A widely shared perspective made the rounds this month arguing that brain-computer interfaces no longer need surgery to be transformative, and that the choice between a surgical and a non-surgical implant has become a strategic question rather than a technical footnote. I think that read is right as far as it goes. It also stops one decision short of the thing that decides whether any of these companies turns into a business. The modality debate is real. It is also downstream of a product question most brain-interface teams have not answered out loud: what measurable improvement are you selling, and who pays for it?
Access is the advantage, and it is a big one
Start with what the non-surgical camp gets right. Synchron’s Stentrode is delivered through the jugular vein and seated in the vasculature next to the motor cortex, no craniotomy involved, and it has let people with ALS operate a computer, send messages, and bank online. A 2023 study in JAMA Neurology reported meaningful communication rates with a safety profile that does not compare to open neurosurgery, and the FDA granted the approach Breakthrough Device Designation back in 2021. The surgical path, by contrast, is slow by construction. The first BrainGate2 trial opened in 2009 and enrolled fewer than twenty participants across a decade, because a craniotomy gates who can enroll and how fast anyone learns.
This is the same reframe I use for the da Vinci. The robot did not win the operating room because it made surgeons measurably better than their own hands. It won on access, by putting minimally invasive capability in front of far more surgeons, and therefore far more patients. Non-surgical brain interfaces are running the same play. Lower procedural risk means a wider eligible population, and the Lancet Commission on Global Surgery estimates five billion people have no access to safe surgery at all. Access, not raw signal fidelity, is where the addressable market actually opens up.
But access to what, exactly?
Here is where the strategic framing quietly skips a step. Access only means something once you have defined what the patient is getting access to, and that is the part the field has not settled. STAT reported in February that Synchron, Neuralink, and Paradromics are all finding it easier to show their devices are safe than to define and measure an improvement in patient outcomes. A brain interface does not cure a disease, so the therapeutic value is genuinely hard to specify and harder to prove to a regulator or a payer. That is not a surgery problem. A non-surgical device with an undefined endpoint is exactly as unfundable as a surgical one.
I ran into how much the definition matters at Galen. The same physical device could be framed as a remote manipulator, which lined it up against the da Vinci and drew a clinical-evidence bar we could not clear, or as a tool that improved a surgeon’s access at the end of a long instrument, which fit a de novo and cleared. The hardware never changed. What changed was the definition of what the device was, and that decided the entire regulatory and commercial path.
Modality is a decision you earn, not the one you lead with
So the order of operations is the reverse of what the headlines imply. First define the win you can measure: the specific capability restored, the outcome a clinician will document, the number a payer will reimburse against. Then choose the modality that delivers that win to the widest population at a risk the market will accept, which today often points to non-surgical. Lead with the modality and you have optimized the delivery of a benefit you never defined. This is product and market definition, the first thing I work through with any hard-tech founder, and in a medical device it belongs to the person binding the product to a market, not to the regulatory consultant who implements the plan later.
Dave’s take
The non-surgical camp has the direction right, and I think it has the market right too. Just do not let the modality argument stand in for the harder work. The company that wins here will be the one that can say, in a sentence a payer understands, what its interface gives back and how you measure it, and only then argue about how it gets into the body. Define the win first. Surgery, or no surgery, is a delivery decision after that.
From Dave’s video library
Dave on how to find the single assumption worth testing before you build, the same discipline a brain-interface team needs before it argues about surgery.
I’m here to help you scale.
Work With DavePrefer a smaller first step? Book a $500 one-hour working session →
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 →