It’s amazing how we humans function on so many different levels. No one really functions on the same point or just not in the same way as the other person, and that’s precisely where we can find our uniqueness. Our exclusive perception of the world and ourselves is personal to us. We can certainly make attempts at explaining that perception to the world, but in reality, it can never be fully disclosed. While some who are able to do it slightly better than their peers become artists, the rest just have to accept the fact that they are a result of several complex mechanisms working in sync, hence any words or visual representation cannot fully encapsulate their tailored school of thought.
As a result of this enormous limitation of ours, we sometimes encounter things that the creator might have intended to exhibit in a very different manner from what we interpret it to be. Therefore, more often than we realize, a gap remains between the intention and interpretation of something and this gap has only ballooned up further following the introduction of technology. Even though it has provided solutions for so many of our problems, technology’s identity of being a complex structure in itself is still very much in place. A prominent consequence of it has been many technologies failing to deliver the kind of services they were designed for. It doesn’t stop here. Many times we see technology getting misunderstood to a point where it’s not even ‘allowed’ to function in its natural vicinity. That’s what happened with TransMedics’ OCS Liver system.
Food and Drug Administration of US had indicated in their analysis of pre-market approval application submitted by the company that there are noticeable safety concerns around the device. However, Gastroenterology and Urology Devices Panel voted unanimously in support of this new technological product. FDA had raised questions regarding the adequacy of the data in livers donated after circulatory death, but the panel was convinced by company’s evidence, and termed the data valid. The decision led to a 10% increase of company’s stock price.
Despite the fact that the company now expects to obtain full approval from FDA over the course of next 3-4 months, analysts predict that the administration will see panel’s decision as subjective to post-approval study and further data accumulation from the ongoing clinical trials of the device.