Regulatory capture - Fun Monday topic, right? In medicine, it’s everywhere. Regulations are generally meant to protect us. You may be a pneumothorax needling expert, but unless you have a credential and a pile of licenses and registrations, you can’t just convert an ice cream truck into a mobile thoracostomy clinic. But sometimes regulations slow progress, drive up prices and cause harm too. Here are some examples.
In my residency I loved suturing, but we had suture techs too who really were the experts. While I was pulled in 20 directions, a suture tech could focus on one wound at a time, and their work was top notch. The joke was: “Do you want a well rested suture tech who does this day in/day out, the ER intern, or the plastic surgery resident who hasn’t slept?” I learned a ton from the techs, but one day it was decided the hospital couldn’t legally charge for their repairs. So that was that. Everyone lost.
Ontario requires traction splints to "have a mechanism that allows the paramedic to determine and document exactly how much traction is being applied". For years that line has afforded the Sager Splint regulatory capture in Canada, and the price is roughly ~1000 Loonies. If you want to “treat the patient not the numbers” with a Slishman Traction Splint, you’ll have to buy your own there. Nationalized healthcare is regulatory capture on steroids, but I do see the benefits of everyone using the same stuff.
People in Ukraine and Israel periodically ask me for Slishman Pressure Wraps. But no NATO number means essentially no wraps. I’m not in the military and I don’t have a fast/easy way to get that number sorted. Occasionally people buy them from me and transport them in their luggage on medical missions, but nothing close to what’s needed. I guess this is more regulatory repulsion than capture.
IP is another regulatory capture tool. Some companies won’t take on new products without IP. They want guaranteed high margins, which isn’t surprising. It’s been a blessing and a bummer for me. I've enjoyed patent protection, but I've also had patents that went nowhere, whose mere existence makes it less likely for someone else to bring those ideas to market.?Patenting something and not bringing it to market can actually prevent the world from seeing that something. Strange eh?
Fees/forms are more regulatory capture mechanisms. The FDA wants >$7000 a year, whether your company sells one or a thousand class 1 devices. The EU regulates with mountains of paperwork instead, greatly hindering iteration. I’d love to offer my wraps in other colors, or with minor tweaks to test their acceptance. But any change is a giant hassle. Hundreds of US products don’t cross the pond at all, and prices are typically higher in the EU for those that do. Then again, my friends there don’t get $2000 bills for dabs of “medical grade" super glue applied by harassed interns.
What's best? I’m not anti regulation either. The devil’s in the details.
