The field of implantable brain-computer interfaces (BCIs) is evolving rapidly. After decades of impressive academic research, only a handful of companies are now moving from the lab toward durable, implantable devices intended for everyday use. The next decade will be decisive: clinical success will require not just impressive hardware, but the ability to deliver meaningful and measurable improvements in people’s lives.

At Paradromics, we are engineering our platform to capture brain activity at the highest data rate, achieved by recording from individual neurons, because higher data rates will lead to a more natural and seamless experience for the BCI user. But evaluating this claim will require the industry to critically evaluate both device capabilities, and how success is measured in terms of making an impact on users’ lives.

Translating engineering metrics to seamless user experiences

Outside of clinical use, BCI performance is evaluated using engineering metrics like data rate, signal fidelity, latency, durability, and number of electrodes. These metrics are important in showing what the technology can do in the lab. 

As the field moves into broad clinical trials and real-world deployment, the final validation will come from the people who use the device. While signal quality and data transmission rates provide a foundation, true clinical evaluation centers on a user’s ability to restore independence through communication, computer control, and daily task management, carried out efficiently, reliably, and with dignity.

Fortunately, Clinical Outcome Assessments (COAs) provide a formal toolkit to measure how BCI users feel, function, and survive. These frameworks support the maturation of BCI as a health technology. But COAs must evolve to reflect modern digital dependence and fully capture the benefits of BCI use.

Traditional clinical assessments need to reflect the realities of modern digital life

Tasks like paying bills online, scheduling telehealth appointments, emailing loved ones, and managing medical records have become increasingly digital, but traditional measures of “daily living” used in health care and rehabilitation were created before digital tasks took over so much of our lives.

This limitation has been recognized in a new framework called the Digital Activities of Daily Living (DADLs). DADLs extend traditional self-care and functional measures to include digital tasks like logging into a portal, managing email, scheduling online appointments, navigating social platforms, or controlling smart-home devices.

It is critical that digital metrics such as the DADL be integrated into outcome assessments of BCI clinical studies, particularly as many contemporary BCI systems interface directly with digital environments, including screens, software platforms, and connected devices.

Paradromics is building AI-enabled BCIs so users can regain independence, communicate freely, and engage fully in today’s digital world.

True clinical impact requires completing everyday tasks with ease

When evaluating the ability to complete digital tasks, it’s important to note the distinction between whether or not the task can be completed and how easily and how well the task can be performed. 

Five years ago, sending a single tweet via BCI could make headlines. But the bar is much higher now; we must evaluate how long and how much effort it took to type the tweet. 

BCIs that support typing below 20 characters per minute allow basic communication, yet fall far short of natural interaction. To support everyday use, BCI communication rates must approach or match the speed and fluidity of human communication. In the future, BCIs need to be judged much more critically by not only evaluating the ability to perform a task, but also by performance quality metrics that reflect speed, ease, accuracy, cognitive load, and the ability to interact socially and emotionally in real time. 

To achieve human-level performance and user autonomy, Paradromics engineered the Connexus BCI to exceed standard clinical baselines.

BCI experiences must feel natural to create true human connection.

Greater independence and performance ultimately leads to a more seamless BCI experience. For users, this means the ability to thrive day to day and to connect and communicate with friends and family in real time.

The importance of seamless experiences is well described by van Balen et. al 2025 with the introduction of Relational Personhood. They note that when someone loses the ability to speak or express themselves, others may unconsciously see them as less “present.” From this perspective, restoring the ability to communicate means restoring identity, dignity, and social connection.

For an implantable BCI to operate at the speed of real, lived experience, it needs a data link that’s fast, rich, and responsive. When information flows freely and instantly, intentions can be expressed in real time and conversations regain rhythm, emotion, and presence. When bandwidth is poor or latency is high, connection fractures and conversations become disjointed, delayed, and hollow.

Paradromics treats high-bandwidth and low-latency as clinical necessities because interface speed directly correlates to BCI user outcomes.

Measurement matters for regulators, payers, and patients

As BCIs move from labs into people’s homes, anecdotal stories are no longer enough. Regulators will require evidence that devices are safe, reliable, and deliver meaningful benefit, while payers will only support devices that demonstrably improve users’ lives compared with existing alternatives. That benefit must be measurable not just in lab tests, but in real-world impact on daily life.

Well-structured COAs will provide interpretable evidence that regulators can approve and payers can justify covering. Without this rigor, “user focus” risks being a marketing slogan rather than a core design principle.

Building a future where BCI restores everyday independence 

BCIs are transitioning from experimental neurotechnology to real-world healthcare. As Paradromics deploys implantable, high-bandwidth BCIs in FDA IDE approved clinical trials, the standards and ethical frameworks will be further developed, refined and advanced to drive enduring clinical impact. 

Paradromics envisions a future in which someone who has lost speech can once again converse naturally with loved ones. Where digital independence is possible again and where social isolation ends, dignity returns, and technology enables human connection.

Click the link to read Matt Angle’s in-depth take on COAs on Substack.