Risk management of IVDs requires a different approach

Unlike a typical medical device, most in-vitro diagnostics (IVD) “do not touch” a patient. IVD-related risks to patient safety are considered to be indirect risks, because the information generated by an IVD is an intermediate step in the sequence of events. In the IVD world, a trained technician will generally run the assay and provide the information to a clinician. In case of an over the counter (OTC) test, such as a rapid COVID-19 test, the end-user directly receives the test results.

How this information is used to make clinical decisions is generally not in direct control of the IVD manufacturer. The focus of IVD risk management is on minimizing false positive, false negative and invalid results by establishing appropriate performance requirements during design and development phase.

In this episode, we discuss practical challenges practitioners face in designing safe and effective IVDs, and share best practices for IVD risk management.

About Shree Koushik

Shree Koushik has over 25 years of research experience in biochemistry and molecular biology. As a consultant in the medical device industry over the last 10 years, he has successfully helped multiple clients receive FDA approvals for medical devices, combination products, software and IVDs in the microbiology, immunology, personalized medicine, cardiovascular, general surgery and dental specialties. He has also conducted numerous Quality Systems audits, developed Quality Management Systems and represented companies in their response to FDA inspections. Currently, he serves as the managing partner of BRDA consulting offering customer-centric solutions in regulatory affairs, quality assurance and business development.

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.