What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device?  

In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS).

Jon and Milton discuss practical pointers for determining and describing the similarities and differences between the two types of devices. Milton also offers some helpful recommendations for IVD manufacturers to consider when it comes to regulatory compliance and their quality system.

• An IVD consists of the agents, instruments, and systems used for the diagnosis of disease or other health conditions, such as HIV, hepatitis, diabetes, and flu.
• From a patient perspective, the IVD is not invasive. A sample of something, such as saliva, urine, or blood from the patient is taken. 
• Then, the sample is prepared and put through an IVD for analysis to determine the results of a specific test. An IVD is the equipment that analyzes the patient’s sample, not the actual patient. 
• The IVD focuses on the fidelity and accuracy of the tested sample. There’s risk for the patient. Who’s performing the test (lab or licensed clinician), what’s being tested for (non-life threatening disease or not), and if results are inaccurate.
• Information has to be crystal clear because the user population could be a child, elderly person, or otherwise who takes the wrong action or misinterprets actions that could lead to death. 
• If you have been tested for the coronavirus (COVID), how was the sample collected? How long was the swab that went up your nose? How long was it in?
• An IVD is a medical device and is subject to the same pre- and post-market controls. It needs a quality system and similar risk-based classification.
• Treat people and their data in your clinical study well. A lab developed test (LDT) and investigative device should not be perceived as a regulatory path.

“That’s the key difference. There’s no patient. There is a sample.” Milton Yarberry

“It clearly gives you a target population, a way they’re going to use it, a way they can misinterpret it, and all of those should become mitigations in your design.” Milton Yarberry

“You can tell if you hit the right spot if the person wants to punch you.” Milton Yarberry

“It’s hard to translate some of that science, that research, that clinical, that laboratory side of things into something that’s commercialized and into something that’s regulated.” Jon Speer

“It’s a mindset of the manufacturer that I think is the main difference.” Milton Yarberry

Integrated Computer Solutions (ICS)

ICS & Greenlight Guru Partnership

Centers for Disease Control and Prevention (CDC) - Waived Tests

Clinical Laboratory Improvement Amendments (CLIA)

FDA - CLIA Waiver by Application

510(k) Premarket Notification 

IEC Standard 62366

21 CFR Part 820

ISO 13485

Laboratory Developed Tests (LDT)

EU MDR and IVDR

Emergency Use Authorization (EUA)

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

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