When I was helping get a surgical robot through the FDA, I made a call early that felt like overhead at the time. We treated the risk and quality discipline as a product requirement from the first prototype, not as a binder we would assemble the month before we filed. That decision is why a standards story out of the robotics world this week landed for me. The Robot Report, syndicating analysis from Interact Analysis, asked whether robot suppliers are ready for the updated ISO 10218 safety standard. Most of the coverage reads it as a compliance chore. I read it as a market-access gate, and the companies treating it as a chore are the ones about to lose their shelf space in Europe.
What the standard actually changes
The mechanics are worth getting right. In Europe, the Machinery Directive that has governed industrial equipment since 2006 is replaced by the new Machinery Regulation, EU 2023/1230, on January 20, 2027. ISO 10218:2025, the revised safety standard for industrial robots, is what companies will build to for a CE mark under that regime, once it is formally listed in the Official Journal of the European Union. That listing was still pending as of mid-2026, and when the standard was last revised in 2011 the harmonization took more than a year, so the full legal transition could slip past 2027. In the United States the parallel update, ANSI/A3 R15.06-2025, is voluntary, but integrators write it into procurement specs and OSHA reaches for it after an accident, so it is optional in name only.
Then comes the part that decides winners. Interact Analysis interviewed manufacturers and found a wide readiness gap. The established global vendors are prepared. Some mid-sized suppliers, including European ones, have limited visibility into what the new standard actually requires, and emerging Asian entrants, especially Chinese firms pushing into Europe, are the least ready and most likely to underestimate what compliance will cost them in R&D. The analysts’ read was blunt: the well-prepared benefit, and the underprepared risk losing market access.
Why the prepared win, and it is not size
The incumbents are ready because they treated the standard as knowledge they own, not a service they buy at the end. That is a play I have run in every regulated thing I have built. Learn the regulation well enough to design to it yourself, do about ninety percent of the work in house, and pay the outside specialist only to tell you what you missed and to certify the result. What you never do is outsource the understanding. A supplier that hands the whole compliance question to a consultant six months before the deadline is buying a document, not a design, and the gap shows up as cost and delay at the worst possible moment.
It is the same instinct as framing a product to fit the regulatory envelope it has to live in. Whoever owns the product owns how it meets the standard, because that decision shapes the roadmap, the bill of materials, and the test plan long before an auditor is in the room. Push it down to a compliance team as a checkbox and you have already given up the months the prepared vendors spent building it in.
The move if you sell hardware into a gated market
If you build industrial robots, automation, or any hardware headed for Europe, the takeaway is narrow and practical. Put ISO 10218:2025 into your product requirements and your cost model now, not in 2027. Plan as if the deadline holds even though it might slip, because being early costs you a little and being late costs you the market. And keep the understanding of the standard inside the company, in the people making design decisions, instead of renting it by the hour. None of this is unique to robotics. A founder selling safety-critical hardware into any jurisdiction with a certification gate, from medical devices to grid and energy hardware, faces the same test. Is the standard a requirement you designed to, or a surprise you have to survive?
Dave’s take
A safety standard changing is one of the most predictable events in hard tech. You can see it coming years out, which means the companies caught flat footed were not unlucky, they were unprepared. Build the standard into the product early and it stops being paperwork and starts being a moat, because on the day the rule takes effect your competitors are scrambling for certification while you are already on the shelf. A gate does not only keep unsafe products out. It keeps unprepared companies out.
From Dave’s video library
Dave on the value-of-your-time test for deciding which work to own yourself and which to hand off, the same judgment behind keeping a standard in house instead of renting it.
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Dave Saunders is the founder of Base Reality Group and a Fractional CPO for hard-tech founders. He was a founder and operator at Galen Robotics, where the surgical-robotics platform earned FDA De Novo authorization in 2023, and he managed a 35-patent portfolio licensed from Johns Hopkins. He wrote Founders Who Finish and publishes The Build. More about Dave →