My first blog provided the necessary insight into in vitro diagnostics and their distinguishing characteristic of never directly coming in contact with the human body. So how do they work? What differentiates them from other medical devices you hear about? The answer is that vast majority of in vitro diagnostics (IVDs) rely on biological properties and materials in order to perform as intended.
The world of IVDs is full of biological jargon as: “immunological reactions, bio-luminescence, mono or polyclonal antibodies, antigens, binding sites, immuno-capture etc.” while the world of medical devices is more “dimensions, materials, tolerances, biocompatibility of materials, sterility etc.”
Once properly set a manufacturing line of syringes can churn out millions of units and the same is valid for many other medical devices. However, IVD productions are much more limited in volume due to the fact that the biological elements involved cannot be reproduced indefinitely like plastic molds or surgical blades. Therefore, biological elements drives the IVD industry to produce relatively small batches (or lots) of IVD components making it an exceptionally difficult task to acquire pre-market approval on every batch by a third party. This is especially burdensome for SMEs (small and medium size manufacturers), which account for over 95% of IVD manufacturers.
This very “biological” nature of IVDs also allows for the capability to evolve very rapidly. It enables them to cope with biological / clinical evolution of new markers, new viruses, new bacteria, new biological material especially when faced with outbreaks that concern us all.
However it doesn’t end there. These biological materials are a crucial component for delivering personalized medicine to us all. This is done by companion diagnostic tests that can identify whether we, as patients, will benefit from receiving a specific treatment before the treatment is prescribed depending on the biological composition of our blood or on our genetic characteristics. If it weren’t for IVDs called companion diagnostic tests, personalized treatment to the specific needs and nature of a given segment of patients will not be possible.
The world of truly personalized medicine is just starting to bloom and IVD industry hopes to deliver on this promise to remain its enablers.
As a professional it seems clear to me that today innovation is more and more in the hands of those countless small and medium IVD manufacturers. They are truly the technological incubators where new and clinically-relevant technologies are being developed. The biological materials that distinguish in vitro diagnostics is an important attribute that needs consideration when drafting and discussing the future EU regulatory framework for the IVD products.
As a patient and a father I hope that the future EU market (and thus its regulatory framework) will continue to be a favorable to IVD SMEs on whom, in my personal opinion, much of our future health will depend.
– Maurizio Suppo, EU IVD Representative, Assobiomedica