Standards & Regulations: A Higher Barrier Than Technology Itself

I will start with a disclaimer: I am not an expert on regulations and standards.

I am a product strategy expert, and over the years of working for companies, and part of teams that promoted innovative solutions to disrupt and improve manufacturing processes, by applying the digital transformation, I learned, that one of the first topics that must be dealt with, is the adherence of the innovation output to the respective industry’s standards, as otherwise, the product will undoubtedly fail. This is encompassing all technologies and products. People are highly aware of medical and pharmaceutical regulations, but standards are regulating everything, from aerospace to automobility, consumer electronics, chemistry construction, and whatnot. I will focus on the effect of regulation and standards on the proliferation of additive manufacturing into mainstream manufacturing applications.

When I joined the additive manufacturing

arena (back in the middle ages, 2008), the common term, for what we were promoting at the time, was Rapid Prototyping. We were all extremely happy, that product development processes could be time-compressed, many iterations were possible, thus making sure that the final product is optimally designed and that by using rapid prototyping we all saved ourselves from very expensive mistakes, to be tracked, always too late.

Back then, we all spoke about the three Fs; Form, Fit & Function, and we were extremely proud about functional prototypes that drove some design and product revolutions.

We could not even dream of actual rapid (mass) manufacturing (excluding unique uses, such as hearing aids and certain dental modeling applications), because of materials’ limited mechanical properties, too low productivity, surface quality, accuracy, etc.

As usual, and especially with creative, innovation-savvy technical people, once you get something you want more of it – while those geeks at the 3D printers’ vendors are trying to improve in all those aspects, how can we bypass the weaknesses and use this technology for real manufacturing?

Then came producing of jigs, fixtures, and tooling. Much time and money were (and still are) saved, by replacing traditionally produced jigs and fixtures with 3D-printed ones.

But that is not enough – we still want to manufacture the real things but cannot. Then, how do we overcome the material barrier that is practically comprised of two; mechanical properties, and even if we mitigate those, then we still have the tall wall of regulatory standards.

This one is partially bypassed by the additive manufacturing of molds, but it is limited (and dissatisfying) compared to the ability to print the end-use part.

No part or assembly will ever be integrated into a product, be it a medical device, an airplane, a boat, a car, a toy a toothbrush, or anything else you use every day unless it and its entire manufacturing process meet very strict and detailed standards. Each industry has its own set of standards and those cover all aspects of the product, including, but not limited to materials used, and the manufacturing methods and procedures applied. in most cases, the average consumer is not aware of the level of regulation around products used, put together made to keep us safe and healthy, but also reduce potential legal liabilities if something that should not happen, does.

Regulation and setting of standards are, by their nature, highly elaborated processes, that require long procedures, run by different labs and highly skilled personnel. These are highly structured and regulated procedures that can rarely be shortened and closely monitored by respective authorities. The process is being carried out by specialized professionals on both sides, the industry, and the regulators. Many tests, a lot of analysis, many discussions, pressures, and some politics are involved.

Obviously, the result of the above is that these are long and very expensive processes. Adhering to existing standards is an elaborate process that requires skills and resources, as well as time. It is significantly more demanding, when different countries are involved, each set different standards and regulatory procedures. Establishing standards for new technology, process, chemistry, etc., and geeing it to be regulated with applicable standardization is way more complicated, time-consuming, requiring unique skills, and expensive, in additional several orders of magnitude.

In the regulation process, it is clear which one is the egg, and which one is the chicken: the new technology is an egg that was not laid by a chicken and is now looking for a chicken to hatch/regulate it. Regulation cannot precede innovation and therefore, will always be late to address the evolving needs.

At a company I worked for, we wanted to help our customers provide large, additively manufactured elements for interior decoration, movie & theatre sets, and theme parks. In these environments, extremely harsh fire retardancy standards exist. Those fire retardancy standards cannot, in no way, ever, apply to additively manufactured elements. The testing procedures and all related references, all apply to the construction industry and are of no relevance to additive manufacturing. We were stuck with unapplicable standards and an obvious market need that could not yet be addressed.

Additive manufacturing has been here for already more than three decades, and yet, it is only in its infancy, as related to regulation and standardization. There are only a few additive manufacturing adapted standards in place, that can hardly be used for mainstream manufacturing. The good news is, that the process already started and is accelerating. There are too many gaps where no published standard or specification currently exists, that prevent additive manufacturing from responding to many industry needs. This will change, faster, if the different industries will push for it harder.

New emerging technologies and industry trends, such as Industry 4.0, robotics, additive manufacturing, autonomous mobility, will make our lives better, but also create unmet yet health & safety risks that must be strictly mitigated. The world of regulation and standardization is now facing huge challenges that must be addressed urgently.

Technology companies (innovation agents) and the regulators must join forces to address this matter, possibly by adopting transformation that will expedite processes without compromising on quality and safety.

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