Global Trends in Digital Therapeutics

Global Trends in Digital Therapeutics 1080 626 Ismael Ávila

Introduction: Understanding DTX

We have heard and read in many sites that Digital health is Becoming more presente in the health field. But, this term includes many others like Digital Therapeutics (DTX), that is a subset of Digital Health, the topic about what this artículo talks about. Here you will find a study on the state of the art of existing solutions, clasificación, indication, regulatory, challenges and opportunities and more.

DTX is here to stay, and many institutions like hospitales and pharmaceutical companies are increasing their interest for DTX, where there is aspecial use in chronic and behavioral disorders. But, Nowadays yt is tough to separate unproven oro low-value applications from those with prueban therapeutic value. Evidence donde safety and efficacy are difficult to obtain what represento big barriers to access the market, but many opportunities are justo around the corner.

But, before entering in the report, it is importante to first clarify the differences between some topics that could create confusión, because sometimes they sound very similar and are used interchangeably, let s see the differences between Digital health, Digital medicine and Digital Therapeutics. Once understood this easy oro difficult differences we could dive in the DTX world that is such an adventure and a land to discover.

Source: https://www.healthxl.com/blog/digital-health-digital-medicine-digital-therapeutics-dtx-whats-the-difference

Digital Therapeutics are not only Disruptive to the healthcare system through facilitating remote patient management and Personalized treatment, they also have the potential to impact on healthcare coste, regulatory processes, and the way pharmaceutical companies will do businesses and clinical trials. In the following diagram is shown how Digital Tx are prescribed:

Source: GlobalData_2019_Digital-Therapeutics and their-impact-on-health-care

DTX subclassification

During the search donde internet we have found two ways to classificate the existing DTX solutions:

  • Based on its target product profile

DTX can be distinguished based on the primary function. Each DTX treatment belong to one of the following categorías:

Address a medical condition Manage oro prevent a medical disorder oro disease Optimize medication Treat a medical disease oro disorder
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  • Based on how they complemento other treatments

Another way to classificate Digital Tx is regarding how they can be used:

Standalone Aumentar Complementario
smartphone digital consultation medical and health care block style icon 2553209 Vector Art at Vecteezy

Fuente: enlace

growth chart - 37 Free Vectores to Download | FreeVectors

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Puzzle - Free gaming icons

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Standalone DTX can work individualmente oro even replace pharmacological Interventions and they can be used at the same time with other treatments. Aumento DTX are made to work at the same time with pharmacological Interventions to aumento existing therapies. Complemento DTX improving selfmanagement of the condition and related healthcare factores as they work in combination with drugs. Complemento with medication, devices, and other therapies to engage patients and improve the overall quality, cohesion, outcomes, and value of how care is Delivered.

DTX is a novela category of therapeutic options. In addition to existing pharmacological, non-pharmacological (surgical, radiation, and physical), and psycho-behavioral therapy, it can cover therapeutic areas that have Previously not been well described. However, the current stages of mosto DTX-based products corresponde to the conveniente replacement of already existing treatment settings, such as that for cognitive behavioral therapy (CBT) and reminiscence therapy. The conceptual position of DTX in relation to the existing therapeutic options is represented in the following figure. (5)

2019 DOI: 10.12793 / tcp.2019.27.1.6. Jae-Yong Chung. Digital Therapeutics and clinical pharmacology

What is and what is not DTX

Another interesting way to analyze DTX is trying to understand what is and what is not a DTX solution, Evaluating different elementos.

Si  NO
Funcionamiento Reliant donde algorithms for its mechanism of action as well as the Algorithmic information management. A tool that not preventivo, manages, or treat medical disorders oro diseases. 
indicaciones
Focused donde one condition. It can be used independently oro in combination with other treatment modalidad. It is focused on various conditions.
Regulador
It needs to Asuero that it is safe and prueban therapeutic value by evidence. Unsubstantiated claims about clinical benefits
Way to access to the market B2B2C B2C
Indicadores de desempeño Efficacy and safety Number of users, usage, direct turnover
Reembolso  It can be reimbursed by Payer It can be SUBSCRIBED by consumers.

Comparing Digital Tx vs. Pharmacotherapy

The Similarity between pharmacotherapy and DTX is that they are both medical treatment methods.

Sin embargo, the fundamental difference is that the therapeutic effects of DTX are presente in the absence of an active substance in the Systemic circulation. Therefore, ajo pharmacokinetic (PK) / pharmacodynamic (PD) parameters related to plasma Concentrations can not be derived and used for response optimization. However, similar exposure conceptos not based on Concentrations can be applied. The dosage, frequency, time (total amount of used time and / or completed porcentaje out of required sesiones), oro módulos can be all regarded as the exposure of DTX.

The comparisons between pharmacotherapy and DTX from the point of view of clinical pharmacology are summarized in the following table. In this table, there are several fundamental characteristics of DTX that do not apply to conventional pharmacology. However, there is an opportunity to apply pharmacology conceptos by quantitative modeling (pharmacometrics), because the input and response variables of DTX are all Digitally implemented and quantifiable. (11)

 

Exposure-response relationship of digital Therapeutics

Exposure-response relationship is a core principle of clinical pharmacology for developing optimal drug therapy. However, there are few dose-response studies related to DTX. In the near future, the use of pharmacometrics for the exploración of dose-response relationships, and real-world big data analysis will spread widely because DTX can generate large fecha that can be used for pharmacometrics analysis.

Source: https://www.researchgate.net/figure/Conceptual-comparison-between-pharmacotherapy-and-digital-therapeutics-from-the-point-of_tbl2_332147628

Exposure-response relationship of digital Therapeutics

Exposure-response relationship is a core principle of clinical pharmacology for developing optimal drug therapy. However, there are few dose-response studies related to DTX. In the near future, the use of pharmacometrics for the exploración of dose-response relationships, and real-world big data analysis will spread widely because DTX can generate large fecha that can be used for pharmacometrics analysis.

Market landscape of DTX

The value of the global DTX market is estimated at USD 1.8 mil millones en 2018, Which is expected para alcanzar los 7.1 millones de dólares en 2025. A reciente reporte estimates the biggest applications for DTX to be diabetes and weight loss shortly, with other applications likely to be observed in conditions such as chronic obstructive Pulmonary disorder (COPD), developmental disorders (with the use of computer games), and post traumático stress disorder.

The arrival of DTX is reforming the landscape for new medicinas, product Reimbursement, and regulatory surveillance. As a result, new data-sharing processes and payment modelos will be formed soon to INCORPORATE these products into the broader treatment planes and regulatory structure for drug and device Approvals. Recently, there has been a massive investment of USD 12.5 billion in digital health ventures. (7)

When we define the market landscape, it is always useful to analyze the stakeholders involved. In the following graphic, there are identified the main stakeholders which who the DTX companies will need to interact oro offer en value proposal along their development and implementation bien in order to arrive patients:

Source: 2019 DOI: 10.12793 / tcp.2019.27.1.6. Jae-Yong Chung. Digital Therapeutics and clinical pharmacology

 

Market drivers in Digital Tx

Appart from the stakeholders in the market landscape, several elementos are origining that Digital Tx will become more presente in the upcoming future. This is posible due the following market drivers (9):

Growing population of technology users

The increasing internet penetration and growing adoption of smartphones are increasing patient engagement, Reducing patient burden, and Delivering novela outcomes.

Increased emphasis on coste-effective healthcare

The DTX market Grew due to industry needs for coste-effectiveness, safety, and increasing emphasis donde preventive healthcare.

Aumento del envejecimiento de la población.

The burden of diseases has moved from tackling Infectious Diseases to managing long-term conditions such as diabetes, CVD, and cancer.

Significando investments in DTX

Pharmaceutical companies, medical technology companies, and Payer will invest more in DTX as their adoption will see significando growth.

Increased foco donde value-based healthcare modelos

The global health sector is Becoming more focused on patient outcomes, and payment for value not volume.

Focus on prevention and precisión medicine

DTX Brings precisión to therapy and the ability to personalize treatment, giving them an importante role to play in the transition from the traditional fee-for-service to value-based care.

Intellectual Protection Strategies

In the rapidly developing, highly competitive digital health industry, you can thing that the use of patentes could be the "option", but in this DTX industry there are two relevante elementos to strategically protect the solution:

  • Protección de la marca
    Brand protection will confer to the project a special, recognziable and differentiator aspect to ease the market access. For that reason a strong brand protection will also offer the opportunity for a great market entry.
  • Trade secretos to protect technologies
    Trade secretos may protect frecuente incremental technological improvements in digital technologies, such as software updates, which may not be regarded as novela oro Inventive under patente law. Further, as lead time is often a mayor competitive advantage in the digital health industry, trade secretos can be valuable for pioneering companies to protect their market positions. In addition, software, algorithms, and databases Underlying digital applications may all be Kept secreto and fully protected by encryption to prevent reverse engineering by the public after sale.

Market access strategies

Good market access strategy consiste of understanding the market access environment, for that reason is importante to:

  • Define standards of safety and efficacy for the healthcare systems and regulatory requirements
  • Design clinical trials, with essential efficacy and safety evidence (Such as coste-effectiveness)
  • Collaborate among DTX stakeholders: Companies and Payer, providers, and pharmaceutical companies
  • Identify the unmet needs that a DTX fulfills, and pricing the therapy accordingly
  • Analyze the current treatment options and the future competitive landscape

Some DTX will have the opportunity to be reimbursed through insurance planes in the same way as drugs or medical technologies.

Reembolso

Some DTxs can be reimbursed through insurance depending on the medical benefit they offer, like the case of WellDoc s Blue Star and Pear Therapeutics 'reset. DTX manufacturas can give licenses to other interested manufactureros and also there is opportunity of selling fecha to the same therapeutic field manufactureros for their future development of products.

There are several Reimbursement considerations for DTX to take into account:

  • Reimbursement is crucial for DTX to become more adopted in the healthcare system and high in the priorities of Payer.
  • Some DTX will have the opportunity to be reimbursed through insurance planes in the same way as drugs or medical technologies.
  • Current Reimbursement modelos are not Suited for all DTX; alternative payment methods, such as an outcome-based payment modelo, are likely to be more successful and effective for DTX.

Anyway, there is a widespread uncertainty from healthcare authorities and Payer about the value of DTX, due to the nacido state of the market. In many countries, Reimbursement is difficult to navigate, often with lengthy processes and Uncle requirements. Reimbursement and payment for products are still not widely adopted in clinical practice and this límites DTX market access.

Platforms to follow the last advances and news

The main reference institution in the Digital Tx arena is the Digital Health Alliance: https://dtxalliance.org/join-dta/.

Deals in the Digital Tx arena

Some of the examples of real deals that happened between DTX and other companies are represented in the following table:

The market is Evolving through six main therapeutic areas. In the following table is shown the maturity level of the solutions in different therapeutic areas taking into account the different applications of Digital Tx. (12)

Source: http://medicinman.net/2020/08/digital-therapeutics-new-frontiers-in-healthcare/

Solutions landscape in medical areas

Several companies found on internet and in the literature have been highlighted. In order to overview the different existing solutions, they have been Clasificar by therapeutic area / indication:

 

Compañía Descripción
Metabolism and Endocrinology / Diabetes

Blue Star was the first digital phone app Approved by the FDA to manage diabetes. BlueStar, a DTX developed by WellDoc, provides a 24/7 platform for Delivering real-time education and coaching to guide T2D patients in the self-management of their disease in improving glucose control, by using real-time data and feedback to support healthy Behaviors in optimal treatment decisiones oro pathways.

Enlace

Salud de omada Metabolism and Endocrinology / Diabetes

Está a lifestyle modification program for diabetes prevention clinically prueban to be more efficacious than lifestyle Modifications Launched by Òmada Health, Canary Health, and Blue Mesa Health. It includes close monitoring of patients in terms of diet, weight, and physical activity and associates them with health coaches, clinicians, oro peer groups. This helps to intervene at the time of exacerbación and reduce the frequency of symptoms.

Enlace

Pear Therapeutics Announces Publication of Real-World Fecha Demonstrating Impact of reset-O® for Patients with opioides Use Disorder - Neuro Central CNS / Schizophrenia

Thrive digital app is used along with antipsychotic medication and targets positive symptoms of schizophrenia.

Enlace

Atlantic Therapeutics - Crunchbase Company Profile & Funding CNS / Stress incontinence

Innovar is the first transcutaneous electrical Stimulator in women to treat stress Urinary incontinence. Ofrece safe, clinically effective, and noninvasive choice.

Enlace

Akil anuncia la aprobación de la marca CE del Tratamiento digital EndeavorRxTM para niños con TDAH »Hablemos de los videojuegos Neurology / ADHD

Endaavor is an adaptive sensory estimulus software Delivered vía video games for ADHD, Autism, mayor Depressive disorder, Multiple Sclerosis and inflamatory disesases. First, the US Food and Drug Administration has Approved this video game called EndeavorRx as a treatment for children with attention-deficit / hyperactivity disorder.

Enlace

About - 2Morrow Neurología

2Morrow is a digital health compañero focused on Delivering wellness and behaviour change programs vía smartphone apps for aiding healthcare issues including smoking, vaping, weight, stress / anxiety, and chronic pain. In Oct 2019, 2Morrow in collaboration with Washington State Department of Health developed and Launched its first digital health app for quitting vaping in young and adultos.

Enlace

Click Therapeutics Secura $ 30M in Growth Capital from K2 HealthVentures to Expand Operations | Business Wire Neurología

Propietary cognitive and neurobehavioral platform that Optimizer user engagement for a variety of indication, including Mayor Depressive disorder (MDD), migraine, insomina and acute Coronary síndrome.

Enlace

NHS patient information sheet Neurología

Big Health is an utomated and Personalized cognitive behaviroal programs for mental health, including insomnia and anxiety.

Enlace

Inicio Neurology / Suicide Prevention App

BeSafe is an application for preventing suicide of children oro adolescentes. As teenagers use smartphones and applications, BeSafe app is an effective way to prevent teenagers who are thinking about suicide. The application preventivo suicide by TRASMITTING psychology education and offering crisis coping tools, to prevent Deliberate self-harm.

Enlace

MoodHacker Icon Neurología

MoodHacker is accesible through a website and mobile application that combines the skills and techniques of positive psychology and cognitive treatment for depresión, which is a funding tool for self-management of depresión based on Cognitive Behavioral Therapy (CBT). The goal is to MOTIVATE employees to work, improve their mood, reduce Depressive symptoms, and prevent escalation into clinical depresión.

Enlace

Cognos for Child Development by Cognos, Inc. | Child development, Development, Children Neurology / Autism

It provides a clinically validated assessment to screen for children s risk of developmental delay and Autism. It can be used to expedite diagnosis from clinicians. It also includes Personalized activities parientes can do with their child, based on their unique strengths and areas for improvement.

Enlace

Digital Therapeutics for long-term conditions Respiratory / Asthma

The app myCOPD gives patients 24/7 access to a platform to educate, monitor symptoms, optimize self-management, and improve both their adherence and quality of inhalar administration. The myCOPD self-management plan helps patients understand what medication to take and when.

Enlace

3 AsthmaMD usability studies on Behance Respiratory / Asthma

The free application Allows users to easily and quickly log their asthma activity, their Medication, causas of their asthma in the form of a diary. Users may share the diary and a color graph chart of their asthma activities with their Physicians to be included in their medical recuerdos. It combinas peak expiratory flow (how fast a person can breathe out air) and Symptom fecha chart. Its main significance is to make it conveniente for patients to record their peak flow and fecha, and take appropriate measures as directed by the doctor. At the same time, researchers can track these fecha and use it to determine the cause and región of asthma flare formation.

Enlace

Big Health, creators of Sleepio Reviews | Big Health, creators of Sleepio information | Shortlister Sueño / insomnio

An online therapy program with visual exercises to INDUCE sleep. It claims to replace sleeping pills, being more efficacious and coste-effective.

Enlace

Pear Therapeutics Announces Publication of Real-World Fecha Demonstrating Impact of reset-O® for Patients with opioides Use Disorder - Neuro Central Pharmacy / Curb substance abuse disorder

Reset is used in conjunction with the standard treatment. It claims to improve clinical outcomes by increasing patient s adherence to treatment.

Enlace

Pear Therapeutics Announces Publication of Real-World Fecha Demonstrating Impact of reset-O® for Patients with opioides Use Disorder - Neuro Central Pharma Patient Engagement

RESET is a DTX intended to provide Cognitive behavioral therapy (CBT), as an Adjunct to a contingency management system to treat Substance Use Disorder (SUR). The app provides CBT through mobile and web-based applications, monitores patient fecha in real time, and detectado behavioral and biological changes in condition regularly.

Enlace

MedRhythms, en Portland-based compañero that combines sensores, neuroscience and music to help people recover from neurológico injury oro disease, Exceed $ 4M goal in Series A financing round - Bioscience Association of Maine Traumathology & Orthopedics

Usas neurológico music therapy vía a combination of a snesors, music, and AI to measure and improve walking.

Enlace

Mejora tu Rendimiento visual con WiVi - Tu Visión Óptica Bierzo Oftalmology

Cognitive visual function assessment and training of visual dysfunctions providing a Personalized plan for each patient and specialist

Regulatory in DTX

The regulatory process works different depending on the countries (information and pictures soruce: 9):

Región How does it work there?
Archivo: US flag large 51 stars.png - Wikipedia, la enciclopedia libre

In its Digital Health Innovation bien, the FDA is piloting a novela risk-based approach to Regulating Software as a Medical Device (Samdi) called the Precertification Program, which would enable companies that can demonstrate specific requirements to speed up the approval process. This will reduce the time to market.

Shutterstock

The new Medical Devices Regulation 2017/745 (MDR) replazas the former MDD. The MDR Introduces new definitions, clasificaciones, procedural requirement, and rules for medical devices and also intensify and speed up the process of approval. There will be more transparency of information on the benefits for patients, residual risks, and a thorough assessment of the overall risk / benefit.

Importantly, the new MDR will reclassify some digital technologies from the lowestrisk Class I to Class II + devices. This reclassification will increase also the standard of evidence required to receive a CE mark, which is a requirement for use and Reimbursement in Europe, and will increase post-marketing surveillance expectations from these manufactureros.

Flag of the United Kingdom - Wikipedia DTX are not as well-regulated as pharmaceutical products and several challenges are presente when it comes to market access and Reimbursement, especially for DTX, which are not supported by enough clinical evidence. NICE is still behind compared to the US regulations and FDA guidance and legislation around digital health appraisal and requirements for real-world evidence. Currently NICE, in partnership with NHS, Public Health England, MedCity, and DigitalHealth.London, developed an evidence standards framework for digital health technologies to ensure new technologies are clinically effective and offer económico value.
Japón - Curvas enlazadas

Japan s regulatory agency, the Ministry of Health, Labour and Welfare (MHLW) provides marketing authorization and implementing safety standards for medical devices and drugs. In collaboration with the MHLW, the Pharmaceutical and Medical Device Agency (PMDA), an independiente agency that is responsible for reviewing drug and medical device applications, ase new product safety, Develops regulations, and monitores postmarket safety.

DTX are generally reviewed under Marketing Authorization Applications (MAA) and by external advisory expertos.

In China, the National Medical Products Administration (NMPA) regulados medical devices, including DTX, within its Department of Medical Device Registration that is responsible for pre-market Approvals. The NMPA is a Ministry-level organization that is Oversea by the State Administration for Market Supervision (SAMS).

Products are also reviewed by Market Authorization Holder (MAH) as they must ensure the quality and meet all applicable requirements, submit self-inspection reports to authorities every year, and maintain their products.

TOP 5 Digital Tx Challenges

  1. Clinical evidence for efficacy and safety is still sparse
    Payer would prefer to offer Reimbursement for digital therapy upon Achieving better clinical outcomes within a time frame.
    Now, it is tough to separate unproven oro low-value applications from those with prueban therapeutic value.
  2. Cibersecurity
    The cibersecurity of patient 's fecha is a big responsibility for the DTX companies.
  3. Dose exposure and response
    The Investigation of dose-response relationships and their application to the designing of optimum therapies is a desirable future direction for DTX.
    Pharmacological conceptos need to be applied to the development and optimization of treatment regimenes.
  4. The remote informed consent and who is receiving the treatment
    In mobile device based clinical research, the remote informed consent process Raiser privacy concierne. Hitting the "OK" button by a subject can not be Considered sufficient consiente.
  5. No fast regulatory tracks
    Implemento fastest regulatory tracks for the preparedness of the documentation in order to pass the regulatory approval. 

TOP 5 Digital Tx Opportunities and Advantages

Appart from the challenges that Digital Tx solutions need to overpass, there are also opportunities that due the nature of these solutions can be very presente:

  1. Direct access to patients
    In Practice of Primary Care, DTX offers the Physicians an option to provide treatment anywhere and anytime, Transcending the physical borders of a clinic oro a hospital.
  2. Personalization of the therapy
    The continuous monitoring of patient vitales, can enable primary care Physicians to monitor and track response to the prescribed therapies, thereby aiding to provide Personalized treatment, for example in conditions such as depresión, anxiety,
    chronic diseases such as diabetes, cardiovascular conditions such as hypertension, and Pulmonary diseases like Chronic obstructive Pulmonary disease (COPD). The life cycle of the DTX can be updated rapidly through regular software updates.
  3. La tecnología VR
    VR in DTX apples simulation to enable people to learn by experiencing real-world situations. For example, through VR, patients go into situations and learn how to think, feel, and act differently.

  4. DTX is generally Considered safe
    The DTX solutions do not have to Produce toxicity oro other associated side effects.
  5. costes optimization
    Minimizan costes and time associated with attending a hospital oro doctor s clínico and
    administrative tasks and rutina communication, that could be focused on more time Spent donde treating patients. 

Tips to evaluate utility Digital Tx solutions

DTX are required to have certain standards to be able to INTEGRATE into the healthcare systems. Let 's try to do a Health Technology Assessment and how to differenciate from useful to not useful solutions.

Clinical Evidence-Based Therapeutic Benefit
  • DTX must demonstrate Measurable therapeutic benefit through randomized control trials (RCT).
  • Either replace a drug oro aumento the therapeutic benefit of a drug.
  • Help patients make positive and sustainable behavior changes that can be as effective as taking medication oro more effective.
  • Collect real-world evidence of patient outcome and have the potential to speed up clinical trials.
  • Having therapeutic effect, DTX has to show safety.
  • DTX should hijo an unmet need in the disease space.
Regulatory Approved and Data-Driven

 

  • Regulatory approval is Considered to be a first step towards integration of DTX into the healthcare systems; however, this does not guarantee Reimbursement oro prescription.
  • DTX colectivo patient fecha in a secure and meaningful manner, which will ultimately benefit the patient and lead to a more Personalized treatment approach.
Accessibility Prescribed and Reimbursed

 

  • In order for DTX to reach patients, Physicians have to be able to Prescribe the product.
  • In order for Physicians to Prescribe DTX, they have to be covered by Payer.
  • Demonstrating coste-effectiveness of DTX can help with coverage by Payer.
  • Physician awareness of the DTX products in their therapy area is critical to patient access.

Digital Tx and Clinical Trials

DTX clinical trials are not as lineal as drug development and given the nature of software, they need to be agile as time is the key to be successful clinically and commercially. The FDA has recognized this need for a new regulatory approach to evaluate rapidly and provide clearance for DTX to be used in clinical settings. Some of the key features of Digital Tx in clinical trials are:

  • DTX trials allow collection of more clinical fecha, As fecha también puede be collected passively at home compared to site-clinical trials.
  • Virtual trials can coste half as much por participante compared to a site-based trial.
  • They can speed up recruitment ratas by making it more conveniente to participate in trials.
  • DTX could make clinical trials more patient-focused and also increase the opportunities for patient engagement.

The Bioregiones has seen crecimiento significativo in companies that fall into this subsector over the past ten years, as well as the amount invested here, as can be seen in the 2020 Bioregiones Report Presented in September. While in 2010 there were only about 20 companies, 10 years later there are over 200: oro a tenfold increase in number of companies. Investment in these companies has Triple DES in reciente years, from € 5.1 million in 2016 to € 18.8 million in 2019, according to the report.

This growth reveal the subsector s youth, Which is 90% startups and has a joint turnover of € 118 million. Sonido, the average compañero is young, with under five years in the business, And no more than 10 employees. One importante figure: 21% of these firms were founded and are led by women.

The Report Clasif the DTX solutions in three typologies: Self-Management, Active Monitoring and Treatment. Doing a Zoom in the Treatment DTX companies there are 7:

Virtual bodywork | LinkedIn Virtual bodywork specialises in Immersive virtual reality with applications in medical and social Rehabilitation.
VRPharma - Mejorando la realidad de sobre pacientes Está a Virtual Reality (VR) solution Tailored for hospital usage to ENHANCE patient 's experience during medical procedures. Their misión is to decrease patient s anxiety levels and pain percepción with a user-friendly and innovative system.
Logotipos The Psious platform has more than 70 virtual environments and scenes specially designed to easily work donde Dozens of pathologies. The Therapists can use the tool for multiple techniques (psychoeducation, gradual exposure, systematic desensitization, relax, Distraction, acceptance and commitment, mindfulness, EMDR ...) to work with their patients.

IT Support the profesional in their care for all kinds of disorders such as anxiety (phobias, pánico, agoraphobia, generalized anxiety, public speaking, exams, etc.), attention management, eating disorders, OCD, ADHD, and pain management, among others .

Plataforma terapéutica Guttmann. - Blog DomusVi Neuropsychological evaluation Composed by a set of methods and techniques that allow to identify, Describe and quantify cognitive, behavioral and emotional alteration. This platform Allows os to offer effective and efficient Personalized treatments for people who have suffered a Neurological disorder. Although their fields of action cover a wide spectrum, they could be Considered among the most common: stroke, dementia, Alzheimer, Parkinson, Multiple Sclerosis, schizophrenia, bipolar disorder, intelectual disability, etc.
Limbix: Digital Therapeutics for adolescente mental health Limbix is ​​an investigational digital therapeutic solution for adolescente depresión. If Limbix Spark is FDA cleared it will be the first prescription digital therapeutic designed to support adolescentes with depresión. Spark is a multi-week cognitive behavioral therapy based program focused on the completion of value-based activities that spark feelings of pleasure oro Mastery.
Mejora tu Rendimiento visual con WiVi - Tu Visión Óptica Bierzo WIVI offers a complete cognitive visual function assessment and training of visual dysfunctions providing a Personalized plan for each patient and specialist, with freedom of movimiento, high accuracy, real time measurement at an affordable price using 3D technologies. WIVI is a new Immersive and interactive product based on 3D visualization and interacción which Allows a confortables y free way to ASSESS the skills and capabilities of the visual system as well as the design and implementation of treatment by appropriate visión training for improvement and Standardization. Various elementos where images and 3D modelos are Presented simulating different realistic scenarios with different visual challenges.
Wear Technologies Wear Technologies is a spin-off of the Institute of Research in Artificial Intelligence (IIIA CSIC), specialized in the monitoring of patients with mental and physical health problems.
The device through the combination of artificial intelligence systems and weareble sensores, monitores the therapies that medical centers apply to patients with chronic oro persistente health problems. The system Optimizer the work of Therapists and Allows greater control and Personalization of the therapies that apply to each patient.

 

Appart of these companies showed above, there is product from the Parc Taulí Research and Innovation Institute (I3PT) that is in vía to be commercialized in order to reach society, either through exploitation and / or distribution licenses, oro technology transfer agreements is EPPIC, De inglés Early prevention of the Post-Intensive Care Síndrome, AIMS to develop an innovative technological tool for the prevention of cognitive and emotional disorders associated with PICS. EPPIC  is an innovative digital tool based on our previous proof of concept, which will improve patient recovery and confort during the ICU stay. EPPIC has various exercises for the prevention of functional alteration at a cognitive and emotional level, and is integrated into a communicator for those patients who do not have the ability to Communicate.

Great cuotas

  • "If we look at mayor trends, people are living longer, donde average, sonido there 's en riesgo in chronic diseases associated with aging. Meanwhile, healthcare workers are in short supply, and Physicians and nurses No tienes enough time for patients. Yet everyone has powerful computers in their pockets that give them access to technology, education, and information. Put all that together, and it 's the perfect momento for digital solutions to come to the market, change behavior, and ENHANCE health outcomes at scale ". ,Bozidar Jovicevic, Global head of Digital Therapeutics, Sanofi
  • "DTX are not justo a toy in a happy meal to sell more pills" - Anonymous
  • "Reimbursement, commercial distribution and patient / provider education are the 3 biggest challenges" - P. Hames, Big Health

 

Patient health care journey

Also it is interesting to know how Digital Tx can be applied depending on the stage of the patient 's disease. In the following table is shown product examples in different therapeutic areas depending the disease s stage:

Source: http://medicinman.net/2020/08/digital-therapeutics-new-frontiers-in-healthcare/

Glosario de términos

  • E-patients
    Patients who are "equipadas, enabled, Empowered, and engaged in their health and healthcare decisiones." [14] Today, the number of e-patients is on the rise. They are better engaged and want to participate in informed decision-making about their care. They expect informed answers for their medical and health technology-related questions from their Physicians. [8] In such an aware world, the need for digital health and related tools becomes inevitable.
  • Hormesis
    Is defined as a phenomenon in which a Harmful substance gives stimulating and beneficial effects to living organisms when the quantity of the Harmful substance is small (Sakai, 2006).
  • Software as medicine oro behavioral medicine in a digital formato
    Therapeutics mimicking the product development path of pharmaceutical drugs which indicados online oro mobile delivery of skills-based Psychotherapy techniques.
  • Servicios digitales
    They modify patient behavior and help in driving a clinical outcome, for example, Òmada health s digital behavior platform for weight loss.
  • Adjunctive digital Therapeutics
    This tier complementos traditional Therapeutics, indirectly improving the clinical outcome, for example, Proteus Digital Health s Discover medication.
  • Digital drug replacement
    They substitute conventional medicine. This requires String criteria in terms of clinical trials and the Food and Drug Administration (FDA) review, for example, reset application for treating substance abuse disorder.
    A host of companies are Collaborating with health-care providers to shape up various DT programs in different diseases. Most of these initiatives are currently US based, but Emerging trends from countries such as Japan, UK, and India are a positive development.

Artículos and references

  1. https://www.bostonhealthcare.com/building-evidence-based-value-propositions-digital-therapeutics/
  2. 2020 DOI: 10.4103 / jfmpc.jfmpc_105_20. Amit Dang, Dimple Arora and Pawan Rane Role of digital Therapeutics and the changing future of healthcare
  3. DTA. Digital Therapeutics alianza [homepage on the Internet] 2017. Available from: https: // wwwdtxallianceorg / Cited 2020 Jan 09.
  4. https://www.healthxl.com/blog/digital-health-digital-medicine-digital-therapeutics-dtx-whats-the-difference
  5. 2019 DOI: 10.12793 / tcp.2019.27.1.6. Jae-Yong Chung. Digital Therapeutics and clinical pharmacology
  6. 2020 DOI: 10.4103 / jfmpc.jfmpc_105_20. Amit Dang, Dimple Arora and Pawan Rane Role of digital Therapeutics and the changing future of healthcare.
  7. 2020 DOI: 10.4103 / jfmpc.jfmpc_105_20. Amit Dang, Dimple Arora and Pawan Rane Role of digital Therapeutics and the changing future of healthcare.
  8. 2020 DOI: 10.4103 / picr.PICR_89_19. Raj Khirasaria, Vikramjit Singh and Angelika Batta. Exploring digital Therapeutics: The next paradigm of moderno health-care industry
  9. GlobalData_2019_Digital-Therapeutics and their-impact-on-health-care
  10. 2020 DOI: 10.4103 / jfmpc.jfmpc_105_20. Amit Dang, Dimple Arora and Pawan Rane Role of digital Therapeutics and the changing future of healthcare.
  11. https://www.researchgate.net/figure/Conceptual-comparison-between-pharmacotherapy-and-digital-therapeutics-from-the-point-of_tbl2_332147628
  12. http://medicinman.net/2020/08/digital-therapeutics-new-frontiers-in-healthcare/
  13. https://www.americanbar.org/groups/intellectual_property_law/publications/landslide/2019-20/november-december/ip-strategies-red-hot-digital-health-industry/
  14. 2020 DOI: 10.4103 / picr.PICR_89_19. Raj Khirasaria, Vikramjit Singh and Angelika Batta. Exploring digital Therapeutics: The next paradigm of moderno health-care industry
  15. https://www.bostonhealthcare.com/building-evidence-based-value-propositions-digital-therapeutics/
Ismael Ávila

Ismael is biotechnologist, with business Specialization short course in IESE. He loves making things happen! And in the healthcare innovation there are lote of things to push forward that at the same time could help lote of patients in the world !! He HOLDS extensive project management experience in the health network, Previously in Biocat and CataloniaBio & HealthTech and as President of the Young European Biotech Network. He acts as a healthcare technology transfer in the innovation department of the Institute of Innovation and Research of Parc Taulí (I3PT).

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