alaric378Contacts in the network : Myspace (no) , Facebook (no) |
What is Biocompatibility and Why Should We Care? (2015-06-11)
Biocompatibility is a comparatively new topic and much of the debate has grown with advances in the medical profession.
It is fair to say that most people do not have adequate knowledge of biocompatibility, what it means and, perhaps more importantly, why people should care enough to educate themselves about it.
To break down the word, biocompatibility means being compatible with our biological environment. In the medical sense, it means whether what doctors and surgeons prescribe for us will be accepted by our body.
The issue has gained more momentum because it has advanced from the medicine we use to the equipment that is literally inserted into our body. Examples vary but take prostheses or pacemakers as example.
Part of the reason medical device biocompatibility testing and medical device biocompatibility requirement have become even more complicated is that the medical devices themselves have multiple components. Each part might pose different biocompatibility issues.
In the United States, the Food and Drug Administration (FDA) is in charge of approving such devices which have to go through the FDA 510 biocompatibility testing for pre-market notification, approval, and examination.
But the FDA is just the approving authority. It relies on the International Organization for Standardization (ISO) to set the biocompatibility testing matrix.
Manufacturing approved biocompatible products is big business in the United States, but also in other countries around the world. According to industry experts, the U.S. demand for such products is expected to grow by an average of 5.4 percent annually until 2018, to about $5 billion.
That level of huge business potential has pushed many companies to the sector. Biocompatibility testing in California has sharply increased in a state which has traditionally been known for innovation and home to many successful Internet startups.
Become a fan