LTR Monthly Webinar: June 2024
“It is all about understanding and breaking things down to their simplest form.”
The practice of risk management is hard, especially for in-vitro diagnostic devices (IVD) because we don’t often have a full understanding of the clinical impact of inaccurate results.
In this Let’s Talk Risk! podcast, Dr. Emanuel Tkach helps us understand the clinical impact of false positives, false negatives and delayed results in the context of a recent warning letter. In this case, FDA noted that the IVD manufacturers had underestimated the severity of the consequences of inaccurate and/or delayed results for 3 different assays.
In each of these 3 issues, we discuss the clinical impact and relative assessment of risk. A key message is that each assay is unique and requires a different balance of sensitivity, specificity and timeliness requirements.
We also discuss career transition tips for medical professionals who might be considering a move to the medical device industry.
Watch the full episode (approximately 60 minutes) or jump to the topic of interest using the timestamps below:
Chapters
0:00:32 Introduction
0:05:45 Setting the stage for our warning letter analysis
0:07:27 Clinical impact of Issue #1: Hepatitis B infection
0:08:55 Understanding risk of false positive in Hepatitis B detection
0:10:36 Understanding risk of false negative in Hepatitis B detection
0:12:00 Understanding risk of delayed result in Hepatitis B detection
0:14:30 Relative assessment of risks in Hepatitis B detection
0:15:53 Clinical impact of Issue #2: Troponin I detection
0:19:40 Understanding risk of false positive in Troponin I detection
0:21:18 Understanding risk of false negative in Troponin I detection
0:23:57 Relative assessment of risks in Troponin I detection
0:24:31 Clinical impact of Issue #3: Therapeutic drug monitoring (TDM)
0:27:51 Understanding risk of false positive in TDM detection
0:28:55 Understanding risk of false negative in TDM detection
0:30:30 Understanding risk of delayed result in TDM detection
0:33:54 Tips of including early clinical input in IVD design & development
0:36:30 Using the pre-sub process to get early feedback from FDA
0:44:18 Career trajectory, lessons learned for career success
0:53:59 Closing comments
Suggested links:
FDA warning letter - Beckman Coulter Inc. (Issued March 15, 2024)
About Emanuel Tkach
Dr. Emanuel Tkach is currently the Medical Advisor at HeartPoint Global, where he leads the global clinical strategy and operations of clinical trials. He also provides advice on breakthrough device designation submissions, recruiting and strategizing with key opinion leaders (KOL) to accelerate medical device innovation. His medical specialty and clinical experience includes Gastroenterology, Cardiology and Primary Care. He holds a BS degree in Biology/Biological Sciences and an MD in Medicine.
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.
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