One of the significant inventions for the healthcare industry lies in “smart pills,” which promise to propel the industry forward. “Smart pills” refer to miniature electronic devices, designed in the mold of pharmaceutical capsules but perform highly advanced functions such as sensing, imaging, and drug delivery. With its market size projected to reach USD 7.5 billion by 2030 [1], smart pills are revolutionizing the healthcare industry.
Reimagining healthcare treatments
The classification of smart pills as ingestible sensors distinguishes them from implantable or wearable sensors. Smart pills may include biosensors or images, pH, or chemical sensors. One of the ways this technology is used is with dissolvable microchips. Tech companies have made this hardware from metal-based minerals (such as copper and magnesium) that are easily absorbed by the body. When the sensor is swallowed, electrolytes in the body activate a signal transmitted to a battery-operated. The patch sends a signal to a smartphone or software on a server that transmits the information to a pharmacy or doctor’s office. The sensors will then identify information such as the accuracy of dosage, time of intake, and when the next intake for the patients would be.
The technology is aspired to help doctors track their drug regimen compliance, increasing patient adherence. With an estimated saving of around USD 100 – 300 billion annually [2], smart pills aim to revolutionize healthcare by monitoring vital signs and treating gastrointestinal orders.
Revolutionizing vital sign monitoring and beyond
The creation of ingestible devices dated back to the 1980s. NASA and Johns Hopkins Applied Physics Laboratory developed a "thermometer pill" to record the core body temperature of astronauts in spacesuits. This presented a risk of overheating from body heat and humidity trapped inside the suits. The device successfully transmitted a signal from astronauts' bowels to NASA computers on Earth. These pills were also used to monitor astronauts' circadian rhythms based on small changes in their core body temperatures.
Earlier ingestible devices have primarily been able to monitor only one thing at a time. Yet, a more recently developed device by Proteus Digital Health offers an FDA-approved microchip pill tracking medication-taking behavior and body responses. This microchip pill benefits individuals with heart issues, schizophrenia, or Alzheimer's disease.
Vital sign monitoring is essential in guiding treatments, confirming effectiveness, and making critical life-saving decisions. Yet, smart pills’ most common use has been core body temperature monitoring. While regular checkups use thermometers, more critical situations would need more accurate inner body temperature sensors. A noteworthy innovation is a pill with a temperature microchip and antennae. This pill stays intact through the entire gastrointestinal tract, transmitting this data using radio to a user base component, then communicating with smart devices or computers. This microchip-embedded pill can be used in monitoring patients with chronic conditions, during surgeries, in critical care settings, or when studying physiological responses during physical activities such as sports performance.
HQ Inc. has developed the CorTemp Ingestible Core Body Temperature Sensor. The pill is mainly used by firefighters, athletes, soldiers, and astronauts, which helps transmit real-time body temperature. HQ Inc. is developing a consumer version to communicate with a smartphone app wirelessly. With projections to reach USD 11.55 billion by 2027, the global vital signs monitoring devices market continues to grow and brings numerous benefits to the healthcare industry [3].
A more cutting-edge alternative to endoscopy?
Gastrointestinal disorders affect a large portion of the population. With an estimated 2276.27 million prevalent cases and around 2.56 million deaths [4], this issue highlights the need for better diagnostic and treatment methods. Conditions such as gastroesophageal reflux disease and gastroparesis, caused by abnormal gut movement, make monitoring food passage speed in the digestive system essential. Existing methods, such as invasive endoscopies and X-ray scans, often need repetitive hospital visits. Thus, a new "smart pill" –with three-fold more magnitude than what microdevices offered – allows for a broader scope, non-invasive, and highly accurate alternative.
Smart pills are transforming gastrointestinal disorder diagnosis and could potentially replace endoscopies. An endoscopy probe is traditionally inserted into a patient’s esophagus and, subsequently, the upper and lower gastrointestinal tract. There is a risk of perforation or tearing of the esophageal lining, and the patient faces discomfort during and after the procedure. Specifically, 30.2% of participants reported severe discomfort, while 23.0% showed poor endoscopy tolerance [5]. Unlike endoscopy, a smart pill is easy to swallow and captures images without much preparation, giving doctors a comprehensive view of the digestive system.
Khalil Ramadi, a bioengineering professor at NYU Abu Dhabi, and his team have created a non-invasive system to diagnose and treat gastrointestinal motility disorders. To track the movement of an ingestible “smart pill” through the gastrointestinal (GI) tract, the researchers have generated 3D magnetic field gradients using high-frequency electromagnetic coils that encode each spatial point with a distinct magnetic field magnitude.
The field magnitude is measured and transmitted by the “smart pill” to determine its precise location, which is then communicated to a smartphone using Bluetooth technology. The wireless device senses and sends its local magnetic field to a receiver outside the body. This technology, which can be incorporated into everyday items, allows continuous monitoring of food movement in the digestive system as patients go about their daily activities, improving the diagnosis and treatment of gastrointestinal disorders.
What the future holds
Although certain pills are currently on the market, it will likely take a while before these technologies become widely adopted. The FDA plays a crucial role in ensuring the safety of these pills for consumption and monitoring potential complications arising from the use of novel technology. Once these technologies gain FDA approval and popularity, this will lead to greater availability and enhanced patient experience. Research efforts are not only focused on overcoming existing challenges but also on devising strategies to encourage greater acceptance of smart pills.
