What some experts call in the body wearables – either implantable or ingestible – are becoming more widespread in medical applications in line with the trend for smaller and smaller devices. The challenge for manufacturers is the need for them to be small enough to be safe, but big enough to hold the necessary electronics, while also being robust enough to resist the environment in which they are placed.

New implantable medical devices

This year’s global tech event CES showed no shortage of new and evolving innovations, and while smart wearables placed outside the body seemed to get the most limelight, the technology for less visible in-body devices is developing just as quickly. With promises to treat issues ranging from Parkinson’s disease to sleep and gastrointestinal disorders, the market for implantable and ingestible devices is on the rise.

Take the most recent CES 2025 Innovation Award. While typically kidney patients are required to visit a clinic several times a week to receive dialysis treatment, this combined solution of a portable dialysis machine and implantable device enables patients to manage their dialysis without leaving home. While its development is still ongoing, it is expected that integration with artificial intelligence (AI) and sensors will enhance precision and monitoring, thus able to prevent complications before they arise.

This other research project on a smart module for implantable, wearable, portable, or a bedside artificial kidney is in fact an implantable chip, equipped with sensors,that can be used in artificial kidneys, and which uses radio waves to get rid of toxic waste.

Sleep apnoea sufferers could also benefit from recent and new implantable devices. Obstructive sleep apnoea is where sufferers stop breathing suddenly when they sleep due to a relaxation of the throat and tongue muscles which then block the upper airways. Current treatments include the use of a breathing apparatus that is worn at night, but these can be cumbersome and uncomfortable. More recent technologies include electronic implants in the body that send signals to the hypoglossal nerve which contracts and moves the tongue to allow more air to pass. A hand-held remote control allows users to turn it on or off and even modify stimulation levels.

Deep brain stimulation technologies are also showing great promise to treat a range of neurological disorders such as epilepsy, obsessive compulsive disorder and Parkinson’s disease. With deep brain stimulation, a small electrode is implanted in the brain and sends electrical pulses to specific areas to modify neural activity. It is powered by a small battery pack placed in the chest wall and connected by an insulated extension wire. The level of stimulation can be controlled by the battery pack.

Implantable devices such as brain-computer interfaces (BCIs) are also gaining traction, promising to treat a range of conditions from chronic pain management to epilepsy and paralysis. (Learn more about  BCIs in The next frontier for brain computer interfaces ). A joint IEC and ISO subcommittee was specifically set up to standardize BCIs. While brain implants or medical devices are not included in its scope, it does aim to standardize much of the related technology and provide foundational support such as defining the common terms and vocabulary.

Eating electronics

Ingestible electronic sensors have the potential to revolutionize gastrointestinal (GI) diseases which affect millions of people around the world. GI disorders such as inflammatory bowel diseases, colorectal cancer and gastroesophageal reflux disease present a significant burden to health systems, not to mention quality of life for sufferers, and their complex and dynamic nature make diagnosis and treatment challenging.

Ingestible electronics can significantly reduce this burden by providing real-time feedback on what is going on in the body. Sensors can measure aspects such as pH variations and a number of biomarkers making it possible to identify flare ups before they happen. Pressure sensors can detect movement patterns throughout the gastrointestinal tract and measure different levels of neurotransmitters, giving greater insights about the GI environment, as well as its mechanisms and patterns. Not only can they provide more precise information in real time, they are far less invasive than current methods such as intranasal tubes or colonoscopies.

These technologies offer enormous potential to advance medical diagnoses and treatments in a more personalized and patient-friendly way. They use a variety of different kinds of sensors to detect pH levels, biomarkers, gases, movement and pressure. An example is the Seropill, an ingestible biomarker sensor that can detect and quantify serotonin levels and transfer the data wirelessly via Bluetooth to a mobile device.

Standards can and should play a role

However, challenges remain for ingestible devices to be safely and widely used. They need to be able to withstand the environment inside the human body for starters, while sending data across bodily tissues, all the while not posing any safety or toxicity risk to the patient. Research and development efforts are attempting to tackle these challenges, but it’s not easy. For example, wireless power transfer technologies have been explored to eliminate the need for batteries to power the devices, thus removing any fears of possible toxic leakages, but transmission is not always reliable. Alternative techniques are being explored including near-field magnetic induction and ultrasound.

All of these areas hold enormous promise for global healthcare, and for which specific international standards will play a fundamental role. Some standards already exist to support the innovation, development and testing required, providing a solid foundation on which the technology can evolve.

IEC Technical Committee 124 provides standards in the field of wearable electronic devices and technologies which includes materials and devices that are patchable, implantable, ingestible as well as those made from electronic textile materials. For example, IEC 63203-101-1 provides frequently used terminology used when one is referring to technologies that are on, near or in the body.

Sensors are the common denominator when it comes to any in-body device. IEC TC 47 publishes key standards for the design, use and reuse of sensors, enabling users to measure their performance. In addition, IEC TC 62 prepares standards for medical equipment, software and systems, and is starting to standardize the use of AI for medical purposes.

Conformity assessment helps to ensure sensors and other materials are of high quality, are safe, accurate and reliable. IECQ, the IEC Quality Assessment System, offers an international certification process to demonstrate that electronic components, assemblies, processes and related materials conform to declared technical standards and specifications. But as ingestible and implantable electronics get closer to being widely used for medical treatment, more standards will be required to ensure the safety of patients.

Source：IEC (International Electrotechnical Commission)