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  • 1.  Regulation and innovation

    Posted 03-16-2023 09:30

    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?



    Habib Alavi
    Senior Materials Scientist/Metallurgist
    Cook Medical
    West Lafayette IN
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  • 2.  RE: Regulation and innovation

    Posted 03-18-2023 11:01
    Habib and co -

    Regulations are the backbone of modern civilization.
    Without laws, standards, codes, policies, etc....
    it would  chaos.

    Arguments about regulations reminds me of the
    scene from A Man for All Seasons, see below.

    - Jim

    "William Roper:
    "So, now you give the Devil the benefit of law!"

    Sir Thomas More:
    "Yes! What would you do? Cut a great road through
    the law to get after the Devil?"

    William Roper: "Yes, I'd cut down every law in
    England to do that!"

    Sir Thomas More: "Oh? And when the last law was
    down, and the Devil turned 'round on you, where
    would you hide, Roper, the laws all being flat?
    This country is planted thick with laws, from
    coast to coast, Man's laws, not God's! And if
    you cut them down, and you're just the man to
    do it, do you really think you could stand upright
    in the winds that would blow then? Yes, I'd give
    the Devil benefit of law, for my own safety's sake!"

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  • 3.  RE: Regulation and innovation

    Posted 03-19-2023 15:09


    Well said.

    A. Alan Swiglo
    Swiglo Metallurgical Consulting
    St. Paul MN

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  • 4.  RE: Regulation and innovation

    Posted 03-20-2023 08:12
    In the USA, lawyers and tort lawsuits may be more of a barrier than the laws themselves. Consider how laws may aid innovation:
    (1) the law itself may provide some protection ("I had to do it this way. The law said so.")
    (2) by forestalling some development paths, the law may prompt deeper consideration of the remaining paths.

    John Grubb

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  • 5.  RE: Regulation and innovation

    Posted 03-21-2023 03:14

    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 Jamnapara
    Institute For Plasma Research

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  • 6.  RE: Regulation and innovation

    Posted 03-22-2023 10:32

    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,

    Sanjay Kulkarni
    Materials Engineer
    2040 Crooks RD, Suite A
    Troy, MI 48084
    Cell: 248-840-1056

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  • 7.  RE: Regulation and innovation

    Posted 03-23-2023 10:55


    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:


    Walter Sperko
    Sperko Engineering Services Incorporated
    Greensboro NC
    (336) 674-0600

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  • 8.  RE: Regulation and innovation

    Posted 04-11-2023 08:35

    Very well said.

    Habib Alavi
    Senior Materials Scientist/Metallurgist
    Cook Medical
    West Lafayette IN

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