The number nobody asks about early enough
People pitching a new catheter or thrombectomy device tend to budget for engineering and testing. They rarely budget for the years it takes to get paid back, or for how much of that time gets spent on things that have nothing to do with the device itself: regulatory paperwork, manufacturing setup, training physicians who did not build the thing and did not ask for it to change.
Dave Ferrera has spent almost thirty years inside that gap, building products and companies in interventional radiology and neurovascular medicine. He was a co-founder of Blockade Medical, which was acquired by Balt Extrusion in 2016, and before that held product development and R&D roles at Microvention, Micrus Endovascular, and MindFrame, all of which were acquired by larger medical companies. He works through RC Medical, a venture studio that funds and builds device companies with physicians. That gives him a view most engineers or first-time founders do not have: he has seen the same cost show up at the same points, across several companies, for several different devices.
Time is the cost people underestimate
The dollar figure on a device budget is usually visible. The time figure is not, and it is the one that breaks founders.
A device idea that looks simple in the interventional suite, a slightly different catheter tip, a coil that deploys differently, can take years to move through prototyping, bench testing, animal studies, and a regulatory submission. None of that time is optional, and none of it can be compressed just because a founder is impatient or a physician wants the product for a case next quarter.
Ferrera’s view is that the founders who survive this are the ones who plan for the slow parts before they start, not the ones who try to outrun them:
“You cannot negotiate with a regulatory review timeline. You can only plan around it, so the companies that do this well build their whole calendar assuming the slow steps take exactly as long as they historically take, not as long as everyone hopes.”
Where the time actually goes
- Design iteration. Early prototypes rarely work on the first pass. Physicians who test a device in a simulated case will find problems an engineer alone would miss.
- Regulatory submission and review. This stage does not move faster because a company is small or well-funded. It moves at the pace of the process.
- Manufacturing scale-up. A device that works as a hand-built prototype is not automatically a device that can be built consistently at volume.
- Physician adoption. Even a cleared device takes time to be trusted and used in real cases, because physicians change practice slowly and for good reason.
Money follows the same pattern, but later
The dollar cost of a device rises as it moves through these stages, and it rises steeply once manufacturing and clinical work begin. Founders who raise enough to build a prototype often run short before they reach commercialization, because the expensive part is not the invention. It is everything after the invention works.
This is one reason RC Medical works through joint efforts with physicians rather than funding ideas cold. A physician who has seen the same problem repeatedly in the interventional suite brings a level of clinical validation that shortens some of the expensive guessing later. It does not remove the cost. It changes where the money goes.
What to do with this if you are building a device
Budget past the prototype. If your funding plan ends at “working device,” you have not built a funding plan. Price out manufacturing scale-up and clinical work before you raise anything.
Ask a physician early, not late. A workflow problem a physician has lived with for years is worth more at the start than after the device is built and needs to be pitched to someone who never asked for it.
Separate the clock from the calendar. Set your internal milestones against how long regulatory and manufacturing steps have actually taken on comparable devices, not against how fast you would like them to go.
Plan for the training cost. Even a device that clears every regulatory hurdle needs physicians willing to change how they work. That takes time and support, and it should be a line item, not an afterthought.
None of this makes the process shorter. It does mean fewer founders get surprised by a cost they should have seen coming, and fewer good devices die in the gap between working and being used.
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