[An overview of investments in the development of the Russian Medtech market and the prospects for the impact of digitalization in medicine on the economic performance of companies until 2030].

Today, the topic of digitalization, the introduction of innovations based on Big Data, the complexity of technologies due to the introduction of artificial intelligence in medicine and healthcare is one of the most relevant in this industry, undoubtedly contributing to its rapid development. As a result of this development, there is a huge number of services and applications. Internet resources, not only for health tracking (more than 3,500 applications are available by the end of 2023), but also the development of diagnostic resources, telemedicine, etc. Quite quickly, it was the pandemic and its consequences that changed the format of interaction between doctors, communication in the community of doctors, and their interaction with patients. Saving time when making an appointment with a doctor, visiting him, constant monitoring of the condition of patients, becoming better and more multidirectional day by day, make it possible to provide timely, relevant care to more people. The use of artificial intelligence technologies and digital solutions in the field of Russian healthcare opens up great prospects for both doctors and patients, as well as for many government agencies, since the development of regulatory and legal regulation and state control and management of innovations in the field of medicine and healthcare is important. An important factor is that not only government programs for the development of healthcare, but also investments are extremely important for the development of digital medicine.

[Analysis of the demand for medical services using digital programs in the Russian healthcare system: an overview of trends].

The research conducted in this article has determined that among Russians, preference for private medical services, including through online technologies, is given for the following reasons: the speed of service provision - 45.1%; lack of queues (44%); quality of medical procedure (39.8%); ease of making an appointment (32.1%); high professional level of the doctor (24.4%). Given the fact that the cost of medical services at a personal appointment is increasing, it is safe to say that the types and forms of services in the format of remote medical care will certainly increase in number and may become the most important trend in 2024 and subsequent years. An important factor in the availability and satisfaction of medical services, and hence its demand, is the use of digital technologies and the direction of development of programs using artificial intelligence in medicine. The article provides an overview of the artificial intelligence resources used and implemented in medicine and healthcare in Russia, and the prospects for their development in the short term.

The Value of Surgical Data-Impact on the Future of the Surgical Field.

The combination of computing power, connectivity, and big data has been touted as the future of innovation in many fields, including medicine. There has been a groundswell of companies developing tools for improving patient care utilizing healthcare data, but procedural specialties, like surgery, have lagged behind in benefitting from data-based innovations, given the lack of data that is well structured. While many companies are attempting to innovate in the surgical field, some have encountered difficulties around collecting surgical data, given its complex nature. As there is no standardized way in which to interact with healthcare systems to purchase these data, the authors attempt to characterize the various ways in which surgical data are collected and shared. By surveying and conducting interviews with various surgical technology companies, at least 3 different methods to collect surgical data were identified. From this information, the authors conclude that an attempt to outline best practices should be undertaken that benefits all stakeholders.

Turning Practicing Surgeons Into Health Technology Innovators: Outcomes From the Stanford Biodesign Faculty Fellowship.

Background. The Stanford Biodesign Faculty Fellows program was established in 2014 to train Stanford Medical and Engineering faculty in a repeatable innovation process for health technology translation while also being compatible with the busy clinical schedules of surgical faculty members. Methods. Since 2014, 62 faculty members have completed the fellowship with 42% (n = 26) coming from 14 surgical subspecialties. This eight-month, needs-based innovation program covers topics from identifying unmet health-related needs, to inventing new technology, developing plans for intellectual property (IP), regulatory, reimbursement, and business models to advance the technologies toward patient care. Results/Conclusion. Intake and exit survey results from three years of program participants (n = 36) indicate that the fellowship is a valuable hands-on educational program capable of improving awareness and experience with skill sets required for health technology innovation and entrepreneurship.

Impact of the COVID-19 pandemic: a perspective from industry.

The global COVID-19 pandemic has led to unprecedented change throughout society.1 As the articles in this supplement outline, all segments of the broader cardiovascular community have been forced to adapt, to change models of care delivery, and to evolve and innovate in order to deliver optimal management for cardiovascular patients. The medtech/device industry has not been exempt from such change and has been forced to navigate direct and indirect COVID-associated disruption, with effects felt from supply chain logistics to the entire product lifecycle, from the running of clinical trials to new device approvals and managing training, proctoring and congresses in an increasingly-online world. This sea-change in circumstances itself has enforced the industry, in effect, to disrupt its own processes, models and activities. Whilst some of these changes may be temporary, many will endure for some time and some will doubtless become permanent; one thing is for sure: the healthcare ecosystem, including the medical device industry, will never look quite the same again. Although the pandemic has brought a short- to medium-term medical crisis to many countries, its role as a powerful disruptor cannot be underestimated, and may indeed prove to be a force for long-term good, given the accelerated innovation and rapid adaptation that it has cultivated.

Practice in financial support of third party organised conferences and courses at a national level for health care professionals in Europe.

Background Ethical MedTech prescribes high standards for the participation of the in vitro diagnostics (IVD) industry in third-party organised educational events in terms of charitable donations, educational grants, scholarships and fellowships. We planned a survey to investigate the previous and current practice in terms of cooperation between professionals or professional societies and the IVD industry, as well as plans under the incorporation of the MedTech Europe Code. Methods Different questions, from general information to specific questions related to the practice and knowledge of the new Ethical MedTech Code, were included in two different surveys; for European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) National Societies' (NSs) representatives, and for their (NSs) individual members. Results Twenty-five out of 40 EFLM NS representatives replied; more than half declared that all different types of financial resources were available for supporting the continuing professional education of health care professionals (HCPs). In addition, 322 individual responses collected from 31 NSs, answered that the institutional director (50.3%) or laboratory chief (70.1%) made generally made a decision, without specific criteria. Conclusions The MedTech Europe Code is already adopted or is about to be adopted in numerous EFLM NSs, but most of them have not implemented it as yet. The use of the Code and better communication between IVD companies and HCPs are necessary to guarantee an improved and fair use of financial support, as well as better choices for the organisation and attendance at scientific events.

Uses of quick response codes in healthcare education: a scoping review.

BACKGROUND: To review published literature on the use of quick response (QR) codes within healthcare education. In addition, the authors aimed to gain information on user perceptions and the challenges faced when implementing QR codes in an educational context. METHODS: Medline, EMBASE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), HMIC (Healthcare Management Information Consortium) and HBE (Health Business Elite) were searched using specified search terms that included 'quick response code' and 'education'. Title and abstract review of 217 publications was performed. Papers which discussed the application of QR codes relevant to healthcare education were included. A total of 24 articles were reviewed and thematic analysis conducted to generate themes. RESULTS: Use of QR codes in healthcare education were broadly aligned to four common themes. These included: to increase participant engagement, for simulation training, for just-in-time (JIT) learning and to facilitate with administrative tasks in training. Perceptions towards the use of QR codes was generally positive. Challenges identified, included: problems with technical infrastructure, unavailability of smartphones and resistance to use in certain environments. CONCLUSIONS: The use of QR codes for healthcare education is increasing, and whilst they offer some advantages there are also some important considerations including: provision of the necessary technological infrastructure, patient and staff safety and governance and adherence to guidelines on safe and appropriate use of this technology in sensitive settings.

Development of Implantable Wireless Sensor Nodes for Animal Husbandry and MedTech Innovation.

In this paper, we report the development, evaluation, and application of ultra-small low-power wireless sensor nodes for advancing animal husbandry, as well as for innovation of medical technologies. A radio frequency identification (RFID) chip with hybrid interface and neglectable power consumption was introduced to enable switching of ON/OFF and measurement mode after implantation. A wireless power transmission system with a maximum efficiency of 70% and an access distance of up to 5 cm was developed to allow the sensor node to survive for a duration of several weeks from a few minutes' remote charge. The results of field tests using laboratory mice and a cow indicated the high accuracy of the collected biological data and bio-compatibility of the package. As a result of extensive application of the above technologies, a fully solid wireless pH sensor and a surgical navigation system using artificial magnetic field and a 3D MEMS magnetic sensor are introduced in this paper, and the preliminary experimental results are presented and discussed.

Industrial clusters, creating a strategy for continued success.

Purpose: This study aims to describe and propose an effective strategy for an industrial cluster and investigates industrial cluster-promoted growth.Design/Methodology/Approach: A qualitative study was carried out within the Irish Medtech cluster with key stakeholders from the cluster. Findings: The findings demonstrate significant opportunities for further cluster development and to potentially double the number of spin-outs and value of R&D investments while enhancing an entrepreneurial culture. This study also recommends that multiple agencies collaborate to achieve the future strategic objectives of the cluster. The soft infrastructure of regulatory and intellectual policies is as important as the hard infrastructure of roads and buildings. Practical implications: This study has implications for government policy, informing how they align the local needs of compact industrial clusters with policies to make the Irish cluster more unique and gain a sustainable competitive advantage. The approach is applicable and has implications for all industrial clusters.Originality/Value: This is one of the first studies to look at the Irish Medtech cluster in terms of its shortcomings and future opportunities.

Requirements to bring a medical device to market.

A roadmap for medical device innovators is presented that highlights the essential steps for regulatory authorization, market access, and reimbursement strategies in the USA, with a focus on strategic planning for commercial success, underscoring the integration of regulatory and market access considerations from the initial development of a medical device.

The impact of a Telehealth-based Behavioral Lifestyle Program on hypertension control in African American participants: results from the HEALS Med-Tech randomized controlled trial.

Introduction: The HEALS Med-Tech program offers a unique blend of lifestyle changes and technology to improve hypertension (HTN) management in African Americans (AAs), a group disproportionately affected by cardiovascular disease (CVD).Methods: A randomized controlled trial compared HEALS Med-Tech against usual care for uncontrolled hypertension in AAs, focusing on diet, medication adherence, and telehealth. Results: In a study of 61 participants, HEALS Med-Tech significantly reduced systolic blood pressure by 12.95 mm Hg (p = 0.008) and 9.19 mm Hg (p = 0.013) at 3 and 12 months, respectively, demonstrating improved hypertension control. Conclusions: HEALS Med-Tech demonstrates potential in HTN management for AAs, advocating for culturally tailored, tech-integrated healthcare expansion.

Lessons learned from the RE(ACT) conference on medical devices for rare diseases.

The field of rare disease therapeutics has witnessed significant growth in recent years, highlighting the need for diverse therapeutic approaches to cater to the unique needs of individuals with rare diseases. Rare disease therapies encompass a broad spectrum of interventions, including orphan medicinal products, orphan medical devices, rehabilitative therapies, and digital therapeutics, with the lines between these categories blurring. This paper covers the session of the RE (ACT)-IRDiRC Conference 2023 and delves into the landscape of orphan medical device research and development, shedding light on the challenges and opportunities in this burgeoning field. It provides a short overview of the different international legislations in the field. In addition, it highlights several exemplary orphan medical devices. The first example is an exoskeleton for boys with Duchenne Muscular Dystrophy, enabling them to maintain arm functionality and independence. Another example presented was an EEG device linked to an app detecting seizures in rare epilepsy conditions, which alerts caregivers to seizures in real-time but also facilitates objective seizure reporting for clinicians, aiding in diagnosis and treatment optimization. It also showcases the role of gamification and enabling technologies in addressing rare diseases, by showing a game designed for children with cystic fibrosis, and a telemedicine system for rehabilitation therapy. Both solutions aim to improve patients' understanding of their conditions and enhance their self-management. In conclusion, this paper underscores the critical need for patient-centric orphan and pediatric medical devices to provide therapeutic options for individuals with rare diseases. It highlights the impact of existing devices on enhancing the quality of life for rare disease patients and emphasizes the necessity for greater incentives and support for research and development in this field.

What is coming next in health technology startups? Some insights and practice guidelines.

Health technology startups are experiencing a significant surge in growth, particularly since the COVID-19 pandemic, as they address gaps in the sector. However, despite their increasing prevalence, there is still relatively limited knowledge about this sector's evolution. This opinion article explores emerging trends in health startups, including their market size, growth, significant challenges, and guidelines for key stakeholders from a global healthcare service industry perspective. By gaining a better understanding of these trends, new research opportunities and evidence-based practices can be identified.

The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study.

The European Union Medical Device Regulations 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study investigates how the increased requirements on medical device manufacturers in relation to how clinical evaluation will challenge manufacturers. A quantitative survey study was utilized with responses from 68 senior or functional area subject matter experts working in medical device manufacturing Regulatory or Quality roles. The findings from the study demonstrated that the highest source of reactive Post-Market Surveillance data was customer complaints and proactive data were Post-Market Clinical Follow-Up. In contrast, the top 3 sources for generating clinical evaluation data for legacy devices under the new Medical Device Regulations were Post-Market Surveillance data, Scientific literature reviews, and Post-Market Clinical Follow-Up studies. Manufacturers' biggest challenge under the new Medical Device Regulations is determining the amount of data needed to generate sufficient clinical evidence, while over 60% of high-risk device manufacturers have outsourced the writing of their clinical evaluation reports. Manufacturers also reported a high investment in clinical evaluation training and highlighted inconsistencies in the requirements for clinical data by different notified bodies. These challenges may lead to a potential shortage of certain medical devices in the E.U. and a delay in access to new devices, negatively impacting patient quality of life (1). This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the E.U.

Orphan medical devices have come a long way.

BACKGROUND: In many countries worldwide orphan drug regulations are installed but only the United States of America and Japan have an orphan device regulation. For many years surgeons have used off-label or self-assembled medical devices for the prevention, diagnosis or treatment of rare disorders. Four examples are given: an external cardiac pacemaker, a metal brace for clubfoot in newborns, a transcutaneous nerve stimulator and a cystic fibrosis mist tent. CONCLUSION: In this article we argue that we need authorized medical devices as well as medicinal products to prevent, diagnose and treat patients with life-threatening or chronically debilitating disorders with a low prevalence/incidence. Several arguments are given to support this statement.

AffectMachine-Classical: a novel system for generating affective classical music.

This work introduces a new music generation system, called AffectMachine-Classical, that is capable of generating affective Classic music in real-time. AffectMachine was designed to be incorporated into biofeedback systems (such as brain-computer-interfaces) to help users become aware of, and ultimately mediate, their own dynamic affective states. That is, this system was developed for music-based MedTech to support real-time emotion self-regulation in users. We provide an overview of the rule-based, probabilistic system architecture, describing the main aspects of the system and how they are novel. We then present the results of a listener study that was conducted to validate the ability of the system to reliably convey target emotions to listeners. The findings indicate that AffectMachine-Classical is very effective in communicating various levels of Arousal (R2 = 0.96) to listeners, and is also quite convincing in terms of Valence (R2 = 0.90). Future work will embed AffectMachine-Classical into biofeedback systems, to leverage the efficacy of the affective music for emotional wellbeing in listeners.

A comprehensive roadmap for MedTech innovations uptake into the public healthcare system in India.

Background: The burden of communicable, non-communicable diseases and reproductive maternal, newborn, child & adolescent health in India, reflects the necessity to develop tailored solutions. The plethora of MedTech innovations has provided healthcare facilities with more effective, affordable and accessible healthcare for people across the country. However, in spite of the Make-in-India scheme in the country, the indigenously developed healthcare technology is far from making an impact on the healthcare system. Objective: To present a roadmap for MedTech innovations for their successful deployment into the public healthcare system. Methodology: In addition to the literature review, recommendations were included from several stakeholders such as innovators, manufacturers, policymakers, subject matter experts, funding organizations, State health officials etc. Results and conclusion: The journey of healthcare innovation from need identification to ideation, to prototyping and validation has paved the way towards the de novo design that caters to unmet needs. Innovations at the advanced technology readiness level (TRL 7/8 and above) demand a holistic and multidisciplinary approach which includes clinical validation, regulatory approval and Health technology assessment. The deployment of healthcare technology into the public healthcare system must consider resources (e.g., time, staff, budget, investment policies), ethical concerns (privacy, security, regulations, ownership), governance (policy, accountability, responsibility etc.), and Skills (capabilities, culture, etc.). The technologies are considered for field trials before the uptake in the public health system. Technology can be a key tool in achieving Universal Health Coverage but its use has to be strategic, judicious, and cognizant of issues around privacy and patient rights.

Circular Business Model for Digital Health Solutions: Protocol for a Scoping Review.

BACKGROUND: The circular economy reshapes the linear "take, make, and dispose" approach and evolves around minimizing waste and recapturing resources in a closed-loop system. The health sector accounts for 4.6% of global greenhouse gas emissions and has, over the decades, been built to rely on single-use devices and deal with high volumes of medical waste. With the increase in the adoption of digital health solutions in the health care industry, leading the industry into a new paradigm of how we provide health care, a focus must be put on the amount of waste that will follow. Digital health solutions will shape health care through the use of technology and lead to improved patient care, but they will also make medical waste more complex to deal with due to the e-waste component. Therefore, a transformation of the health care industry to a circular economy is a crucial cornerstone in decreasing the impact on the environment. OBJECTIVE: This study aims to address the lack of direction in the current literature on circular business models. It will consider micro, meso, and macro factors that would impact the operational validity of circular models using the digital health solutions ePaper label (medical packaging), smart wearable sensor (health monitoring devices), smart pill box (medication management), and endo-cutter (surgical equipment) as examples. METHODS: The study will systematically perform a scoping review through a database and snowball search. We will analyze and classify the studies from a predetermined set of categories and then summarize them into an evidence map. Based on the review, the study will develop a 2D framework for businesses to follow or for future research to take a standpoint from. RESULTS: Preliminarily, the review has analyzed 26 studies in total. The results are close to equally distributed among the micro (8/26, 31%), meso (10/26, 38%), and macro (8/26, 31%) levels. Circular economy studies emphasize several circular practices such as recycling (17/26, 65%), reusing (18/26, 69%), reducing (15/26, 58%), and remanufacturing (8/26, 31%). The value proposition in the examined business model is mostly dominated by stand-alone products (18/26, 69%) compared to product as a service (7/26, 27%), involving stakeholders such as health care professionals or hospitals (20/26, 77%), manufacturers (11/26, 42%), and consumers (9/26, 35%). All studies encompass societal (12/26, 46%), economic (23/26, 88%), and environmental (24/26, 92%) viewpoints. CONCLUSIONS: The study argues that each digital health solution would have to be accessed individually to find the optimal business model to follow. This is due to their differing life cycles and complexity. The manufacturer will need a layered value proposition, implementing several business models dependent on their respective product portfolios. The need to incorporate several business models implies an ecosystem perspective that is relevant to consider. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47874.

Meaningful involvement of children and young people in health technology development.

The anatomical, physiological, and developmental changes which arise as children mature through childhood and adolescence support the need to develop new health technologies that meet the specific requirements of children and young people (CYP). Failing to involve CYP during the development of technology increases the risk that the outcome falls short of their expectations and needs, leading to rejection of novel interventions. Through participation in health technology development, CYP and their families can provide context, insight, personal experience and tacit knowledge to ensure that the end-product is usable, acceptable, and can be integrated into its intended environment. A nuanced, balanced understanding of the methods that can be used to facilitate participation will support researchers in choosing an effective approach to involving CYP in health technology development. Methodological approaches include patient and public involvement and engagement, co-design, and experienced based co-design. These methods can be used in isolation or in combination, to facilitate meaningful involvement of CYP and encourage the development of impactful solutions, in consideration of the context, stakeholders, and objectives of the project. We provide the rationale and justification for involving CYP in health technology design and development, an explanation of the methods supporting meaningful involvement, and case studies exemplifying real world application of these methods with positive outputs.

Learning From Agility, Partnership and Innovation During the Covid-19 Pandemic: A Perspective From Industry.

Two years after the COVID-19 pandemic started, the world continues to adapt to the profound effects that Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has had on our lives. As the global crisis took hold, many looked to the medical technology/device industry for guidance and solutions. All while the industry itself, was disrupting its own processes and activities. In order to evolve and deliver accelerated innovation the industry had to be agile, resilient and collaborative with the broader healthcare community and technology partners. Now comes a time when we will start to see what changes were temporary and which ones will become part of the new process, but one thing is certain, we will not be going back to where we were pre-pandemic.