WILL MEDICAL DEVICES TRANSFORM THE THERAPUTIC PROCESS TO MAKE IT PATIENT-CENTRIC?

For some years now, financial institutions, the press, regulatory process and large web corporations dealing with healthcare have increasingly focussed attention on medical devices.??Whilst the general public may not yet fully understand, or possibly even be aware of the topic, many analysists are convinced that the growth in relevance of medical devices, coupled with the management and subsequent processing through artificial intelligence algorithms of their data, will, when compared to ‘normal’ pharmacological treatment, enable a Copernican revolution in healthcare.??Not only will this transition finally put the patient firmly at the centre of the process?but potentially could also provide new solutions to manage the exponential growth of healthcare spending in developed countries' budgets, generating significant savings.

Let's see how, starting with a very interesting article published in May 2019 by McKinsey and written by Shubham Singhal and Stephanie Carlton, in which the two researchers tell us about nine new technologies that could have disruptive effects on the therapeutic path.

·????? Connected and cognitive devices: all those portable and wearable tools that provide us with data that when connected within an ecosystem can return information. We are talking about standard devices that measure heart rate, number of steps, speed, sleep quality and other information, but we are also talking about new systems to monitor more medical parameters such as glucose level and blood pressure. Many of these devices are already available, others in the testing phase, others are in advanced design. Some of these devices will be worn (like normal watches), others will be implanted, still others "ingested" to give us information on the digestive system, for example.
        

·????? Electroceuticals: this will be a huge revolution. It has been discovered that the emission of electromagnetic waves inserted inside the brain can modify the electrical impulses emitted by the nervous system with the consequence of modifying the transmission codes between synapses to cure a large number of neurological diseases - diseases on which the classical pharmaceutical is today only marginally effective.
        

·??????Targeted and personalized medicine: the old dream of personalisation of treatment is back and today is truly becoming reality. Soon we will use patient-specific active ingredients with personalized dosages; treatments will be made with patient’s own cells or genetic material directed to specific cells. All these techniques are already under clinical trials and appear to work much more effectively than any form of traditional drug.

·????? Robotics: the next generation of robots will facilitate increasingly precise operations, making most surgeries more effective and less invasive as well as reducing the physical burden of surgery. ?In another field, a new class of robot could replace healthcare personnel for repetitive problems of low value or dangerous and dirty actions (3D: Dangerous, Dirty, Dull) and will therefore be ideal in the healthcare environment as it will leave operators free to carry out real added value activities. ?During the Covid-19 emergency in China we have already seen robots replacing healthcare workers in the disinfection of machinery, supply of drugs and delivery of food to infected patients in order to avoid contagion among nurses.

·????? 3D printing: this technology, already in use in various health sectors (with higher cost compared to traditional techniques), will facilitate the creation of a completely customized prosthetic, replacement of organs and the possibility of delivering customized precision dosing for a new way of delivering therapies.

·????? Big Data Management: dream or reality? Today it is still difficult to predict where this trend can lead us. One thing is certain: through connected devices and the enormous amount of information derived from modern diagnostics, we have more precise and personalised data that can be correlated through computers which are powered by higher than ever computing capabilities. It is estimated that once this trend becomes a daily reality, the amount of data that will enter the health system will increase by 48% per year.

·????? Artificial intelligence: the next step to Big Data. Bundling raw data provides us with information, but if we then process them with artificial intelligence algorithms, we can find new relationships between data and identify wider implications. We will be able to evaluate the outcome of our therapeutical pathway and therefore predict the patient's final state at the beginning of the therapeutic path. The goal is to improve diagnostic solutions, anticipate therapeutic treatments according to scientific criteria and optimize clinical productivity. Many companies and institutions are starting to connect data to improve therapeutic protocols, pre and post-operative plans, rehabilitation, patient management. The goal is to transform data into "actionable insight" (deep knowledge that suggests action).

·????? Blockchain: this huge store of private data, considerations and forecasts will require the certainty of a level of confidentiality and privacy unthinkable today. It will therefore need to be managed by a system where information is completely decentralised and code breakers will never be able to access the patient’s information. The blockchain system used in the financial field becomes very useful for the ethical health revolution.        

It is interesting to note that eight of these nine new technologies are medical devices or IT systems fed by data from medical devices. It is also important to consider that we are not talking about a futuristic vision but a reality that is already active today: in the last decade, the FDA has approved twice the amount of therapeutic processes it had approved in the previous decade and the majority of these are in some way linked to these technologies.

The reason many analysts believe this may be the new Copernican revolution is that the new devices will transform not only the way we treat patients, but also the very concept of health management. It is estimated that in the next ten years, clinical care, an important focus for healthcare today, will affect only 15% of patient results; social factors, appropriate behaviour and genetics will affect the remaining 85%. And a large part of these elements can be measured, monitored, influenced, known, through medical devices.

The paradigm of health is shifting.??My father lived his life going to the doctor when sick whereas my daughter will know in advance what her genetically weak areas are.??She will have a personalised master plan to follow so that she can manage those vulnerable areas, regular and planned contact with medical staff (who may also include a personal trainer) to help her choose the most suitable regimen for her specific situation.??Her data will be constantly monitored (not by Big Brother, but by herself) and she will be alerted of diagnostic investigations or pathologies at a very early stage. In a word, in the past we treated the disease, today we understand we must manage health. Tomorrow we will simply do it.

We are in the transition phase where we are beginning to understand the potential of these technologies, but we have not yet completely solved the problems related to their application. And, as always, a problem that seems technological is instead surprisingly human. This new paradigm cannot become reality without the active participation of the patient.??Without data, correlations will not exist, and it will be impossible to build any predictive algorithms, provide advanced diagnostics or suggest empowering behaviours. Data will be the driving force behind this transformation that cannot happen if the patient does not understand the importance of collecting them, will not agree to transfer them, will not want to have them analysed, will not participate in the process to improve them.

The minimal experience we have makes us understand that there is still a lot to do. If the subject does not use the connected device and leaves it on the bedside table when they wake up, if they do not connect it, do not allow the use of personal data, do not participate by adapting behaviour to what is suggested by the "digital personal trainer", if they are not actively interested and invested, the system does not work.

Co-participating in health management requires a strong commitment and active involvement by the subject and their family - an attitude that is not yet established because of lack of infrastructure, the complexity of making technology accessible to everyone, especially the elderly, but more importantly because of the mindset of patients.?

The great scientific and technological healthcare revolutions of the previous century were largely elitist and confined the decision-making element solely to the physician.??In contrast, this transformation must be "popular", it must admit, encompass, and convince all the players but especially the patient.?

Any of this transformation, even the more traditional (because fully managed by physicians) like robotics, 3D printing and electroceuticals will require mindful and informed choice. Because in order to use these technologies a patient must decide to undergo a longer and more complex pre-operative path or choose to collaborate with clinical trials and sometimes accept a higher price to have a qualitatively better treatment.

The revolution will therefore have to be systematic.??New processes will have to be invented, new metrics and a new nomenclature defined.??The industry will have to start factoring in patients at the early design stages of new commercial projects and it will have to understand the problems and create a technology that can actually be used. I am convinced the very concept of patient will disappear and will turn to "individual with a health project”.

Communication will be fundamental: ethical, objective, responsible, authoritative, all so that the subject can actually “see” the vision of this new project and the benefits available.??A project that involves all of us; a project with great potential as well as risks to manage.??In the last century we conquered space - what if this was the century that we conquered health?

For more information about CommuniD?Enabling Medical Device Awareness?please contact me:?[email protected]

Reference:

·??????The era of exponential improvements in healthcare? – Shubham Singhal & Stephanie Carlton -?McKinsey blog

·??????Relationship between determinant factors and health outcomes.?American Journal of preventive Medicine. 2016; 50(2):129-35

·??????Bureau of Labor Statistics; Robert Wood Johnson Foundation. IBM Watson

·??????Stanford Medicine 2017 – health trends reports. Harnessing the power of data in health. June 2017?med.stanford.edu

·??????Patient-centric approach more important than ever: Deloitte. N+Jenni Spinner – 7 April 2021

·??????Robotica e intelligenza artificiale applicate al settore sanitaria. Darya Majidi blog.

·??????Electroceuticals – Nerve stimulating therapies could replace drugs for many chronic conditions. Geoffrey Ling, Corinna E Latham – September 2018