Technology-driven innovations are dramatically altering the way modern life sciences operate, enabling a paradigm shift from treating diseases and their symptoms to preventing and curing them.

The UK-based Galleri trial uses Artificial Intelligence (AI) based algorithms to analyse blood samples. This enables the early detection of 50 types of cancers. Examples like this are many, and they make it increasingly clear that it is time for biopharma and medtech to transition. In other words, embrace modern technologies such as artificial intelligence, machine learning, and advanced statistical analyses to remain competitive.

We explore five tangible ways the life sciences industry can move toward technology-driven convergence.

Use AI and ML to develop new drugs and treatments

In early 2020, Exscientia’s AI-designed drug entered clinical trials for the first time. Since then, more than 160 AI-enabled drug discovery programmes have been under development. Fifteen of them have already reached the clinical development stage.

Such trials highlight the growing importance of in silico (an experiment conducted via computer simulation) drug development, which uses AI and machine learning (ML) models to discover new and effective medicines to treat conditions efficiently.

In the future, companies operating within life sciences can use these AI and ML technologies to identify structurally novel molecules and effectively develop new treatments and drugs.

Related: Better experiences and improved outcomes with AI

Leverage technology-enabled mental healthcare

A recent article by the Cambridge University Press describes just how promising digital CBT is. In that vein, companies operating in mental health can leverage gamification and digital simulation to deliver effective intervention programmes.

Digital therapeutics are becoming exceedingly popular in discovering new treatment paradigms in mental health, addictions, and neurological conditions. For instance, insomnia and other disorders have been successfully treated with the help of digitally administered cognitive behaviour therapy.

Adopt a customised approach toward treatments

Healthcare companies can also customise their treatments better with the help of genetic profile archetypes and genetic sequencing. Statistical models and predictive analysis can customise treatment approaches for everyone, enabling exact intervention techniques.

Life sciences companies can use these predictive and prescriptive technologies to make educated decisions regarding treatment options instead of relying on pharmaceutical treatments that have depended on extensive patient cohort studies.

Use AI-enabled decision making

Making treatment-related decisions and triaging can become more accessible with AI-enabled decision-making. AI algorithms can predict the best treatment outcomes and aid in clinical decision-making. Possible outcomes include:

• Detecting how responsive a tumour will be to a specific treatment.
• Pre-emptively identify potential infections in at-risk populations.
• Reduce the cost of treatment by choosing the most effective and affordable approach.

Related: Three reasons AI is not ready to replace radiologists

Focus on early detection and prevention

The COVID-19 pandemic has brought to light the importance of using technology to deliver telemedicine and remote monitoring of patients. By the end of June 2020, 41 per cent of adults had delayed medical care because of concerns related to COVID-19. The human cost could be staggering if one accounts for all the delays and treatment avoidance due to the pandemic over the last few years.

AI and ML-enabled devices can help with the monitoring and early detection of infections so that mortalities can be prevented by adequately monitoring patients remotely.

AI and ML will breathe new life into life sciences

Life sciences and medical industries have primarily depended on extensive cohort studies involving diverse patients. However, this approach has its limits.

Treatments cannot be customised, and practitioners cannot give adequate medical attention remotely. Thus, the convergence and adaptation of technologies such as AI, ML, and genomic sequencing are necessary for the future.

Such an adaptation will help companies discover new drugs, treatments, and therapeutic approaches and remain competitive. In addition, these advanced technologies will play a crucial role in the early detection and prevention of diseases rather than treating them at a later stage. In the future, we expect them to enhance the remote delivery of interventions as well.

This article appears in Omnia Health magazine. Read the full issue online today.

Learn more about managing healthcare data in the Metaverse era by accessing our ebook here.

Back to Technology

The stress tracking devices market is estimated to secure a valuation of US$ 2.5 billion in 2023 and is estimated to rise to US$ 4.7 billion by 2033. The market is anticipated at a CAGR of 6.5 per cent during the forecast period.

The factors accelerating the demand for stress-tracking devices are:

• Increased number of health enthusiasts.
• Increased technological advances in stress management devices.
• Increased awareness regarding health and fitness.
• Increased use of mobile apps to manage the health.
• Government support for product development.
• Development of technology like the Internet of Things.
• Growing consumer awareness and increased healthcare spending.
• Increased trend of a healthy lifestyle.
• North America dominates the stress tracking devices market during the forecast period.

The technological advent and increased use of AI technology are expected to drive market growth. The growing consumer spending on remote monitoring activities like heart rate, temp, calorie count, and other potential factors is driving the stress-tracking devices market demand.

Related: How wearables can bridge the current gaps in women’s health

The increased incidences of stress-related disorders like high blood pressure, anxiety, and depression are expected to fuel the demand for stress-tracking devices.

Regional analysis of stress tracking devices market

North America dominates the stress-tracking devices market. The major factor contributing to market growth in the region includes the increased penetration of stress-tracking devices owing to the increased prevalence of chronic diseases.

Europe is expected to account for a significant share of the market during the forecast period owing to the increasing number of individuals opting for stress-tracking devices to track their health.

Asia Pacific is expected to witness the highest growth in the stress-tracking devices market during the forecast period. Increased disposable income in developing nations like India and China is expected to favour market growth.

The leading players operating in stress-tracking devices include WHOOP, NeuroSky, Germin Ltd, Fitbit Inc, Apple Inc, SAMSUNG, Pebble technology corp, Google Inc, Xiaome Technology, Jawbone & Nike, and Oura Health Oy, among others.

The stress tracking devices market is highly fragmented with the presence of many large and small-scale players. The players are adopting various strategies such as collaborations, mergers & acquisitions, and new product launches to increase their market share. Leading players are also focusing on innovation to develop sustainable products.

The stress-tracking devices market is expected to exhibit a positive growth rate during the forecast period. The increasing demand for stress-tracking devices due to the increased emphasis on health and fitness among the adult population and professional athletes is expected to drive market growth during the forecast period. With the increased demand for the product, several start-ups have entered the stress-tracking devices market with innovative products and technology.

For instance, Sensed at is an app founded in 2006 for monitoring and managing stress in real-time. The wearable device is used to monitor stress levels, emotional responses, and other vital data. The data is tracked by the cloud platform by using ML and AI technology to provide intervention in real time for reducing stress.

Related: Digital wellness wearables evolve from trendy gadgets to integral part of healthcare

Driving demand for stress tracking devices market

According to a recent study conducted at ITOnline, 66 per cent of respondents use mobile apps to manage their health. A closer look at the study revealed that 79 per cent of respondents were willing to manage their health through wearable devices.

It is expected to increase in number as the FDA encourages the development and use of mobile apps and stress-tracking devices to improve healthcare and provide valuable health information to healthcare professionals.

CardioChip (NeuroSky), the world’s smallest ECG chip, contains an easy-to-use SDK that allows it to adapt to use in any wearable device.

According to Tracker IDC, about 5 per cent of wearables shipped worldwide last year came from Fitbit, below Apple’s 32 per cent share. Aiming to challenge Apple together, Google agreed to buy Fitbit in November 2020 for US$2.1 billion.

Released in December 2020, Cove tracks stress via heart rate to a device that wraps around the back of the head, vibrates quietly from behind the ears, soothes the wearer and promotes better sleep. The vibration frequency of Cove was designed to stimulate nerve endings in the skin, activate the posterior insular cortex of the brain, and relieve stress.

Increasing incidence of stress likely to augment stress tracking devices sales

Some of the most common stressors, like money, work and family responsibilities, never change. However, in 2020, a number of new contenders appeared, including the COVID-19 pandemic, the controversial political atmosphere and more.

According to the American Psychological Association, 2020, about one-third of the world’s population reported feeling stressed, anxious or angry. About eight out of 10 Americans reported that coronavirus induced stress.

According to The American Institute of Stress, it is estimated that the US industry spends more than US$300 billion annually due to absenteeism, turnover, and reduced productivity, medical, legal and insurance costs due to work stress. Stress costs businesses an estimated US$125 billion to US$190 billion in additional health.

USA and Canada stress tracking devices market outlook

It is estimated that stress causes US$300 billion in losses to the US economy every year. According to a June 2015 study by the New York University Lang one Medical Centre, more than 50 per cent of smartphone users in the US have downloaded health-related applications to their devices.

With the popularity of such health monitoring technologies, successful developers must ensure that their products continue to evolve to meet consumer needs and standards. Stress is affecting productivity in the workplace and is leading to an increase in sick and long vacations. Although stress can cause chaos in the professional world, it can also affect people’s personal lives and overall physical and mental health.

Europe’s demand outlook for stress tracking devices

Work pressure is common throughout Europe. Ineffective work control between people is the main source of pressure, and the negative geopolitical situation in Europe threatens stability issues.

In Europe, according to data from the WHO, nearly 83 million of the European adult population are affected by mental disorders each year, and the proportion of women is higher than that of men. This means high demand for stress and anxiety devices. The market is witnessing the integration of artificial intelligence technology into test solutions to improve functionality.

These insights are based on the report 'Stress Tracking Devices Market'  by Future Market Insights.

This article appears in Omnia Health magazine. Read the full issue online today.

Back to Technology 

Virtual reality’s use in mental health provides an innovative approach that proves to be transformational. When used in a thoughtful and conscious way, it can provide a much-needed engaging and affordable therapeutic experience that can leave a lasting impact on people’s mental health and well-being.

VR company Jolly Good and its partner Otsuka Pharmaceutical are working to expand the use of social skill training VR in treating mental disorders in Japan. Sumitomo Dainippon Pharma and US-based BehaVR are collaborating to develop prescription digital therapeutics for treating major mental health disorders.

In early 2022, Massachusetts General Hospital, in conjunction with Rocket VR Health, created a VR therapy research intervention for managing distress in blood cancer patients undergoing haematopoietic stem cells transplant.

Related: The potential of metaverse in disrupting healthcare

This digital technology can be utilised as a therapy to treat and support a broad range of conditions and challenges, including;

Stress and pain alleviation

Virtual reality has been shown to be a practical tool for immersive, three-dimensional (3D), multisensory experiences that distract patients from painful stimuli. VR for stress and pain alleviation typically provides engaging forms of distraction within a virtual environment.

Depression

Studies at the University of Barcelona have shown that applying VR to depressed patients can reduce the severity of their depression and self-degradation while increasing satisfaction.

VR for depression ranges from immersive cognitive behavioural therapy, telemedicine sessions made immersive, avatar-to-avatar live therapy sessions, and on-demand therapeutic exercises.

Phobias and PTSD

VR exposure therapies are particularly effective for anxiety, provoking realistic reactions to stimuli that can cause fear. Exposure therapy is a well-established treatment for post-traumatic stress disorder (PTSD) that requires the patient to focus on and describe the details of a traumatic experience. Exposure methods include a confrontation with frightening, yet realistically safe, stimuli that continue until anxiety is reduced.

VR exposure therapies have shown many benefits for patients with a specific phobia or PTSD through the extinction of traumatic experiences through repetitive exposures within a virtual environment.

The immersive power of VR provides a more engaging and authentic experience that results in greater effectiveness. Under evidence-based research, it has been found that it allows patients greater control over their own exposure. Virtual reality experiences can be designed to be highly interactive, allowing patients to maintain a sense of control even as they experience anxiety triggers.

Related: Mental Health Awareness Month highlights innovations, technological advancements to make mental health accessible

In addition, VR therapy offers a drug-free method of reducing trauma-related anxiety. A well-designed treatment programme can offer improved cost-effectiveness over conventional treatment programmes.

Apart from patients, this also democratises virtual reality treatments for therapists and patients around the world by providing mental health professionals with animated and live environments they can use in their clinical practice. This treatment can be applied for anxiety disorders, treatment of fears and phobias, as well as for the practice of mindfulness and relaxation techniques.

However, as encouraging as the growing body of clinical evidence is, VR still faces barriers to widespread implementation, as well as lingering ethical concerns about personal data sharing. While researchers work to address these remaining issues, many predict VR treatments will soon become available to anyone who needs help, whether a patient has access to a real-life therapist.

This article appears in Omnia Health magazine. Read the full issue online today.

Learn more about managing healthcare data in the Metaverse era by accessing our ebook here.

Back to Technology

In today’s fast-paced business world, inventory management is essential to the success of any business, and the healthcare industry — in this region specifically — is no exception.

According to a report by ResearchAndMarkets, the UAE healthcare market is expected to grow at a CAGR of 9.9 per cent from 2020 to 2025, driven by factors such as the growing population, the increase in the prevalence of chronic diseases, and the government’s focus on improving healthcare infrastructure. The GCC healthcare market is also expected to grow at a CAGR of 6.3 per cent from 2020 to 2025, reaching a value of US$71.3 billion by 2025. However, it is important to address the growing demand and expenditure by controlling costs and investing wisely in the future, so the healthcare industry is efficient, effective, and patient-centric.

Related: An appetite for inventory innovation in healthcare

One of the key elements of securing this ideal future is to manage the second highest costs in healthcare after people, i.e., inventory of medical supplies and devices. By maintaining optimal inventory levels, healthcare businesses in the UAE and GCC can reduce inventory costs and improve cash flow. This means they have more money to invest in other areas of their business, such as improving patient care, developing new medical devices and treatments, and providing employee training and development. In addition to financial benefits, effective inventory management also leads to increased patient satisfaction. When healthcare businesses have the right medical products in stock at the right place at the right time, they can fulfil patient orders quickly and accurately, and avoid unnecessary delays in care or surgery cancellations, resulting in satisfied patients that were treated when they needed it most.

Despite the benefits of effective inventory management, many healthcare businesses in the UAE and GCC struggle with common challenges associated with clear visibility of what they have and where, which leads to instances where products are overstocked or out of stock. Excess inventory or overstock ties up capital and takes up valuable storage space. On the other hand, inventory shortages can lead to lost revenue, delays in patient care, and patient dissatisfaction. The challenge of inventory management is further exacerbated as many processes and procedures of managing inventory are heavily dependent on manual work that falls on the shoulders of clinical staff. This leads to the inefficient use of resources, potential manual data entries, inaccurate or labour-intensive inventory counts and audits.

Related: How your business can navigate supply chain complexities in MEA

It is estimated that in the UAE alone, approximately Dh7 billion of labour expenditures can be attributed to clinical staff performing non-clinical administrative activities related to inventory management. This is not unique though to just this region. According to a study published by the Journal of Hospital Administration and Management, “The cost of inventory management represents around 35 per cent of a hospital’s supply chain costs, while the remaining 65 per cent is attributed to non-value-added activities, such as receiving, unpacking, and transporting supplies to their final destination.”

This is where inventory management software can be a game changer. By automating inventory management and optimising workflows, healthcare organisations can improve operational efficiency and ensure that clinical staff can focus on delivering quality healthcare services to patients who need them most.

These options provide features that help organisations achieve their goals beyond financial and operational gains, such as:

• Enhanced patient safety by ensuring that the right product is in the right place at the right time.
• Improved clinical outcomes by providing real-time data analytics that enables healthcare organisations to make informed decisions.
• Reduced manual data entry errors through automatic tracking of inventory levels and reorder points.
• Seamless integration with other business systems, such as ERPs and patient management.

In summary, effective inventory management is essential to a healthy, healthcare industry, be it here or globally. As experts in this field, we need to be committed to helping organisations achieve their financial, operational, and clinical goals while ensuring that the right product is at the right place in the right quantity at the right time.

Hamid Dean Refai is General Manager at WebOps, whose expertise lies in healthcare delivery & transformation, management advisory & healthcare consulting, business development & strategy, commercial excellence & partnerships, and P&L leadership. He has led medical projects across the Middle East, US and Singapore, among others.

This article appears in Omnia Health magazine. Read the full issue online today.

Back to Management

The antibody index (AI) is a measure of local antibody synthesis in the central nervous system (CNS) and represents an important and growing tool in neurological diagnostics. Determination of the AI supports diagnosis of acute CNS infections and some non-infectious inflammatory diseases such as multiple sclerosis (MS). The analysis can be performed easily in any routine laboratory using standardised assays for measuring antibodies in cerebrospinal fluid (CSF) supported by specialised software for calculating the AI.

CNS infections

Acute infections of the CNS have high morbidity and mortality and often present as medical emergencies. They can be caused by viruses, bacteria, protozoa or fungi. Manifestations include inflammation of the protective membranes surrounding the brain and spinal cord (meningitis), inflammation of the brain tissue (encephalitis), or a combination of both (meningoencephalitis). Symptoms can be unspecific, for example, fever, headache and altered mental state. There is potential for seizures, paralysis and coma.

Related: World Multiple Sclerosis Day: Increasing need to address underreporting, barriers to disease management

Identification of the causative agent of infectious CNS diseases is essential for providing appropriate treatment. Diagnosis typically involves a combination of physical examination, blood tests, imaging studies and analysis of cerebrospinal fluid (CSF) obtained by lumbar puncture (spinal tap)1.

CSF analysis

Detection of specific antibodies in CSF supports the diagnosis of CNS infections. It is especially helpful in situations where direct methods such as PCR have a low positivity rate, for example, due to rapid pathogen clearance or in chronic stages of infection. The analysis is recommended by the German Society of Neurology (DGN) as part of the diagnostic work-up for suspected CNS infections. It is used alongside other CSF laboratory tests such as cell count, total protein, lactate, oligoclonal bands, cytology and direct pathogen detection.

Related: Biomarkers for neurodegeneration – diagnosis of Alzheimer’s and more

In the DGN diagnostic guidelines for Lyme neuroborreliosis and neurosyphilis, in particular, the detection of intrathecal antibodies against the respective causative organism (Borrelia or Treponema pallidum) serves as a main criterion for confirming a diagnosis2, 3.

Multiple sclerosis

Some non-infectious inflammatory conditions such as MS trigger a polyspecific humoral immune response. In these cases, antibodies against multiple non-causative pathogens may be detected in the CSF. A reaction against measles virus, rubella virus and/or varicella zoster virus (MRZ) is a specific indicator of MS and can help to distinguish MS from clinically similar diseases. MRZ testing in patients with suspected MS is recommended by the German Society for Cerebrospinal Fluid Diagnostics and Clinical Neurochemistry in its current guidelines4.

AI determination

In CSF antibody analysis, it is important to distinguish antibodies that are produced in the CSF from antibodies that have diffused from the blood into the CSF across the blood-brain barrier (figure 1). The AI takes the barrier function into account by setting the concentration of specific antibodies in CSF and serum in relation to total immunoglobulin.

The AI is calculated using the following formula: the quotient of pathogen-specific antibodies in CSF to serum (Qspec) divided by the quotient of total IgG in CSF to serum (QIgG) (figure 2). An AI of more than 1.5 indicates pathogen-specific antibody synthesis in the CSF.

If total IgG in CSF is elevated, as occurs with polyclonal antibody stimulation in MS, the quotient of albumin in CSF to serum is additionally measured as a counterbalance. This is used to derive the limes quotient, which is used instead of the total IgG quotient in the calculation of the AI5.

ELISAs for CSF/serum pairs

Specific antibodies in CSF and serum pairs can be measured quantitatively using specialised ELISAs. A broad range of CE-marked CSF ELISAs for the detection of intrathecal antibodies is available from EUROIMMUN. The parameters encompass HSV-1/2, EBV-CA, VZV, measles virus, mumps virus, rubella virus, TBE virus, CMV, Borrelia, Treponema pallidum and Toxoplasma gondii. 

The processing of the ELISAs is standardised with identical incubation schemes and exchangeable reagents. This enables easy parallel analysis of different parameters, as well as efficient automation. Results are quantified by means of 4- to 6-point calibration curves or using a single recalibrator with reference to a stored master curve generated by EUROLabCSF software. Use of a single calibrator increases the cost-effectiveness since fewer ELISA wells are required per analysis.

Automated quotient calculation

Specialised software simplifies the computation and interpretation of results. The EUROLabCSF software calculates the CSF/serum quotients for total IgG, specific IgG and albumin, as well as the limes quotient and AI. The results are displayed clearly in quotient diagrams according to Reiber and Lange. The software communicates bidirectionally between the EUROIMMUN ELISA processor or photometer, LIS and nephelometer, so that time-consuming and error-prone manual data transfer is no longer required.

Quality assessment

External quality assessment institutes such as INSTAND and ESfEQA offer programs for CSF diagnostics to help diagnostic laboratories to meet the high analytical standards required. These schemes cover a range of parameters such as measles virus, rubella virus, VZV, HSV-1/2, TBEV and Borrelia. In the INSTAND CSF schemes from October 2022, results obtained using EUROIMMUN CSF ELISAs matched the target values in 92 per cent to 99 per cent of the samples. This represented the highest pass rate of all tests used.

CXCL13 in neuroborreliosis

The chemokine CXCL13 is an additional CSF marker that can aid early identification of neuroborreliosis. High concentrations of CXCL13 in CSF are often detected before antibodies appear. CXCL13 determination can thus help close the diagnostic gap between infection and positive antibody test and identify neuroborreliosis at an earlier stage. CXCL13 is, moreover, useful for detecting reinfections, where intrathecal antibodies may be present from previous infection. CXCL13 also serves as a marker for therapy monitoring, as its concentration in the CSF sinks rapidly with successful treatment. CXCL13 can be determined by ELISA. EUROIMMUN offers the first CE-marked ELISA for this application.

Perspectives

Determination of the AI plays an important complementary role to PCR and other CSF analyses in the diagnosis of inflammatory CNS diseases. The antibody analysis can substantially increase the chances of identifying the causative agent of an acute CNS infection, enabling the implementation of potentially life-saving therapy.

Furthermore, the polyspecific MRZ antibody reaction is the most specific known marker for MS — a disease which often requires extensive differential testing before a diagnosis can be established. If no infectious cause for acute neurological symptoms is found, further differential diagnostics may focus on analysing autoantibodies against neural target antigens. This can help to delimit autoimmune encephalitis from CNS infections, which is critical due to different treatment regimens.

References

Tumani H. et al. S1 guidelines “lumbar puncture and cerebrospinal fluid analysis” (abridged and translated version) Neurological Research and Practice 2020; 2:8. https://doi.org/10.1186/s42466-020-0051-z

Rauer et al. Clinical practice guideline Lyme neuroborreliosis. Dtsch Arztebl Int 2018; 115: 751–6. doi: 10.3238/arztebl.2018.0751

Klein et al. German guidelines on the diagnosis and treatment of neurosyphilis. Neurol Res Pract 2020 Nov 17;2:33. doi: 10.1186/s42466-020-00081-1 

Jarius S. et al. The MRZ reaction as a highly specific marker of multiples sclerosis: re-evaluation and structured review of the literature. J Neurol 2017; 264(3): 453-466.  doi: 10.1007/s00415-016-8360-4

Reiber H. Knowledge-base for interpretation of cerebrospinal fluid data patterns. Essentials in neurology and psychiatry. 2016; Arq. Neuro-Psiquiatr. 74 (6). https://doi: 10.1590/0004-282X20160066

This article appears in Omnia Health magazine. Read the full issue online today.

Back to Laboratory

Recent scientific advances and the introduction of sophisticated clinical research platforms have enabled medical researchers and healthcare practitioners to cater to the evolving challenges within the pharmaceutical industry and deliver improved quality of care to patients.

Healthcare systems are now recognising the need to fully understand exogenous factors (such as genomics, behaviour, and social and environmental factors) affecting disease progression, as well as response to the treatment. Further, the industry is witnessing a drastic change in its functioning, post the advent of big data, the introduction of wearable devices, and increased use of telemedicine and eHealth solutions.

Related: Decentralised clinical trials are amplifying health equity

As per the estimates, the number of connected wearable devices is expected to exceed a billion by 2022, with the world’s data volume doubling in less than three years. This surge in data availability is known to potentially revolutionise clinical research across various application areas.

Clinical trials are crucial for assessing the efficacy of novel therapeutic products. However, these studies are prone to significant delays due to various constraints, such as insufficient patient recruitment, inefficient study protocols and low patient retention.

Related: Innovation vital in the evolution of clinical trials

Even though clinical research is a highly expensive process, such delays increase the expenditure of drug developers to meet the primary and secondary endpoints. It has been observed that researchers are proactive in implementing advanced technological solutions to generate valuable insights from the enormous amount of unstructured clinical data.

Additionally, trial sponsors are incorporating operational data, financial data and real-world evidence to benefit the most from their R&D investments. Virtual clinical trials, also known as decentralised clinical trials, are believed to significantly reduce the time and capital invested in clinical research by using certain advanced technologies, such as remote monitoring devices and sophisticated custom-made applications.

Virtual clinical trials in healthcare

Virtual clinical trials present a novel approach to collecting safety and efficacy data from clinical trial participants, starting from study start-up through execution to follow-up. In such designs, the participants need not travel to a clinical research site, facility, or a doctor’s clinic. Such trials make use of software applications, monitoring devices and online social engagement platforms to conduct the complete clinical trial process, including recruitment, patient counselling, informed consent, measuring clinical endpoints and adverse reactions, as per the patients’ comfort. Although virtual trials still require the study site to accommodate support staff and invest resources in data gathering and analysis, these are significantly more cost-effective as they do not require traditional brick-and-mortar set-up of multiple investigation sites.

In addition, these trials enable elderly individuals or patients living in far-off areas to actively participate, thus enabling the involvement of a highly diverse population. Such an arrangement offers opportunities for a more patient-centric approach, as patients can participate in the trial at their convenience and without worrying about the need to travel to study sites. Virtual trials also enable researchers to capture and access data through remote monitoring devices in real time, thereby, improving the trial designs based on accumulated data.

In 2011, Pfizer pioneered the first-ever virtual research on electronic monitoring of overactive bladder treatment experience (REMOTE) trial. It was the first randomised clinical trial that used web-based patient recruitment and collection of study data without requiring patients to visit the actual study site.

Virtual clinical trials have experienced rapid investment growth in the past years, with investments of over US$1 billion in 2019 for applying modern technological solutions to clinical research. Further, the existing constraints in clinical drug development have prompted trial sponsors to incorporate various innovative technological solutions to improve the ongoing processes.

Opportunities associated with virtual clinical trials management

• Virtual models for trial conduct are known to offer numerous advantages over traditional models; some of these have been highlighted below:
• Innovative technological solutions enable trial sponsors to achieve maximum patient enrolment and minimise patient attrition rates.
• Virtual studies provide sponsors with access to a larger and more diverse patient pool, which minimises trial delays and prevents innovator companies from incurring significant losses.
• Such studies leverage advanced monitoring and data collection solutions that allow remote participation of patients in clinical studies, further enhancing patient engagement.
• Virtual clinical studies require significantly lower capital investments, by eliminating the need for multiple study sites.
• These trials hold the potential to minimise the risk of drug failure by allowing investigators to study the data generated from monitoring devices on a real-time basis.
• This approach has the potential to reduce enrollment challenges associated with studies related to rare diseases.

By eliminating challenges such as distance and discomfort, and thereby, assisting patients from rural areas and those from an unfavourable socio-economic background, there is a direct positive impact on patient comfort and understanding, which is likely to drive retention and compliance.

Future perspectives

Clinical drug development is associated with several challenges, such as inadequate patient recruitment, poor patient engagement and monitoring, and improper study design and site selection, which leads to significant delays and capital loss. Clinical trial software solutions offer a novel approach to address these inherent challenges. Since virtual/decentralised clinical trials are more patient-centric, this approach not only reduces the clinical drug development timelines but also addresses the challenge of high capital investments required in the development of pharmaceutical products.

Science 37, one of the clinical research service providers, claims to have achieved 97 per cent patient retention in their virtual trials and expedited the process. Virtual clinical studies augment traditional study practices and workflows by leveraging remote monitoring workflows and sophisticated data analysis software. Decentralisation of trials is also effective in improving patient enrolment, retention and satisfaction while preserving the data quality.

The outbreak of COVID-19 further led to increased adoption of virtual clinical trial platforms, thereby, prompting stakeholders to develop novel clinical trial methods that can easily engage patients, sites and sponsors. Moreover, regulatory authorities have issued several guidelines for conducting studies virtually amidst the ongoing pandemic. Driven by the increasing preference for virtual clinical trials and ongoing technical advancement in this field, the clinical trial software market is anticipated to grow at a commendable pace in the foreseen future.

Sanyukta Katkar is the SEO Specialist at Roots Analysis, a global leader in pharma and biotech market research.

This article appears in Omnia Health magazine. Read the full issue online today.

Back to Technology

It is estimated that around £900 million is wasted in nursing time each year. Healthcare professionals spend their time searching for missing medical equipment and unplanned equipment maintenance. Limited visibility of medical equipment is having a significant impact on patient care.

Healthcare has been in a perfect storm for quite some time with the world not being prepared for COVID-19. With an overwhelming number of patients, nurses and doctors having to self-isolate, healthcare facilities had unparalleled demand, a very limited and fluctuating supply of healthcare professionals, and an unprepared medical situation.

Related: Invisible to invaluable: Resolving challenges faced by nurses

As we are moving towards normalisation, healthcare organisations are now focussed on efficiency gains.

The need for improved visibility of medical equipment

In the healthcare industry, one mistake can significantly affect operations within a facility. Asset management is vital to ensure operations are running safely and efficiently.

Related: Support systems essential to nursing sector growth

Lack of asset management poses a risk to any asset-intensive facility – especially in the healthcare field. Often, facilities will use outdated systems to track and monitor digital assets such as patient records. This is done by using spreadsheets to record important information. Whilst some may argue that spreadsheets are useful to collect and find information, it also leaves room for human error. In 2020, nearly 16,000 COVID-19 cases were left unreported due to using spreadsheets to report this information.

Healthcare facilities have the responsibility to dispose of waste safely and securely so that it doesn’t affect the public or the environment. Asset management software can ensure waste is disposed of appropriately, meets regulatory standards, and keep a record of how this waste is disposed of.

Implementing asset management software can ease the unsustainable strain we are currently seeing on GP practices. Doctors are struggling to care for patients, with more patients coming in and less staff being available due to self-isolation, strikes and a lack of funding.

Asset management software can be used to monitor patient records without the risk of loss or damage, which would increase the stress and difficulty on staff. Even pre-pandemic general practices were struggling with a lack of investments, high workloads, and workforce problems, according to Dr. Becks Fisher. COVID-19 has made work even harder so all the support doctors and nurses can get to track and manage equipment and records would significantly improve workloads and patient care.

Saving time and money by tracking medical equipment

Healthcare facilities are often spread across multiple sites, which can prove to be difficult when managing assets.

Asset management gives healthcare professionals the ability to track and manage the inventory of physical assets such as blood pressure machines, medication, or even patient documents. Without asset management software in a healthcare facility, staff can quickly become overwhelmed with the laborious task of locating medical equipment or dealing with unplanned maintenance problems. This inevitably slows down the time it takes to care for patients, which in turn prolongs waiting times and leaves a lack of beds available with more delays and cancellations.

GS1 UK found that, on average, nurses spend a third of their time trying to locate medical equipment. If a nurse needs to quickly find an infusion pump, they may not be aware that another member of staff is using it, or it may be offsite. Without this information, nurses can spend a long part of their shift locating gear only for it is not available to them at all. This also heavily impacts patient care as the patient who needs the infusion pump will have their wait prolonged further.

Healthcare professionals can easily keep track of medical equipment by using asset management software. They will have access to a detailed inventory which includes data such as the quantity of PPE available. By having this information readily available, nurses will spend less time searching for the medical gear that they need, which leaves more time to care for patients.

Implementing this software also results in any maintenance of assets being planned for in advance. This reduces any disruption by allowing repairs to be carried out during less busy periods and helps facilities keep track of stock levels and the location of equipment, which prevents them from bulk buying and reduces costs.

Staff can easily predict and plan the number of items they need to purchase using asset management tools. This minimises the waste of multiple resources because they have an insight into the inventory and won’t need to bulk buy equipment. Instead, they can make use of the equipment available as they will be able to track the location and see if any maintenance is required.  

Without asset management software’s ability to keep track of physical assets, the chance of equipment being stolen from facilities significantly increases. This results in an unexpected financial burden upon a healthcare facility that will need to find the money to replace stolen physical assets. Some asset management software systems provide theft alerts to ensure expensive and valuable assets are not stolen and save the facility a huge amount of money. Around US$4,000 worth of equipment is stolen or lost from medical facilities per bed each year in the US alone.

The aftereffects of good healthcare asset management

Asset management in healthcare provides staff with detailed insights into tracking and managing their assets, which in turn reduces the amount of time locating assets or disruption from maintenance. This enhances patient care as staff have more time to focus on their patients, which means less waiting times and more beds available for new patients. Using asset management software to maintain assets, such as medical equipment, improves the reliability and efficiency of care.

Healthcare asset management manages and maintains machinery, equipment, and physical assets within a healthcare facility. This is done most cost-effectively and efficiently as possible. Assets can include wheelchairs and beds, heating, refrigeration, and ventilators. Healthcare facilities contain large amounts of these physical assets that need to be kept in reliable condition so that the healthcare facility is running efficiently. This also means that well-maintained equipment works for longer and has fewer disruptions.

Assets are a crucial part of healthcare facilities, and asset management software is a vital part of an efficient operation. Not only does it provide patients with enhanced care due to staff having more time to see to them and saves the facility money, but it provides staff with a less overwhelming space in which their main responsibility is the duty of care. Allowing staff not to worry about locating missing assets or coming across last-minute maintenance issues eases the stress of their job significantly.

Prasanna Kulkarni is a Product Architect at Comparesoft.

This article appears in Omnia Health magazine. Read the full issue online today.

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On a shuttle ride from work, Dr. Jacques and Dr. Smriti Zaneveld found themselves in the company of medical residents and students engaged in a discussion about acquiring practical experience, particularly in complex surgical skills through patient operations. With an ongoing PhD in human genetics, their curiosity led them to uncover a remarkable and relatively unknown fact that the surgeon’s role is pivotal in driving over 90 per cent of key outcome metrics for numerous procedures. As a result, Lazarus 3D was born.

According to Founder and CEO Dr. Jacques, critical factors such as cancer recurrence, hospital stay duration and readmission rates primarily rely on the surgeon, their expertise, team and preparedness, compared to the technologies employed, which contribute only around 10 per cent to the overall outcomes.

Related: How technology is shaping the future of surgery

“Looking at some of the challenges faced by these students, we thought of building an exact replica of a patient with a complex surgery profile. For example, if a patient has a brain tumour, we could build a similar structure of the brain and tumour, complete with the skull and blood vessels, to give surgeons a chance to rehearse on in a mock operation,” he said.

Dr. Jacques and Dr. Smriti Zaneveld, Founders Lazarus 3D

Related: Slime robots to usher in a new era in surgery

This led to the emergence of Lazarus 3D’s breakthrough tissue-mimicking models. Its patented PRE-operative SUrgical REhearsal (PRE-SURE®) technology offers a transformative approach to surgical training and optimisation. By closely imitating real tissue properties and allowing surgeons to simulate procedures, these models enhance surgical training, optimise approaches, and ultimately benefit patients. 

“The hypothesis was if we could be successful with this model, surgeries would be more seamless, efficient, and safer,” he added. Drs. Zaneveld started their company 

in a kitchen where they built their first 3D printer, but years of development and iteration later, they were able to develop a technology that allowed them to rapidly create prototypes of new materials that behaved like real tissue. “Now, when you cut into a Lazarus model, you can make a cut that will bleed and can be sutured. The same tools and techniques can be used when treating a patient,” he explained.

Regulatory milestones and market expansion

Lazarus 3D received an FDA clearance five years after its inception, which was a significant milestone for the company. This achievement helped introduce their innovative technology to the US market in 2022. Their advancements in surgical simulation also garnered recognition, including appearances at global healthcare events such as Innov8, which takes place every year as part of the Arab Health exhibition in Dubai. This not only helped raise awareness of their technology but also shed light on the potential benefits it holds for patients beyond borders. 

“The Innov8 competition was pivotal in building our awareness of how this technology could potentially be used to benefit patients in the UAE. We received clearance in the US for the treatment of various genitourinary conditions, such as kidney cancer. However, it is important to note that our technology has not yet been approved for human use in the UAE at this time. We are actively working towards obtaining clearances for additional indications and expanding the scope of our approvals,” he said.

Forging partnerships and expanding horizons

Lazarus 3D’s recent partnership with Abu Dhabi Ports Group marks an exciting chapter in its journey. Through this collaboration, they will be able to provide their revolutionary Pre-Sure models in the UAE after regulatory approvals. The prospect of bringing their cutting-edge technology to the region reflects their commitment to improving patient outcomes and elevating surgical practices. “Looking ahead, we seek collaboration with pioneering surgeons who are eager to embrace cutting-edge technologies. We understand that, like any new product, there is a continuous learning process involved, and we are committed to iterating and enhancing our offerings. During this initial launch phase, we are particularly interested in partnering with top-tier professionals who share our excitement for new technology and are willing to explore its clinical advantages. We are focused on delivering optimal value and, in the future, plan to expand our collaborations further,” he concluded.

This article appears in Omnia Health magazine. Read the full issue online today

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We are at a critical crossroads when it comes to women’s health and well-being. Earlier this year, the World Economic Forum recognised the requirement for increased investment in women’s health. While the depth of research in women’s health stagnated during the pandemic, the area is now starting to receive the attention it deserves, with a promising increase in research and initiatives tapping into unmet needs. 

Some of the gaps in women’s health include:

• Timely diagnosis and support for conditions like Polycystic Ovary Syndrome (PCOS), perimenopause and menopause: Many women affected by these conditions wait several years before receiving a clear diagnosis and experience debilitating symptoms with no answers as to what is going on in their bodies. These women also lack honest and evidence-based supportive resources and often do not know who to turn to. 
• The management of infertility: The Agency for Healthcare Research and Quality (AHRQ) has published a report showing that the management of infertility remains a topic that is not delved into adequately enough despite 20 per cent of women being infertile. 
• Menstrual cycle and reproductive health awareness: Without a balance between the male and the female hormones or a timely menstrual cycle, there is an increased risk of conditions like osteoporosis, certain female tract cancers, immune dysfunction, cardiovascular disease, and metabolic syndrome, amongst other conditions.

The femtech sector has grown tremendously in the last few years, with an industry size between US$500 million to US$1 billion.

Related: Digital wellness wearables evolve from trendy gadgets to integral part of healthcare

There has been much more emphasis on untapped needs, including personalised healthcare, data-driven insights using artificial intelligence (AI), wearable devices, telemedicine, mental health support and inclusivity. The industry is also expanding into new areas of women’s health, such as PCOS, menopause, cancer screening and chronic disease management. The sector is looking at integration into healthcare systems, collaborations and partnerships between specialities and companies, and global expansion into markets where healthcare is limited. The evolution of this sector can potentially target accessibility issues in women’s health and help to address health inequities. 

Dr. Aarti Javeri-Mehta, Internal Medicine Specialist & Lifestyle Medicine Physician, said: “Wearables like the Apple Watch have the potential to provide valuable information to patients and healthcare professionals. Advanced tracking of health and wellness parameters like menstruation, cyclical changes, symptoms (bloating, cramping, nausea), cervical mucous changes, temperature changes, heart rate variability and sleep quality can now be done easily and accessibly. From a clinical perspective, this automatically provides vast data that can be objectively analysed and interpreted to aid in the diagnosis, further medical management, and improve patient self-management.”

How are menstrual cycles connected to overall health?

Related: How wearables can help support mental health and well-being

The topic of menstruation is still one that is surrounded by stigma and taboos, particularly when women experience difficulties with their cycles. What is often overlooked is that the significance of menstrual cycles and menstruation extends far beyond just the bleed. It is required for: 

• Bone health: Oestrogen plays a vital role in the growth and maturation of bone and its turnover by controlling the balance between bone-making cells and bone-breaking cells. 
• Cardiovascular health: Oestrogen plays a protective role in heart health through a variety of mechanisms. These include an increase in HDL (good cholesterol) and a decrease in LDL (bad cholesterol), which is beneficial for cardiovascular health. It also helps dilate and smooth blood vessels to allow for better blood flow. 
• Immune function: Oestrogen and its receptors have also been shown to regulate and modulate immune pathways in the body. 
• Brain health: Oestrogen plays a protective role in brain health by reducing or blocking the proteins implicated in the development of Alzheimer’s disease. 

Furthermore, studies have shown that up to 35 per cent of women can have irregular cycles during their lifetime, and some studies show even higher numbers. Irregular cycles can be temporary and can occur in periods of illness, extreme stress, shifts in time zones, and changes in weight and lifestyle (nutrition, movement and sleep cycles). These usually resolve once the disruption or trigger reduces. On the other hand, long-term changes in cycles can indicate an underlying health condition, of which PCOS is one. Irregular cycles or menstrual dysfunction occur in 75-85 per cent of women with PCOS but can also occur in several other conditions like thyroid dysfunction, female tract cancers, and pituitary or hypothalamic disorders. 

Dr. Aarti Javeri-Mehta

The Apple Women’s Health Study, a first-of-its-kind research study conducted with the Harvard T.H. Chan School of Public Health and the National Institute of Environmental Health Sciences (NIEHS), found that 12 per cent of participants reported a PCOS diagnosis. Participants with PCOS had more than four times the risk of endometrial hyperplasia (precancer of the uterus) and more than 2.5 times the risk of uterine cancer.

Dr. Javeri-Mehta shared that using wearables to track periods can help one recognise period patterns, potential irregularities and helps with overall life planning and self-awareness. When a pattern deviates from what is typical across the population or for that individual, that may indicate an underlying condition. For example, always having long and painful periods may be a sign of fibroids, or frequently missing periods can be an indication of PCOS, whilst increased cycle variability can be a sign of perimenopause. 

Also, tracking cycles, along with other metrics like urine hormone testing, temperature testing, and evaluation of cervical mucous, can help identify the most fertile window for family planning and help women optimise their chances of getting pregnant.

“Looking at the timing, frequency, and co-occurrence of other symptoms (cramping, mood swings, nausea, etc.) can help healthcare providers determine the root cause of symptoms and provide an easier platform for diagnosis and management,” she added. “Rather than relying on memory for determining the last period date, the apps allow for objective and quantifiable data that is easy to access and interpret.”

In conclusion, Dr. Javeri-Mehta said that for the progress of the women’s health sector, a multi-pronged approach is required that spreads across various stakeholders, from healthcare professionals to policymakers to the patient. Encouraging comprehensive education on women’s health topics like PCOS, menstrual health, menopause, reproductive health, and mental health is paramount. Reaching out to grass root and engaging schools, communities and workplaces to provide accurate and accessible information on these topics is also valuable. 

She said: “It is important to create a safe space and platform for women to share their experiences, foster curiosity, ask questions and discuss their fears and concerns without judgement and shame. These things need to happen while mindfully focusing on optimising accessibility for underserved communities. Our global responsibility is to ensure women of all ages, backgrounds, and socioeconomic statuses are engaged in such conversations and initiatives. Encouraging and educating men to actively participate in these conversations, as well as policymakers, government and healthcare professionals to ensure a universal understanding of women’s health, and that laws, regulations, and ongoing research are inclusive of women’s needs.”

This article appears in Omnia Health magazine. Read the full issue online today

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A growing number of organisations are leveraging blockchain technology to improve services in the healthcare industry. Because of its diverse applications, including medical supply chain management, patient data security, and drug discovery, blockchain is quickly becoming one of the most promising technologies for improving healthcare outcomes and reducing costs. Blockchain could save the healthcare industry up to US$100 billion per year in costs related to IT, operations, support functions, personnel, and health data breaches by 2025.

Data breaches are a major problem for healthcare organisations. This is largely because healthcare records are valuable to criminals as they often contain sensitive personal information like credit card numbers. Many current healthcare systems are simply not equipped to deal with the growing threat of data breaches. 

Related: AI, big data, VR and blockchain expected to power patient-centric applications

Because of this problem, there have been an increasing number of data regulations on how organisations collect, use, and store personal data such as General Data Protection Regulation (GDPR) in the European Union and Health Insurance Portability and Accountability Act (HIPAA) in the US. Any individual or business that works in healthcare or with healthcare clients that need access to health data must be HIPAA compliant.

Blockchain solutions that can help healthcare providers 

Fortunately, now there are blockchain technology solutions like decentralised identifiers (DIDs) and Verifiable Credentials that can be integrated into healthcare systems to enable data security, compliance, authenticity, privacy, and portability. These tools can help organisations efficiently use and share data to provide health services and conduct research while providing patients with more ownership and control of their health information. 

What is blockchain?

Related: Immunity passports can be blockchain’s breakthrough application

A blockchain is a distributed database that is used to store data in a secure, tamper-proof way. Blockchain’s distributed and immutable nature gives all stakeholders the same source of truth about a piece of certain information, establishing immediate trust between all parties. 

Some ways blockchain can be applied in healthcare is that it can be used to track the provenance of drugs or verify the authenticity of data from clinical trials without revealing any personal information of participants. 

Decentralised identifiers (DIDs)

Centralised identifiers like email addresses and usernames have often resulted in data breaches by being stored on centralised servers and the misuse of personal information without people’s knowledge. In contrast, decentralised identifiers provide privacy and data security. A decentralised identifier (DID) is a globally unique digital code that can be used to identify an online identity and be applied to objects such as medicine. Because DIDs can be stored on the blockchain, it is much more difficult to hack or steal. 

DIDs could be used to verify patients’ identities and access their medical records when they give explicit consent. This helps protect patients’ privacy and safeguard their data from being accessed by unauthorised individuals. Also, DIDs could be used to track the movement of medical supplies. 

Verifiable Credentials 

A verifiable credential is a fraud-proof electronic record that contains information about an individual or object that can be independently verified by a third party. The Verifiable Credentials data format ensures that organisations can share data within and outside their systems, guaranteeing that it will remain tamper-proof and its authenticity verifiable. 

In the healthcare context, Verifiable Credentials can be used to store and share information such as immunisation records, allergies, and medications. This information can then be accessed by authorised parties in order to provide better care. Verifiable Credentials can help reduce errors, improve care coordination, and efficiently transfer health data while maintaining patient privacy.

BurstIQ case study

BurstIQ is a blockchain-based platform as a service that gives organisations the ability to build health apps, work apps, life apps, and data exchanges. Because the company’s technology complies with GDPR and HIPAA regulations, they integrated Dock’s Verifiable Credential technology which allows them to: 

• Turn any health data into a Verifiable Credential that is portable and secure.
• Enable their customers (businesses) to manage sensitive data. 
• Provide people with ownership and control of their personal information.

Dr. Wendy Charles, BurstIQ’s Chief Scientific Officer, has been involved in clinical trials for over 30 years and has extensive experience in regulatory compliance. She has been a leader in helping organisations implement blockchain in healthcare operations.

Use case 1: Individual ownership and control of data

Clarinda is a nurse who uses applications powered by BurstIQ’s LifeGraph platform to easily manage and securely share her data.

The information will be securely packaged and shared as a Verifiable Credential.

Thanks to Verifiable Credentials and DIDs, Clarinda can securely share her information and a verifier will be able to accept it with full assurance that the data is authentic and not compromised. 

Use case 2: Verifying skills and experiences

Verifiable Credentials enable staff to build a lifelong record of the skills and experience that they acquire from school, training programmes, and their workplaces. These credentials can be verified instantly by future employers, which makes their onboarding process much faster than traditional verification processes. 

Why BurstIQ chose dock

When Dr. Charles was looking for a Verifiable Credential provider, she wanted to choose a solution that was flexible, had privacy-preserving strategies, scalable, and a technology that could be adapted to changing needs and regulations. Dock’s solutions met all of these criteria.

Amber Hartley, BurstIQ’s Chief Strategy Officer, said, “We’ve looked at a lot of the systems that allow you to issue DIDs and VCs and generally, what we’ve found is that Dock is far easier to use than many of the existing tools out there. It can deploy very quickly and it will be very easy for our developers to use the tool.”

Blockchain technology in the global healthcare market was valued at US$531 million in 2021 and is projected to reach US$16.3 billion by 2031. This demonstrates growing interest and recognition of the tremendous impact blockchain can have in the health services.

This article appears in Omnia Health magazine. Read the full issue online today.

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