Understanding GUDID

by | Mar 19, 2019 | Medical Device, Speaker Interview

Dawn Fowler
Director, UDI/Master Data Management
Masimo

Can you give a brief overview of your role at Masimo?

I’m currently responsible for the Global UDI & Master Product Data initiatives here at Masimo. This is a rapidly growing area within the medical device arena and presents its’ own unique challenges. For example, one specific change was the Global Unique Device Identification Database (GUDID), which is “a database administered by the FDA that will serve as a reference catalog for every device with an identifier.” During FDA GUDID implementation, Masimo recognized the strategic importance of developing an in-house program to manage our data. And, as more and more countries, regions and trading partners are requesting more and more data, this was the right move for us.

Please share a brief overview of your presentation, “Practical Analysis: MDM Structure & Continuous System Management.”

After the initial panic at meeting GUDID deadlines, we have been able to take a step back and review and analyze the programs we implemented. We have evaluated how they performed and found there were many lessons learned in both implementation and the vision of building a long-term, sustainable system/process. I’m looking to share our results for others to learn from and hopefully avoid the mistakes we made AND to leverage the areas where we have been successful. 

This will provide a framework for others to build productive long-term Master Product Data programs.

 

Can you describe your experience towards CMS or ELS establishment? Any insight for beginners in this process?

Neither of these systems are widely used for MDM; however, there are some excellent systems in the industry that can be used for management or transacting data. For Masimo, we are a heavily vertically integrated company, so we preferred building an internal system within our Agile PLM environment to maintain complete control of our data.

 

Can you explain the Single Source of Truth?

Single source of truth is the concept that vetted and validated data is stored once in a system of record which is updated and synchronized to ensure that everyone uses the single point of data-based truth throughout an organization. Single source of truth (SSOT) is a key component of a successful Master Product Data program.

 

What are 1-3 things you hope attendees will take away from your presentation?

  1. A clear understanding of options for the establishment of a successful program for managing Master Product Data
  2. The techniques and tools to manage constant expansion and diverse, evolving requirements from the global landscape
  3. All about maintenance – the requirements for reviewing and updating data per requirements and as it changes

Learn more about the upcoming Q1 9th Annual Medical Device & Diagnostic Labeling Conference on April 29-30 in Chicago. Reserve your spot today!

 

Gianna Canning is the Content Marketing Specialist at Q1 Productions, where she is responsible for developing, writing and disseminating emails, blogs and other marketing materials within the Life Sciences industry, with a specific focus on medical devices.

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