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The Evidence Base Video

Video: The use of RWD and RWE in medical device evaluation with Ariann Stone & Myla Maloney, Premier Applied Sciences

  • The Evidence Base

Real-world evidence (RWE) is playing an increasingly important role in how medical devices are developed, evaluated, and monitored across their lifecycle. As regulators look to more flexible and data-driven approaches for assessing device safety and performance, real-world data (RWD) is becoming an important complement to traditional clinical investigations. Recent developments, including updated regulatory guidance, greater acceptance of de-identified data, and growing public–private collaborations, are further shaping how RWE is being used in regulatory decision-making.

In this interview, Ariann Stone, Vice President, Business Development and Strategic Relationships, and Myla Maloney, Chief Growth Officer, of Premier Applied Sciences share their perspectives on how large, fit-for-purpose healthcare datasets can support regulatory needs for medical devices, the role of partnerships such as National Evaluation System for health Technology (NEST), established by the Medical Device Innovation Consortium (MDIC), and what is needed to enable broader and more consistent adoption of RWE.

Questions

  • 00:00: Introduction
  • 00:58: To start, could you introduce yourself and your roles at Premier, and briefly describe how the work of Premier Applied Sciences relates to RWD and RWE generation for medical devices?
  • 02:47: From your perspectives, what are the key advantages of using RWE for medical devices across the product lifecycle, including both pre- and post-market settings?
  • 04:31: How can data from sources such as the Premier Healthcare Database be used to support regulatory needs and submissions for medical devices, both before and after market entry?
  • 09:06: Premier has been involved in collaborations with industry organizations to advance the use of real-world evidence for medical device evaluation. Can you talk us through these partnerships and how they help?
  • 10:27: Are you able to share an example where real-world data has supported regulatory decision-making for a medical device? What insights did the data enable, and what made that approach effective?
  • 12:50: What are some examples of industry advancements supporting the use of RWD and RWE in regulatory submissions?
  • 14:28: Finally, looking ahead, how do you see the role of RWD and RWE in medical device regulation evolving over the next few years, and what is most needed to support broader adoption?

Published as part of the Evidence Insights, "Real-world evidence in medical device regulation: From data to decision-ready evidence", sponsored by Premier Inc.

Speakers

Ariann Stone
Vice President, Business Development and Strategic Relationships, Premier Applied Sciences

Ariann Stone is the Vice President of Business Development and Strategic Relationships for Premier Applied Sciences, the research and analytics division of Premier. She is responsible for innovation, strategy, and business partnerships. Stone joined Premier in 2015, serving as a member of the Performance Services sales leadership team, with responsibilities in channel partner business development and engagement, and government sales. Her professional experience spans 18 years working in health information technology and strategic partnerships.

Myla Maloney
Chief Growth Officer, Premier Applied Sciences

Myla Maloney is the Chief Growth Officer for Premier Applied Sciences, the research and analytics division of Premier. With 25 years of experience in the healthcare industry, Maloney supports Premier’s mission of transforming healthcare by leading population health improvement collaboration between Premier Applied Sciences and life sciences organizations. Maloney has been with Premier for the last eight years and previously served as Premier’s Chief Commercial Officer, PAS and Vice President of Strategic Supplier Engagement, where she partnered with leading biopharmaceutical and IT companies. Myla received her BS in business administration and MBA from East Carolina University.

The opinions expressed in this feature are those of the author and do not necessarily reflect the views of The Evidence Base® or Becaris Publishing Ltd.

Published as part of the Evidence Insights, "Real-world evidence in medical device regulation: From data to decision-ready evidence", sponsored by Premier Applied Sciences.