How Cadwell Implemented a UDI Strategy Customized for a Diagnostic Technology ManufacturerHow a neurotechnology manufacturer leverages Reed Tech SingleSource™️ for Medical Devices
Cadwell is a global medical device company founded after their creation of the world’s first microprocessor EMG. In 2019, they celebrated 40 years of delivering innovative neurodiagnostic, neuromonitoring, and sleep diagnostic solutions to the world.
Cadwell sought an experienced vendor to help them create and implement a strategic approach to Unique Device Identification (UDI) data submissions to US FDA and later to other Global Health and Regulatory Authorities.
Cadwell needed to streamline its complex medical device data submission requirement process due to the number of Health and Regulatory Authorities, regions, and divisions involved. In addition, they wanted to gain control over their data which was in disparate sources and spreadsheets.
Compounding complexity made their processes arduous, time-consuming, difficult to track and not to mention prone to errors. Moreover, it was difficult to understand the performance of the data submission process and even more difficult to use that data to make informed decisions.
- Becky Corral is the Director of Quality Assurance and Regulatory Affairs at Cadwell. She joined Cadwell in 2014 and is a degreed electrical engineer with over 15 years of regulatory experience. At the time, Cadwell was a small business, with just over one hundred employees worldwide.
- When the US FDA UDI announcement came in for UDI implementation, it was left to Becky to understand what was required and lead the implementation.
- After reviewing the requirements, Becky knew that she would have to work with the engineering team to see them implemented on ~300 SKUS. Wanting to limit the extra workload for this team, Becky quickly concluded that the ~300 SKUS would be too much for their limited resources and that they would need to find a third party to assist with the collection of data and transmission of this data to the US FDA GUDID. Becky’s research of available options brought her to Reed Tech.
When looking for a solution to streamline their global data submission requirement, Cadwell had six key objectives which were: track the status of all global data submission requirements, automate their registration process and provide real-time visibility to key stakeholders. Additionally, they wanted to improve accuracy and reduce manual errors. The ability to generate reports efficiently and alert users of any changes in data automatically was also key.
Why Reed Tech?
- Ease of use – Machine-to-machine submissions of UDI product data
- Constant support and “friendly, easy communication”
- Customer Webinars
- Q&A Sessions
Summary of Challenges
- Small team, limited bandwidth
- New team, new members learning about UDI for medical devices
- Changes, extensions, and proposals make it difficult to stay up to date with EU and other global regulations
- Discrepancies between FDA and other Health and Regulatory Authority data attribute requirements
Summary of Results
- All FDA GUDID submissions are up to date.
- No extra lift was required by the engineering team.
- Cadwell has constant contact and a great relationship with the Reed Tech team.
- Becky can educate her team using Reed Tech Life Sciences resources. With this added support, she feels her team receives ongoing info. One person is no longer solely responsible for UDI monitoring.
The Reed Tech Life Sciences team, including Account Executive, Patti Shragher, was able to streamline and complete FDA GUDID submissions for Cadwell. Becky attributes this success to the productive relationship she maintained with the Reed Tech team, and the ease of use in understanding and utilizing the product data spreadsheet. The Cadwell team relies on Reed Tech to provide ongoing education and real-time updates on developing Global Health and Regulatory Authorities requirements. Becky plans to continue to work with Reed Tech as timelines for EUDAMED and other governing bodies solidify.
Cadwell is currently up to date with its US FDA GUDID submissions. Becky now has a team of three responsible for UDI compliance. She relies on Reed Tech for ongoing education and training for her team. She is in constant contact with the experts at Reed Tech, who are available for any UDI-related questions. As timelines unfold across Global Health and Regulatory Authorities, Becky continues to work with Reed Tech to navigate the complicated aspects of global UDI regulatory compliance.
“I appreciate the Reed Tech seminars that inform us about what is top of mind with UDI deadlines. Your company is doing what is appropriate to gather the information we need, keeping us ‘in the know’ so we don’t have to stress about that part of the submission.”
The opinions expressed within this case study represent customer opinions. Reed Tech believes this case study experience generally represents the experience found with other similar customer situations. However, each customer will have its own subjective goals and requirements and will subscribe to different combinations of Reed Tech services to suit those specific goals and requirements. This document is for educational purposes only and does not guarantee the functionality or features of LexisNexis Reed Tech products identified. LexisNexis does not warrant this document is complete or error-free. This case study may not be deemed to create any warranty or representation that other customer’s experience will be the same as identified herein.
About LexisNexis Reed Tech
LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.
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