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Hello my fellow Materials Engineers,

I am interested to seek your opinion on advantages and perhaps disadvantages of regulation. I do not carry a long work experience (5 years) like some of you, but sometimes it does feel that regulation is preventing new ideas or innovation. I can only (and barely!) speak about my field, medical device, which is highly regulated and I find it very difficult if not impossible to be innovative as a metallurgist. is my perspective wrong? What do you think?

Best,

Habib

Jim:

Well said.

Dear Habib,

Fields like medical science and bio-medical engineering demand a lot of regulations and they are good for humanity. For companies investing in the research to develop new materials and solutions, they would like to keep the matter confidential so that they become successful in commercializing their research. Every field has its pros & cons. When you work in a regulated field, you may not be able to publish more, but may be you could patent. Maybe once you see your research work saving human lives, you could get more satisfied than just publishing papers. Self introspection can help decide what careers/sectors of industry one should choose.

best regards,

nirav.

Hi Habib,

As far as I understood the term "Regulations", you called it for industry regulations. I worked in the field for few years as a part of my job and found those regulations were in place based on years of experience in Medical Device industry. Also, FDA is very strict, and I do fully agree with it. It takes twice as long to achieve the target but there is a guarantee that the manufacturer will not get into legal issues. The testing part is very lengthy. 

I totally understand your frustration about launching in the market before anyone else which is dominated by big sharks out there.

Our supplier was also located in Indiana. Appears the state of Indiana has many Medical Devices making companies.

Good luck,

Hi,

The issue with regulations is the regulators.  There is no penalty to the regulator if an innovation saves lives but entails some risk, so they say "no."  The other issue is that once a regulator had taken a position and that position has a long history, it is impossible to change it even if it is technically incorrect.  Regulators have lost their minds when it comes to lead, asbestos, radiation, and now "forever chemicals."  Biological response is predominately about dose rate, not about exposure.  My favorite is NRC's official position that there is no threshold radiation exposure below which there is no damage.  There is plenty of evidence that there is one, and that there is clearly unwillingness of the NRC to correct that perception by the public.  See: https://www.cato.org/regulation/spring-2019/troubled-history-cancer-risk-assessment.

Walt

Very well said.