Articles

Innovation. Different ideas come to mind when one hears this word. Innovation rhymes with avant-garde, progress, improvement. Most young people will automatically associate it with the release of a new gadget. Indeed, innovation rhymes with technological development. For scientists, innovation rhymes with creativity, a breakthrough discovery, a new method that revolutionizes the way we currently work or think science. Innovation and industry go hand‑in‑hand and it is what propels progress forward. Innovation also rhymes with a need for solutions! ‘Necessity is the mother of invention’ is an expression that speaks volumes for many people affected by Rare Diseases! Expressing a special gene, in many cases, defines a life with challenges that, sometimes, surpass the humanly possible. But special is the keyword. Special rhymes with superpowers, a force within that is vast, unlimited. And that is what characterizes patients (and/or caregivers) of rare diseases: their unstoppable quest for the understanding of their condition, for a treatment or solution that makes lives, sometimes, possible. In a nutshell, innovation is a driving force that makes things happen in the field of rare diseases. It is not for the faintest of heart!

Are you familiar with rare diseases? I must confess that, working for years in the field of gastrointestinal pathogens, the term rare diseases was not in my scope, even less on my day‑to‑day radar. It was quite a humbling experience to dive into this field when I supported a medical writing team working on a few rare diseases. Paradoxically, it was somehow a rewarding experience, to be able to use my skills to raise awareness for a condition that impacts so many people. So, what makes a disease rare? According to EURORDIS-Rare Diseases Europe, a disease is considered rare when it affects less than 1 in 2000 people, with chronically debilitating or even life‑threatening aspects. An estimated 3.5% – 5.9% of the worldwide population (~350 million people) is touched by rare diseases, a surprising number particularly if one takes into consideration that it impacts more people than cancer and AIDS combined. The majority of patients are diagnosed in childhood with a rare disease of genetic origin. About 6000 to 7000 rare diseases are reported worldwide and, due to the low prevalence of each disease, currently only 5% have a treatment. The leading pitfall in the treatment of rare diseases remains the large scarcity of medical and scientific knowledge, coupled with a commercially unattractive market for pharmaceutical companies. Remarkably, a growing number of associations, non‑profit organizations, and governments endorse global awareness of rare diseases and its strain in the life of patients, families and caregivers, and also in the general society. Notably, several public health policies are fostering the investigation of rare diseases by research institutions and some programs support the development of orphan drugs by pharmaceutical companies, alleviating the economic loss inherent of non-commercial therapeutic agents. Recently, a big player in the identification of new rare diseases and potential therapeutic approaches is Artificial Intelligence. The fast development of AI-based tools (ML-machine learning- and NLP -Natural language processing) along with the increasing availability of patient health registries and multi‑omics databases is paying off, leading to the identification of disease biomarkers and the repurposing of an existing drug to treat some conditions. Taken all together, the growing global awareness of rare diseases, along with incentives to boost scientific research by governmental agencies and private organizations, is shaping how rare diseases are diagnosed. We, slowly, move towards the improvement of the quality of life for a large number of people worldwide. Yet, 95% of patients lack treatment and their life quality is, still, far from ideal. In the absence of real solutions, many courageous patients and caregivers take measures into hands, becoming patient-innovators and empowering rare diseases in unprecedented ways.

Being unique is something that many strive for, the ability to stand out, to be original. The uniqueness of disease comes as a hindrance for patients, families, and caregivers. Feeling alone in this long journey is overwhelming for thousands of families. A major difficulty for patients and caregivers is the lack of a social network within their local community that supports them daily in their endeavors to minimize the burden of rare diseases. Online communities are burning down the bridges of isolation. At the ease of a click, patients and caregivers discover a plethora of information, share concerns but also victories. Several open‑source platforms of health innovation connect patients and caregivers with health professionals. The possibility to discuss with physicians or a team of researchers that is at the antipodes drastically changes the lives of many. A significant number of online tools, particularly apps, are being created by caregivers, family, or friends of patients. To find the tools specific to your disease, please, visit the websites of the associations Global Genes, Eurordis, or Orphanet (links below), where information and resources are updated regularly. Apps with an interface that is user friendly, interactive, effective, and no time consuming, are bearing fruits, with many young patients connecting easily with peers and health professionals to seek support. This type of innovative communication also allows the patient and the caregivers to monitor their health status, to learn about the latest medical updates, and to enter medical information, on a daily basis, into shared online databases. Notably, for the medical community, this is transforming the landscape of rare diseases. The paucity of clinical data and published studies translates to insufficient healthcare procedures. Therefore, the gathering of medical information from several patients, across the world, results in observational studies otherwise impossible to conduct. Clinicians can use this evidence-based resource data to generate models that establish disease progression, and, even, to draw an analogy with other disease areas and identify existing therapeutics and, thus, repurpose it with a potential high efficacy. Online communities encourage the exchange of information, the conduct of medical surveys, and the vital continuous engagement of patients and caregivers. Ultimately, the increase of patient registries contributes to the understanding of the burden of the disease from a medical standpoint. Furthermore, it also creates a source of accurate information for patient advocates to raise awareness of rare diseases, its inherent economic burden for the family, but also indirectly to society. This provides invaluable strong evidence of facts to bring together stakeholders and policymakers and to make a difference, sponsoring the investigation of rare diseases and the development of orphan medicines

Online platforms serve as a niche for patients and caregivers to connect with others facing the same questions and fears. More, it is an essential place to easily share and search for solutions, exchange health information, testimonials, and discussions that go beyond the improvement of the quality of life. Online communities are, in a way, a driving force that triggers innovation. It is interesting to note that some innovations arose from the collaboration of patients or simply through inspiration after reading a successful medical story someone has shared. ‘Patient Innovation’ is a platform that illustrates the power of patients and caregivers when they take the centre stage in the design of tools that make their lives easier. Their slogan ‘Sharing solutions, Improving life’ speaks for itself. A few minutes navigating on this platform is enough to be inspired by many stories but it also an opportunity to expand our horizons, to realize that what we consider trivial in our routines for many is a substantial triumph. It is a platform that brings us closer as a society, and, above all, brings to light anonymous real winners that put us to shame. We are flooded by the courage, strength, and generosity that characterize patient‑innovators.

Opportunities emerge at the intersection of technology and patient needs. The collaborative environment found in online communities is only the tip of the iceberg when it comes to innovation. Collaborations that transcend patients and caregivers to englobe research institutes, universities, and pharmaceutical or medical devices companies are creating solutions that set in motion the business of tomorrow. The booming of innovation hubs where researchers and entrepreneurs meet is gaining momentum. A growing number of companies and research institutes have a holistic approach when it comes to the development of therapeutics, including patients and caregivers in the innovation process. The engagement of patients and caregivers early on often results in disruptive solutions that provide insight about simple and practical aspects of a product, boosting its commercialization to a broader public. Moreover, the future of healthcare is technologically based, with digital therapeutics quickly taking the spotlight. The input from patients and caregivers in the initial phases, from brainstorming to co‑design, is, thus, fundamental to the innovation process underlying the improvement of therapeutic products. This is particularly relevant in the field of rare diseases, where the number of patients is not enough to conduct the classic clinical trials with a homogeneous population.

Patient‑innovators are having a say in the medical devices landscape. Little attention is given by industries to medical devices for people with rare conditions. The design of clinical trials with an insufficient number of patients is a challenge, in some cases it might even take decades to gather clinical data to request commercial approval by authorities. The Humanitarian Device Exemption is a program created by FDA to accelerate the development of devices (or combination products) that benefit small (rare) populations, particularly pediatric populations. Companies can apply for funding to conduct research and clinical studies, with the compromise that only a limited number of devices can be sold for profit. Remarkably, patient‑innovators fill a gap in the development of medical devices, tackling commercial safety regulations when they share their innovations with everyone for free, in a system run by patients and for patients. The number of patient‑innovators is growing by the day and a survey conducted in 6 countries revealed that nearly 1 million patients, in a 3 year period, have developed medical products to facilitate their daily tasks. Most of those medical products will never be commercially available. Curiously, the majority of patient‑innovators rejoice when other people test and even improve their initial design, joining forces to make updated versions freely available. The self‑reward seems to be their only driving force to create and share solutions. Most innovations are practical and simple DIY solutions that alleviate the daily burden of rare diseases, without any invasive procedure. The risks for health are minimal, while the possibility to improve the quality of life of many is, poignantly, maximal.

Medical innovation is a long journey filled with challenges and a blind commitment to create a product that improves the wellbeing of many. The rewards are immense. And this takes a whole other dimension when patient‑innovators seek solutions and answers that are not available for a small (rare) population. A driving force of patient‑innovators is the ability to share their innovations, free of costs, with people with similar needs. Online communities are shaping how rare disease’s patients connect and find support. The booming of medical apps to monitor disease progression, to find the latest medical discoveries, and to share tips and success stories is bringing people closer. Despite being physically distant, patients and caregivers find a voice that together speaks louder and raises public awareness of rare diseases. In a nutshell, the fascinating world of patient‑innovations puts rare diseases on a pedestal and promotes the development of therapeutics to improve the quality of life of patients and caregivers. Their innovations are the result of persistence, creativity, strength, and courage. Inspiring!.

References

Brasil et al., 2019. Artificial Intelligence (AI) in Rare Diseases: is the future brighter? Genes (Basel) 10 (12): 978

DeMonaco et al., 2018. Free medical innovation by patients – no producer required. Available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3241760

Oliveira et al., 2015. Innovation by patients with rare diseases and chronic needs. Orphanet Journal of Rare Diseases 10:41.

https://www.eurordis.org

https://www.fda.gov/medical-devices/premarket-submissions/humanitarian-device-exemption

https://globalgenes.org/

https://www.orpha.net/consor/cgi-bin/index.php?lng=EN

https://patient-innovation.com/

We are living in convoluted times. Part of the world, as we know it, is on hold to contain the spread of a pandemic virus. Projects are on hold, dreams are on hold, lives are on hold. We are experiencing an unprecedented stillness, with governments inviting people to stay home, to slowly return to the outside world, to respect safe social distancing measures, and wait! That seems easy to do, to simply wait! Yet, the mind of many is on a triathlon race. The initial fear of contagion was soon replaced by the fear of being confined indoors and deprived of the freedom of a much appreciated and healthy unwind time with friends. And, at the final sprint, the mind faces the fear of an economic collapse and its consequences in the years to come. Paradoxically, it’s mostly quiet outside our houses… but noisy inside our minds. More than ever, we hear advice to be compassionate, to turn into mindfulness and meditation in order to find a balance, a sense of hope and well-being, and to cope with these uncertain times.

Mindfulness is popping everywhere in the western world, even a growing number of corporates use ‘mindfulness culture’ as branding to attract employees and/or customers. We became accustomed to the word mindfulness that most of us don’t even know its origin or what it really means. As a matter of fact, many argue that there is not such a thing considered mindfulness per si! That mindfulness is a broadly defined term encompassing practices from yawn and stretch, body scan and focused breathing, to many eastern traditions such as yoga, Qigong, or Tai Chi. In a certain way, all these practices include mindfulness. But, what mindfulness practices have to do with compassion and meditation?

Meditation is a spiritual thematic practice part of many ancient religious traditions and based on the recitation (and reflection) of scriptures, devotion, visualization, and contemplation. Meditation is taught differently according to the tradition, through the practice of the prayers of Teresa of Avila (Christianity), Sufism (Islam), Kabbalah (Judaism), and Sūtras (Buddhism). Despite the different forms of practice, meditation is an ethical and spiritual guidance that aims for the development of spiritual friendship, love for one another, and a mystical orientation to a transcendental love. In Buddhism, the focus on the feelings of love, warmth, kindness, well‑wishing, or even compassion, is thought to be fundamental for a strong interconnection of all beings. This form of focus is designated by love‑kindness or compassion meditation. In addition to these thematic practices, Buddhism also emphasizes the focus on pure technical practices, namely body and breath techniques and awareness exercises, commonly known as mindfulness. Actually, mindfulness, more precisely mindfulness of the breathing, is a key meditative practice. In the last decades, this millennial practice became popular in the western world. Practitioners of mindfulness, either in a religious or purely technical context, experience an inner transformation, a gain of deeper awareness, grounding, fulfillment, and even, sometimes, a life-changing experience altogether.

Mindfulness, a practice some call a contemplative science, can be defined as a moment to moment awareness, a form of attention without any type of judgment. In mindfulness, one cultivates the mind to be focused in the moment and to simply contemplate the thoughts without engaging in any mental chatting. This practice leads to a decrease in the background noise we all have going on nonstop. We become less absorbed with a myriad of engaged or conscious thoughts, from endless ‘to do lists’, self-talk, and, more often than healthy, self-judgmental and negative reinforcement ruminations. Once we surpass this preoccupied, stressed state, we become familiar with another level of thoughts, we gain access to what some call consciousness. The path is, therefore, clear for the rise of a deep awareness, insightful and even creative or inspirational thoughts, which are, otherwise, buried under the constant state of mental alertness we live in. The meditative mind starts to develop a state of awareness that is broader and deeper than simply the mind. It unveils the complex interconnectivity of our emotional state and body sensations with our surrounding environment. In a nutshell, mindfulness is a heart felted attention, open to a multi-level integrated sensory state of the body, mind, and the outside world. Yet, it requires training and persistence. Initially, most people give up meditation tout court. By the simple fact of being still, people finally notice all their thoughts and states of stress and anxiety. How can one manage to reduce the noise, to have a quiet mind? It seems to be an impossible task! Do we have to become a yogi or those so-called ‘free spirit people’ who seem to live in a parallel world? The answer is: actually no! A motivation to consistently engage in the mindfulness practice is to be aware of how its benefits are beyond the grounding and presence in the moment.

The vast potential of meditation has been the subject of scientific research in the last decades and it is bearing fruits in many research fields, from neurophysiology to immunology. The development of technology, particularly electroencephalography (EEG), has contributed to the noninvasive record of the electric activity of the brain, over a period of time, and, consequently, to a better understanding of the brain function. For instance, sleep research has unveiled a correlation between the levels of consciousness and the frequencies of the different electric brain-based waves. While all four brainwaves are present all the time, one brainwave predominates over the others at any given time. For example, beta waves, which have low amplitude with high frequency (15-40 Hz), are representative of a strongly engaged mind, linked to active thinking and problem-solving mode. Following the order of frequency, the alpha waves (9-14  Hz) are associated with a reflective and quiet flowing of thoughts. Theta waves (5-8 Hz) are coupled to daydreaming and mental relaxation, while delta waves (1.5-4  Hz) are predominant during a deep dreamless sleep state.

It is a dogma that with meditation one attains consciousness. So, what does the research on brain waves of monks during meditative stages show us? Curiously, a disparity of data between the different studies! This disparity of data reflects the type of meditative practice, whether it was merely focused on the breathing or included mantra recitation or visualization. For instance, theta waves are the main recorded brainwaves in practitioners of meditation based on visualization, a common practice in Tibetan Buddhism. Interestingly, sleep research has shown that theta waves are dominant during sleep, particularly in the twilight state, and are the prevailing brainwaves when we experience vivid imagery, intuition, learning, and memory training. Also, theta waves occur when we attain a state that is beyond our conscious awareness. Fascinating, right? Despite the inconsistency of the data among the different studies, a major common finding suggests a high incidence of theta and alpha waves during the initial stages of meditation. This indicates an attention engagement and active training of the mind, important for the proficiency of the practice.

Notably, comparative EEG‑signature examination of long term Tibetan Buddhist monk’s practitioners and healthy non‑meditator volunteers revealed a higher synchronization of another brainwave in Buddhist practitioners, the gamma waves. Additionally, the long term meditators had a surprisingly high gamma activity even during the resting state, which had never been recorded before. This was a particularly intriguing result, as gamma waves were considered to be background noise with no key role. So, what are actually gamma waves? Gamma brainwaves are the fastest (25-140 Hz) and the most subtle waves, detected mainly when the mind is quiet. Gamma waves are involved in the simultaneous processing of information from the different brain areas associated with the formation of memory, learning, and conscious perceptual functions. As mentioned previously, the initial meditative stages are characterized by a high frequency of theta and alpha waves. Further studies revealed a desynchronization of alpha waves and an increased synchronization of gamma waves in advanced practitioners, supporting an integrated sensory mental processing. Remarkably, the coupling of the theta-gamma brainwaves during the meditative state is involved in the hierarchical reorganization of the connectivity network between the central nervous system and the autonomic nervous system. During meditation, large-scale spatiotemporal brain network reconfigurations activate neural synchrony, key for several cognitive and affective functions. Changes in the neural representations of visceral activity, particularly the heartbeat, are reported during meditation. Recent research revealed that gamma waves are involved in the intrinsic organization of brain networks associated with the cardiac activity important for the perception of the heartbeat, the conscious awareness of the self, and the emotional feelings. Curiously, the vivid perception of the heartbeat during meditation underlies the Buddhist concept that the brain is physiologically located at the place of the heart. Today, science is able to explain this millennial perception.

The unexpected prevalence of gamma brainwaves during meditation urged further investigations and it has been contributing to new fields of research. It is interesting to note that a higher predominance of gamma waves recorded during a specific form of meditation, i.e. love-kindness or compassionate meditation. It is thought that gamma waves modulate the perception, consciousness, prevailing in states of universal love, altruism, during spiritual emergence, or development of higher values. Remarkably, brain imaging studies using functional magnetic resonance imaging (fMRI) revealed an increased activation of brain areas associated with the limbic system. Insula and anterior cingulate cortices (ACC) are highly activated in Buddhist monks during meditation, versus rest. Both insula and ACC are typically involved in consciousness, cognitive functioning, impulse control, morality, and emotion. Other active regions of this neural network include the gyrus (middle occipital, middle frontal, inferior frontal, and precentral), precuneus, thalamus, and caudate nuclei. The activation of the complex limbic network is known to regulate several self-awareness processes, namely interoception, exteroception, proprioception, and kinesthesia. Curiously, interoception is important for the emotional regulation, body awareness, and perspective of the self, in which thoughts and feelings are an integral part yet are observed in a distant and objective sense as a transient mental event. In sum, interoception means the focus on the here and the now. In other words, mindfulness! Quite remarkable the correlation between meditation and the activation of the insula and, subsequently, the interoceptive network. This opens new avenues to neuroscientists and psychologists to further study this subject and to incorporate observations and empiric data from the millennial contemplative science in the treatment and prevention of mental illness.

In the last decades, many programs that combine traditional cognitive therapies with meditation have boomed. Patients with major clinical depression seem to have an atrophy of the hippocampus, among other neurophysiological features of depression. After 8 week meditation training, it was found a significant increase in the neural thickness and density of the hippocampus in patients with depressive states. Another study using fMRI scans has also revealed the activation of the insula and the reduction of the amygdala (also known as the fear center) reactivity in participants undergoing a 8 week of meditation training. It is striking to note the reduction of the amygdala reactivity after a 8 week meditation program and its correlation with reduced anxiety and worry reported by the patients. It seems that the direct attention focus to connect body sensations to a deeper physical and emotional meaning, in a state of a reduced perceived stress level, unveils a broader state of consciousness and understanding of actions and reactions. In a certain way, the psychosocial patterns are displayed in a nonjudgmental, nonreactive way, with direct access to the inner self. Moreover, clinical patients that routinely practice love-kindness and compassion meditations, particularly directed to the self (i.e. self‑compassion), often present a decrease in the negative loop reactivity, depressive states, and even depression relapse. Although growing evidence of the efficacy of meditation-based treatments, the meta-data analysis of clinical trials must be taken carefully, due to inconsistency of results across the studies, which is largely depending on the meditation practice followed by the clinical patients.

A remarkable outcome of the study of the brain of experienced and new Buddhist monks was the identification of neuroplasticity. Brains were thought to have a conserved structure at its full development in earlier adulthood. fMRI studies of the brain of monks with over 40000 hours of practice (what is considered to be an intermediary Buddhist monk!) revealed an impressive increase in the grey matter volume. Thankfully, one doesn’t need to become a meditation expert to ‘attain’ brain plasticity. A few months of daily practice (20 minutes) is enough for the increase of grey matter in the right AAC, the left, middle and right gyrus, and the right thalamus. Notably, it is observed a brain asymmetry, at the level of precuneus, prominent particularly in long term meditators. A change in the grey matter volume, particularly in the AAC, is known for the enhancement of self‑control, self‑regulation, and problem‑solving. It has also been shown to be involved in prosocial behavior. This is particularly relevant when the meditative practice is love‑kindness and compassion. Many centers use meditation to reintegrate young delinquents into society with good success rates, compared to the ones who didn’t engage in a mindfulness program. Qualitative studies revealed a lower level of stress, better management of emotions and behavior, and improved social skills of participants. Obviously, one needs to take into consideration the innate willingness of the participant. This seems crucial to successfully follow the mindfulness program, but also other proposed cognitive behavior methods. Nevertheless, the incorporation of Buddhist technical practices in cognitive science is unprecedented. It changes the scientific school of thought of human behavior, no longer seen as static but as an evolving process towards brain plasticity without (or reduced) the intervention of pharmacological approaches.

We observe a growing wellness trend, with an emphasis on ‘be present in the moment’ as the only way to manage day-to-day stresses and have a fulfilling life. All this while we experience increasing expectations to be reachable even past the classic working hours, not to mention the basically immediate pace of social media. Quite a contradictory world we live in! In the last years, mindfulness became mainstream and it has been sold as the solution, at the reach of each individual, not only to have a balanced fulfilling life but also as key for optimal productivity. This culture of McMindfulness has received criticism from numerous Buddhist practitioners and/or scholars and some consider it a disrespectful capitalistic take on Buddhism for the masses. A controversy among the scientific community is also on the rise, as many scientists continuously see their work being presented by third parts out of context and with a clear intention of economic profit. Regardless of whether people are using compassion and meditation as a trendy practice, there is a consensus that a high percentage of people will effectively benefit from mindfulness with major improvements in their healthcare and well‑being. Some Buddhist leaders even emphasize that, although initially it is a purely technical practice without any spiritual meaning, inevitably, as people deepen their practice more interested they become in the ethical and spiritual guidance inherent to meditation, with an overall benefit for the global society.

In sum, times are rich in uncertainties and it is hard to cope with all the demands (work, family, friends, household) while maintaining healthy mental sanity, supporting countless people in despair. More than ever, our minds need stillness and clarity about what is going on here and now. The millennial spiritual practice of mindfulness can be applied, in a context stripped out of religious connotations, with major benefits for our well‑being and the well‑being of those around us. Meditation and, consequently, the access to a state of consciousness is a seed of a vast infinity of possibilities to change our experience and perceptions, and to, indubitably, change ourselves in the midst of adversity. And science backs it up!

References

Amihai & Kozhevnikov, 2015. The influence of Buddhist meditation traditions on the autonomic system and attention. Biomed Res Int. 2015: 7312579

Boccia et al. 2015. The Meditative Mind: A Comprehensive Meta-Analysis of MRI Studies. Biomed Res Int. 2015:419808. 

Brandmeyer et al., 2019. The neuroscience of meditation: classification, phenomenology, correlates, and mechanisms. Prog Brain Res. 244: 1-29

Donald et al., 2019. Does your mindfulness benefit others? A systematic review and meta-analysis of the link between mindfulness and prosocial behavior. Br J Psychol. 110: 101-125.

Gibson, 2019. Mindfulness, Interoception, and the body: a contemporary perspective. Front Psychol 10: 2012.

Jiang et al., 2020. Brain–Heart Interactions Underlying Traditional Tibetan Buddhist meditation. Cereb Cortex. 30 (2):439-450.

Kaur & Singh, 2015. EEG Derived Neuronal Dynamics during Meditation: Progress and Challenges. Adv Prev Med. 2015:614723. 

Klimecki et al., 2014. Differential pattern of functional brain plasticity after compassion and empathy training. Soc Cogn Affect Neurosci. 9 (6):873-9.

Lumma et al., 2018. Change in emotional self-concept following socio-cognitive training relates to structural plasticity of the prefrontal cortex. Brain Behav. 8 (4):e00940.

Lutz et al., 2004. Long-term meditators self-induce high-amplitude gamma synchrony during mental practice. Proc Natl Acad Sci U S A. 101 (46):16369-73.

What is science communication? It seems a simple question, yet a plethora of answers can fit under this umbrella. Most scientists will say, without a blink, that it means publishing your work preferably in a high impact journal! Medical writers will add disclosure of pharmacological data to lay audiences. For science journalists, raising awareness of the latest discoveries is important for the development of democratic and technologically advanced societies. Science educators are motivated by sharing information about key topics with a wider audience and by captivating young people to the marvelous world of science. Interesting! Yet, this seems quite limiting. Can other forms of communication be at the service of science? What art has to say about science communication? Do literature and science belong together? What about the current social media language, can it be effectively used for the diffusion of rigid scientific knowledge? Is it even possible dialogue between all these, apparently, antagonist worlds?

Science communication is an art in itself. The dissemination of scientific knowledge is fundamental to inform and educate the general public of the latest findings and breakthroughs that, sooner or later, will contribute to an evolving society. Moreover, by communicating its aspirations, methods, and results in a clear and accessible language, the scientific community opens the door for political and social debates. We are currently dealing with a Covid-19 viral outbreak that with globalization quickly becomes pandemic. Environmental concerns are no longer a problem of a few countries, it is a discussion that should be taking place in every household. Misinformation, fake news, and the denial of obvious facts by political figures have catastrophic consequences. Effective, engaging, and clear science communication is, thus, key for political and ethical thinking and to trigger reflections and reforms that go beyond borders. The challenge is how to spread complex scientific information without losing credibility.

Most top-notch international Institutes have taken measures about how their scholars communicate and Science Communication offices are a reality in most Universities. They support scientific research to be published in peer-reviewed journals and to be funded by a variety of external foundations. Another main role of Science Communication offices is to widespread innovations developed in the Institute and promote good scientific practices. For many decades, scientists were reluctant to use media to publicize their work. Researchers who became entertainment stars saw their scientific credibility questioned by peers. Moreover, it is not easy for a scientist to step out of the jargon used every day and explain complex concepts in a language understandable by broader audiences. This has been the basis of the separation, even distance, of science from society. Unfortunately, anti‑science organizations have learned pretty soon the concept that an apocalyptic language propagates faster than sound. For years, news related to science was associated with scandals and scientists were portrayed as mad and heartless people who joyfully sacrifice animals to satisfy their egos! Indeed, there is some misconduct in science, we cannot deny it. However, effective science communication and growing transparency, coupled with better regulations to eradicate fabrication/falsification of data and ethical dubious research, is yielding a fruitful trust in science. Social media is also reshaping this dogma. Well‑known scientists are no longer shy to use Twitter to announce their latest discoveries or to comment on their peers’ research. Interestingly, Instagram (InstaStories) and YouTube became platforms used by many creative scientists and science communicators to get the message across borders and generations. Karim Montasser is a Veterinary Medical Writer who also uses YouTube as a platform to inform the general public about veterinary medicine, the newest research, curiosities about animals, but also about complex regulations that the veterinary industry must comply with, as does the Pharma Industry. Taking into account the niche (veterinary medicine in the German language!), Karim Montasser channel, Der Tierartz1, has many subscribers, several popular videos and he is a growing respected YouTuber in Germany. Who would think years ago that YouTube could be at the service of scientific communication?

Visual communication is gaining popularity within the scientific community as a method to explain complex and intensive projects. Most conferences nowadays are exciting places to learn the newest discoveries in an almost Hollywood style. We are past tedious and long presentations and snoring attendees, particularly after the lunch break. Visual communications seem to be more efficient than caffeine in the battle against food coma! In recent years, a boom of communication agencies that specialize in developing innovative visuals is shaping the way scientists disclose their findings. A conference presentation includes infographics, graphic designs, or even short films. Grants proposals with animations aim to effectively inform and convince the reviewers of the quality and relevance of new projects and directions in a specific field of research. The dialogue and close collaboration between scientists, artists, graphic designers are originating a new way of communication that surpasses the classic scientific communication and we are only at the beginning of this fruitful collaboration. Visual storytelling is another growing field within visual communication. European Research Council (ERC) has specific programs that foster the collaboration of scientists and artists. Interestingly enough, ERC supports the creative and innovative project ERCcOMIC2, which aims to use founded ERC projects as a source of inspiration for visual storytelling and to bring academia and the public closer together. Blogs are a prominent form of communication that combines visual art and science. Top peer review journals also host a blog with free available content to reach huge audiences and to captivate the attention to the research they publish. Another form of communication in expansion is Science Fiction. New initiatives promote the collaboration of scientists and writers to create new stories about science. Notably, Fiction meets Science3, an academic research program (Bremen University, Germany), has a growing database of fiction literature based on scientific concepts, famous scientists, and institutions. This academic research program aims to reduce the asymmetry between people who are less interested in science per si and the ones who are innately fascinated by this topic.

Arts have long been essential for the record and dissemination of the scientific world. One can easily remember Jacques-Louis David’s famous painting dated from 1788 portraying Lavoisier, a known French chemist. Not to mention all the work of Leonardo da Vinci, the sketches of his studies in the different fields are a historical reference. David Goodsell, a computational biologist at Scripps Research Institute, took his aptitude for drawing and painting to the next level. He combines his expertise and art to create scientific illustrations that represent the subject, mainly proteins, accurately and to make science accessible to a wider audience4. Goodsell is considered by many as the father of the field of molecular visualization. Strikingly, performing arts have a saying in science communication. Eva Meyer-Keller5 works at the interface of performance and visual art and has a deep interest in science, notably in what cannot be seen by a naked eye. Her latest work, Living Matters, resulted from an intense dialogue with cell biologists, mostly scientists of the laboratory of Dr. Simone Reber at Humboldt University, Berlin. It is mind‑blowing how a performer can design a sequence of movements that represent accurately the process underlying cellular cytoskeleton reorganization, at the protein level, captivating the attention of a specific type of audience to science and, at the same time, mesmerizing even scientists. Furthermore and in the field of performative arts, since a few years, Science magazine hosts the annual context ‘Dance your Ph.D’6 and it is fascinating the quality of the work. This year (2019/2020), Antonia Groneberg (Champalimaund Foundation, Portugal) was awarded first place with a choreography illustrating the zebrafish brain development. A must see!

The way we communicate is an evolving matter. Science and knowledge transfer is a two‑direction communication that can only lead to great progress. In one way, scientists are able to explain to society the relevance of their discoveries with transparency, generating trust and gaining again the status of a reference for answers and to address complex issues in the fields of healthcare, environment, (cyber)security, social politics, just to name a few. Well informed and educated citizens and stakeholders have a primal role in the debates surrounding science, its applications, and have the power to decide ethically in which direction society should develop. We live in an era with methods of communicating that transcend the scientific results published in journals accessible only by elites. Initiatives that bring academia and the public close together can only strengthen global education and awareness of critical issues and innovative scientific achievements. The intersection science-society is fundamental in the accelerated process of decision making with impact worldwide. And science communication has, here, an essential role. Times are, indeed, exciting for science communication.

References

  1. https://www.youtube.com/channel/UCvthEwlJSHzrjg9m8faCwdQ
  2. https://www.erccomics.com/
  3. https://www.fictionmeetsscience.org/ccm/navigation/
  4. https://ccsb.scripps.edu/goodsell/
  5. http://evamk.de/works
  6. https://www.sciencemag.org/news/2020/02/watch-winner-year-s-dance-your-phd-contest

I came across the book ‘Invisible Women: Exposing Data Bias in a World Designed for Men’, Criado‑Perez, where the author addresses how gender shapes our daily life from a structural, educational, and health standpoint. While this is a hot topic in the light of the re‑emergency of the discussion about the gap between genders, what led me to read the book was the assembled amount of statistical data that goes beyond any ‘feminist movement’. I was particular interested in the data supporting a gender bias in healthcare. The book refers how studies about the demographics of Swedish patients (fractures and flu) in winter time resulted in a simple change of the priority of snow‑ploughing of sidewalk over roads (women being the main users of public transportation) and, consequently, in a decrease in the medical care bill. The author also skims the implication of clinical studies using mainly male subjects in the misdiagnosis and treatment of heart diseases in women. Although the book fell short on the gender bias in healthcare, it compiles many surprising evidences of an inadequately designed world. Well, one might even question if the word gender has any meaning in an age where some countries have approved legislation in favor of a neutral gender with repercussions at many levels, from birth certificates to linguistics. In matter of fact, the words sex and gender are often interchangeably used without a clear definition of the concept! While sex refers to the biological physiological nature that is dependent on genetics (chromosomes XX and XY), gender refers to the psycho‑social and cultural representations of sex. And in science, this is of major importance when studying characteristics that are dependent on the sex, either behavior or simply a differential physiological response to medications. However, even in scientific literature there is no consensus and gender is, often, used in place of sex. In order to avoid confusion, hereafter, the term sex‑gender will be used. So, if sex‑gender is of major importance in biology, why there is a bias in clinical studies?

Sex‑gender bias in clinical trials has an historical reason: the (wrong) assumption that man and woman are biologically similar and treatments tested in men are, therefore, equally effective in women. In addition, it is easier to recruit male patients. Recruitment campaigns among military personnel were effective. For many generations women were stay‑home wives and primary caregivers (participation in clinical studies was a time burden for their family obligations), with limited access to information about clinical trials, and a reduced travel mobility to and from clinical trial centers (financial burden). Additionally, recruiters did not wish to deal with the monthly hormonal fluctuations and its direct influence on the pharmacokinectics of a drug. If only this last critical point had been taken into consideration when designing clinical trials, many lives would have been saved! Some studies are quite curious. In the 80’s, a trial to evaluate the influence of obesity in uterine cancer used a sample population of male volunteers only. Yep, you read it correctly! It is surprising to notice how the principal investigator designing such study (and the ethical commission approving it) did not take into consideration the rational approach that males don’t even have a uterus! Interestingly, until the 90’s, FDA recommended the exclusion of women of child‑bearing age in studies to test drugs. In sum, studying the effect of drugs in male models was, simply, the norm!

An effective change in this paradigm occurred in the 90’s and resulted from concerns over the health risk of prescription drugs in the female population. Severe side effects were reported, leading to the withdraw of about 10 prescription drugs in a period of 4 years. Strikingly, the safety and efficacy of the majority of these approved drugs was evaluated in strict clinical trials where women were, in fact, underrepresented. Cross‑sectional studies advocated by FDA and NIH revealed a dark side of sex‑gender bias in clinical trial studies. A subject that made the headlines was the recurrent incorrect diagnosis and treatment of coronary heart diseases in women. In one hand, there was a major gender stereotyping and bias by healthcare providers. Despite an equal prevalence of cardiac diseases, the perception that it is a male disease led often to misdiagnosis (symptoms were seen as panic attacks or hypochondriac behavior) and reduced follow up tests in female patients admitted to hospital. On the other hand, bias in clinical trial studies result in incorrect prevention measures of coronary heart diseases. For example, while aspirin therapy is efficient in the prevention of heart failure in men, it was, later on, shown to have no preventive effect in women. One way to avoid the negative outcomes of uneven sex‑gender clinical trials was the establishment of single-sex studies before the approval of the drug. This measure ensured that the benefits observed in the studied male population were also applicable to women. Nevertheless, single‑sex studies are far from effective, because the sample size is not big enough to fully detect the effect of the drug in women. The awareness of a sex‑gender disproportional enrollment in clinical trials and its consequences in the prevention and treatment of diseases resulted in major policies change. In fact, the new implemented guidelines specified that participants should be representative of the population (not only at the sex-gender level but also to include minority groups). Moreover, pharmacokinetics, pharmodynamics, safety, and efficacy of the tested drug have to be evaluated in every population subsets before approval for commercialization.

What is the current situation of sex‑gender bias in clinical trials? This is really a hard question to address. It is widely observed an increase in the number of female participants in clinical trial studies, over the last two decades. Yet, it is difficult to know the accurate recruitment ratio, despite strong policies that foster the analysis of data by sex. Confidentiality policies to safeguard the identity of participants in clinical trials restrict the access to demographic indicators of the sample population. Moreover, depending on the clinical trial database and the peer‑reviewed journal where the study was published, there is no requirement to report the percentage of male and female participants and, thus, a high percentage of studies lack this information. As a consequence, data relative to sex‑gender in clinical trial studies lacks consistency and this is problematic. First, it raises questions on the safety and efficacy of prescription drugs to female patients. Healthcare professionals and female patients have the right to access this kind of information, in order to make conscientious decisions on the diverse treatment options. Second and foremost, the amount of data gathered in large clinical trials is not entirely examined. The inability to sort out the data by sex impairs scientist to gain insight on a variety of biomedical information that is sex specific. There are remarkable differences in pharmacokinetics and pharmacodynamics of a specific drug that are dependent on the physiology of the sexes. A meta‑data analysis of the different biological characteristics inherent to the sex can only result in an insightful knowledge of a variety of diseases and, thus, in the design of effective therapeutics. This is of particular relevance in an age where we evolve to personalized treatments. How can we have personalized prescriptions drugs when we don’t fully understand its effect in the different subsets of the population? And this goes beyond the sex‑gender. An inclusive understanding of the biological variability within a population based on race, ethnicity, age, can only bear globally beneficial fruits.

The scientific community is aware of the sex‑gender bias not only in clinical trials studies but also in basic research. Physiologic differences are observed at a cellular level but most models for pre‑clinical studies of diseases remain based on male cells and/or animals. Quite a big debate on which is the best approach to establish a model to understand diseases in a holistic and integrative manner. Concerning clinical studies, progress in the last decades is remarkable. Some work has been dedicated to monitor whether equal percentage of men and women are enrolled in clinical studies. No statistical significant difference is observed between sex‑genders in phases II and III (48% and 49% females, respectively) of clinical trials, compared to 22% of females in phase I. This is an encouraging indicator that, after an initial safety and efficacy screening, deeper testing of a drug in the different subsets of a population is carried out and ensures a reduced potential health risk for general population who will use the prescription drug. However, some other studies indicate a clear bias in clinical trials, without an explanation for men over-representation, and revealing a pattern hard to change in clinical research. Those studies argue in favor of a full disclosure of the percentage of men and women in the sample population to unravel and solve issues intrinsic to design of trials and interpretation of data but also present in implemented procedures in clinical practice.

Going forward, large set of epidemiological data sorted by sex‑gender, race, ethnicity, age, and even social and environmental living conditions, combined with genetic and metabolic studies can be useful in the better understanding of diseases, discovery of drugs, and the development of accurate diagnosis and treatment options. Medical writers also have a role in this issue. A consistency of terminology used across regulatory and communication documents, both for the scientific community and lay people, can contribute to reduce the variability of findings and misinterpretation of data. In an age where the term gender (specifically gender fluidity) gains popularity, attention to the biological significance of sex in the development of diseases and response to pharmacological therapies is necessary. Only this way we can have an insightful understanding of physiological nature of sexes and provide a better healthcare for all.

References

Criado‑Perez. Invisible Women: Exposing Data Bias in a World Designed for Men. 1st ed. Harry N. Abrams, 2019.

Daugherty et al., 2017. Implicit Gender Bias and the Use of Cardiovascular Tests Among Cardiologists. J Am Heart Assoc. 6(12). pii: e006872.

Franconi et al., 2019. Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies. Cells 8(5). pii: E476.

Ka et al., 2016. Women’s involvement in clinical trials: historical perspective and future implications.Pharm Pract (Granada) 14(1):708.

Kim & Menon, 2009. Status of Women in Cardiovascular Clinical Trials.Arterioscler Thromb Vasc Biol. 29(3):279-83. 

Labots et al. 2018. Gender differences in clinical registration trials: is there a real problem? Br J Clin Pharmacol. 84(4):700-707.

Mazure & Jones, 2015. Twenty years and still counting: including women as participants and studying sex and gender in biomedical research. BMC Womens Health. 15:94.

Phillips & Hamberg, 2016. Doubly blind: a systematic review of gender in randomised controlled trials. Glob Health Action. 9:29597.

First of all, what is a medical writing? Well, it is a written text about medicine, simple right? Actually, it’s not that straightforward. Many types of documents fall under the umbrella of medical writing, from scientific manuscripts, medical brochures, regulatory documents, or educational material, just to name few. To add a layer of complexity, medical writing can be a fluid concept, with the different branches interlinked or even overlapping. In recent years, medical writing became an attractive career path for many scientific researchers with a passion for writing. Regulatory and medical communications, two known branches within medical writing, are important departments in Pharma/Medical Devices industries. The increasing stringent legislations triggers a need for qualified writers who effectively communicate discoveries, develop documentation that certifies all requirements are met, and guarantee, through lay language, the benefit and safety of the products to the general public. Academic modus operandi is also transmuting and medical writers are gaining a pivotal role. This is evident at top‑notch Institutes, where medical writers support complex funding applications and ensure the publication of data with the highest quality level in short timelines. Moreover, the emerging business of ‘wellness/healthy lifestyle’ is leading to a paradigm change in healthcare communication. We observe a shift from the individual blog (and other social medial), aiming to share personal experiences and convictions, to a growing demand for a much credible, scientific based communication. In this line, many entrepreneurs and corporations soon realized the benefit to invest in effective medical communication and educational material to attract customers, creating, thus, a new niche for medical writers. Taking all together, one can only predict a bright future and that medical writing is, indeed, a trendy career path with many opportunities for growth. So, why are uncertainty clouds invading a sky bursting of prospects?

The advance of technology results in globally accessible medicines and a longer life expectancy, making medical and healthcare industries a growing business with a revenue of billions. Paradoxically, this sector remains quite traditional and resistant to a rapid implementation of technology. This is the case of Artificial intelligence (AI), which is a reality transforming many business sectors, from transports to telecommunications. Remarkably, the potential application of machine-learning technology in the medical and healthcare industries is revolutionary, yet its implementation is, still, at an embryonic stage. A growing number of start‑ups and companies invest millions to develop and improve tools to alleviate the burden of medical and healthcare professionals. DeepMind Health and IBM Watson have already successfully placed some AI programs in the market. Notably, AI developed by IBM Watson for Oncology, has accurately diagnosed a patient through analysis of thousands of genetic data, databases of patients medical records, and millions of research articles. In the Pharma industry, AI also has numerous applications in clinical trials, from the initial step of drug discovery (drug identification, validation, biomarker identification, target discovery…) to a complete analysis of tens of thousands of patient data, reducing greatly the process (and costs!) by which a drug is approved. Overall, the prospects of AI in the medical and healthcare industries translates into a customized, cost effective healthcare service, with increasing treatment options and practical implications in the daily life of billions.

AI grows towards a technological disruption and, consequently, a disruption of the current medical writing landscape is expected. Many Pharma/Medical Devices companies are investing in supercomputers to facilitate the complex regulatory writing process. AI tools, such as Natural Language Processing (NPL), are rapidly revolutionizing the ‘language’ technology, greatly due to the competitive interest of Microsoft, Google, or Amazon. The ongoing development of NLP customized to the needs of Pharma/Medical Devices industries results in tools that easily scan meta‑data, perform deep and tailored literature searches, and extract targeted information from vast unstructured full-text databases. This simplifies the preparation of many documents in a fraction of time (with cost benefits) and is relevant in the case of Clinical Study Reports, where a large percentage of the final text is pulled out from source documents. The automation of standard documents by AI tools has also undeniable advantages at many levels. It reduces the burden of medical records by clinical staff, decreasing human errors and promoting a higher anonymization of patients enrolled in clinical trial studies. Moreover, NPL technology is useful for exhaustive systematic reviews and, even, for the design of new studies, based on the identification of potential relevant data issued from a customized cross‑check of thousands of (full text) publications otherwise missed in citation or keyword based searches.

The revolutionary progress of AI in the coming years will, indubitably, transform the field of medical writing. Will AI replace the medical writer? AI will trigger a shift in the craft of medical writing. The medical writer will no longer be the person who gathers pieces of information from the different sources into a final succinct document. The medical writer of the future will expand his skills to use AI tools, in a complementary fashion, and enhance the writing process. A big advantage of AI technology is the reduction of the burden of clinical review. The extraction of information from source documents accurately and consistently coupled to standardized structured documents will reduce the errors and, consequently, the review cycles. The medical writer will ensure the final document has a clear and concise language and meets all requirements. Highly skilled medical writers can apply their know‑how to produce complex scientific work. The plethora of data available is invaluable yet it’s a challenge to extract meaningful information from complex and often unstructured databases. Medical writers can successfully use AI technology to perform target analyses of meta‑data, identify potentially new treatments or even hidden findings that will contribute to the advancement of a personalized and effective medicine. Furthermore, it is important to keep in mind that medical writers have a major role bridging Pharma/Medical Devices industries, legal authorities, healthcare providers, patients, and the general public. The success of this role is correlated with their distinctive set of soft skills, unlikely to be easily mimicked and surpassed by AI.

In summary, the intersection between medical writer and AI will have major implications across medical and healthcare industries, with significant reduction of time and costs required for the commercialization of new medical products. Moreover, a higher disclosure of information to a wider audience, in a transparent and accessible language, will promote a strong awareness and trust in medical and healthcare industries, expand the access to innovative treatments, and contribute to better (and personalized) decisions of patients and healthcare professionals. AI‑driven innovations can only be a window of opportunities for medical writers to expand their skills and to thrive in this trendy career path!

References

Extance A, 2018. How AI technology can tame the scientific literature. Nature 561(7722):273-274.

Loh E, 2018. Medicine and the rise of the robots: a qualitative review of recent advances of artificial intelligence in health. BMJ Leader 2:59–63.

Velupillai et al., 2018. Using clinical Natural Language Processing for health outcomes research: overview and actionable suggestions for future advances. J Biomed Inform 88:11-19

https://deepmind.com/applied/deepmind-health/https://www.ibm.com/watson

http://ec.europa.eu/growth/sectors/healthcare_en

https://www.emwa.org/

Ensuing John Oliver’s (Last Week Tonight, HBO) humorous analysis of a very serious problem within the Medical Devices Industry, I took a look at the current regulatory landscape of medical devices (MD) in the European Union (EU). Like in USA, MD industry has been involved in many scandals over the years. The PIP silicone breast implants’ fraud (France, 2009-2013) was publicly scrutinised and led to an increasing mistrust in the multimillion euro MD industry.

The European Commission expressed concerns for the protection and safety of patients by outdated MD’s legislations and proposed revision and amendments, which entered into force in 2017.

Currently, we are in a transition period between EU directives and EU regulations for MD. These regulations are divided in two categories, namely Medical Devices Regulation (Regulation (EU) 2017/745, applicable in May 2020) and the In-vitro Diagnostic Regulation (Regulation (EU) 2017/746, applicable in May 2022). The aim is to strength the process by which a MD earns the CE (Conformité Européenne) mark certification that guarantees its quality, safety, efficacy, as well its post‑market monitoring. What does this mean for us, medical writers and European citizens?

A first change with the new regulatory framework is the reinforcement of the responsibility of the European Medicine Agency (EMA) to ensure MD meet all legal requirements, including the assessment of conformity issued by accredited Notified Bodies (certified agencies by the country where the marketing application is filled). For the manufacturers, this translates into a large amount of documentation to be updated, or generated, for each MD already placed in the market. This is problematic for the MD industry because of the short transition time between directives and new regulations (3 years for MD), yet it represents a window of opportunity for medical writers.

A major change with the Regulation EU 2017/745 concerns the classification of MD, with the application of new definitions and up‑classification of some MD. This is a critical point due to the different requirements and scrutiny for each class of MD. The MD classification is based on the potential risks and vulnerability of the human body and is divided into 3 classes (I, II, III). Class I (plaster, bandages, stethoscope) represent the lowest risk class and it is subject to the least scrutiny, while class III (implantable MD) represents the highest risk and must conform to a strict clinical evaluation and an independent conformity assessment by Notified Body. With the increasing use of software applications (apps) and online remote patient monitoring systems, an update on the definition of MD was necessary to legally protect the patients. Now, software with a medical purpose is considered to be an active medical device and its classification is dependent on its risk to the patient. Moreover, software associated with a device now falls automatically into the same class of the device and is evaluated accordingly. In practice, this means that MD that were exempted of a strict evaluation will now be extensively examined during the assessment of conformity.

In order to be approved for marketing, the MD undergoes evaluation studies. Briefly, these studies consist of (a) a systematic review of literature to determine the safety and performance of similar devices, (b) an extensive analyse of clinical investigation data ensuring the safety and benefit of the MD, and (c) a collection of the alternative treatment options available to demonstrate the advantage of the MD. On top of this, class IIB and III MD are required to show further clinical evidence of safety and efficacy, through clinical trials, and the manufacturer has to submit clinical investigation protocols and clinical reports/evaluation besides other technical documents. Thus, the stringent rules of the new regulatory framework results in an extensive list of documents to be provided by manufacturers and the MEDDEV (MEDical DEVice) guidelines have already been amended to meet the new requirements.

Surveillance, monitoring, tractability and transparency are critical points to take in consideration. The PIP silicone breast implants’ scandal brought to light a gap in the surveillance of the MD post‑market. To comply with Regulation (EU) 2017/745, manufacturers will have to frequently provide safety updates and clinical performance reports (annually for class IIB and III), and declare all adverse events occurred during the clinical studies and throughout the MD lifecycle (post‑market). The post‑market surveillance requires PMCF (Post‑market Clinical Follow‑up) studies to evaluate the risk/benefit of the MD, particularly for high risk classes. This includes new clinical investigation data, analysis of data from observational studies and also from the continuous follow‑up of the patients from the pre‑market clinical investigations studies. An additional major implementation of the new regulatory framework is the obligation of a lay summary for each device published in every official European language. Also, it will be mandatory to attribute an identification number (UDI for Unique Device Identification) to each MD that identifies the labeler and the specific version/model. This measure will enhance the safety of patients by promoting a close traceability and transparency of MD during their lifecycle and facilitate an efficient recall in case defects are reported in similar devices. Moreover, and in line with the transparency measures, information about the safety of MD must be publicaly available. For this purpose, Eudamed will be partially accessible to the general public. Eudamed is a centralised repository for information exchange between competent authorities that promotes market’s surveillance and aims to increase the safety standards for MD industry. While only competent authorities have full access to the Eudamed database, information regarding the MD, manufactures and authorised representatives, notify bodies, as well as certificates and field safety notices will be available for consultation by the general public. A transparent, official, and intuitive database enables patients, families, and healthcare providers to make informed decisions and promotes a trust of the general public in the MD industry.

In sum, with the new regulatory framework that will be applicable in 2020, manufacturers have to generate and update extended documentation that ensures MD complies with stringent conformity assessments and meets the surveillance requirements for safety throughout its lifecycle. This translates to a demanding need for qualified professionals that are able to write a plethora of documents in the short transition period between the previous directives and the implementation of new regulations. Furthermore, surveillance and transparency are critical measures and manufacturers are obligated to provide frequent evaluation reports to competent authorities, besides lay information to the general public. Science moves at fast pace and, technologically speaking, times are revolutionary! Humans are living longer and longer and to maintain (or attain, in some cases) a good life quality, the replacement of ‘defective parts’ becomes trivial. A medical cyborg is no longer a futuristic utopic creature, they are already among us and, at some stage in our lives, we will also (gladly) become one. The future holds huge perspectives for therapy, from tissue engineering and organ printing to brain‑machine interfaces. Moreover, a new generation of implantable MD is at the corner, where prosthetics will be, progressively, replaced by biocompatible integrated electronic devices and immune therapy will rely on nano-machines that selectively target the organ to be treated. A whole range of technology will converge to create a personalised medicine, from the initial steps of diagnose to the final therapeutic. This high‑speed technological prospect entails a multidisciplinary team (scientists, healthcare professionals, politicians, lawyers, ethical experts, stakeholders…) that bring together a holistic view to evaluate the risks and benefits of MD. It is inevitable, in the near future, amendments of the regulations that entered into force in 2017 and the implementation of new ones that keep up with technological advances. Medical writers have a role in those multidisciplinary teams and are key players in the disclosure of information, within the MD industry and to the general public. The window of opportunities is, therefore, wide open for medical writers. We can only embrace these revolutionary times to expand horizons and thrive in an ever-growing MD industry, which, indubitably, will have a profound impact in our healthcare in the following decade(s)!

References

Giselbrecht et al., 2013. The chemistry of cyborgs- interfacing technical devices with organisms. Angew Chem Int Ed Engl. 52 (52):13942-57. doi: 10.1002/anie.201307495.

https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

https://www.ema.europa.eu/en/news/first-guidance-new-rules-certain-medical-devices

https://www.emwa.org/sigs/medical-devices-sig/