“There is a very strong push (in the EU) to look at threshold values and acceptance criteria in the clinical evaluation, and these acceptance criteria for benefit risk have to be based on the state of the art.”
State of the art (SoTA) is a very important topic in the medical device industry, because it is directly connected to risk acceptability and benefit-risk evaluation, which in turn, is directly tied to safety and effectiveness for regulatory purposes.
But what is SoTA and how do you define it for your medical device?
In this Let’s Talk Risk! conversation, Chris Whelan helps us understand the nuances of SoTA and encourages us to consider both the engineering and clinical aspects of SoTA for our devices. Also, remember that it is an iterative process and you may have to review SoTA throughout the development process and even after product launch in the post-market process.
Listen to this Let’s Talk Risk! conversation with Chris Whelan, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:02:00 Introduction
00:03:26 Definition of State of the art (SoTA)
00:04:57 Understanding SoTA in the context of intended use and standards
00:06:17 Two aspects of SoTA - engineering and clinical state of the art
00:06:53 How to define the SoTA for your product
00:10:20 When to start defining SoTA during product development
00:11:51 Does clinical SoTA depend on standard of care in different markets?
00:14:13 Audience Q&A and general discussion
00:31:25 Closing comments and key takeaways
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Suggested links:
LTR Podcast: Clinical evaluation is a lifecycle process, not a one-time activity
FDA Guidance: Appropriate use of voluntary consensus standards
ACHIEVE: Risk management fundamentals on-demand training which covers 25 key terms and basic concepts, including state of the art, for medical devices.
About Chris Whelan
Chris Whelan is currently the New Product Development Manager at ITL BioMedical where he leads multiple global engineering teams. He has nearly 20 years of industry experience in medical device design, engineering and project management, as well as teaching experience at a university. Other areas of expertise include design controls, usability engineering and risk management. He holds a B.S. in Industrial Design from the University of Technology, Sydney, Australia.
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
LTR 60: Defining state of the art can be challenging; here are a few tips.