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But that must change if medical device or combination product manufacturers and their component suppliers are to stay the right side of the authorities. Continuing to track products using spreadsheets is unsustainable, and is preventing a clear line of sight across component sourcing, and device production and distribution. This is both risky to patient safety, and inefficient operationally.
Pharma companies with a medical device portfolio may have focused so heavily on drug-related regulatory information management that they’ve neglected to apply equivalent systematic rigor to handling medical device product data. As new waves of international Unique Device Identification (UDI) mandates hit, and as the respective authorities look to extend the scope to component manufacture, it’s time to rebalance attention and budgets.
UDI: A Global Initiative
Around the world, starting with the most safety-sensitive medical devices, regulators are gradually phasing in a Unique Device Identification (UDI) system. This is designed to provide single, globally harmonized positive identification of medical devices across their distribution and use. The goal is to ensure that any piece of medical ‘equipment’ – whether an implant, wearable device, syringe, or MRI scanner – can be traced back to its source for safety and accountability reasons. Worldwide, requirements across more device Class types are becoming mandatory and manufacturers without UDI risk being refused market access, and may be subject to legal and financial penalties.
UDI Compliance: Traceability is empowering
From the side of the public, a major benefit of UDI is its ability to enable a swift response to quality issues for efficient, targeted, and timely product recalls. From the manufacturer side, systematic device identification and information tracking paves the way for improved inventory management and supply chain efficiency, helping healthcare providers and manufacturers track the movement of devices, minimize errors in distribution, and optimize inventory levels.
The great thing about UDI is that it promotes the standardization of data related to medical devices, making it easier to integrate and exchange information across different healthcare systems and databases. The US FDA categorizes these slightly differently than the EU, and several other regions or countries each have their own guidelines. (Click here for overriding international guidance.) But once manufacturers across the world are all using an agreed system for identifying devices, and indeed for recording and reporting adverse events, it will become easier for healthcare systems to communicate and share associated information across borders.
Technology & Data Decisions
Technologically, there are a number of considerations as Life Sciences companies look to bring their medical device identification and end-to-end regulatory information management (RIM) up to scratch. Generally, this starts with the selection of a suitable RIM platform or system; then it’s about creating the right data fields, and flowing in reliable and robust device information in a compliant, standardized, and readily-exchangeable format.
Strategic decisions include whether to choose a single-vendor software platform. This may make it easier to integrate with manufacturing/SAP systems to ensure data consistency and accuracy, as well as process efficiency, across and between functions as part of companies’ broader digital transformation initiatives. Another option is whether to settle on a best-of-breed RIM solution, which stays within its lane and does pure regulatory information management very well.
Work will be needed to assess where relevant data already exists in spreadsheets and other information silos, the state and format of that data and to prepare it for migration into the new target system. To complete the end-to-end system, manufacturing and shipping processes will need to be adapted to ensure that devices are identified and tracked consistently and systematically across the entire product lifecycle, from component manufacture (e.g. all the parts that go into a pacemaker) to post-market surveillance.
In some cases, manufacturers may decide to cease production of one device, replacing it with another so they can start with a clean sheet. But even then there will be base data from the older-generation device that will need to be migrated into the new system to save completely reinventing the wheel.
fme is your Best Partner for UDI Compliance Initiatives
As Life Science and content lifecycle experts, we can help with all of the above. Our business consultants and technical teams are deeply experienced in Life Sciences data-based system projects and end-to-end services; most of our core data team having been RIM system developers for many years.
Crucially, in addition to this vital industry inside knowledge, we are vendor independent. We provide holistic solutions that focus on your unique needs, ensuring you maximize the ROI of your technology budget. We can perform gap assessments, provide regulatory timeline updates, and advise on the optimal roadmap based on the size and complexity of your current medical device portfolio and the structure of your current associated data. fme’s experienced team guides you from beginning to end with comprehensive data migration planning, expedited execution with our proprietary tools and methodologies, plus validation and ongoing support.
To discuss a particular requirement with our business or technical consultants, or discover more about our full range of services, contact us. We’d love to learn your challenges and provide an independent perspective designed to maximize your business success.