits.
More than Just Compliance
Medical device manufacturers are nearly three years into compliance with the UDI requirements. The FDA has set the next two deadlines for September of 2016 and 2018, with the last deadline in September 2020. The specific requirements for each of those deadlines depend on the class of the device, whether it has FDA approval already, and whether the device must be marked directly on the part or just on its packaging. (See Figure 2)
But whether you are labeling and packaging of Class III medical devices or permanently marking a device to be used more than once, the main thrust for this mandate is to adequately identify medical devices through their distribution and use.
The FDA assures there will be benefits of a UDI system, be it improving patient safety, modernizing device surveillance (especially postmarket) or facilitating medical device innovation. These benefits will specifically apply to industry, the FDA, consumers, health care providers and health care systems in the following ways:
- Allowing more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reducing 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.
- Enhancing analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post-market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
- Providing a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
- Providing a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
- Leading to the development of a medical device identification system that is recognized around the world.
It’s understandable that most device manufacturers will view the UDI mandate as something that must be met. However, some forward-thinking companies have seized upon the fact its arrival coincides with the maturity of Internet of Things (IoT) platforms, which allow communication and data within your products. This convergence offers those companies a rare singularity: The opportunity to explore technologies and solutions that not only meet the UDI mandate, but also deliver on the IoT promise that analytics will drive better decision making.
IoT and the Promise of Data
Data is already the currency of the modern economy, but the IoT emphasizes just how much impact that data can have, improving everything from manufacturing to distribution to the entire supply chain. This is emphasized by Industry 4.0 and the digitization of things, in other words, your products and assets, which allows businesses to be smarter as they go about creating and delivering safe products to the marketplace.
UDI compliance for medical devices is a natural extension of this trend. It is first and foremost about how having a small amount of identification information creates benefits for all stakeholders, whether they are manufacturing, distributing or using the product.
Manufacturers benefit in many ways. For instance, automating the process for all their products allows them to avoid manual pick/packs. Costs can also be reduced through the efficient electronic management of a product’s movement through the distributor to the hospital, turning them into beneficiaries, as well. And, patients benefit from UDI, because the shared data provided by the ID of their medical device eliminates risk and makes it easier to recall.
This is a natural extension of early incarnations of the IoT, whose initial concept was everyday objects sharing data and taking action across a network… though initial scenarios trended toward the domestic. Running low on milk? Don’t worry, the refrigerator already noticed and has arranged for a delivery from the closest grocery store. Today, however, we are much closer to that singularity, where everything—products, assets, things—will continue to get smarter and become rich with localized data gathered over time.
Opportunity Knocks for Manufacturing and Distribution
For medical device companies, information will become the foundation for their manufacturing, and it will be augmented by more data about the product’s distribution, condition, and directions for use, re-use, and upkeep. In other words, devices will ship with a pedigree and become embedded with a digital record of their entire life history. That local information will be the benefit made available for all stakeholders.
Consider the following case studies of customers looking to use asset intelligence solutions to gather data that improves their business.
A large pharmaceutical manufacturer is looking to embed data on clean room materials, automating the environmental condition monitoring during production. Automation and embedding of information inside those materials saves time, reduces exposure to contaminants, and offsets risk of one bad manufacturing batch, which is vital when a bad batch can cost $500,000.
A medical device manufacturer wants to embed data on disposable device that must be gamma sterilized. The data on the disposable provides two benefits. Firstly, it provides authentication at the time of use that the right disposable is connecting to and operating with the right system within. Secondly, additional data exchange between the disposable and the device sets operation parameters of use, such as the rate of flow of fluids or speed of rotator blades. This data exchange ensures that the disposable and the system will be used in conjunction, reducing likelihood of counterfeit parts that can cause harm, and eliminates inaccuracies of human entry error by setting parameters digitally and automatically.
A manufacturing service provider is embedding detailed data about the product with its packaging. As the product moves through different stages of its production—assembly, sterilization, and final packaging—it gathers confirmation of completion of each stage. The embedded record of quality, sterilization confirmation, and release is carried with it into the distribution channel. Even then, digital data continues to be gathered on the product so when it is eventually opened for use, a digital chain of custody is visible. Manufacturers can monitor and act just in time depending on whether the device used in the hospital is consigned or not consigned, bringing unprecedented visibility.
Now, the FDA is agnostic to the technology that provides the non-human readable identification on the medical device. Whether this part is a bar code or RFID matters not, as long as it meets the labeling requirement. Each solution has had their challenges, though. Bar codes may not print well, they are difficult to read when subjected to frost or inside plastic wrapping, and they require labor intensive unpacking and packing for line-of-sight reading of the information. Traditional RFID technology had its limitations, too, because the data written to the tag couldn’t survive rugged processes or manufacturing conditions. This forced the tagging of products much later in the manufacturing cycle, thereby lessening the impact of this data to provide value add analytics and feedback to the manufacturer.
Smart assets, however, are made intelligent with the capability to gather and communicate digital information throughout a device’s entire lifecycle. Installed at the time of manufacture, their rugged memory structure gathers data constantly through all processes, including irradiation and harsh storage environments. If cold transport is a concern, for example, a sensor can be added to track environmental conditions. Authentication can be assured by applying a digital certificate. It will automatically create an audit trail and electronic pedigree, which in turn enables real-time reordering and more accurate revenue recognition. All of these add value across the spectrum of stakeholders, while simultaneously addressing the UDI requirements being rolled out by FDA.
If you believe the premise of the Internet of Things—that data and devices will continue to become smarter—then you must believe data stored locally on your product, at your fingertips, will continue to drive business innovation beyond mere compliance mandates.
By bringing intelligence to your products and assets, you provide a platform to leverage localized data across all current and future infrastructure, business units, and among stakeholders. Once you have realized the IoT through a smart factory, a smart supply chain, a smart you-name-it, you will also realize the data at your fingertips is changing the way the world does business.
This article was written by Timothy Butler, Founder and CEO, Tego, Inc. Waltham, MA. For more information, visit http://hotims.com/61063-160 .