Wearable Medical Diagnostic Devices: A Sociotechnical Plan

 

 

            Advancements in science within the medical sector have increased as a result of advanced information and technological innovation.  Devices designed to monitor temperature, heart rate, oxygen and glucose levels, blood pressure, and respiration rates have emerged to obtain point-in-time patient information; however, the discovery of more comfortable materials and the innovation of flexible, low-powered silicon-based electronic sensors have expanded the utility of medical devices into constant wearable technology (Khan, Ostfield, Lochner, Pierre, & Arias, 2016).  This socio-technical plan features the design of wearable medical diagnosis devices to support patient health monitoring and diagnosis at home, work, and during travel.

Scope

                The medical diagnosis technology scope will focus on leveraging current wearable medical sensors' existing monitoring capabilities into more of a comprehensive analysis of those symptoms in conjunction with other information gathered from the host.  Additional host information will include the aggregation of blood, saliva, and other diagnostic sources to analyze the presence and indicators of emerging existing illness or disease. The indications and warning capabilities of wearable medical diagnosis devices serve to identify early signs of potential disease and illness beyond the typical symptomatic nature of the host feeling ill.  Many conditions and diseases manifest in the host without noticeable symptoms. The wearable medical device, much like a check engine light in a motor vehicle, indicates a potential underlying problem when traditional symptoms of illnesses are not present.  Overall, the wearable medical diagnosis device will analyze blood, saliva, temperature, heart rate, and other vital signs; however, it will not diagnose a health condition.  The device seeks to provide a more comprehensive view of the host's general health with capabilities to identify the onset of acute or chronic illness for more effective and proactive means of taking care of oneself.

            While the wearable device contains diagnostic connotations, the design of the device's intent is not to replace or serve as an alternative to a clinical diagnosis conducted by tests in the medical community and medical professionals.  As seen in the automotive industry's innovative advances, sensors have evolved with technology to provide more timely notification of the vehicle's emerging mechanical issues and system status.  While tire pressure sensors alert the driver of a developing flat tire or merely an anomaly in the current pressure due to changes in environmental temperature condition, the definitive diagnosis requires an inspection of the tire.  Similarly, the wearable medical diagnosis device intends to serve as a more comprehensive sensor for the human host in collecting more information that may not be felt or identified by existing biological sensing capabilities.

Purpose

            The Covid-19 pandemic illustrated the importance of timely and accurate illness testing based on the accuracy in the testing capabilities, methodologies, and the varying symptomatic nature of the population's illness.  The asymptomatic nature of Covid-19 in many infected hosts contributed to the spread of the disease.  Through a systematic analysis of illness indicators in an otherwise asymptomatic individual, early indications of symptoms, when sent to a qualified physician, can prompt a more proactive response in restricting contact with others and promoting the individual to seek a more definitive diagnosis through a certified medical facility.

            Chronic and more severe illnesses, such as cancer, often go unnoticed until more significant and noticeable symptoms emerge.  Timely identification of white cell counts and other signs of infection early in the process can help patients more proactively capture the onset of indications and precursors of more serious illnesses to seek medical attention, early treatment and improve their chances of survival.

            Finally, the wearable medical diagnostic device can facilitate more medical community advancements in the form of additional diagnostic information for identification and treatment options for patients and a more precise understanding of an illness's origin.  By analyzing more comprehensive data, the availability of more information on a patient's health, behaviors, and physiological changes can assist in defining characteristics and additional causes of specific disease and illness.

Supporting Forces

            Technology serves as a driving force in the development, use, and medical advancement of wearable diagnostic devices.  Through advancements in Internet of Thing devices, mobile technology, and the transfer of data across high-speed broadband networks, wearable technology has advanced the sports and medical communities, facilitating the speed of collection and analysis of physiological data for improvement of health and wellness and treatment options (Khan et al., 2016).  Khan et al. (2016) argued that wireless communications and technological advances in insulin pump devices had shown increased efficacy in the treatment of diabetic patients by administering the appropriate amount of insulin based on sensing capabilities of patient glucose levels.

            As environmental conditions evolve, the ability to obtain information relating to the subject's response to changes in their respective climate, working and living conditions may provide added value in illness detection and treatment.  Climate changes and the introduction of new materials and the environment have often been regarded as underlying factors impacting health.  The struggle to keep up with changing environments may be reduced through early indications and warnings of impacts on individuals wearing wearable medical diagnostic devices. 

            As seen by the global nature of Covid-19, the ability for early detection, warning, and sharing of information relating to a highly asymptomatic and contagious illness may prevent the spread of disease at global levels. The development and proliferation of a global economy have manifested increased information sharing and personal and business travel and travel methods increasing foreign contact.  Asymptomatic transmission of a highly contagious illness and disease has far more severe implications given the emergence of a global economy.

Challenging Forces

            The adoption of wearable medical diagnostic devices faces ethical, cultural, social, and legal challenges.  Privacy issues serve as the more significant concern with wearing medical devices given the sensitive nature of the personal health and potentially identifiable information collected.  Protecting the information collected from the medical device serves as a significant legal concern for many.  Identifying the access and use of information gathered presents a problem with existing privacy laws at the state, federal, and international levels. 

            In addition to the privacy concerns, the ethical nature of collecting information for analysis serves as a challenge for wearable medical diagnostic technology.  While identified as not a definitive diagnosis, a severe illness's potential indication brings up moral concerns associated with causing panic and hysteria among patients wearing the devices.

            Challenges centered on the social and cultural acceptance of a wearable medical device may impact the adoption of technology providing indications of illness and early diagnosis.  Despite the use of current wearable fitness technology, the aggregation of additional physiological data and the analysis into a more comprehensive assessment of the individual's health may seem too intrusive beyond the point-in-time assessment of fitness-related metrics and data.   

Methods

            Given the highly sophisticated nature of the technology, the scientific implications, and the privacy concerns of potential information gathered, the Delphi technique has been determined to serve as the most appropriate methodology for the chosen socio-technical plan centered on the analysis and introduction of the wearable medical diagnostic device into the population.

            The Delphi technique leverages an approach centered on including a group of experts, straightforward communication methods, and critical feedback (Yousuf, 2017).  With the highly sophisticated, scientific nature of the subject matter and the implications concerning privacy and security of the data collection, use, and storage methodologies, the Delphi method provides a more viable approach in the execution of the socio-technological plan.  Through the process of surveying expert opinions on the medical subject matter and the security implications of technical implementations in the device characterized by the Delphi method (Yousuf, 2017), the socio-technical plan for the introduction and adoption of wearable medical diagnostic devices outlines an approach for success based on expert opinion in both the medical and information security fields.

Models

            The model featured in the wearable medical diagnosis device's development and implementation incorporates an informative approach to the end-user or patient, medical personnel, and information technology/cybersecurity professionals.  As depicted in Figure 1, the implementation model begins with training for all end-users and medical professionals.

Figure 1 - Wearable Medical Device Implementation Model

                Patients and medical professionals will require device and information security training to obtain an understanding of the device's capabilities and use as well as the importance of patient information security per Health Insurance Portability and Accountability Act (HIPAA) compliance and protection of other Personably Identifiable Information (PII) of device users.  Into the implementation phase, periodic collection of vital signs, data, blood, saliva, and other specimen data for analysis will be aggregated and sent to a networked, qualified physician for further medical examination.  Where available and applicable, clinical testing of the collected information will be conducted to assess current health conditions, symptoms, or other indicators of illness.  Upon completing all testing analysis, a patient assessment will determine if a medical visit is required for further analysis, testing, and confirmation of a diagnosis.  At the culmination of the testing and diagnosis phase, the treatment and prognosis stage can begin based on the medical diagnosis. Patient device information will be updated with specific data relating to current or historical diagnosis for a more comprehensive analysis of the patient moving forward.

Analytical Plan

            Evaluation of the wearable medical device will comprise analysis of captured vital information, symptom identification, and overall patient analysis with current and traditional clinical tests conducted in person by a medical professional.  Statistical analysis on the accuracy of the device's ability to detect indicators against traditional clinical tests will serve as a critical metric for the device's success and promotion. 

Analysis of the device performance in terms of elapsed time from detection of indicators to a clinical diagnosis with patients not wearing the medical diagnostic device will also serve as a critical metric for evaluating the timeliness of the device's detection capabilities, treatment, and prognosis of the patient.  Additionally, the incorporation of patient history into the device will provide a more comprehensive nature of the patient's current overall health by considering previous diagnoses into the collection and analysis of future physiological and biological data collection and analysis efforts.

Anticipated Results

            Initial expected results of implementing a wearable medical diagnostic device include the early detection of asymptomatic and undetectable illnesses through the collection and analysis of critical biological and physiological specimen data.  The device expects to decrease the timeframe between the onset of disease, visible or noticeable symptoms, medical visits, testing, and disposition of a diagnosis through early patient data analysis and specimens.  The device is designed to increase the timeliness of treatment for diagnosed disease or illness through early detection methods and increase the quality of life and life span of patients wearing the diagnostic device.  Finally, the device is expected to improve the medical community through big data analysis of early indications of patient symptoms to facilitate improvements in preventative measures and medical diagnosis treatments.

Conclusion

            Innovation often generates an equal stir of potential and skepticism across society.  Technology has served as the vehicle for innovation by tearing down time and space barriers by establishing a more connected virtual world (Hiyashi & Baranauskas, 2013).  Developing more efficient and effective production methods and providing services has always been met with legal, social, and moral based obstacles questioning the accuracy, need, or ethical premise of innovative implementation.  Scientific methodologies of testing and evaluation coupled with socio-technical implementation plans have paved the road for a safe and accepting innovation and technology introduction to a carefully identified population.  Identifying the potential challenges facing innovation and contingency planning efforts designed to address emerging issues throughout the socio-technical plan improves success while maintaining a realistic mindset in the implementation method. 

            Changes within society and throughout organizations often face rejection; however, the careful planning, execution, and rollout of new and innovative technology and methodology through open communication fosters a collaborative approach in incorporating the potential participants into a more active role while addressing their concerns.  Participant investment into the innovative process includes the end-users concerns and addresses preconceived notions into the overall socio-technical deployment and implementation plan. 

            While the development and implementation of a medical diagnostic device are designed to introduce innovative advances in medical technology and treatment, legal, social, and technical challenges await the future medical device.  Through a carefully designed and executed socio-technical plan, a proactive approach in identifying and addressing concerns regarding patient information privacy, data use, and the device's accuracy will help diffuse the hard-line stance of opposing innovation. 

Areas of Future Research   

            Opportunities for future research in the device implementation may include the development of profiles for treatment plans among patients with similar symptoms, medical histories, and diagnoses.  Virtual medical visits and holographic examinations by a medical professional may further reduce the timeline from the point of data collection to a potential diagnosis and treatment.  As technology advances, such as quantum computing, analysis of large volumes of data can strengthen statistical and other analysis techniques to improve the medical community's overall quality in preventative and diagnosis treatments.

References

Hayashi, E. S., & Baranauskas, M. C. (2013). Affectability in educational technologies: A socio-technical perspective for design. Journal of Educational Technology & Society, 16(1), 57–68.

Khan, Y., Ostfeld, A. E., Lochner, C. M., Pierre, A., & Arias, A. C. (2016). Monitoring of vital signs with flexible and wearable medical devices. Advanced Materials, 28(22), 4373-4395.

Yousuf, Muhammad Imran (2007) "Using Experts` Opinions Through Delphi Technique," Practical Assessment, Research, and Evaluation: Vol. 12, Article 4. DOI: https://doi.org/10.7275/rrph-t210