The rising use of "smart assets" for medical devices makes the Internet of Things particularly valuable to the medical device industry.
The Internet of Things has received a lot of press, often for consumer use cases of questionable value, such as connected refrigerators, but don’t dismiss it. We’re now starting to see what Internet-enabled interconnectivity makes possible and how it delivers value—specifically in the medical device industry. Why? Because of two major factors: quality and compliance.
Pushing data to the edge
For med device makers, “smart assets”—materials and products that hold digital data about product safety and authenticity, chain of custody, tracking sterilization records, and other business data—are the key to realizing the value in the Internet of Things. The industry’s increased interest in smart assets has in part been driven by the necessity of FDA-mandated UDI compliance and the e-pedigree documentation required to identify and assure a product’s safety and efficient use.
Hospitals and health care providers, in part to help meet compliance with UDI standards, have pushed responsibility for product identification and safe use onto manufacturers. Manufacturers need to make information associated with their product visible and accessible, from initial creation through to clinical use. So, as customers push UDI compliance responsibility out to manufacturers, those manufacturers now need to push quality and safety data out to the edges—and onto the products they make and distribute.
Some manufacturers are currently doing this using RFID technology, but companies that are not looking at solutions beyond standard RFID are missing out on the full host of benefits provided through IoT-like connectivity. One of the biggest drawbacks is that standard RFID technology cannot survive sterilization: tags can only be placed on devices post-sterilization. This makes it impossible to track the full lifecycle data of each product from the time it is manufactured through to use.
The ability to put data on assets pre-sterilization, and have that data survive sterilization, enables a wealth of efficiency and visibility gains throughout the entire product lifecycle. Data collection and management from the point of manufacture lets users both read and write information over and over again, including updates for recalls and other events. Only sterilization-proof technology enables this, and it's functionality that the industry has sought for a decade. Asset intelligence that is sterilization-proof represents a big hurdle we have finally overcome.
Bringing intelligence to assets
Providing dynamic, updatable information that lives on a device or drug throughout its life cycle was unheard of even five years ago. With next-generation RF technology breakthroughs, it’s now a reality.
So what does a “smart” asset look like in the medical device and life sciences industry?
Smart assets have more than basic identification data on them. They have a “digital diary” that is stored right on the product. They store digital certifications validating quality during each stage of manufacturing, and they store digital certificates of authenticity for confirmation and identification and removal of counterfeits in the supply chain. Digital information on a smart asset is updated as the product moves through the supply chain.
Manufacturing information, product information, and distribution information is stored on the smart product wherever it goes. This means granular business intelligence is available at the point of use, with no dependency on a connection to a back end database. Having product lifecycle information at your fingertips increases efficiency, saves money, and mitigates risks. When needed, product recalls can be based on much more specific information. It also opens up a whole new world of analytics for companies, and can solve big data, operational, and supply chain problems across a range of functional areas.
Why, then, don’t we just store all product information in the cloud? Storing data on products means that data follows the product wherever it goes—and accessing distributed information is more efficient than accessing information that only lives in the cloud. Distributed digital data is safe and secure thanks to new technology, and it’s not dependent on an IP address or network connection.
It’s hard to think of a type of device that wouldn’t benefit from intelligence and IoT connectivity, but not every manufacturer is ready to make the case for this kind of implementation (and investment). A key question that manufacturers should ask before making the shift is, what business problem will the technology help solve? For example, are you most interested in meeting FDA mandates or are you also looking to reduce targeted costs or product safety risks?
Having a clear objective will make it easier to understand how the data you’re going to collect will benefit your business, and to quantify the value of doing so. Smart assets store, manage, and relay all kinds of data, from UDI and e-pedigree data to supply chain data and ordering behavior. A successful implementation of data-gathering technology has to be backed by a strong data analytics strategy: once you have more information, where does it go, and what can you do with it?
Like any technology, the new generation of IoT solutions must ultimately make your business function better—and you must be able to measure what “better” looks like. The industry is getting smarter, assets are gaining intelligence, and the IoT is going to enable it. The leaders in effectively deploying this technology will plan ahead. If you believe things will get smarter in the next 5 to 10 years, making assets smarter now will be smart planning for your business.
|Check out the future of medical technology at the world's largest medical design and manufacturing event—register for the MD&M West Conference, February 9-11, 2016.|
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