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Episode 198  |  34:09 min

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

Episode 198  |  34:09 min  |  04.21.2021

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

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This is a podcast episode titled, Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices. The summary for this episode is: <p><span style="background-color: transparent; color: rgb(0, 0, 0);">What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a medical device?&nbsp;&nbsp;</span></p><p><span style="background-color: transparent; color: rgb(0, 0, 0);">In this episode of the Global Medical Device Podcast, Jon Speer talks to Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS).</span></p><p><span style="background-color: transparent; color: rgb(0, 0, 0);">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.</span></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Some highlights of this episode include:</strong></h3><ul><li><span style="background-color: transparent;">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.</span></li><li><span style="background-color: transparent;">From a patient perspective, the IVD is not invasive. A sample of something, such as saliva, urine, or blood from the patient is taken.&nbsp;</span></li><li><span style="background-color: transparent;">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.&nbsp;</span></li><li><span style="background-color: transparent;">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.</span></li><li><span style="background-color: transparent;">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.&nbsp;</span></li><li><span style="background-color: transparent;">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?</span></li><li><span style="background-color: transparent;">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.</span></li><li><span style="background-color: transparent;">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.</span></li></ul><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Memorable quotes from this episode:</strong></h3><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“That’s the key difference. There’s no patient. There is a sample.”</em><span style="background-color: transparent; color: rgb(0, 0, 0);"> Milton Yarberry</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“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.”</em><span style="background-color: transparent; color: rgb(0, 0, 0);"> Milton Yarberry</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“You can tell if you hit the right spot if the person wants to punch you.”</em><span style="background-color: transparent; color: rgb(0, 0, 0);"> Milton Yarberry</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“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.” </em><span style="background-color: transparent; color: rgb(0, 0, 0);">Jon Speer</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“It’s a mindset of the manufacturer that I think is the main difference.”</em><span style="background-color: transparent; color: rgb(0, 0, 0);"> Milton Yarberry</span></p><p><br></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Links:</strong></h3><p><a href="https://www.ics.com/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Integrated Computer Solutions (ICS)</a></p><p><a href="https://app.casted.us/partner-ics" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">ICS &amp; Greenlight Guru Partnership</a></p><p><a href="https://www.cdc.gov/labquality/waived-tests.html" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Centers for Disease Control and Prevention (CDC) - Waived Tests</a></p><p><a href="https://www.cms.gov/clia/oigclia.asp" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Clinical Laboratory Improvement Amendments (CLIA)</a></p><p><a href="https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-waiver-application" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - CLIA Waiver by Application</a></p><p><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">510(k) Premarket Notification&nbsp;</a></p><p><a href="https://www.iso.org/standard/63179.html" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">IEC Standard 62366</a></p><p><a href="https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">21 CFR Part 820</a></p><p><a href="https://www.iso.org/iso-13485-medical-devices.html" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">ISO 13485</a></p><p><a href="https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Laboratory Developed Tests (LDT)</a></p><p><a href="https://ec.europa.eu/growth/content/medical-devices-regulationin-vitro-diagnostics-regulation-mdrivdr-roadmap_en" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">EU MDR and IVDR</a></p><p><a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Emergency Use Authorization (EUA)</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru Academy</a></p><p><a href="https://virtual-summit.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">The Greenlight Guru True Quality Virtual Summit</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru</a></p>

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.

Some highlights of this episode include:

  • 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.

Memorable quotes from this episode:

“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


Links:

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

Greenlight Guru

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