How to Gain Regulatory UDI Submission Efficiencies with Reed Tech SingleSource™ for Medical DevicesHow a major global provider of life-saving devices spanning the continuum of care leverages Reed Tech expertise and UDI know-how.
Our customer is a global respiratory solutions provider, dedicated to supporting and improving the lives of patients. With several acquisitions over the past decade, they have grown to approach the size of a billion-dollar company with tens of thousands of SKUs sold in more than 100 countries. They are focused on innovation to advance the care of the patients served by their customers. Known as industry leaders, their history spans several brands who have, over time, merged and advanced the innovation of respiratory solutions.
They are a global workforce operating facilities around the world to manufacture and market thousands of unique products for the diagnosis, treatment and monitoring of respiratory conditions in every stage of life.
This customer is committed to driving innovation through technology and raising the bar on aligning clinical goals in critical care with the efficiencies sought after by medical institutions. Managing related regulatory product data has become a core component in this quest.
Challenges and Objectives
After moving from a large corporate regulatory department with an internally built SPL solution for data staging, the customer found that in most respects, they needed to rebuild product data sets and processes. They sought an experienced UDI vendor who would take them to a future state of automation. Regulatory submissions of Unique Device Identification data (UDI) are an ongoing process for a growing product line. When the UDI submission mandates for Class III Devices (implantable, life-supporting, life-sustaining) came about in 2015 and 2016 the Class II mandate for FDA GUDID, the regulatory department was challenged to meet critical mandate deadlines. Without the automation and resources of a large corporate infrastructure, they submitted UDI data to FDA GUDID in 2016 via manual entry for several hundred products for Class II. The customer found that gaps existed and manual processes were slow and prone to error.
Collecting data is a big task, figuring out what is missing and preparing for future product changes. Their RIMS (Regulatory Information Management System) database required a rebuild in some data sets to create current versioning. They found that missing data may be in a paper file in a filing cabinet, residing with a subject-matter expert or another system. Keeping data sets up to date and staging spreadsheets for submission upload became an ongoing endeavor. Pursuit of a single platform for versioning and machine-to-machine uploads for UDI submission led them to source several vendors specializing in this area.
“With spreadsheet validation rules and the opportunity to make error corrections by receiving automated messages, the UDI submission process is more efficient. The template simplifies and standardizes our process. It’s been five years now and our internal processes have been significantly smoothed out.”– QA Director Regulatory Operations
With about 3,000 skus in the US product portfolio, they needed to scale up regulatory health authority UDI submissions on ideally a single, cloud-based platform. Centralization of UDI data for one source of truth would be the cornerstone for improving efficiencies, saving resource time and assigning appropriate roles and responsibilities within their regulatory team. Eventually, participation in a global data pool (GDSN) would ensure accurate sharing of current data with customers and others for use in digital catalogs and informational interfaces.
Anticipating portfolio and customer markets expansion, our customer knew the ability to export data to e-commerce portals and customers would become a routine part of business. With experience in collecting and cleansing Unique Device Identification (UDI) data, the customer wanted to establish a shared team view into product data for both corporate team members and affiliates in other global locations. They have found that expansion beyond US FDA GUDID reveals many health authority nuances region by region. EU EUDAMED, China NMPA and others are all on the roadmap. Keeping up with all the variations in rules and interpretations presents an ongoing challenge.
“Using SingleSource is really easy. Once the spreadsheet is validated, submitting the data can be done with a click. I appreciate that we can get alerts for error corrections and learn from those messages to avoid the same mistake twice. Gathering data takes time and planning. Gaps need to be remedied and mistakes will occur. Once the spreadsheet validates the data, it is easy for us to make corrections and successfully upload a UDI file.”— Senior Specialist Regulatory Operations
UDI Solution Now and Future
With an eye to future UDI needs, solving for standardization and quickly identifying errors via template validation checks, SingleSource™ for Medical Devices stood out against competitors. Experienced guidance with a UDI-focused solution makes a difference. The customer found that Reed Tech is actively engaged with customer needs, planning for future health authority mandates for UDI support and linking product data to GDSN by collaboration with 1WorldSync™. Onboarding meetings with an Account Manager guided staff step-by-step through the process. Questions are quickly answered and attentive help is readily available, including exclusive update webinars on the latest published information on global health authorities.
Our customer is actively preparing for MDR/IVDR and looking forward to submitting to EUDAMED as soon as it becomes available for voluntary submissions. The plan is to submit as soon as possible and not wait for the actual compliance deadline. Learning from the lessons of corporate acquisition, preparing ‘now’ for multiple contingencies that could occur is the best path forward. Mandate deadlines are like looking in the rear-view mirror, they are always ‘closer’ than they appear. The next few years are dotted with various UDI submission checkpoints that must be closely monitored.
On the road ahead, they are learning the requirements specifically for the UK (post-Brexit), EUDAMED, China NMPA and ultimately activating Global Data Synchronization Network (GDSN) for sharing information with downstream customers and hospital networks. The customer is currently assigning UDI number schemas per GS1, as required by their internal documentation. For EUDAMED, they plan to work ahead of the mandate as the modules for UDI become available and are actively assigning BUDI-DI numbers.
“We appreciate the help and guidance and Reed Tech webinars are extremely helpful. These unique customer courtesy events are a huge benefit to our team. We appreciate knowing what’s coming, updates to regulatory information and how to plan for deadlines.”— Senior Specialist Regulatory Operations
This customer successfully transformed their regulatory process approach to UDI from the ground up, rebuilding datasets and engaging with an experienced UDI submission provider. The journey was just beginning with FDA GUDID and continues into new global regions with sometimes similar, often nuanced requirements and rules to master. Data collection of sometimes highly complex information is no easy task. Maintaining a ‘single source of truth’ to share internally and externally with customers is a critical step. Leveraging innovation and know-how with trusted collaboration translates into better outcomes both for corporate customers and the patients who depend upon the life-saving services and devices provided.