The $10 Billion Question: Reimagining iBCI's Path to Market Transformation

TL;DR: With nearly $1 billion invested in implantable brain-computer interfaces, investors expect a 10x return on a $10 billion market. Yet the path to this scale requires fundamental shifts beyond technical innovation—from regulatory frameworks to reimbursement models, from device-centric thinking to platform ecosystems, and from passive medical devices to living pharmaceutical systems that partner with human agency.

The Cochlear Implant Benchmark: A 70-Year Reality Check

When Jacques Vidal coined "brain-computer interface" in 1973, cochlear implants had already been in development for decades. It took nearly seven decades for cochlear implants to go from idea to widespread clinical treatment, reaching over 300,000 people with sensorineural hearing loss. Now, 50 years into real-time neural decoding from Fetz and Baker's pioneering work in the 1970s, we stand at a similar inflection point.

iBCI represents a fundamentally new class of neurotechnology—direct neural interfaces for sensorimotor restoration in severe motor paralysis. Unlike established neurotechnologies such as cochlear implants, DBS, VNS for stroke recovery, or RNS for epilepsy, iBCI must solve the unprecedented challenge of translating motor intent from paralyzed individuals into external device control. The question isn't whether iBCI technology works—early human trials have demonstrated proof of concept—it's whether we can architect a sustainable path to the scale investors envision.

The Market Math That Doesn't Add Up

The investment thesis reveals a stark mathematical challenge. Nearly $1 billion in iBCI investment, with investors expecting 10x returns, implies a $10 billion market opportunity.

Yet the initial addressable market—severe quadriplegia from advanced ALS, brainstem stroke, and high cervical spinal cord injury—represents fewer than 1 million people globally.

To achieve $10 billion in market value, iBCI companies would need to:

• Implant virtually every eligible patient worldwide, AND

• Achieve reimbursement rates far exceeding current U.S. private insurance levels

Even optimistically, historical precedent suggests only 1-17% of eligible candidates actually receive transformative neurotechnologies like cochlear implants or DBS. This would require reimbursement rates 10x higher than today's levels—demanding massive legislative change.

The reality? Investors are betting on iBCI as a platform technology, not a niche medical device.

Beyond the Technical: Four Critical Market Transformation Imperatives

1. Regulatory Revolution: From Cyber-Secure Moats to Interconnected Ecosystems

Current FDA frameworks prioritize cyber-secure isolation—sensible for pacemakers, potentially catastrophic for iBCI. People with quadriplegia need their brain interfaces to communicate with wheelchairs, environmental controls, smartphones, and potentially other implanted devices like spinal cord stimulators.

The opportunity: Work with FDA to develop new regulatory frameworks that allow controlled interoperability while managing cybersecurity risks. This isn't about compromising safety—it's about enabling the autonomy that makes iBCI transformative rather than another expensive medical device.

2. Reimbursement Reimagined: From One-Time Sales to Subscription Healthcare

CMS and private insurers operate on fundamentally different models than investors need for platform-scale returns. Current reimbursement assumes one-time device purchases with limited ongoing costs.

The paradigm shift: iBCI requires ongoing software updates, calibration, neural interface optimization, and expanded functionality over decades—more like pharmaceutical subscriptions than traditional devices. This demands new reimbursement models that current policy doesn't support.

Strategic insight: While vendors and payers typically have opposing interests, both benefit from definitively proving who will respond to treatment. Developing biomarkers that predict individual success could be the game-changer that aligns all stakeholders.

3. CPT Code Strategy: Aligning Stakeholder Incentives

Success requires reimagining the entire care ecosystem. Consider who must do what for iBCI success:

• Surgeons (implantation)

• Neurologists & physiatrists & psychiatrists (device management)

• Rehabilitation therapists (training, calibration)

• Technicians (setup, maintenance)

Critical insight: Neuropace had to secure specific CPT codes that made neurologist device data review more profitable than alternative activities. Without proper financial incentives, any absence of payment becomes an active disincentive.

The rehabilitation bottleneck: If your device requires 90-120 minutes of skilled therapy when CMS only reimburses 60-minute sessions, therapists are actively discouraged from providing optimal care. This market preparation must be built into National Coverage Determinations from day one, not after FDA approval.

4. From Medical Device to Living Pharmaceutical

The most transformative opportunity lies in biological integration. Current iBCI companies focus on synthetic arrays, electrodes, and silicon interfaces. But neurons fundamentally work by secreting neurotransmitters—glutamate, GABA, dopamine.

The moonshot with massive returns: iBCI that incorporates living electrodes, organoids, and bioengineered tissue constructs becomes a living pharmaceutical secreting precise spatiotemporal patterns of neurotransmitters. Historically, CMS reimburses pharmaceuticals at far higher rates than devices for equivalent patient value.

This isn't just about better biocompatibility (the brain reacting to a foreign body) and biostability (the device being dissolved by the brain)—it's about accessing entirely different reimbursement categories with higher margins and recurring revenue models.

The User-as-Co-Creator Revolution

Unlike any previous neurotechnology, iBCI users aren't passive recipients but active agents with creativity, critical thinking, and will. This transforms the value equation fundamentally.

The platform insight: Rather than traditional device companies, successful iBCI companies might operate more like app stores—creating marketplaces where users trade neural interfaces, calibration protocols, and novel applications. This user-driven innovation could exponentially expand addressable markets.

Imagine iBCI users as co-inventors, creating value not just for themselves but for others facing similar challenges. This collaborative ecosystem could drive the network effects necessary for platform-scale returns.

The Expansion Strategy: Beyond the <1M Severe Paralysis Market

Current iBCI architecture assumes intact sensorimotor control pathways—effective for spinal cord injury and ALS, but not automatically applicable to the much larger stroke market where the cortical architecture itself is damaged.

Strategic implications for platform expansion:

1. Diagnostic pivot: iBCI platforms that provide unprecedented neural monitoring could unlock new diagnostic markets

2. Cognitive augmentation: The most bullish investors see potential for enhancing normal brain function—though this requires fundamentally different risk-benefit calculations

3. Hybrid biological systems: Living neural components could adapt to damaged brain architecture in ways current synthetic systems cannot

The Fun Factor: Making Neural Training Sustainable

A crucial but often overlooked insight: decoder algorithms need massive amounts of data, but boring, repetitive tasks cause fatigue and habituation effects that degrade performance.

The solution: Training paradigms must be engaging, salient, and personally meaningful. Whether through gaming elements, personalized content, or social interaction, the user experience directly impacts the quality of neural data and long-term device utility.

The Dual Learning Challenge: Optimizing Human-Machine Convergence

Ground Truth Advantage: Leveraging Residual Function

Most iBCI candidates retain some residual function—shoulder shrugs, facial movements, eye tracking, voice control. This presents a transformative opportunity: if implanted sensors can detect the neural substrate driving these intact outputs, the system gains access to ground truth data that matches real external kinematics with internal neural representations.

This bypass strategy could eliminate lengthy, boring training sessions by providing immediate neural-to-output calibration using movements the person can still perform. Rather than weeks of imagined movement training, systems could rapidly calibrate using the neural patterns already driving preserved functions.

The Convergence Problem: Two Learning Systems, One Goal

iBCI faces a unique challenge: two learning systems must converge—the AI/ML decoder (whether discrete or continuous) and the human brain learning to control the interface. When these systems fail to converge, they chase noise rather than signal, leaving users without reliable voluntary control.

The spectrum of solutions:

• Human-centric approach (Fetz & Baker 1970s): Provide direct neural feedback; let the human brain do all the learning through voluntary control of neural activity patterns.

• Machine-centric approach (most current systems): Build comprehensive training datasets; let sophisticated decoders handle pattern recognition and translation.

The critical variables beyond decoder choice:

Feature selection fundamentally shapes performance:

• Action potential rates vs. local field potential spectral power

• Spatial statistics of features across electrode sites

• Phase patterns across cortical topography

• Temporal vs. rate coding windows for spike detection

• Phase offset relationships between spikes and low-frequency oscillations

• Phase-amplitude coupling coefficients across frequency bands

Instruction paradigms create different neural landscapes:

• Naturalistic: "Imagine moving your hand" or "Think about typing"

• Learned gestures: Palm Graffiti-style specific imagined movements requiring training

The Neural Sign Language Opportunity

Rather than expecting brains to naturally produce easily classifiable patterns, teaching users a neural gestural "sign language" could dramatically improve performance. Just as stenographers learn optimized manual gestures for speed and accuracy, iBCI users could learn to generate inherently more orthogonal neural patterns that enable:

• Better discrete classification: Clear separation between intended commands

• More accurate continuous decoding: Reliable, stable signal patterns

• Reduced calibration needs: Consistent, learnable neural signatures

Dynamic Representations: Beyond "Set and Forget"

In 1906, Brown and Sherrington noted that stimulation of the same, tiny patch of cortex could cause flexion of the contralateral wrist at one moment and then reverse and identical stimulation at the identical target, cause extension of that wrist, such that they posited that, "reversal is one of the specific offices of the cortex cerebri."

Thus, unlike FaceID's stable facial recognition, brain representations appear fundamentally dynamic.

This reality demands strategic choices:

Option A: Frequent recalibration to track neural drift

Option B: Continuous ground truth signals for real-time adaptation

Option C: Train users to maintain stable, orthogonal neural patterns

Artificial Corollary Discharge: Creating Motor Shadows

Advanced systems might implement artificial corollary discharge—creating "motor plan sensory shadows" that provide spatiotemporal feedback patterns to sensorimotor cortex, mimicking natural motor-sensory loops even when physical movement is impossible.

Strategic insight: The most successful iBCI companies will optimize the entire human-machine learning ecosystem, not just decoder algorithms. This requires simultaneous innovation in neurofeedback, user training paradigms, feature extraction, and adaptive calibration strategies.

Strategic Recommendations for iBCI Leaders

For CEOs:

1. Engage stakeholders early: Don't wait until technology is finalized to involve surgeons, therapists, payers, and potential users

2. Think platforms, not devices: Plan expansion pathways beyond your initial indication from day one

3. Address the entire care ecosystem: Success requires incentivizing every stakeholder who touches your technology

   
   

For Investors:

1. Fund the translation gap: Consider consortiums that could streamline regulatory testing and reduce per-company costs

2. Think 20+ year timelines: Platform-scale returns require patience for market development, not just technical validation

3. Bet on teams with regulatory and reimbursement expertise: Technical innovation alone is insufficient

4. Market preparation: iBCI offers a tremendous opportunity and to be transformed into reality, new clinical care pathways need to be invented, incentivized, and refined.

   
   

For the Ecosystem:

1. Create new funding mechanisms: Bridge the gap between academic R01s and commercial VC with industry-government partnerships

2. Develop interoperability standards: Enable the device ecosystems that create real user value

3. Pioneer new reimbursement models: Work with CMS to develop subscription-based models for ongoing neural interface optimization

   
   

Conclusion: The Transformation Imperative

The iBCI industry stands at a critical juncture. Technical proof-of-concept has been demonstrated repeatedly. The question now is whether the ecosystem can evolve beyond traditional medical device thinking to create the platform-scale markets that justify current investment levels.

Success requires simultaneous innovation across technology, regulation, reimbursement, and user experience. Companies that treat these as afterthoughts to technical development will struggle. Those that architect comprehensive market transformation strategies from the beginning could unlock the $10 billion market investors envision.

The next decade will determine whether iBCI becomes the most transformative neurotechnology in human history—potentially doing for motor function, sensation, language, cognition, perception, attention, executive function, mood, and self-regulation what cochlear implants achieved for sensorineural hearing loss. But iBCI's potential extends far beyond restoration: it could open entirely new forms of cognition and perception, especially in children whose developing brains could integrate these capabilities as naturally as native sensory modalities.

This isn't about joining the ranks of successful neurotechnologies—it's about defining an entirely new category of human-machine collaboration that could fundamentally expand what it means to be human. The choice is ours, and the window for foundational decisions is closing rapidly.

The most successful iBCI companies won't just build better brain interfaces—they'll build the ecosystems that make human-machine collaboration not just possible, but inevitable.

POST-SCRIPT

After publishing the above, I received feedback from a variety of colleagues and friends involved in iBCI, including Jayme Strauss at Precision Neuroscience and Sumner Norman at Forest Neurotech, and summarize here my thoughts in response:

The Platform Economics Dilemma

Current incentives force myopic focus on short-term, tractable markets instead of the decade-spanning platform thinking necessary for transformative returns. While FRO models provide temporary revenue relief, that may not be an option for most companies and transitioning to a sustainable path remains a challenge. Regulatory or reimbursement shifts toward SaMD models could incentivize long-term thinking, but would require powerful consortiums with substantial resources.

iBCI economics are fundamentally broken under current payment structures. The field faces a critical choice between consortium approaches:

iBCI-specific lobbying: Narrow focus with limited resources, but if successful could crack CMS reimbursement wide open specifically for brain interfaces.

SAMD coalition joining: Broader funding base, but existing SAMD reimbursement levels are orders of magnitude below what iBCI requires.

An instructive lesson emerges from customer redefinition: Akili bills patients/insurance and struggles, while Viz.ai bills hospitals as operational expenses and thrives at $25K/year/hospital. Yet this model breaks for iBCI—Viz.ai software rides high-volume, high-margin stroke imaging, whereas capital-intensive iBCI depends on low-volume, low-margin functional neurosurgery.

Near-term options remain the same ones discussed twenty years ago: premium cash-pay markets, DARPA rehabilitation contracts, medical tourism loss leaders for elite institutions, and niche international markets. One new possibility: cross-platform consortiums where multiple iBCI vendors take equity in unified "iBCI program in a box" offerings—shared patient identification, screening, protocol standardization, and rehabilitation pairing.

The Reimbursement Revolution Imperative

iBCI must be recognized as an entirely new therapy class, not another glorified cochlear implant. It incorporates product plus service plus lifelong adjustment. Current CMS policy cannot handle software updates, calibrations, or the complex interaction between therapist, vendor, patient, and family.

The economic case: if CMS spends over $15K monthly forever on vent-dependent cervical quadriplegia nursing care, and iBCI enables wheelchair positioning and medical bed adjustments that prevent costly complications, the return on investment proves itself within quarterly financial cycles. Complications like decubitus ulcers, pneumonia, and wound care cost millions and happen quickly enough to demonstrate clear cost savings.

Critical insight: CMS will not recognize this need organically—it must be legislated. The law itself must change to create entirely new categories beyond existing DME frameworks.

Investment Narrative Decoded

Investor excitement likely follows this logic: "Quadriplegia is tiny, but this technology treats ALL neurological disease. Clever engineers with neural data will magically pivot between indications, making DBS target-hunting look amateurish. Every condition—spinal cord injury, ALS, epilepsy, MS, stroke, brain tumors, autism—becomes treatable. It's a platform for curing all neurological disease collectively worth massive returns. Neural data itself is valuable for helping engineers pivot and for Big Pharma clinical trial de-risking. We'll make this data mandatory for all nervous system trials. Yottabytes of neural data will solve AI/ML bottlenecks, crack hyperparallel non-backpropagation learning, and sustain crisp cognition and brain integrity for multi-century lifespans. Next, iBCI will be popularized to the masses and will allow Matrix like immersion and people will use NUIs (Neural User Interfaces) to join in a Matrix-Pantheon-like neural metaverse virtual world. The iBCI will allow every person to manually adjust their own settings: dialing down pain, dialing up alertness and intelligence, just like Maeve in Westworld. Ultimate transhumanist pinnacle: brain augmentation making everyone trillions of times smarter than Bradley Cooper's character in Limitless—we can each be our own singularity- obviously infinite returns."

This messianic scope explains the investment enthusiasm despite tiny initial markets.

Regulatory and Clinical Frameworks

FDA will never develop new frameworks alone but is responsive and will respond when people with lived conditions advocate for change. The path forward involves giving FDA specific use cases with black boxes, sandboxes, and clear guardrails where users and clinicians can intervene. Existing software V&V principles can adapt to allow rapid AI/ML iteration while maintaining safety.

Cross-company calibration protocols may not make sense, but shared benchmarks would help—like how different phones use FaceID variations yet compare on accuracy and speed. Personalization remains essential; systems cannot work if people must act like consistent robots.

The Human-Machine Learning Convergence

The field's central challenge: navigating academic science-fair approaches with hundreds of overfit instruction/decoder/mapping methods requiring unscalable personnel, versus plug-and-play delusions expecting FaceID-level reliability.

Success requires talented therapist-engineers who can select from carefully curated menus of approaches, similar to how physical therapists and occupational therapists craft care with various modalities, or to how any skilled teacher works. Ideally, biomarkers will predict who succeeds with different approaches—neural-gesture learners versus those needing bare-bones systems leveraging residual inputs like eye movement or voice.

Having expert teams for every patient isn't scalable, but making systems so automated that any clinician could use them would be unwise. The solution involves trained clinician-engineers—perhaps OTs, PTs, or other medical professionals with specialized training—billing like MRI with technical plus personnel fees for "synaptic weaving" and neural mapping to real-world applications.

The Consortium Path Forward

Until dramatic CMS reimbursement reform occurs, everything else feels like shuffling chairs on the Titanic. An iBCI-specific consortium focused on winning complete CMS policy change—netting vendors minimum $100K per device lifetime, ideally much more, and netting the hospitals just as much—represents the best option. Yet this approach faces skepticism because people want immediate reimbursement using existing policies.

The bigger risk isn't taking time to build proper infrastructure—it's the entire fledgling industry flying off a cliff without sustainable economics. Success requires simultaneously revolutionizing technology, regulation, reimbursement, and user experience. Companies treating market transformation as an afterthought to technical development will struggle.

Those architecting comprehensive strategies from the beginning could unlock the platform-scale markets that justify current investment levels and define an entirely new category of human-machine collaboration.

Addendum: The Inconvenient Truth About CMS and iBCI Reimbursement

Blog above originally published August 18, 2025. This section updated September 30, 2025, based on ongoing discussions with colleagues and friends at iBCI-cc.org in Baltimore, 2025.

Since publishing this piece, I've engaged in extensive discussions with colleagues across the iBCI ecosystem—including researchers, clinicians, investors, and policy experts. I've had the opportunity to reflect on the past 20 years of interactions with officials at CMS, scientific and medical officers at private insurers, and administrative law judges. These conversations have crystallized a harsh reality: the primary barrier to iBCI adoption isn't scientific or technical. It's political.

The Pattern of Selective Logic

Consider the following medical technologies that CMS currently covers without question:

Left Ventricular Assist Devices (LVADs): Don't cure heart failure. They pump blood mechanically while the original heart remains damaged. Sometimes, taking workload off the injured heart allows recovery—but that's not why CMS covers them. They cover them because they restore cardiac function.

Cochlear Implants: Don't regenerate damaged hair cells or reverse sensorineural hearing loss. They bypass the damaged auditory system entirely, providing artificial hearing through electrical stimulation. CMS covers them because they restore auditory function.

Deep Brain Stimulation: Doesn't treat the underlying neurodegeneration in Parkinson's disease or eliminate epileptic networks. It provides symptomatic control through electrical modulation. CMS covers it because it restores motor function and seizure control.

Vagus Nerve Stimulation for Epilepsy: Doesn't cure the seizure disorder or repair damaged neural circuits. It reduces seizure frequency through electrical stimulation. CMS covers it because it restores seizure control.

Pain Management Technologies (Spinal Cord Stimulators, Intrathecal Drug Pumps, etc.): Don't treat underlying pain pathophysiology or provide objective biomarkers of pain relief. There is no blood test, imaging study, or physiological measure that objectively quantifies pain. Instead, CMS accepts purely subjective visual analogue scales (VAS) and numerical rating scales—essentially asking patients to point to an emoji or pick a number from 1-10. These measures, used since the 1950s, are influenced by mood, catastrophizing, and non-pain factors. Yet CMS covers spinal cord stimulators costing $50,000+ based entirely on these subjective reports, with no requirement to demonstrate underlying tissue healing or pathophysiologic improvement.

Each of these technologies provides functional restoration without disease modification—exactly what iBCI does.

The Double Standard: Selective Enforcement

Yet when it comes to iBCI, CMS suddenly demands proof that neurally-controlled bed positioning prevents pressure ulcers (Braden scale), rather than accepting that the ability to reposition oneself has inherent medical value. They've indicated that enabling someone to communicate, work, or control their environment constitutes mere "convenience"—comparable to taxpayer-funded iPads. In other words, functional restoration is only valuable if it prevents quantifiable medical complications—independence, communication, and employment don't count.

Meanwhile, CMS refuses coverage for eyeglasses and hearing aids, dismissing them as "convenience items that don't treat underlying disease." But cochlear implants, which also don't treat underlying disease, receive full coverage. When confronted with this inconsistency, CMS officials deploy procedural distinctions and bureaucratic rationalizations rather than addressing the logical contradiction.

The pattern becomes even clearer when examining what CMS demands from iBCI versus what they accept from established technologies. While they cover pain management based on emoji-like visual scales, subjective patient reports suffice for $50,000 spinal cord stimulators—but iBCI must demonstrate specific medical complications prevented. This reveals selective enforcement: LVADs aren't required to prevent specific cardiac complications beyond their primary function, and cochlear implants aren't required to prevent ear infections.

The Fragmentation Trap: Why "Pathways" Aren't Solutions

Well-meaning colleagues often point to regulatory pathways like the New Technology Add-on Payment (NTAP) as potential solutions. But NTAP exemplifies the problem rather than solving it. Even if iBCI receives NTAP approval, it provides only device reimbursement—leaving the same fragmentation that has plagued other complex neuromodulation technologies.

Why Traditional Pathways Won't Work

To be clear: CMS is staffed by dedicated public servants working within an incredibly complex system. The challenge isn't the people—it's the nature of the institution itself. CMS is, by design and necessity, a careful steward of public funds, operating within a framework of accumulated policies, legislative mandates, and political compromises built over decades. It's fundamentally reactive rather than visionary—and that's not a criticism, it's a feature of how democratic healthcare policy must work.

But this creates a profound mismatch for transformative neurotechnology. When colleagues point to pathways like NTAP or transitional pass-through status as 'proof' that routes exist, they're missing the timeline reality: these mechanisms take years to navigate, require completed clinical trials, and depend on demonstrating incremental improvements to existing covered conditions. For iBCI—which doesn't fit neatly into existing diagnostic categories, requires ongoing software updates, involves family training, and serves a small initial population—expecting CMS to blaze this trail is like asking an institution fundamentally designed for caution and precedent to suddenly become venture capital.

This isn't CMS's failing. It's a category error to expect Medicare, which must answer to Congress and taxpayers for every coverage decision, to fund the infrastructure development phase of entirely new therapeutic modalities. We need different mechanisms for this earlier stage.

The Incentive Misalignment

The structural challenge goes even deeper: CMS's mandate creates a profound misalignment of incentives for transformative neurorehabilitation. Unlike healthcare systems in countries where the government captures the full economic benefit of returning citizens to work or reducing caregiver burden, CMS operates within a narrow budgetary silo.

When an iBCI user returns to work and pays taxes, that benefit accrues to the Treasury. When a family member can return to their career instead of providing full-time care, that economic gain happens outside CMS's ledger. From CMS's organizational perspective—constrained by their mission to manage Medicare spending—even a wildly cost-effective intervention looks like pure expenditure.

This creates an impossible calculus: a technology that costs CMS $500K but returns $5M to the broader economy through employment, reduced disability payments, and caregiver productivity looks like a $500K loss in their accounting. CMS staff can recognize this intellectually, but they can't act on it—their fiduciary responsibility is to the Medicare Trust Fund, not to whole-of-government economics. This isn't poor stewardship; it's structurally rational behavior within a fragmented system.

The Implication

The implication is stark: we cannot wait for coverage pathways designed around preventing medical complications to recognize the value of restoring human agency and economic participation. Those are fundamentally different value propositions requiring different funding mechanisms.

The VNS for Stroke Cautionary Tale

CMS covers the VNS device for stroke rehabilitation at approximately $40,000 (NTAP+DRG), but issued no National Coverage Determination or Local Coverage Determination for the 90 minutes of rehabilitation therapy required to make it effective. The result? Most centers either don't offer the therapy, volunteer therapist time as an unsustainable loss, or provide suboptimal care. Surgery departments capture device revenue while therapy departments—who provide the actual therapeutic benefit—receive nothing.

To be clear: MicroTransponder has excellent leadership and solid technology, and I believe they'll succeed clinically. But even in their success, this fragmented reimbursement model just doesn't scale for the broader neurotech space we're trying to build. For iBCI—which has orders of magnitude less initial population than the VNS-for-stroke base, and which requires weeks of training, ongoing technical support, software updates, family education—this fragmentation will be exponentially worse. We need infrastructure that can support the entire ecosystem, not just device reimbursement.

The Second Sight Warning

Often cited as a "success story," Second Sight actually demonstrates the fundamental problem. They achieved $150,000 Medicare reimbursement for their Argus II retinal prosthesis—far higher than typical device payments. Yet the company failed economically, investing over $300 million across 24 years while generating only $32 million in total revenue before discontinuing the product in 2020. Why? Because they uncoupled device reimbursement from the ongoing optometry and ophthalmology services required to find the right patients and then sustain the technology to function. Existing healthcare workflows couldn't scale to support this revolutionary technology.

The Economics of Small Markets

Unlike established neuromodulation devices that serve large patient populations, iBCI addresses perhaps 10,000 total patients in the U.S. (end-stage ALS, brainstem stroke, high cervical spinal cord injury). At fragmented reimbursement rates of $40,000-$150,000 per device, distributed across multiple competing companies, no one can build a sustainable business model—especially when the extensive ongoing support services remain uncovered.

This creates a zero-sum trap: companies compete for a tiny market with inadequate reimbursement, leading to industry consolidation or failure rather than innovation and patient access.

The Political Reality

These aren't evidence-based policy decisions—they're politically determined frameworks dressed up in medical language. Given the precedents already established, the barriers facing iBCI cannot be scientific or evidentiary in nature.

CMS has already demonstrated that:

• Subjective patient-reported outcomes ARE valid medical measures (visual analogue scales for pain)

• Symptomatic restoration without disease modification IS legitimate medical benefit (all the devices listed above)

• Lack of objective biomarkers is NOT a barrier to coverage (pain management broadly)

The difference with iBCI isn't scientific—it's that these other technologies achieved coverage when they had political support, industry advocacy, and congressional pressure. CMS doesn't voluntarily expand coverage for expensive new technologies; they do so when forced by political reality.

The Path Forward

The iBCI field faces a choice: spend the next decade developing perfect outcome measures and navigating bureaucratic pathways while hoping CMS will voluntarily change their position, or mobilize the political coalition necessary to force systematic reform.

History provides the answer: Medical technologies achieve broad coverage through political mobilization, not through technical perfection alone. The ALS community's recent legislative successes, the cochlear implant advocates of the 1980s, and LVAD supporters all understood this fundamental truth.

The window is narrow: As companies approach FDA approval and reimbursement negotiations, the industry will either secure a transformative framework that enables sustainable business models and patient access, or become locked into the same fragmented, economically unviable precedent that has limited other breakthrough neuromodulation technologies.

What Comprehensive iBCI Reimbursement Should Look Like

If CMS were to apply the same whole-of-government economic analysis used for other major medical interventions, iBCI coverage would recognize that restoring independence, communication, and workforce participation generates returns that dwarf device costs. Here's what evidence-based reimbursement should include:

Device Implantation Phase

• Surgical/facility fee: $250,000 (reflecting neurosurgical complexity, OR time, imaging requirements, and hospital stay)

• Provider fee: $250,000 (reflecting neurosurgeon expertise, team coordination, and long-term device management responsibility)

• Pre-operative assessment: 2x standard consultation rate (~$600) for neurologist or physiatrist conducting candidacy evaluation, functional assessment, and care planning

Subtotal: ~$500,500

Training and Calibration Phase (Weeks 1-12)

Current CPT codes grossly undervalue the specialized expertise required for iBCI training. Standard occupational therapy rates ($150/hour) and speech-language pathology rates ($140/hour) assume routine rehabilitation, not the technical sophistication of neural interface optimization.

Proposed specialized rates:

• iBCI-certified OT/PT: $300/hour (2x standard rate, requiring specialized certification)

• iBCI-certified SLP: $280/hour (2x standard rate, requiring specialized certification)

• Training intensity: 20 hours/week for 12 weeks = 240 hours

• Provider mix: 60% OT, 40% SLP (as devices start mobilizing limbs/body certain % moves to PT, starting with hand certified and then whole-body)

Training phase cost: ~$70,000

Device Optimization and Follow-up (Year 1)

• Neural interface adjustments: 2x standard device programming rate (~$200 per session)

• Frequency: Monthly for first 6 months, quarterly thereafter = 9 sessions

• Software updates and troubleshooting: New CPT code for remote neural interface management: $500/month

Year 1 ongoing cost: ~$11,800

Long-term Maintenance (Years 2+)

• Quarterly device optimization: $400/session x 4 = $1,600/year

• Annual comprehensive assessment: $1,000

• Remote monitoring/software updates: $300/month = $3,600/year

Ongoing annual cost: ~$6,200

Family/Caregiver Training

• Initial training: 20 hours at specialized rate ($250/hour) = $5,000

• Refresher training: 5 hours annually = $1,250/year

Total First-Year Comprehensive Coverage: ~$593,500

Ongoing Annual Coverage: ~$7,450

The Economic Return

For a 45-year-old with high cervical SCI or locked-in syndrome:

Direct savings to government:

• Avoided institutional care: $150,000/year x 30 years = $4.5M (Medicaid nursing home costs)

• Reduced caregiver burden: Family member returns to work, pays taxes: $40,000/year x 30 years = $1.2M in tax revenue

• Reduced disability payments: Potential return to part-time work reduces SSI/SSDI: $20,000/year x 20 years = $400,000

Conservative 30-year return: $6.1M in government savings/revenue Government investment: $593,500 + ($7,450 x 29 years) = ~$809,500

Return on Investment: 7.5:1

This doesn't even account for the patient's own economic productivity, quality of life, or the societal value of technological innovation. Those savings are conservative because while we should certainly track additional medical complications that will add even more savings—such as reduced urinary tract infections, pneumonia, and skin breakdown because iBCI-controlled repositioning of medical beds and wheelchairs helps with vascular and lymphatic circulation—we cannot wait to prove this. The core economic case is already overwhelming, and delaying coverage to document every secondary benefit repeats the same mistake that has limited other breakthrough technologies.

Why This Model Works

1. Recognizes specialized expertise: iBCI isn't standard rehab—it requires technical sophistication comparable to cardiac device management or cochlear implant programming

2. Covers the entire care continuum: Not just surgery, but the training and support that makes the technology functional

3. Creates sustainable business models: Multiple companies can succeed serving 10,000 patients at these rates

4. Aligns incentives: Providers are compensated for outcomes, not just procedures

5. Generates measurable ROI: Even at premium rates, the government comes out massively ahead

The Negotiation Strategy

This model represents what comprehensive coverage should look like based on actual resource requirements and economic returns. If CMS negotiates down to 60% of these figures (~$350K first year, $4,500 ongoing), the economics still work for both patients and industry—but we must start from an evidence-based position that reflects true value, not arbitrary historical precedents from unrelated technologies.

The question isn't whether taxpayers can afford iBCI coverage—it's whether we can afford to continue paying institutional care costs while denying technologies that eliminate those costs and restore economic participation.

Strategic Notes:

• The 2x rates for specialized OT/SLP/PT work because we're creating a certification pathway that legitimizes higher compensation

• The $500K device cost anchors high and is defensible given device and procedure complexity

• Breaking out family training separately highlights a cost everyone forgets

• The 7.5:1 ROI is conservative and defensible

• Even if negotiated down , can arrive at a sustainable price point to get this to people who can benefit

The Call to Action

Researchers, clinicians, investors, and most importantly, people and families affected by ALS, spinal cord injury, and stroke must unite to demand that CMS apply the same standards to iBCI that they already apply inconsistently to other functional restoration technologies.

This isn't about perfect science—it's about political will. And political will requires organized, sustained advocacy that makes the status quo more politically costly than change.

Addendum: The iBCI Investment Delusion - A Reality Check on Platform Fantasies and Transhumanist Dreams (November 29, 2025)

The Inconvenient Question Nobody Wants to Ask

Recent conversations with colleagues across the iBCI ecosystem have crystallized an uncomfortable truth that deserves explicit articulation: the nearly $1 billion invested in invasive brain-computer interfaces may be making two assumptions that cannot be easily defended.

While the original blog post above addressed market economics, regulatory frameworks, and reimbursement models, it stopped short of confronting the deeper strategic assumptions driving current investment decisions. This addendum addresses what was left unsaid.

The Narrow Market Reality Check

What Eye Gaze and Voice Recognition Already Solve

Before examining iBCI's purported advantages, we must confront an awkward fact: for the vast majority of paralyzed individuals, existing non-invasive assistive technologies work remarkably well.

Current state-of-the-art:

• Eye gaze typing: 20-40+ words/minute (expert users exceed this)

• Voice recognition: 150+ words/minute at natural speaking rates

• Eye gaze environmental control: Instant, accurate control of lights, beds, wheelchairs, thermostats

• Switch scanning: 10-20 words/minute even with minimal motor control

iBCI's "breakthrough" demonstrations:

• BrainGate handwriting decoder: ~90 words/minute

• Speech decoding from motor cortex: 60-78 words/minute

• Point-and-click cursor control: 2-3 bits/second

The performance differential is marginal at best, while the cost differential is extraordinary:

• Eye gaze system: $15,000, non-invasive, works immediately

• iBCI system: Neurosurgery, infection risk, requires expert teams, months of training, ongoing calibration

The True Clinical Niche Is Limited

The actual addressable market for iBCI—patients who genuinely need it over existing alternatives—includes only:

• Complete locked-in syndrome with no reliable eye control

• Late-stage ALS with both anarthria (loss of speech) AND ophthalmoplegia (loss of eye movement)

• Severe brainstem strokes affecting all voluntary movement including eyes

Global estimate: Perhaps 500-1,000 patients who truly cannot use eye gaze or voice recognition.

While helping these individuals is an urgent need, it is not a $10 billion market. This is barely a $50 million market, even at premium reimbursement rates. If we really want to help people, we have to honestly dig through assumptions to converge on a sustainable value proposition.

The Two Core Investment Fantasies

If investors understood these market realities, no rational capital allocation would flow to iBCI. So what explains the $1 billion invested? Two interrelated assumptions:

Assumption #1: The Platform Assumption - "One Hammer for Every Neurological Nail"

The pitch: "iBCI is a platform technology. Once we solve cursor control and communication, the same hardware/software can treat Parkinson's, epilepsy, depression, ADHD, enhance memory, improve executive function, boost attention, restore vision, cure addiction..."

The grounded reality: This is neurobiologically illiterate.

The Hammer & Wrench Metaphor

Medtronic, Boston Scientific, and Abbott have deployed implantable pulse generators (IPGs) for decades. Same basic hardware architecture. Yet each new indication required:

• Different anatomical targets (STN for Parkinson's, anterior thalamic nucleus for epilepsy, Brodmann Area 25 for depression)

• Different stimulation parameters (frequency, amplitude, pulse width, cycling patterns)

• Different patient selection criteria

• Separate multi-year clinical trials proving efficacy

• Distinct surgical approaches and expertise requirements

They could not use the identical hammer to hit every new nail. Each application was a separate product development cycle.

One iBCI investment assumption seems to be that a system optimized for decoding attempted hand movements will somehow also:

• Enhance working memory (requires prefrontal cortex, entirely different circuits)

• Treat depression (monoaminergic systems, limbic structures)

• Improve attention (distributed networks involving noradrenergic and cholinergic systems)

• Restore vision (requires organized retinotopic stimulation of visual cortex)

• Cure addiction (reward circuitry: nucleus accumbens, VTA, completely different neuroanatomy)

This is like claiming that because you own a wrench, you can now fix cars, plumbing, computers, and perform surgery.

Why Cursor Control "Works"

The cursor/typing task succeeds because:

1. Motor planning areas have clear topographic organization 

2. Attempted movement produces robust, decodable signals

3. The neural-to-output mapping is relatively stable over short timescales

4. The task is constrained and well-defined (2D or 3D coordinate space)

Do these conditions hold for complex cognitive functions?

Memory encoding involves:

• Distributed hippocampal-cortical networks

• Theta-gamma coupling across temporal and parietal regions

• Consolidation processes spanning hours to days

• Context-dependent reinstatement patterns

There is no simple "cursor control for memory." The computational architecture is fundamentally different.

The Cathedral vs. Skyscraper Error

The platform assumption commits a category error similar to assuming:

• A medieval cathedral architect could design modern skyscrapers (both are "tall buildings")

• A excellent Formula 1 driver could pilot commercial aircraft (both are "vehicles")

• An expert chess player would excel at poker (both are "strategy games")

The surface similarity ("brain interface") masks fundamental architectural differences.

Assumption #2: The Transhumanist Aspiration - "Direct Brain Access = Superhuman Capabilities"

The pitch: "Bypass the keyboard/mouse bottleneck! Direct neural interface = infinite bandwidth! Merge with AI! Become superhuman!"

This fantasy appears in two forms:

1. Medical fig leaf version: "We'll start with paralysis, but the real market is enhancement for able-bodied people"

2. Explicit transhumanist version: "Neural lace for AI symbiosis, downloading skills, telepathy, becoming godlike superintelligences"

The Fundamental Category Error: Confusing the Information Channel with Information Generation

The transhumanist pitch imagines: "I'll think 'send email to John about Q3 projections' and it happens instantly."

The reality: You still have to:

1. Formulate the thought clearly

2. Compose the actual message content (which requires... thinking)

3. Review it mentally (unless you want embarrassing errors sent)

This is exactly what voice dictation already does, minus neurosurgery.

The CPU Voltage Analogy

Expecting direct cortical access to dramatically enhance cognition is like expecting better computer performance by manually adjusting CPU voltages rather than using the keyboard, mouse, and monitor.

The interface isn't the bottleneck. Your cognition - which relies on the entire brain - is the bottleneck.

Ask yourself:

• Can you think faster than you can type what you're thinking? (Usually no)

• Can you formulate ideas faster than you can speak them? (Rarely)

• Is your constraint motor output or actual thinking? (It's thinking)

The Brain Already Has Optimized I/O

Evolution spent millions of years optimizing human information channels:

Input bandwidth:

• Visual system: ~10 million bits/second

• Auditory system: ~100,000 bits/second

Output bandwidth:

• Skilled typing: 150+ words/minute

• Natural speech: 150-200 words/minute with rich prosody, emotion, context

What exactly would direct cortical readout improve?

The "Download Kung Fu" Fallacy

The Matrix fantasy—downloading skills directly to the brain—reveals profound misunderstanding of how expertise works.

Kung fu expertise IS:

• Specific patterns of synaptic weights in cerebellar-cortical-basal ganglia loops

• Built through years of practice-dependent plasticity

• Encoded in the physical structure of neural circuits

You cannot bypass this with bandwidth. There is no "kung fu file" to download. The skill is the neural circuitry itself, which requires time-dependent biological processes to develop.

Similarly:

• Musical expertise requires cerebellar timing circuits refined over thousands of hours

• Language fluency depends on probabilistic predictions across distributed cortical networks

• Mathematical intuition emerges from years of pattern recognition in prefrontal-parietal circuits

Direct neural access doesn't eliminate the need for learning. It doesn't even accelerate it.

Why "Superhuman" Enhancement Fails

The enhancement fantasy fails because:

1. Human cognition is already the limiting factor, not I/O bandwidth

2. Expertise comes from learned cortical representations, not hardware upgrades

3. Skill acquisition requires practice-dependent synaptic plasticity, not data transfer

4. Consciousness and executive function are emergent properties we barely understand

Adding more neural recording channels doesn't make you think faster, just like:

• A faster internet connection doesn't make you write better emails

• A higher-resolution monitor doesn't improve your ideas

• A mechanical keyboard doesn't increase intelligence

The Wizard Hat Proposition

Elon Musk has been explicit about the real goal: not helping people with paralysis, but achieving "human-AI symbiosis" as an existential response to AGI.

Without casting any doubt on the good-hearted nature on DJ and the Neuralink clinical teams in their goal of providing a novel medical device to help people with quadriplegia, this instead is a response to Musk's own words that imply the medical applications are the regulatory fig leaf—the FDA pathway that makes invasive human experimentation acceptable.

The strategy:

1. Get FDA approval for medical indication (tetraplegia)

2. Generate spectacular demos for press coverage

3. Gradually expand claims toward "enhancement"

4. Eventually offer "cosmetic neurosurgery" to wealthy early adopters

One can reflect on the language of "bandwidth" and "symbiosis," versus, "clinical benefit" and "lived experience."

The Four Explanations for $1B in iBCI Investment

Given the narrow true market and the platform/enhancement assumptions, how did nearly $1 billion flow into iBCI? Four possibilities:

4.1 What Do Investors Believe?

Some investors may truly believe:

• The platform will magically generalize across neurological conditions

• Direct brain access will enable superhuman cognition

• "Neural data" itself has massive value for AI/pharma

• "Let the future figure it out" (hedging bets that something valuable will come out of it)

They're betting on sci-fi intuitions rather than biological reality.

4.2 Betting on Medtech Acquisition

Some investors may be counting on acquisition by Medtronic/Boston Scientific/Abbott before economic reality sets in.

The problem: Big medtech has no incentive to validate inflated valuations. Their strategy is:

• Let startups burn through venture capital, Series D, E,...Z

• Watch them navigate FDA and discover real market size

• Wait for desperation valuations when runway hits 6 months

• Acquire devalued assets for $100-200M

• Integrate into existing sales channels

Isn't it more likely that iBCI startups will be picked over by scavenger seagulls, than acquired as unicorns?

4.3 The Telepathy Fig Leaf - Real Play is Consumer Enhancement

Medical indications are the FDA pathway. The real market is:

• Wealthy biohackers paying $200K-$2M for "cognitive enhancement"

• Tech billionaires wanting "neural augmentation"

• Wealthy despots seeking exclusive technology

• Medical tourism in countries with lax regulation

This is the space tourism model: You don't need millions of customers if you can find 100-500 ultra-wealthy individuals willing to pay premium prices for exclusive access to novel technology.

This could sustain companies indefinitely—not as healthcare businesses, but as luxury transhumanism theater.

4.4 Prestige Play - Not About ROI

Some investors treat iBCI like space tourism or America's Cup yacht racing:

• Prestige and visibility matter more than returns

• Association with "moonshot" technology provides reputational value

The Counterpoints

The Medtech Vulture Strategy (Against 4.2)

Big medtech companies have seen this movie before. The 2010-2015 neurostim startup wave crashed against the same rocks. They learned:

• Don't overpay for unproven markets

• Let venture capital fund the expensive FDA trials

• Wait for realistic valuations when desperation sets in

Medtronic/Boston Sci/Abbott etc will not bail out any of the current iBCI startups at a $2B valuation when they can acquire any one carcass for $150M.

The Infinite Demo Loop (Against 4.3)

Is this a perpetual demonstration machine?

The cycle:

• Demo 1: Monkey plays Pong → $1B valuation, massive press

• Demo 2: Patient moves cursor → $3B valuation, TED talks

• Demo 3: Patient types with thoughts → $5B valuation, TIME cover

• Demo 4: Patient controls robotic arm → $8B valuation, Nobel speculation

Each demo:

• Generates 6-12 months of hype

• Resets the investment cycle

• Buys another funding round

• Delays questions about sustainable business model

This can continue indefinitely as long as:

• New demos remain technically impressive (even if not clinically transformative)

• Press coverage remains credulous

• Some billionaires remain willing to pay for exclusivity

Like space tourism, you don't need scale if you have spectacle.

However: Even this strategy requires periodic "wins" to sustain belief. Eventually, the demos must translate to:

• Actual revenue

• Meaningful patient access

• Clinical outcomes beyond research participants

Given that BrainGate has been demonstrating cursor control for 20 years without commercial deployment, the infinite demo loop starts to lose credibility.

The Inevitable Writedowns

Unless companies can demonstrate:

1. Sustainable revenue from the narrow true market (locked-in patients), OR

2. Regulatory approval for cosmetic/enhancement applications, OR

3. Genuine platform expansion to other neurological conditions

There will be massive writedowns in 5-10 years.

The math is inescapable:

• $1B invested

• True market: 500-1,000 patients globally

• Realistic reimbursement: $100-200K lifetime per patient

• Total addressable market: $50-200M

• Timeline to profitability: 15-20 years

This does not generate 10x returns on $1B investment.

What Would Actually Be Worth the Investment?

If you're going to do neurosurgery and implant electrodes in someone's brain, it seems we should offer a benefit dramatically better than what eye tracking or voice control already provides.

Applications that might justify invasive intervention:

1. Restoring dexterous hand manipulation - Fine motor control that requires motor cortex precision

2. Closed-loop control of electrical stimulation (FES to periphery or SCS) - Reanimating paralyzed limbs with natural movement

3. Bilateral arm control with sensory feedback - Not just moving a robotic arm, but feeling through it

4. True sensory restoration - Not "detecting touch," but naturalistic tactile perception

5. Ambulation without exoskeletons - Actually walking, not being held up by machinery

All of these are dramatically harder than cursor control, require orders of magnitude more degrees of freedom, demand stable sensory-motor integration, and cannot rely solely on visual feedback loops.

Current iBCI companies and their investors appear to be deferring the hard problems.

Where Are We Entering 2026?

The current iBCI pitch appears to be built on:

1. Overstating the limitations of existing assistive technology

2. Magical thinking about "platform" generalization across neurological conditions

3. Transhumanist fantasies about bandwidth enabling superintelligence

4. Hope that spectacular demos will sustain investment indefinitely

Are these foundations solid?

The narrow true market exists—perhaps 500-1,000 patients globally who genuinely cannot use eye gaze or voice systems. That market deserves to be served.

Does that by itself justify $1 billion in investment and $10 billion in expected returns?

The platform assumption doesn't recognize that neurobiology doesn't work that way. Motor planning cortical arrays won't cure depression. Cursor control algorithms won't enhance memory. Each clinical application requires different targets, different signal processing, different validation.

The transhumanist assumption misunderstands that the bottleneck isn't your fingers or eyes—it's your cognition itself, your overall brain itself- the entire brain. Direct neural access doesn't make you think faster or better, any more than a faster internet connection makes you write better emails.

The question is: Will the industry acknowledge these realities and pivot toward genuine clinical needs (dexterous manipulation, sensory restoration, FES control)? Or will it continue chasing platform and enhancement assumptions until the inevitable writedowns?

The answer will determine whether iBCI becomes a transformative neurotechnology or a cautionary tale about hype-driven investment cycles.

Coda: The Road Not Taken

There actually is a path to giving investors their 10x return and to broadening the application of iBCI far beyond the narrow cohort of people with severe motor impairment. However, I have not heard any company thus far articulate it. While you may have guessed by now what it is, I'll gladly share my perspective if you're curious. The answer requires thinking about brains differently than the entire industry currently does. Not as machines to be read, but as something else entirely. For those ready to explore this send me an email at mdserruya @ icloud . com and put 'neurodelphus' in the subject header. May you be at ease.