Innovative Medical Technologies Research Articles

OP33 Expectations, Needs And Challenges Of Setting Up An International Collaboration On Horizon Scanning For Medical Devices

IntroductionInternational collaboration on horizon scanning for medical devices is seen as desirable, because the development of medical devices is not limited to the national level, and horizon scanning for medical devices on a country-level can be challenging due to scarcity and diversity of information. The International Horizon Scanning Initiative Medical Devices Working Group (IHSI MDWG) was set up in June 2021. The objective of this study was to research the expectations and experiences of the participants of this initiative, in order to reflect on the possibilities and challenges of governing innovative medical technologies.MethodsA questionnaire was sent out to 10 purposively selected representatives of the IHSI MDWG participating counties: Austria, Belgium, Canada, Denmark, Italy, Luxembourg, Netherlands, Norway, Portugal, and Sweden. The survey covered individual countries’ respective purposes for an international horizon scanning system as well as questions related to the desired scope and perceived challenges of such a system. The questionnaire was supplemented with online, semi-structured, in-depth interviews with the same representatives from each participating country. These interviews provided for diving deeper into the survey topics as well as discussing the relation between horizon scanning and health technology assessment, the relation to other international horizon scanning collaborations, and the relation between an international versus a national horizon scanning system. In addition, participant observations were conducted at the Dutch National Health Care Institute and during IHSI MDWG working group meetings.ResultsPreliminary results are discussed first with participants after which we will draw our final conclusions and recommendations for practice. Our analysis focuses on exploring participants’ expectations and experiences with international horizon scanning through triangulating the three sources of data in our analysis.ConclusionsThe study will report on the expectations, needs and challenges of setting up an international collaboration for horizon scanning of medical devices and reflect on the regulation and governance of innovative medical technologies across several countries in Europe and Canada.

PP76 Database On Evidence-Based Telemedicine In A Hospital Setting

IntroductionThe use of telemedicine services has increased worldwide during recent years because of national strategies for digitalization of health care and the coronavirus disease 2019 (COVID-19) pandemic. However, healthcare professionals often express uncertainty regarding the effectiveness of telemedicine interventions. The TELEMED database (https://telemedicine.cimt.dk/) was introduced by the Centre for Innovative Medical Technology (CIMT) at Odense University Hospital to ensure that hospital managers, healthcare professionals, and other stakeholders have access to scientific studies of telemedicine interventions.MethodsThe database constitutes a structured literature search in PubMed for randomized and non-randomized controlled trials on the use of telemedicine for treating somatic diseases in the hospital setting. The search was conducted by staff members in the health technology assessment unit at CIMT. Identified studies were sorted by first screening titles and abstracts and then by reading full-text versions. The data extracted from the studies included setting, intervention, patient group, type of telemedicine, clinical effect, patient perception, and implementation challenges. The value of each study was also assessed with respect to effectiveness.ResultsA total of 510 articles were selected for data extraction and assessment. The database provides results from 22 different specialties and can be searched using the criteria of medical specialty, country, technology, clinical effect, patient experience, and economic effect. The database serves as an information platform for clinical departments who wish to implement telemedicine services. It has great potential for supporting digital transformation during COVID-19 by providing accessible evidence-based information on patient groups and relevant technologies and their effects. More than 95 percent of the studies in the database that compared telemedicine with a control group showed either statistically significant improvements in clinical outcomes with telemedicine or no statistically significant difference between the two groups.ConclusionsThe TELEMED database provides an easily accessible overview of existing evidence-based telemedicine services. The database is freely available and is expected to be continuously improved and broadened over time.

A Review of Current and Novel Methods of Medical Waste Management

According to the World Health Organization (WHO), high-income and low-income countries generate on average up to 0.5 kg and 0.2kg of hazardous waste per hospital bed per day, respectively. However, hazardous waste only accounts for 15% of total medical waste. The amount of total medical waste has increased over time, especially with medical supplies ordered during the COVID-19 pandemic. The purpose of the paper is to increase awareness of the problem regarding the difficulties of medical waste management and discuss possible solutions to these challenges. This review will inquire into the various methods of medical waste management, their current statuses, and their environmental, economic, and social impacts. Types of medical waste include pharmaceuticals, blood/blood-related products, sharps, body parts/tissues/organs, contaminated equipment, and COVID-19 products. The author describes in detail the environmental, economic, and social implications of the use of landfills, incineration, steam sterilization, sewage, and common forms of improper disposal, during which the author discusses impacts such as leaching and social disparities faced by developing countries. The author also considers economic and environmentally friendly medical waste management such as redistribution of medical supplies to vet clinics as well as innovative medical waste management technologies including thermal plasma treatment and plasma pyrolysis. The author suggests that medical waste management focuses on economical methods that have small environmental impacts and large social benefits such as methods of redistribution.

Fostering Medical Materials Innovation.

Close collaboration between basic researchers and clinicians is at the root of medical material and technology innovation. However, the distinctly different educational curricula and various boundary conditions put barriers on such interactions. This short perspective describes current challenges and provides subsequent solutions that may help research laboratories to overcome frequent hurdles and maximize interdisciplinary interactions. The involvement of various stakeholders is key to establishing an environment for barrier-free, effective collaboration, overcoming disciplinary boundaries and creating a strong source of inspiration and motivation for biomedical innovations with clinical impact.

Design and Modeling of Bioreactor Utilizing Electrophoresis and Di-Electrophoresis Techniques for Regenerating Reabsorption Function of Human Kidney PCT in Microfluidics Environment.

The need for innovation in medical device technology is immense; especially to replace dialysis techniques the necessity is extremely high. Available techniques that promised to replace dialysis have not yet geared up to the marketization level. The utilization of live kidney cells makes these devices costly, delicate, and unreliable. This paper aims to design a bioreactor to mimic the reabsorption function of the kidney that is fully artificial and highly controllable, which can be one step forward to the emerging Kidney-on-Chip (KOC) technology. The additional benefit of the proposed design is that it utilizes size-dependent reabsorption along with charge-dependent reabsorption phenomena to make it more compatible with human kidney function. The electrophoresis (EP), and di-electrophoresis (DEP) techniques are utilized to mimic the reabsorption function in this report. The structure utilized in the present design exactly replicates the proximal convoluted tubule (PCT) dimensions and functions as well. The whole setup is implemented in the COMSOL Multiphysics FEM benchmark tool for simulation, and analysis with appropriate boundary conditions. The device when excited by an electric field, Electrophoresis has produced a maximum velocity of 1.07 m/s for DC excitation and di-electrophoresis has produced a maximum flow velocity of 1.23 m/s, where both the offset voltages are the same (0.7 V). The flow velocity obtained utilizing both EP and DEP produced a reabsorption rate of 50-58% depending on the voltage applied and dimensions considered which is close to 60% reabsorption rate of the normal human kidney PCT. In accordance with the outcomes produced, the di-electrophoresis technique proved to be more efficient in realizing bioreactor as compared to electrophoresis. The novelty of the present work lies in the creation of a simulation environment, rigorous analysis, and optimization of the bioreactor supported by compact mathematical model.

Open-Source Hardware May Address the Shortage in Medical Devices for Patients with Low-Income and Chronic Respiratory Diseases in Low-Resource Countries.

Respiratory diseases pose an increasing socio-economic burden worldwide given their high prevalence and their elevated morbidity and mortality. Medical devices play an important role in managing acute and chronic respiratory failure, including diagnosis, monitoring, and providing artificial ventilation. Current commercially available respiratory devices are very effective but, given their cost, are unaffordable for most patients in low- and middle-income countries (LMICs). Herein, we focus on a relatively new design option—the open-source hardware approach—that, if implemented, will contribute to providing low-cost respiratory medical devices for many patients in LMICs, particularly those without full medical insurance coverage. Open source reflects a set of approaches to conceive and distribute the comprehensive technical information required for building devices. The open-source approach enables free and unrestricted use of the know-how to replicate and manufacture the device or modify its design for improvements or adaptation to different clinical settings or personalized treatments. We describe recent examples of open-source devices for diagnosis/monitoring (measuring inspiratory/expiratory pressures or flow and volume in mechanical ventilators) and for therapy (non-invasive ventilators for adults and continuous positive airway pressure support for infants) that enable building simple, low-cost (hence, affordable), and high-performance solutions for patients in LMICs. Finally, we argue that the common practice of approving clinical trials by the local hospital ethics board can be expanded to ensure patient safety by reviewing, inspecting, and approving open hardware for medical application to maximize the innovation and deployment rate of medical technologies.

A decade of pecision neurosurgery: the informative and systematic upgrading of brain glioma surgery

Precision neurosurgery concept as well as the establishment of it's technical platform, have played essential roles in promoting the modern surgical management of brain gliomas in China.In the past decade,the multidisciplinary integration of medical sciences and technology innovations has significantly promoted the clinical implementation of new imaging and novel navigation technology.With active clinical translational research and practice,precision neurosurgery has developed from "startup prologue" (simple anatomical navigation) to "precision neurosurgery 1.0" (intraoperative MRI with multimodal neuronavigation),followed by "precision neurosurgery 2.0" (informative and systematic upgrading).In the past decade,Chinese researchers have made significant and remarkable achievements in precision neurosurgery through continuous efforts and innovation.In the future,state-of-art technologies such as artificial intelligence on deep learning and machine learning,multimodal real-time navigation,intraoperative optical imaging,and targeted molecular imaging technology will promote the development of precision neurosurgery in a coordinated manner, leading to the advent of "precision neurosurgery 3.0".

Medtech innovation guide: an empiric model to support medical technology innovation

Innovation has become increasingly important for most industries to cope with rapid technological changes as well as changing societal needs. Even though there are many sectors with specific needs when it comes to supporting innovation, the medical technology sector is facing several unique challenges that both increases the lead-time from idea to finished product and decreases the number of innovations that are developed. This paper presents a proposed innovation guide that has been developed and evaluated as a support for the innovation process within medical technology research. The guide takes the unique characteristics of the medical technology sector into account and serves as a usable guide for the innovator. The complete guide contains both a structure for the process and a usable web application to support the journey from idea to finished products and services. The paper also includes a new readiness level, Sect. 4.2 to provide support both when developing and determining the readiness for clinical implementation of a medical technology innovation.

Innovative medical technologies for the treatment of urinary tract infections in peri- and postmenopausal women

Objectives: to evaluate the effectiveness of Utipro Plus AF for uncomplicated urinary tract infections in women in the peri- and postmenopausal period.Materials and methods. The study included 45 patients aged 48–70 years with verified uncomplicated urinary tract infection. All patients received antimicrobial agents in accordance with approved guidelines. 25 women (main group) also received Utipro Plus AF, 20 women (control group) received only antimicrobial agents. The effectiveness of treatment was assessed on the 6th, 11th, 30th and 75th day of observation. Efficiency criteria were a decrease in the intensity of clinical symptoms, a decrease in the number of relapses, and bacterial sanitation based on the results of urine cultures (≤ 103 CFU/ml). Results. Clinical picture changed dramatically in the patients of the examined groups after treatment. Main group had no urinary incontinence, imperative urges to urinate, the frequency of dysuria disorders decreased by three times in this group, pain in the lower abdomen and burning sensation during urination were 5 times less common. Recurrences of urinary tract infections were noted in both groups by bacteriological and symptomatic criteria, but their frequency was much lower in the group that received Utipro Plus AF in addition to antibiotics. The number of positive results of urine cultures on the 75th day of observation decreased to 16% in the main group, and to 65% in the control group. Recurrences of urinary tract infections according to clinical criteria on the 75th day of observation were verified in 3 patients of the main group and in 12 patients in the control group. Conclusions. The medical product Utipro Plus AF effectively reduces bacteriological and clinical signs of uncomplicated urinary tract infections, which makes its use advisable as an additional agent to antibiotic therapy in women with uncomplicated urinary tract infections in peri- and postmenopausal period.

Review of investigational medical devices' clinical trials and regulations in Africa as a benchmark for new innovations.

Medical technologies present a huge potential in improving global health playing a key role toward achieving Sustainable Development Goal 3 by 2030. A number of clinicians, innovators, business entities and biomedical engineers among others have developed a number of innovative medical devices and technologies to address the healthcare challenges especially in Africa. Globally, medical devices clinical trials present the most acceptable method for determining the risks and benefits of medical device innovations with the aim of ascertaining their effectiveness and safety as compared with established medical practice. However, there are very few medical device clinical trials reported in Africa compared to other regions like USA, UK and Europe. Most of the medical device clinical trials reported in Africa are addressing challenges around HIV/AIDS, maternal health and NCDs. In this mini review, we report about some of the published medical device clinical trials in Africa PubMed and Google Scholar and their associated challenges.

PERANCANGAN OTOMASI ALAT INFUS BERBASIS FUZZY LOGIC

Starting from the development of medical technology that is increasingly sophisticated and rapidly growing,researchers conduct medical research, namely about patient infusion handling services. In handling patient infusion, currently it is still manual which is carried out by nurses / medical personnel. Infusion handling services for patients still have shortcomings, namely the process of monitoring and replacing infusion fluids which are often late. If the problem is not treated quickly, it can lead to problems, namely the presence of air embolism in the blood vessels (the entry of foreign objects into the blood vessels, for example air). From that problem, the researchers made a new innovation in medical technology in handling infusions automatically and based on IoT. In this study, the smart online infusion device that has been made has good features and is very effective in handling infusions. This device has 3 main functions, namely: it can monitor the remaining infusion, it can change the infusion fluid automatically and it can indicate a blocked patient's infusion. This device already has a method for processing data with fuzzy logic. Media monitoring has been supported by a website that can be controlled remotely and in real time. Tests have been carried out and the effectiveness of the system is found to have an error rate of 0.2% - 0.7% and has an accuracy of 98%. Thus this tool can be used in terms of handling patient infusion automatically.

Informed decision-making: Statistical methodology for surrogacy evaluation and its role in licensing and reimbursement assessments.

The desire, by patients and society, for faster access to therapies has driven a long tradition of the use of surrogate endpoints in the evaluation of pharmaceuticals and, more recently, biologics and other innovative medical technologies. The consequent need for statistical validation of potential surrogate outcome measures is a prime example on the theme of statistical support for decision‐making in health technology assessment (HTA). Following the pioneering methodology based on hypothesis testing that Prentice presented in 1989, a host of further methods, both frequentist and Bayesian, have been developed to enable the value of a putative surrogate outcome to be determined. This rich methodological seam has generated practical methods for surrogate evaluation, the most recent of which are based on the principles of information theory and bring together ideas from the causal effects and causal association paradigms. Following our synopsis of statistical methods, we then consider how regulatory authorities (on licensing) and payer and HTA agencies (on reimbursement) use clinical trial evidence based on surrogate outcomes. We review existing HTA surrogate outcome evaluative frameworks. We conclude with recommendations for further steps: (1) prioritisation by regulators and payers of the application of formal surrogate outcome evaluative frameworks, (2) application of formal Bayesian decision‐analytic methods to support reimbursement decisions, and (3) greater utilization of conditional surrogate‐based licensing and reimbursement approvals, with subsequent reassessment of treatments in confirmatory trials based on final patient‐relevant outcomes.

HPR6 An Overview of New Payment System for Innovative Medical Technologies in Korea

This article provides an overview of new payment schemes for Innovative medical technologies (IMT) to be applied in January 2022 in Korea.

Developing a paediatric healthcare research network: key learnings from the 'Starworks' child prosthetics project

The context of child prosthetics is a complex and important area for research and innovation. Yet, like many areas of paediatric medical technology development, there are several barriers to innovating specifically for the unique needs of children (i.e., a relatively small patient population or ‘market’). As such, much child prosthetics technology is developed from the downsizing of adult prosthetics, leading to suboptimal outcomes for children and young people. Since 2016, the Starworks Child Prosthetics Research Network has been exploring this space, bringing children and their families together with key opinion leaders from the NHS, clinical Academia and leading National Research Centres with capabilities in child prosthetics with the aim of increasing research across the system. Above all else, Starworks is centred on the needs of children and their families, ensuring they have an equal voice in driving the ongoing research agenda. This article will share key learnings from the creation and development of the Starworks Network that may be applicable and/or adaptable across a wider paediatric medical technology research and innovation landscape. In particular it will discuss how it addressed three key aims of; (1) Addressing child-specific issues; (2) Building a sustainable network; and (3) Fostering impactful innovation.

Experience of forming practical skills by four-stage simulation training method

Due to the development of medical science and practice, rapid growth of the industry of medical devices and the introduction of innovative medical technologies, mid-level healthcare workers have to study throughout their working career. Methods of mastering skills and competencies, the use of which should be justified, are improved and modernized. Given the applied nature of nurses and paramedics’ professional activities, the use of simulation trainings is the priority in the range of educational technologies.

Effects of Electromyographic Biofeedback on Functional Recovery of Patients Two Months after Total Knee Arthroplasty: A Randomized Controlled Trial.

The incidence of total knee arthroplasty (TKA) is steadily increasing worldwide. Therefore, it is crucial to develop efficient rehabilitation protocols and investigate the innovations in medical technology, which could improve rehabilitation outcomes. The aim of the study was to investigate the effect of adding electromyographic biofeedback (EMG-BF) to the conventional program of rehabilitation after TKA on quality of life, intensity of pain, and functional performance. The study was designed as a randomized controlled trial. A total of 131 patients were randomly assigned to two groups: an experimental group (n = 67; median age 70 (IQR 10)), and a control group (n = 64; median age 69 (IQR 9)). Both groups participated in an inpatient program of 21 days of rehabilitation, including land-based and aquatic exercise therapy, electrotherapy, and education. In the experimental group, a portion of land-based exercise therapy was supplemented by EMG-BF. A numeric rating scale (NRS), Knee Injury and Osteoarthritis Outcome Score (KOOS), use of mobility aids, 30 s chair stand test (CST), and timed up and go (TUG) test were used to measure outcomes. Both groups improved their functional abilities from day 1 to day 21 of rehabilitation. A higher proportion of participants did not use a walking aid (p < 0.002), and their NRS, KOOS, 30 s CST and TUG scores improved (p < 0.001). There were no significant differences between the groups in the outcomes. EMG-BF did not provide additional benefits to the conventional rehabilitation after TKA.

Innovative medical technologies in the percutaneous treatment of tricuspid regurgitation in Poland.

Tricuspid regurgitation (TR) usually develops secondarily to left-sided heart diseases, whereas primary lesions to the valve apparatus is less common. Untreated severe TR has a poor prognosis and surgical treatment, i.e., valve repair or replacement, is the only treatment option with class I recommendation. However, cardiac surgical procedures may be associated with a high risk of complications. Recent advances in percutaneous approaches to managing structural heart diseases, especially mitral valve diseases, have enabled the implementation of this therapeutic strategy in the population of patients with TR. This paper presents data on the clinical efficacy, cost-effectiveness and expected population size for one of these procedures, namely the TriClip TTVr System procedure. Its efficacy was assessed in the TRILUMINATE study involving 85 patients with co-morbidities and at high surgical risk. After 1 year of follow-up, the reduction in the TR grade was reported in 71% of patients. Clinical improvement in New York Heart Association functional class, a 6-minute walk test, and the quality of life were also observed. A published analysis comparing percutaneous treatment modalities with a drug therapy based on data from medical registers was utilized, and propensity score matching was also employed. Percutaneous treatment reduced 1-year mortality and rehospitalization risk. The economic analysis showed the use of TriClip TTVr System is cost-effective: the cost of an additional quality-adjusted life year ranged from approximately PLN 85,000 to PLN 100,000, which is below the official threshold in Poland. The potential annual number of candidates for this treatment modality in Poland is estimated at 265.

Basic points to consider regarding the preparation of extracellular vesicles and their clinical applications in Japan.

In recent years, extracellular vesicles (EVs)1 have attracted attention as a new therapeutic tool. In Europe, the United States, and Asia, there is an accelerating trend of moving beyond basic research on clinical trials. However, treatment using EVs is still in the research and development stage, and the general public has insufficient awareness and understanding of the risks involved in ensuring safety and efficacy, the status of laws and regulations, and global research and development trends regarding their use. The Japanese Society for Regenerative Medicine, which has promoted the research and development of regenerative medicine, an innovative medical technology based on the principle of delivering it safely, effectively, and promptly, including the establishment of laws and regulations, would like to express two positions in light of the rapid development of therapies using EVs: 1) concern about treatments that are based solely on the discretion of medical practitioners, and 2) active promotion of treatments based on sound scientific evidence.Because EVs are released from cells, there are many similarities between EVs and processed cells2 in terms of manufacturing processes and safety hazards. As for efficacy, the mechanism of action of EVs is still unclear, as is the case with specified processed cellsb; in such cases, it is difficult to measure potency, identify efficacy-related quality attributes, and evaluate the comparability of quality before and after a change in the manufacturing process. In other words, the number of quality attributes that can be obtained for EVs is limited because of their complex characteristics, and it is difficult to grasp their quality through specifications and characterization. Therefore, while designing a quality control strategy for EVs, it is important to ensure the quality of the final product (EVs) by controlling the raw materials and manufacturing process.On the contrary, since EVs do not contain living cell components and are not classified into specified processed cells, non-commercial clinical research on treatments using EVs and individual medical treatments with EVs at the discretion of medical practitioners are out of the scope of the Act on the Safety of Regenerative Medicine of Japan3. At present, there are no relevant laws or regulations for the use of EVs other than the Medical Practitioners’ Act and the Medical Care Act in Japan. Therefore, there is a concern that treatment will be performed without sufficient objective evaluation of the scientific basis for safety and efficacy.Despite these concerns, the development of therapies using EVs is underway worldwide. This could potentially lead to a wide variety of new therapeutic areas if the methods needed to stably secure and mass cultivate cells as raw materials and the technologies needed for the mass production of EVs can be developed, in addition to understanding the risks involved and developing relevant laws and regulations. As part of the Japanese Society for Regenerative Medicine, we will continue to work on the development of these methods and technologies and hope that such a promising field will be promoted with a high level of safety before reaching the public.

The emergence of temporality in attitudes towards cryo-fertility: a case study comparing German and Israeli social egg freezing users

Assistive reproductive technologies are increasingly used to control the biology of fertility and its temporality. Combining historical, theoretical, and socio-empirical insights, this paper aims at expanding our understanding of the way temporality emerges and is negotiated in the contemporary practice of cryopreservation of reproductive materials. We first present an historical overview of the practice of cryo-fertility to indicate the co-production of technology and social constructions of temporality. We then apply a theoretical framework for analysing cryobiology and cryopreservation technologies as creating a new epistemic perspective interconnecting biology and temporality. Thereafter, we focus on the case of ‘social egg freezing’ (SEF) to present socio-empirical findings illustrating different reproductive temporalities and their connection to the social acceptance of and expectations towards the practice. SEF is a particularly interesting case as it aims to enable women to disconnect their reproductive potential from their biological rhythms. Based on 39 open interviews with Israeli and German SEF users, the cross-cultural comparative findings reveal three types of attitudes: postponing motherhood/reproductive decisions (German users); singlehood and “waiting” for a partner (Israeli and German users); and the planning of and hope for multiple children (Israeli users). For theory building, this analysis uncovers temporality formations embedded in gender and reproductive moral values; including the ‘extended present’, ‘waiting’, and ‘reproductive futurism’. We conclude by discussing the contribution of our findings by advancing the theoretical framework of ‘cryopolitics’ highlighting the theoretical implications and importance of gendered and cultural imaginaries (re)constructing medical technological innovations and related temporalities.

Free fatty acid receptor 4 deletion attenuates colitis by modulating Treg Cells via ZBED6-IL33 pathway

SummaryBackgroundInflammatory bowel disease (IBD) has complex genetic and environmental aspects, and free fatty acid receptors (FFARs) may bridge genetic and dietary aspects. FFAR4 is highly expressed in the intestine and acts primarily as the receptor of long-chain fatty acids, which are major components of the human diet. It is unclear what role, if any, FFAR4 may play in IBD.MethodsMouse and human colitis samples, mice with complete FFAR4 knockout, intestine-specific FFAR4 knockout and FFAR4 overexpression and cell culture were used. RNA-sequencing analysis and flow cytometry were performed to examine the mechanisms.FindingsThe results showed that FFAR4 expression was upregulated in colitis tissues and that the loss of intestinal FFAR4 ameliorated colitis, whereas intestinal FFAR4 overexpression exacerbated the disease. We identified intestinal epithelial cell deletion of FFAR4 by upregulating ZBED6, which in turn induced L33 transcription, and L33 elevated Treg cell numbers, ameliorating colitis.InterpretationFFAR4 deletion attenuates colitis by modulating Treg cells via the ZBED6-IL33 pathway.FundingNational Natural Science Foundation of China, Innovation and Application Project of Medical and Public Health Technology of Wuxi Science and Technology, Fundamental Research Funds for the Central Universities and the Fund of Wuxi Healthcare Commission.