Technologies for life
Digital technologies for Healthcare
Evolution is the fundamental idea in all of life science – in all of biologyBill Nye
Life sciences encompass a range of knowledge that touches on very different aspects. The basis is biology, the study of physical and chemical processes that characterise living systems. From this, come fields of application such as biochemistry, molecular analysis, genetics, physiology, up to emerging processes that regulate development and adaptation, the assessment of behaviour and the interaction between organisms.
In Italy, biomedical engineering is an area of real excellence in the healthcare world. This intricate work sector includes subjects such as mathematics, chemistry, physics, biomechanics, materials science, electrophysiology, neurophysiology, cognitive sciences and the cybernetic field, such as in bio and nanotechnologies. With an engineering technical and design approach, it is possible to study effective solutions and systems for the biomedical sciences. Starting with the definition of a problem from a medical-biological point of view, engineers build artificial organs and prostheses, and develop electro-medical equipment for diagnosis, treatment and rehabilitation.
Biomedical engineering is also involved in organising hospital departments, compliance with safety regulations relating to medical devices and acquiring and processing data in the field of diagnostics and monitoring.
Biotechnology is a complementary field to biomedical engineering. In this area, which is more directly linked to research and development activities, biotechnological investigation method techniques and the use of laboratory equipment are focussed on designing products for the chemical-pharmaceutical industry. Microbiological, biochemical and genetic analyses and toxicology checks allow for drug experimentation and development. The ability to use and manage innovative software for collecting, documenting and drafting complex reports is one of the biotechnology research management activities.
Healthcare is one of the most dynamic industrial sectors and in recent years has undergone a real revolution thanks to a series of technological evolutions and innovations that are reshaping the future. In particular, this profound transformation has impacted products for patient care and at the same time the dynamics and working rules for doctors. Together, these two inputs have generated new business models for the entire sector.
But what are these instruments that are revolutionising healthcare? They include telemedicine and artificial intelligence, digital-health Clinical Decisional Support Systems (CDSS), virtual environments and computational approaches, blockchain to track the health of patients, and personalised and precision medicine. The virtuous chain that has led to this involves a demand for continuous innovation, followed by huge investments in the Research & Development sector and finally the resulting solutions applied to the medical field.
The focus on this issue is not limited to companies in the healthcare and biopharma sectors of expertise, but inevitably extends to the big technology players, Google, Microsoft and Apple above all. The figures coming out of some recent reports highlight this dizzying interest and predict the value of investments will grow to over $500 billion dollars between now and 2025.
The medical device industry in Italy
The average per capita healthcare expenditure on medical devices in Europe is around €212, while in Italy it is €189.
In our country, there are almost 4000 companies in the market, including internal and export markets, with 76,400 employees. The relationship between big market players and small companies, such as start-ups or spin-offs and R&D companies, is becoming increasingly intense, with the latter often acting as a reference point for the possible future of the sector. The graph below shows the Italian landscape with data collected by Confindustria.
In its national guidelines, the Italian Government’s Ministry of Health provides the definition of Telemedicine as “meaning a way of providing healthcare services, through the use of innovative technologies, in particular Information and Communication Technologies (ICT), in situations where the healthcare professional and the patient (or two professionals) are not in the same place. Telemedicine involves the secure transmission of medical information and data in the form of text, sound, images or other forms that are necessary for prevention, diagnosis, treatment and subsequent monitoring services for patients. Telemedicine services must be in line with existing diagnostic/therapeutic healthcare services”. The definition goes on to specify that telemedicine does not in any way replace the traditional healthcare service, and the related personal doctor-patient relationship, “but is integrated with it to potentially improve its efficacy, efficiency and appropriateness. Telemedicine must also comply with all the rights and obligations under any healthcare act”.
By 1997, the WHO (World Health Organization) had already defined how it should look. “The delivery of healthcare services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities”.
The global pandemic starting at the end of 2019 linked to COVID-19 (see FOCUS) has made the need for a radical change in medical care even more urgent.
Telemedicine has different healthcare purposes:
|Improving the quality of healthcare|
|Enabling improved usability of care and diagnostic services|
|Allowing for remote medical advice|
|Allowing constant monitoring of vital signs and therefore of the state of health of patients|
|Reducing the risk of complications in people at risk or suffering from chronic diseases.|
In relation to the social fabric, telemedicine gives administrative areas the possibility to increase equity of access to social and healthcare services, especially for those who are geographically isolated, thanks to the service’s flexibility of delivery and use. In this way, continuity of assistance in the area is guaranteed, at the same time allowing resources to be allocated where they are most needed, without wasting valuable professional time on simple physical supervision. Finally, teleconsultation can offer significant support to emergency mobile services, with the use of remote clinical resources, even directly on board ambulances.
Telemedicine, COVID-19 and post-pandemic
Terms such as “monitoring” and “distancing” have become familiar when talking about health protection, particularly following the spread of the COVID-19 virus from the end of 2019. Apps to track people’s movements and the need to manage discharged or asymptomatic patients with telehome methods, if not fully resolving issues, have put them at the centre of the debate.
Telemedicine is also very effective in preventing the collapse of emergency service management, as was observed above all during the early months of the spread of the pandemic. For example, for asymptomatic positives, it allowed us to measure the parameters we learned were the most evident manifestations of the virus infection and its most aggressive. These include above average body temperature, respiratory rate and oxygen saturation, and heart rate related to respiratory rate. Home monitoring can help with taking prompt action where the condition worsens. Similarly, it is advisable to continue monitoring patients after they are discharged, since they are considered recovered, the aforementioned parameters in the full recovery stage can then be observed.
Another issue dramatically brought to the fore throughout 2020, was the care of patients with emergencies not related to COVID-19. With intensive care units at full capacity, it was not possible to treat cases such as heart attacks in a timely and appropriate way. Monitoring of this category of patients is also essential when the relationship between hospital and patient is rendered impossible for various reasons. In general, the emergency accelerated the transformation of telemedicine from an emergency tool to one used routinely.
How can the huge amount of data coming from the biological, chemical and clinical sectors be transformed into something to be used in the development of more effective drugs? The data is accumulating at ever increasing rates and has the potential to accelerate and provide information on drug development. The challenges and opportunities now lie in developing analytical tools to transform this often complex and heterogeneous data into verifiable hypotheses and actionable insights.
Computational pharmacology uses in silico techniques to better understand and predict how drugs affect biological systems, which can, in turn, improve clinical use, avoid unwanted side effects, and guide the selection and development of better treatments. One exciting application of computational pharmacology is drug reuse, looking for new uses for existing drugs. With many promising candidates already, this strategy has the potential to improve the efficiency of the drug development process and reach patient populations with previously unmet needs, such as those with rare diseases. Current computational pharmacology and drug repurposing techniques focus on single data modalities such as gene expression or drug-target interactions, or methods such as matrix factorisation that can integrate different types of data to improve predictive performance and provide a more complete picture of a drug’s pharmacological action.
Simulating the dynamics of a disease with computers has several advantages. Firstly, the possibility to assess the effectiveness of new drugs or vaccines, not least without having to test them on humans or animals. In this last case, in addition to removing the related ethical issues, it also eliminates the grey area related to the margin of uncertainty on equal effectiveness for humans of a treatment tested an animals.
Health Technology Assessment – HTA is the multidisciplinary process that summarises information on clinical matters, but also on economic commitments, social impact and assessments from an ethical point of view related to use of a healthcare technology. Its goal is to develop health policies focused on creating the best possible value for citizens.
From this perspective, it is clear that cultural development must go hand in hand. Clinical choices run in parallel to technical choices and must be measured on evidence of efficacy and value in terms of health results for patients who, as well as the professionals in the sector, must be involved and updated on the development of the process. For example, in understanding the role that artificial intelligence has already played and can play in the coming years, the next “revolution” in the medical field could be linked to the introduction of applications derived from AI in clinical practice, for example for predictive diagnostics. How will a patient treated by a robot react, one’s own health being an area of such profound “human” implications?
“Personalised Medicine”, or “Precision Medicine” is a form of medicine using specific genetic information of the patient’s illness for prevention, diagnosis or treatment. Personalised medicine is mainly related to treatment (therefore the cure) while precision medicine is applied to both diagnosis and targeted treatment. In oncology conditions, personalised medicine uses specific information about an individual’s cancer to help with diagnosis, planning treatment or giving a prognosis. Examples of personalised medicine include the use of targeted treatment for specific types of cancer cells, such as HER2-positive breast cancer cells or the use of tumour marker tests to diagnose cancer.
Our health is determined by our hereditary genetic differences combined with our lifestyles and other environmental factors. By combining and analysing information about our genome, with clinical and diagnostic information, and then comparing that with data from other subjects, it is possible to help determine our individual risk of developing diseases, detect previous ones, provide an accurate diagnosis and determine the most effective things to improve our health. The answer could be medicine, but also lifestyle choices or simple dietary changes.
The true value of personalised medicine for our healthcare lies in the integration and analysis of information from genomics, clinical analysis, diagnostic data and lifestyle.
20 years ago, in 2000, an important step was taken when the first human genome was sequenced, giving us clues as to how weight differences may impact our health. Today, new sequencing technology has brought down the exorbitant initial cost of £2 billion for a single sequence and it is now possible to consider this technology an integral part of healthcare.
The Life Sciences sector is growing rapidly. The relationship between treatment and disease, between doctor and patient is heading for a radical change. The next challenge is the transition from the traditional medical approach to 4P medicine.
Predictive : with diagnostic processes and cutting-edge technological tools, it is possible to prevent diseases and limit their effects.
Preventive: to support and promote adequate prevention processes with a specific focus on the individual’s well-being.
Participatory: where the patient can interact, discuss and choose what action to take following the logic of prediction and prevention.
Personalised: to respond in the most detailed and effective way possible to the physical, physiological and clinical characteristics of the patient.
In 2013, the world of digital information already stood at around 98% of all information produced globally. In healthcare, the annual growth rate of generated data has reached 48%. Medical records are often include videos, images, texts and audio files that support research of the patient’s clinical profile. In the same way, increasingly advanced diagnostic programmes go hand in hand with the affirmation of BigData and IoT, opening up the possibility for everyday objects such as clothing, smart home systems, vehicle technology and smartphones to collect data on the health of the body, such as heart rate, glucose levels, blood pressure, body temperature and then transmit this crucial information via the internet.
BigData has put the delicate issue of data processing and analysis at the centre of the debate. Thanks to a new research approach, with cognitive analytics and machine learning systems, algorithms can process an impressive amount of data, but in order for it to have value and be readable to extract valuable information, it is necessary to refer to the skills of data science specialists. Precision medicine, used in diagnosis, will increasingly encourage the use of in-depth sectoral knowledge to treat diseases, prevent epidemics and improve people’s quality of life and life expectancy. The 4 P’s are, indeed, the objectives to aim for.
Medicine is changing rapidly. From a system focussed on disease management to a molecular and systemic approach typical of systems biology, which studies living beings as structures in evolution. In particular, we are trying to understand genomics better to evaluate the dynamic system changes. From mathematics-statistics to bioinformatics, up to biomolecular disciplines, the idea is to collect the digital behaviours of patients and users, and to work with the data for a preventive purpose. Technology’s continuous growth is the additional tool which will make this possible.
Interview with Donatella Vecchione, Project Manager Teoresi Group (december 2020)
Prompt intervention in an emergency situation can play a crucial role in a patient’s health. Teoresi’s in-house design is based on a combination of AI systems with health diagnostic systems using imaging and forecasting and AI analysis to support health assessments, monitoring patients’ vital signs. Applying this technology to a continuous mobile assistance system during sporting events or emergency situations guarantees more efficient monitoring and rapid support.
A software platform which reproduces the workings of at least 2 primary organs connected to each other, to test drugs currently in clinical use for applications other than those for which they are currently on the market. The idea involves the creation of a remotely accessible software platform that is User friendly – end to end, implemented with tools approved by government bodies. It is an expandable computational model that can be extended to cover more functions and organs.
The project is based on the development of a medical device prototype through the study, design and integration of HW and SW platforms for theranostic applications (a combination of diagnostic and therapeutic functions), to carry out joint and sequential diagnostic and therapeutic treatments in real time for breast cancer and liver cancer. The project is aimed at liquid biopsy, spectroscopic imaging for developing tissue biopsy functionality without biological sampling and controlled release of drugs on site.
A biomedical data processing platform is being developed to create a platform for Health Technology Assessment (HTA) applications through the use of various statistical methodologies for assessing different surgical techniques for pathological treatment.