Remember the drama Kermit the Frog could invoke on a Sesame Street ‘News Flash’ segment? As a roving reporter, he always got the scoop—and gave his viewers the final word.
We wish we could offer Kermit’s kind of clarity when it comes to UDI compliance and the FDA’s UDI Final Rule effective dates. Alas, this developing news story is something all of us in the industry are trying to unpack as new compliance deadlines are likely to take effect between now and 2021. (Looking to get up to speed on the what, why and when of UDI compliance? Check out our first article on this topic.)
Product development is, of course, a forward-looking undertaking. And, as smart product development keeps UDI compliance in its sights, it also seeks to create the bridge between today and a more innovative tomorrow. At ImplantBase, we believe that innovation and digitization, hand in hand, will transform chain of custody for manufacturers, creating transformative accuracy, accountability, and efficiency, with benefits including:
- New operational efficiencies
- Mitigation of risk of non-compliance
- Drastically improved accuracy and accountability in inventory movement
Before we take a journey into the not-so-distant possible future to see how, though, let’s spend a moment in the present.
The chaos of the present
Today, mid-size and large orthopedic medical device manufacturers grapple with complex challenges in the chain of custody, all of which can stoke operational chaos. With patient safety and device efficacy as top priorities, compliance issues (and their consequences, such as Form 483 letters) and part recalls can send a manufacturer’s teams scrambling. And counterfeiting is big business, too, bringing genuine risk to both patient safety and manufacturers’ reputations. After all, while it’s difficult (and sobering) to imagine counterfeiting life-saving medical devices, it happens: Interpol seized more than $51 million in counterfeit medicine and medical devices as recently as September 2017.
The larger your company is, the more potential there exists for complexity: consider the challenges of chain of custody, compliance, recalls, and risk mitigation when you’re managing multiple brands, each with multiple product lines.
The promise of the future
System digitization, though, can offer transformative control, accountability, and accuracy when it comes to UDI compliance and chain of custody visibility.
Imagine direct-part-marking your device components with far greater ease and working within a system that handles:
- Automatic UDI generation, seamlessly creating, assigning, and tracking the correct UDI for each and every component of every product—at all times.
- Assignment of UDIs to sales orders, done automatically, without a human having to handle data entry.
- Passive tracking, as parts and devices move from one place to another in your supply chain.
- Greater simplicity in your audit trail, easily referenced for enhanced visibility into chain of custody.
In this transformed future, all the information you need on chain of custody is available to you, whenever you need it. If and when a recall happens, you can initiate immediate measures necessary for patient safety and communication. Enhanced visibility into your chain of custody can help mitigate the risk of being a victim of counterfeiting. Scanners can take the place of visual inspection. Greater efficiency—by way of reduced administrative burden and data input, at your facility and in the field—can help drive down costs and reduce the potential for human error.
And all of this can happen passively in the background while your team focuses on your organization’s core competencies of designing and developing products, marketing, and growing your customer base.
When it comes to UDI compliance and digitization, it’s this kind of future that excites us at ImplantBase. We’re committed to supporting the real current and future needs of the industry—and taking UDI compliance needs into account—so that we are fully prepared when all UDI Final Rule compliance deadlines take effect. And while we can’t have Kermit’s reporting confidence on telling you how and when exactly that will be, we can channel some of his verve when it comes to the promise of the future.
ImplantBase is a leader in digital transformation for the orthopedic implant industry. Its platform provides manufacturers of every size with a unique cloud-based solution that transforms how the business operates on every level and across your critical functions of finance, sales, and operations. Learn more at implantbase.com/solutions.