The standard Standards?
The Bimek SLV had to overcome an array of hurdles throughout its development. Many of these were actually put in place by me and it resulted in a flawless product. It was, however, no easy feat.
Every year the approval of a patent application increases the costs for the product, leading to the possibility of a cost build up. In order to avoid this, I first studied medical specialist literature, searching for reasons why my invention would not be able to work.
I spent weeks in the library on the Benjamin Franklin Campus at Charitè, burying my nose deep in medical literature, the information of which, at that point, was all new to me. With time the initial doubts I had for my idea began to resolve themselves. I became more and more confident; it just had to work!
On to the research
So I began construction and produced the first prototype. In order to create a medical implant out of the micro-mechanical metal structure, the valve had to first be checked for any health hazards by a kind of MOT for medical products. The next step involved the preparation of a long list of supporting documents. Among other things, I had to list which medical standards are relevant for the Bimek SLV and should be complied with.
Standards for medical products? Up until that point I had never heard of such a thing. Where was I supposed to get these standards? My first impression occurred at bookstore with a never ending computer list, where I could purchase the desired standards… Purchase? No way. I received a useful tip to take a look at all the standards at Beuth Verlag Berlin at no charge. Making photocopies is of course forbidden, handwritten notes though… not really.
DIN, EN, ISO … or a combination thereof?
I spent 2 weeks in the public library of Beuth-Verlage (www.DIN.de) from morning to night, searching through and taking notes of about 500 medical standards relevant to the valve. In the process I learned the difference between a DIN-, EN- and an ISO standard and also that combinations like DIN EN, DIN EN ISO, EN ISO or DIN ISO standards are possible. In the beginning I suspected there would be a mountain of red-tape waiting behind these terms. However I was finally uncovered that standards involve tried and tested rules, which make sure that a product is safe and designed with the least possible risk for the user. Additionally I became familiar with which materials implants should be made of, how individual parts are cleaned, under which cleanroom conditions they are supposed to be assembled, how they should be packaged, sterilised, labelled and so on. In the end it saved so much development time, as I only needed to comply with the medical standards and didn’t have to create or think up every step for the first time.
From the standard to what’s normal
So I can safely say that the spermatic duct valve complies with all applicable standards for medical products. This I made sure of myself. The relevant inspection bodies will also confirm this. Since the tragic cases of defective breast implants these institutions have intensified the test criteria. Which is a good thing. It can only have a positive effect on the safety of the Bimek SLV.
Whether the valve will become ‘normal’ after its compliance with all medical standards, will be decided at the end of the clinical trials. Until then, it is definitely not something normal, but something totally new.
Kind regards
Clemens Bimek