“The first thing I do whenever I am starting design control or risk is that I make sure that the intended use and the indication of the device are as nailed down as they can be.”
Yes, design control and risk management can be challenging, especially in a startup or a small medical device company. Generally, there is just one person, a “team of one”, responsible for setting up the entire quality system and the risk management process.
That is why Becki Hiebert advises practitioners to focus on the intended use first. Get to know what your device is supposed to do, where, on whom, and who interacts with it, to set the framework for your quality system. She recommends following the steps outlined in ISO 14971 for risk analysis, and involving your medical/clinical subject matter experts as early in the design process as possible.
Listen to this Let’s Talk Risk! conversation with Becki Hiebert, which also includes an open discussion with the audience. Jump to a section of interest using these timestamps.
00:02:20 Introduction
00:04:32 How to succeed as a “team of one” in a startup
00:06:24 Getting started with design controls and risk management in a startup
00:08:41 Best practices for following ISO 14971 steps in risk analysis
00:12:31 Connecting risk analysis to design controls
00:14:15 Lessons learned in managing cybersecurity risk
00:17:05 Overcoming challenges in risk management documentation
00:19:57 Audience Q&A and general discussion
00:30:19 Closing comments and key takeaways
If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.
About Becki Hiebert
Becki Hiebert is currently a consultant specializing in implementation and improvement of quality management systems in medical device industry in compliance with ISO 13485, 21 CFR 820 and MDSAP. In her 10+ years of professional experience across both pharmaceutical and medical device industries, she has developed a hands-on expertise in regulatory requirements for current good manufacturing practices. She has served in a variety of roles in quality planning, process improvement, internal audits, quality system training and supplier/purchasing programs.
About Let’s Talk Risk! with Dr. Naveen Agarwal
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 54: Start your risk analysis by first defining the intended use