Basics – IVDs in Medical Technology
What are IVDs?
In Vitro Diagnostic devices (IVDs) are a subgroup of medical devices.
In vitro means that diagnostics are performed based on organic processes outside the living organism.
Conversely, the term “in vivo” means that something takes place within the living organism.
By definition, IVDs are intended for the in vitro examination of samples derived from the human body. They provide information on the following:
- physiological or pathological processes or conditions,
- congenital (inborn) physical or mental impairments,
- the predisposition to a specific health condition or disease,
- determining the safety and compatibility with potential recipients,
- the predicted effect of a treatment or the predicted reactions to it, or
- determining or monitoring therapeutic measures.
By the way, sample containers are also considered in vitro diagnostic devices.
The most well-known example of an IVD is probably a pregnancy test from the pharmacy. However, there are also many other products that are less known but still important: Many IVDs consist of different reagents used in the lab, for example, to detect a specific pathogen. These reagents serve to detect the DNA or RNA of the pathogen. Many COVID-19 tests are based on this technology.
What Role Do IVDs Play in Medical Technology?
Analyzing samples from the human body is very commonly used in diagnostics to detect a wide variety of diseases. In this way, it is also possible to monitor a drug treatment or to determine in advance whether it may be suitable.
In prenatal diagnostics, samples can be analyzed from the embryo.
Example: In the context of in vitro fertilization, parts of an embryo can be removed in vitro using a weak laser (medical device, not an IVD) and analyzed using in vitro diagnostics. This allows various diseases or genetic defects to be detected. The separated cells do not harm the embryo, by the way. At this stage, the embryo is only a few days old, and the separated cells are replaced as it grows.
During the COVID-19 pandemic, the IVD industry came strongly into the focus of media and public attention. Suddenly, everyone realized what an important component IVDs are in medical technology and healthcare. What this period also showed is the great adaptability and speed of this industry. The first COVID-19 tests were available in the shortest possible time. This ability for rapid adaptation is an important characteristic in this field, because viruses and bacteria are constantly changing. An IVD manufacturer must be able to react quickly to this, so that mutated pathogens can also be reliably detected.
Why is this Field so Unknown?
As a patient, you generally have no contact with IVDs. You or a doctor takes a sample, which is then analyzed in the lab using an IVD. The patient only receives the result – but how it came about in the lab is usually unknown.
Additionally, IVDs are often somewhat more abstract, harder to imagine. Most people know what an X-ray machine looks like. You see at least parts of the device during use.
But reagents that facilitate various processes in conjunction with a blood sample, first to isolate DNA or RNA and then to detect it – that’s harder to imagine. And as I said, as a patient, you don’t notice any of this. The doctor just tells you the result.
Another reason for the relative obscurity of IVDs is that there are few incidents or scandals involving these products. IVDs generally have no direct patient contact and therefore pose a significantly lower risk of harm to patients than typical medical devices.
How Will the Industry Develop in the Future?
The industry is growing very rapidly and is gaining increasing importance in diagnostics. New technologies in genetic testing offer unprecedented opportunities. In particular, the shift from laboratory diagnostics to home-based patient diagnostics will enormously change our lives. There are already more and more IVDs for home use. Mostly, various vitamin levels and hormones are measured – that’s not yet a revolution.
But imagine the following scenario:
Telemedicine in Germany is gradually establishing itself. So you don’t have to visit the doctor in person for every minor issue. One day, you’ll have a small device at home into which you put a drop of blood, and it will then be analyzed. The result will be available to the doctor, who will advise you via video call. Does that sound like science fiction? But in vitro diagnostics, combined with telemedicine, will offer such possibilities in the future. This will drastically improve our lives and the opportunities for various preventive examinations.
Despite these possibilities, the industry also faces problems. You have certainly heard that the new EU regulation MDR is causing great chaos in medical technology. The effects of the IVDR are many times greater, and awareness of this impact is much lower compared to the MDR. You can find out why this is the case and what happens next in our next article on in vitro diagnostics.
