Closed-loop neuromodulation devices are an exciting frontier in the development of electrostimulation therapies to treat chronic neurological conditions, with devices now starting to appear on the market. By using real-time biomarker readings to adjust the neurostimulation parameters on-the-fly, they make it possible to tailor the therapy to the individual, with benefits in terms of efficacy, safety and patient experience.
In many cases, companies are starting their journey towards closed-loop technology from the open-loop equivalent. But making this transition requires adding sensing functionality, developing the algorithms, and validating the safety and effectiveness of the resulting therapy parameters across all edge cases – none of which is trivial.
Taking account of power demands
One of the most significant hardware challenges in moving from open-loop to closed-loop is accommodating modified power demands into the device, within the constraints of the available supply.
For example, closed-loop devices will normally require extra power for data collection, compression and communication, which on the face of it would decrease battery lifetime. But there’s also an opportunity to reduce power requirements by using algorithms to avoid unnecessary stimulation, or by carrying out some processing externally.
Complicating these decisions further is the fact that in a closed-loop system, therapy levels can adapt to the user’s needs, so there’s bound to be more uncertainty over power usage anyway. This all requires a more complex power architecture, especially if you’re moving towards are chargeable setup rather than a primary cell. The electronics needed for simultaneous sensing and stimulation, using the same or separate electrodes, are another important consideration.
Successfully managing productisation
Making all these decisions involves numerous trade-offs, which is best done using a full ‘systems design’ approach. This means integrating every aspect – hardware, software, sensing, stimulation and power management – into the design of a closed-loop neuromodulation device, all while keeping an eye on regulatory demands, the challenges during scale-up, and post-market optimisation.
By doing that, it’s possible to successfully navigate the path from a preclinical development system all the way through to a product that’s ready to be launched as a medical device. Navigating that path with the minimum of iterations is one of our skills at TTP, thanks to our knowledge and experience of medical devices, software engineering, signal processing and patient experience.
Read the e-book: Closing the loop in neuromodulation
To read more about our approach, and how TTP’s systems thinking could help ensure that you successfully transition your closed-loop concept to a market-ready medical device, read the e-Book, “Closing the loop in neuromodulation therapy".
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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