Closed-loop systems promise smarter, more personalised neuromodulation therapies, but only if they are guided by the right signals. Selecting a biomarker that can reliably reflect the patient’s physiological state is often where neuromodulation programmes gain their competitive edge, or conversely, lose momentum. It’s a decision that affects everything downstream: device complexity, clinical adoption, patient experience, and ultimately therapeutic success. This insight piece explores how to navigate that decision and integrate biomarkers effectively into closed-loop neuromodulation devices.
Defining an effective biomarker: what good looks like
Design of a closed-loop neuromodulation device starts with the biomarker. Reliable measurement of a clinically relevant biomarker enables continuous monitoring of the patient’s condition, precise titration of therapy, efficient delivery of treatment on demand, and the ability to track how patients respond to treatment guiding how the therapy should be adjusted to achieve the best outcomes. In this way, a biomarker provides deeper insight and tighter control over the condition and the therapy, ultimately improving clinical outcomes.
A biomarker can be something familiar and easy to measure, like heart rate or a blood oxygen level, or it can be an electrophysiological signal from the brain, nerves, or spinal cord. The key challenge is choosing a biomarker that strikes the balance between being specific, sensitive, and stable enough to provide reliable, clinically meaningful feedback, yet simple to use and feasible to deliver at scale.
Biomarker discovery
Biomarker discovery requires significant investment, long timelines and often comes with uncertain outcomes. Selecting the wrong biomarker, or failing to demonstrate that it’s truly reliable and clinically meaningful, can stall programs and weaken competitive advantage. Yet, the potential upside lies in creating stronger IP, clearer clinical differentiation, and a foundation for future innovations.
Discovery usually begins in pre-clinical studies, where a number of questions come into play. The choice of animal model is crucial for ensuring results translate to humans. Variability between individual subjects often means some level of personalised calibration is needed. Stability can be affected by medication, anaesthesia, sleep state, or even small difference in electrode placement. And specificity can also be challenging, as many biomarkers appear in both healthy and disease states.
Ultimately, extensive research and testing is required to prove that a biomarker can genuinely guide therapy and deliver a clear therapeutic benefit.
Integrating biomarkers into an existing therapy workflow
Once a biomarker has been identified, the next challenge is integrating it seamlessly into a therapy without disrupting clinical practice, patient experience, or device performance.
For clinicians, the sensing workflow must be intuitive, easy to interpret, and compatible with existing procedures. Any added complexity risks slowing adoption or reducing confidence in the system.
From the patient’s perspective, sensing should introduce no additional burden. This means avoiding more hardware, extra maintenance, new routines, or charging the battery more often.
At the device level, the sensing stack needs to integrate cleanly with implant’s electronics, mechanical housing, and data pathways without creating architectural instability or adding excessive cost. It must also remain reliable over time, protected against humidity, sensor drift, material degradation, and physiological variability.
Power consumption is another critical factor. Biomarker sensing can become a major energy driver reducing device longevity or increasing charging frequency. Low-power sensing electronics and efficient signal processing pipelines are essential to keep long-term therapy possible.
Bringing a biomarker into a real-world therapy ecosystem is therefore as much a systems-engineering challenge as it is a scientific one: the solution must be clinically intuitive, patient-friendly, power-efficient, platform-compatible, and robust over the full device lifetime.
Read the e-book: Closing the loop in neuromodulation
At TTP, we’ve developed considerable expertise in this field and supported clients at every stage of the journey, from early biomarker exploration through to late stages of product development.
To find out more, get a copy of “Closing the loop in neuromodulation therapy” here.
About TTP's Neurotechnology team
From proof-of-concept studies to manufacturing scale-up, TTP's dedicated neurotechnology consulting services can help you rapidly engineer advanced neuromodulation solutions, guiding you every step of the way. With our multidisciplinary team of engineers, scientists and human factors designers, you can hit the ground running. Combining deep expertise with a proven track record in end-to-end product development, we will help you create technologies and devices that push the limits of what's possible in neurotechnology. Find out how our neurotechnology product development team can help you start strong and finish ahead.
TTP's Neurotechnology team is part of a broader MedTech team. Learn more about TTP's approach to medical device design and development and our medical device consulting services.
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