Vital Signs Submits IPO Prospectus: Pioneering the Future of Digital Health Monitoring

As people’s living standards continue to rise, their concepts of health have undergone significant changes. In the past, individuals would only visit hospitals for check-ups after falling ill, where healthcare providers would run a series of diagnostic tests and interpret the results to determine the nature of their conditions. Today, public attention to health has far surpassed those basic needs of the past. Understanding one’s own physical condition has become a fundamental aspect of modern health consciousness.



What is meant byVital Signs？

“Vital Signs,” as the term implies, are physiological indicators used to assess the severity and criticality of a patient’s condition. In other words, monitoring vital signs provides clinicians with objective data to evaluate an individual’s health status, and the analysis of these metrics can offer essential clues for disease diagnosis. Furthermore, vital signs help physicians gauge a patient’s recovery progress, thereby enabling continuous optimization of the most appropriate treatment plan. An individual’s vital sign parameters are not static; they vary dynamically with age, body weight, sex, and overall health status.

From the perspective of modern medicine, vital signs can be broadly classified into the following three categories:

1. Four Vital Signs

Human vital signs typically encompass four fundamental components: respiration, body temperature, pulse, and blood pressure. These four vital signs serve as the essential pillars for maintaining normal physiological functions in the human body; each is indispensable, and any abnormality in these signs can lead to severe or life-threatening conditions. Conversely, the onset and progression of certain diseases can directly cause corresponding changes in these four vital signs. In short, there is a close, bidirectional causal relationship between the four vital signs and human health.

2. The Fifth Vital Sign

In recent years, with the rapid development of modern medicine, new elements have been added to the medical definitions of vital signs.



In 2001, Professor Lynch M. published an article in the prestigious medical journal *J Intraven Nurs*, advocating that pain should be recognized as the fifth vital sign of the human body. The article pointed out that pain during treatment had long been an important yet overlooked indicator, and it is essential for clinicians to assess pain as the fifth critical vital sign. Only through objective assessment and effective management of patients’ pain can doctors and nurses better provide more humane treatment plans. The article further clarified that a successful pain control plan should include establishing a pain diagnosis, analyzing the causes of pain, optimizing analgesic regimens, and implementing non-pharmacological interventions, thereby maximizing patients’ treatment experience.

As early as 1995, James Campbell, President of the American Pain Society, proposed that attention should be paid to patients’ pain responses during treatment. At the 2001 Asia-Pacific Pain Forum, a broad consensus was reached among clinical scholars that “freedom from pain is a fundamental right of patients.” At the 10th Congress of the International Association for the Study of Pain (IASP) in 2002, it was explicitly stated that pain is a disease.

We all recognize that pain is a subjective experience for patients; therefore, objective assessment using pain scores is necessary: 0 indicates no pain, while 10 represents the most severe pain imaginable. According to large-scale epidemiological data from Europe, 19% of adults have experienced pain for more than six months, with more than two episodes in the past week and an intensity exceeding 5 points. Among these individuals, 46% report persistent pain, 56% experience intermittent pain, and 49% have suffered from pain for over two years. Furthermore, 21% are diagnosed with depression due to pain, 61% report reduced work capacity, 13% have changed their job roles due to pain, and 19% have become unemployed as a result of pain. In summary, it is both logical and essential to regard pain as the fifth vital sign.

3. The Sixth Vital Sign

Survey data from the U.S. journal PLOS Medicine indicate that more than one-third of cancer patients suffer from severe psychological disorders, yet very few of these patients receive adequate psychotherapy. Cancer has now become the leading cause of death worldwide, and the suffering associated with the disease, along with its high mortality rate, exerts a profound impact on patients’ psychological well-being. Psychological distress has been recognized as the sixth vital sign. To guide clinical oncologists in assessing and managing adverse psychological reactions in cancer patients, the National Comprehensive Cancer Network (NCCN) has developed specific clinical practice guidelines for the psychological assessment of all types of cancer patients.

Vital Signs Monitoring Device

How are vital signs data collected? In traditional medicine, it is widely recognized that the collection of vital signs data is predominantly conducted in hospitals. Various hospital departments are equipped with relevant vital signs monitoring instruments, such as electrocardiogram (ECG) monitors, blood pressure meters, and thermometers. These devices share several common characteristics: they are bulky and require specialized operation. With the continuous advancement of medical technology, vital signs monitoring instruments have undergone significant development and improvement, becoming more portable and easier to operate. As a result, accurate monitoring of many vital signs can now be performed without the need to visit a hospital. The following are some representative mobile medical monitoring devices:

1. Smart Health Scanner Scanadu Scout



This smart health scanner is no larger than a child’s palm and features an extremely user-friendly interface, allowing users to execute diagnostic commands via a mobile app. By simply placing the device against the forehead for 10 seconds, all relevant parameters are accurately recorded and transmitted to the smartphone. This mobile self-service medical diagnostic device encourages people to reevaluate and prioritize their physical well-being. With just a few simple steps, users can obtain precise measurements of key vital signs, including heart rate, skin temperature, blood oxygen saturation, respiratory rate, blood pressure, electrocardiogram (ECG), and emotional fluctuations. These data provide insights into one’s health status, enabling timely and appropriate adjustments.

The functions of this mobile medical device can be summarized into three main aspects: First, it enables individuals to better understand their physical condition through vital signs data. Second, it reduces the frequency of doctor visits and helps avoid unnecessary concern over minor issues. Finally, these data provide your private physician with more comprehensive physiological information, facilitating a thorough diagnosis of your condition.

2. ZIO Patch Mobile ECG Monitor



The ZIO Patch, a mobile ECG monitor developed by iRhythm, a San Francisco-based company in the United States, is an FDA-cleared, non-invasive, waterproof device that can be worn continuously on the chest for up to two weeks.

The Scripps Research Institute in the United States compared data from the ZIO Patch and Holter monitors in 146 patients whose conditions were suitable for monitoring with both devices. Notably, the Holter monitor has been the benchmark device for ambulatory heart rate monitoring over the past half-century. The study results revealed that the ZIO Patch identified arrhythmia in a total of 96 patients, whereas the Holter monitor detected it in only 61 patients, further demonstrating the advantages of the ZIO Patch in electrocardiographic monitoring.

3. Wireless Blood Pressure Monitor



In 2015, the US-based company Withings launched a wireless blood pressure monitor. This mobile health product enables users to check and record blood pressure fluctuations anytime and anywhere, and transmit the measured data to smart mobile devices via Bluetooth. The monitor features automatic inflation and measures heart rate within a range of 40 to 180 beats per minute. It replaces traditional mercury columns by displaying readings on the screens of iOS and Android smart devices through a dedicated application. Compatible with iPhones, iPads, and iPod touches, the device allows users to conveniently self-measure blood pressure, pulse, diastolic pressure, systolic pressure, and heart rate once connected.

Issues with Mobile Medical Devices

Mobile health has become a global trend, with an increasing number of pharmaceutical companies and medical device manufacturers developing their own apps and wearable medical monitoring devices. A recent study published in The BMJ (British Medical Journal) clearly pointed out that current mobile health apps and their associated devices suffer from numerous issues. These problems primarily include the following:

1. Data Security and Privacy Issues in Mobile Healthcare

Mobile medical terminals extensively record consumers' vital signs, electronic medical records, health profiles, consultation information, imaging data, and more. A breach of such data would deal a devastating blow to the mobile healthcare industry.

2. Inconsistent Accuracy of Detection Data from Mobile Medical Devices

Currently, the quality of mobile medical devices varies significantly; some devices produce inaccurate or even erroneous data. If users assess their health status based on such incorrect data, it could lead to unforeseen consequences.

3. Chaotic Mobile Health Market and Lack of Legal Regulation

Due to the lack of necessary legal management and regulations, mobile healthcare apps not only pose risks of misdiagnosis, inappropriate treatment, and delayed care but also suffer from issues such as non-standardized practices, unscientific approaches, and excessive commercialization. These problems have led to chaos in the mobile healthcare market order, creating a “gray” area characterized by inadequate legal oversight.

Outlook: Modernized Mobile Healthcare

Monitoring patients' vital signs has long been a focal point for medical professionals. With the rise of wearable devices, such as Apple's iWatch, scientists have made encouraging progress in this field. However, this is not the endpoint of researchers' efforts. The development of more patient-centric vital sign monitoring devices to better track patients' critical physiological indicators has become one of the hotspots in international medical device R&D. While current mobile medical devices are relatively mature in monitoring the four primary vital signs, capabilities for detecting the fifth vital sign (pain) and the sixth vital sign (psychological distress) remain very weak, necessitating greater investment and research.

By Chen Kun

Editor: Huang Jia