Sparks of change

Electroceuticals are poised to revolutionize the world of medical treatments.

The growing need for minimally invasive procedures and rising chronic diseases is resulting in higher demand for electroceuticals. These implanted devices deliver electrical impulses that stimulate the nervous system to proactively detect and treat diseases. With minute electrodes attached to nerves, these devices can also control nerve impulses and monitor neuroactivity. Electroceuticals can address a wide range of common and complex disorders with the help of bioelectronics that target specific regions of peripheral nerves. 

Why do electroceuticals look promising? These devices can be used to treat many diseases—including spinal cord injuries, hypertension, heart conditions, and gastrointestinal diseases—creating a better quality of life for people. Moreover, electroceuticals can be used to monitor diseases in a way that helps improve a medical provider’s understanding of diseases. This will aid in making therapy regimens even more effective.

Growing concerns

Device-related infections, hardware or software failures, and external interferences can affect effective treatment.

The human body comprises nearly 86 billion neurons and 150 trillion synapses. Manipulating groups of neurons and managing huge volumes of neural information flowing through these circuits can be really challenging. It’s only through this effective mapping that electroceutical-based treatments can be effective. Electroceutical devices allow for sophisticated monitoring, diagnosis, and treatment. However, the implications if these devices were to malfunction are serious. Hardware failures such as issues with the battery, capacitor, and sealing are a leading cause of device malfunctions. Simultaneously, the software of these devices has been developing at a fast pace. Given the criticality of these devices to human lives, it is vital to ensure the software is reliable and bug-free for safe operations while also complying with regulatory requirements and standards.

External sources, both within and outside the hospital environment, can interfere with the proper functioning of electroceutical devices. To overcome this challenge, it's essential to ensure electromagnetic interference compliance when designing these devices. Although the risk of hacking these devices represents a small part of security vulnerabilities, recent studies have demonstrated security attacks on electroceutical devices. Hence, companies need to leverage an appropriate cybersecurity framework when designing and developing these devices.

Four-fold approach

Take the following measures to overcome challenges in the design and development of electroceuticals.

Miniaturization

Electroceutical devices can be clunky and large, requiring stimulation of large areas of neural tissue to achieve the desired results. The efficacy of these devices is still determined by trial-and-error methods. What’s needed is deep miniaturization of electrodes and chips that can interface with a single nerve, using technologies such as application specific integrated circuits or field programmable gate arrays. Additionally, there is a demand for wireless devices, eliminating the need for traditional batteries. 

Miniaturization, although a monumental task involving the shrinking of systems to micro- and nano-levels, is crucial for efficient electroceuticals. A millimeter-scale, nerve-stimulating implant that engineers from Stanford University have developed outperforms other devices of similar size in its form factor. Interestingly, electroceuticals can be administered through a needle, eliminating the need for invasive surgery. 

Low-power design 

Developing miniaturized sensors and advanced micro-electromechanical systems is met with one significant obstacle—the limitation of power. Deep miniaturization requires smaller, smarter devices with more functionalities that, in turn, necessitate larger batteries. However, batteries have fixed energy density, limited lifetimes, and can cause chemical side effects. Furthermore, the size of the battery determines the overall size of the device. This makes the designing of such devices extremely challenging. 

Companies can develop battery-less devices that rely on humans or the environment for energy, although this energy alone would be insufficient for complex tasks. They can design battery-less electroceuticals that use different energy harvesting mechanisms that provide enough energy for complex tasks. For instance, they can design integrated circuits to operate in an extremely low-power mode and utilize low-voltage design techniques to complete complex tasks. 

Integrated electroceuticals and soft bioelectronics

Combining soft bioelectronics and deep miniaturized electroceuticals enables seamless integration into curvilinear, sensitive skin, or internal organs. There’s been significant progress in fabricating and characterizing soft and stretchable sensors for monitoring vital signs. However, there are different challenges and requirements in electroceuticals that need to be overcome. 

To succeed, designs need to integrate electronics, power sources, and suitable mechatronic materials into a small form factor. For instance, when implanting a device into the body, it must not only have the right functional properties but also exhibit mechanical properties that match those of native tissues or organs. If the material is too soft, it may succumb to wear and tear and degrade quickly. Conversely, if it is too hard, it may cause damage to the surrounding tissue. Hence, resolving this technical contradiction during design is crucial. 

In-silico testing of electroceuticals

For assured safety and efficacy of electroceuticals, it needs to be thoroughly tested on humans. Typically, this is done in phases during clinical assessments before these devices reach the market. However, due to complex disease patterns and variability in administration of treatments, these devices may perform well in tightly controlled laboratory tests but fail during clinical trials. 

Moreover, extensive and intricate invitro experiments, animal testing, and subsequent clinical trials often escalate the cost of device development to unsustainable levels. This can stifle innovation and drive healthcare costs to unprecedented levels. Successful outcomes in animal testing do not guarantee the same outcomes in humans. Therefore, the elimination of animal testing is a significant aspect, underscoring the importance of in-silico testing to get things right from the outset.

Instead, it would be effective to develop mathematical models of organ behavior in response to different stimuli. These models can be used to design and test optimal signals that can eliminate disorders. Scientists can collaborate on developing organ models and therapies, while also establishing connections with device and technology manufacturers. They can create cloud-based solutions that leverage machine learning and model-based algorithms and test them using in-silico, cloud-based simulations. That said, given the complex nature of the human body, researchers should work in tandem to tackle intricate challenges that electroceuticals may present along the way.

Next steps

Ecosystem partnerships as the forerunner for success

The design and development of electroceuticals calls for interdisciplinary collaboration among domain experts. For this, providers of medical devices, pharmaceuticals, and healthcare services must consider ecosystem partnerships.

With TCS as a partner, electroceutical companies can leverage TCS’ domain expertise and technological prowess, while also protecting their intellectual property and complying with stringent regulatory requirements. TCS’ Bringing Life to Things™ serves as a foundational framework in the design and development of such smart and connected medical devices that leverage IoT, AI, ML, and bio-digital twin technologies. With prolonged development cycles and zero room for error, it’s these collaborations that will chart the course for success for electroceutical companies.