Author: Sofia Pelanda Mazza

Medtech regulation

Medtech – Reconciling Regulation and Innovation Efforts

Medtech is one of the fastest-growing technology fields, and also one of the most regulated. In the past two years alone, it has grown by 235 percent, developing a broad range of innovations and technologies – in the areas of personalized medicine, algorithm-aided diagnostics, augmented reality, and self-driven healthcare – aimed at improving health and ensuring more equitable, easy, and distributed access to patient care. This proliferation of medical technology has been accompanied by regulatory measures, standards, requirements, and processes to ensure that patients’ safety always remains at the forefront.

According to AND Technology Research CEO Nicole Thorn, the tension between agile technology development and stringent regulation will continue to grow in the future unless a new approach is developed. On the one hand, iterative and dynamic approaches to development are proven to result in better technology. On the other hand, however, a lack of strict regulation in medtech can open the door for under-tested and under-managed systems, devices, and products that can be dangerous and harm patients.

Thorn suggests that regulatory compliance geared toward patient safety could be better aligned with the aim of agile medical innovation by focusing on three areas. The first is to ensure that auditing bodies and regulatory consultants are given better guidance to enable engineering teams to easily combine compliance standards and agile development processes. This would help reduce innovators’ confusion when faced with a cascade of regulations and long lists of product requirements, and allow them to proceed smoothly through all stages of development.

The second suggested area of focus is to leverage technologies to help innovators better understand the requirements. To this end, electronic quality management systems can be employed, although they can be expensive and require special expertise. Decision support algorithms, classification algorithms, natural processing language, and visualization tools are some of the technologies that can support companies in generating documentation, tracking testing, and assembling evidence of compliance.

Finally, Thorn suggests consolidating information sources in one place, as far as possible, to help innovators find information such as relevant contacts of bodies and authorities, submission requirements, ethical approvals, and so on more quickly.

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Mental health - Supertrends

Mental Health – A Rising Issue That Calls for Digital Solutions?

Mental health is an issue that is gaining increasing relevance, as associated disorders – such as anxiety and depression – are found to be on the rise globally. Worryingly, these also involve young people and children to a significant extent. As little progress has been made in the development of new medicines and treatments in the past decade, experts in the field are looking to digital technology as a valuable resource to help counter and prevent this trend.

According to data provided by the US National Intelligence Council in a report (March 2021), it appears that mental health disorders have grown by 13 percent during the past decade, and that currently between 10 and 20 percent of children and adolescents globally are affected. As a result, suicide is the third major cause of death among people aged 15 to 19. This is a growing phenomenon, to the extent that health experts estimate that the annual expenditures on treating mental illness could exceed US$6 trillion by 2030.

Predictions by the World Health Organization (WHO) support this future outlook. In fact, the WHO believes that by 2030, mental health conditions will be the leading public health burden globally, fomented by the failure of mental health services to be able to understand and intervene early enough to provide patients with appropriate care. According to the WHO, technology and innovation could make up for shortfalls in these areas.

In the wake of these considerations, healthcare providers, tech providers, and disruptive innovation companies have already begun to work independently or in collaboration with a wide range of public and private actors – governments, insurance entities, research centers, and universities – to enhance and further develop digital technologies to address different types of mental disorders while increasing the scalability, affordability, and accessibility of the global mental health system for afflicted patients.

Mobile applications – passive symptom tracking

Mobile apps for mental health conditions

A lot of effort is going into the development of mobile apps that can assist and monitor mentally ill patients at different stages of their condition. For example, researchers are currently exploring methods to enhance mobile applications for passive symptom tracking. Through sensors inside smartphones, these apps can record movement patterns, social interactions, and collect other data relevant to behavior analysis, such as tone of voice, speed of speech, and more.

By cross-referencing this data, the app is able to identify significant behavioral changes that could be indicators of upcoming episodes of mania, depression, or psychosis. This makes it possible to alert mental health professionals early on, allowing them to intervene before these episodes occur.

To date, the analytical capacity of these apps is still relatively limited, but the goal of enhancement is to make them capable of greater accuracy in analyzing behavioral data, with the ultimate goal of being able to manage even patients with more acute disorders.

Virtual Reality – Supporting doctor-patient communication and therapies

Mental health therapy through VR - Supertrends

In the past two years, there has been a growing interest in the development of virtual reality as a way of supporting therapies to enhance mental health. Worldwide, researchers are studying the benefits of VR from different perspectives, ranging from increased patient engagement to the possibility for the mental health professional to be more in close contact with severe cases, to actual therapeutic applications.

Regarding greater involvement, research on VR-based solutions conducted in 2021 (Dilguel et al.) showed that Virtual Reality Group Therapies (VRGTs) stimulate patients to interact more with each other and with the therapist, and to be more participatory and honest in sharing, leading to greater group cohesion overall. This is due to the virtual environment and especially the anonymity provided by the avatars, which allow greater openness for patients who have difficulty talking freely about their disorder.

From the mental health professional’s perspective, virtual reality can facilitate stronger connections with the patients, allowing them to be more closely followed. What’s more, it is a technology that lends itself well to various therapeutic models, including preventive ones, and can give greater access to mental health services even for patients who are unable – or reluctant – to reach out to the therapist in the physical world.

From the point of view of therapeutic outcomes, advances in the study of VR therapies involve more disorders such as pain management, phobias, and anxiety, while the treatment of depression, for the time being, is least addressed in the current literature. The focus of research is also primarily geared toward using VR technology for the development of therapies rather than as a tool for diagnosing mental health conditions.

What to expect in the near future?

Currently, much effort is still focused on researching the possible uses of VR to ensure accessibility, patient care, and effectiveness of virtual therapies. Moreover, the support provided by mobile applications has not yet reached the level of maturity where they can handle the analytical complexity required for effective and preventive management of mental health conditions. However, according to experts, VR technology will become increasingly popular and widespread in the future due to a gradual reduction in costs and an increase in the quality of VR headsets. This will have a positive effect on the progressive development and testing of VR interventions to support mental health.

The digital approach to mental health as a whole has the potential to be implemented in a multitude of different regional and cultural settings and thus achieve a generalization of therapies that can reduce the burden of mental disorders globally.

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5G Health tech - Supertrends

5G Can Unlock the Full Potential of Health Tech

The faster, the better: Recent research on the potential of 5G in healthcare carried out by Massachusetts-based International Data Corporation confirms that this technology can boost healthcare technology by making it faster, more precise, and more accurate, with clear benefits for patients. The list of technologies boosted by 5G includes remote robo-surgery, tele-treatment, and augmented and virtual reality for the purposes of medical diagnostics and practice.

Regarding robo-surgery, the application of 5G would enable connectivity with extremely low latency – that is, very small delay times – between command and execution. This enables greater precision and accuracy by the surgeon controlling the robot. It also means that, unlike now, the doctor would no longer be required to be physically close to the patient and operate from the same room for safety reasons, but could do so completely remotely. Reinforcing surgical robots with this technology would thus enable them to perform surgery even during crisis situations that prevent doctors from reaching patients in remote locations.

The higher connection speed provided would also normalize tele-treatment as a practice, as it would ensure the enhanced and more stable video streaming quality that doctors require for detailed checkups and identification of symptoms. In addition, 5G-supported telemedicine can easily integrate and store extensive patient data, images, and documentation without compromising connectivity. Thus, tele-treatment would provide greater accuracy in remote medical practices, greater coverage of patients scattered in remote locations, and greater safety even in the event of pandemic outbreaks while ensuring compliance with any social distancing norms.

The increased bandwidth and low latency will also facilitate the latest applications of virtual reality (VR) and augmented reality (AR) in the medical field and help to unleash their full potential. For medical students, the accuracy of VR and AG technologies enabled by 5G would eliminate the need to practice surgery on human corpses.

In addition, 5G-based AG allows diagnostic images to be accurately projected onto the patient, helping the surgeon identify less damaging surgical pathway alternatives. The technology is expected to pave the way for many more improvements in next-generation healthcare technology, as well as in other industries.

Did you enjoy this article?
To learn more about the technology, challenges, and opportunities in the health and life sciences sector, read our industry overview.

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