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There is a disparity between low and middle-income countries (LMICs) and high-income countries (HICs) in translating medical device innovations to the market, affecting health care service delivery. Whereas medical technologies developed in HICs face substantial challenges in getting to the bedside, there are at least clear pathways in most of the major markets, such as the UK, the EU, and the USA. Much less is known about the challenges that innovators of medical technologies face in LMICs. The aim of this study was to map out current bottlenecks in medical device innovation in Uganda, a LMIC in Sub-Saharan East Africa. A cross-sectional survey was carried out using a digital questionnaire. Twenty-one individuals completed the questionnaire, with the majority being medical device innovators (n = 12). Only one of these had undertaken all the innovation stages, up to clinical validation. Very few innovators had established companies, and/or acquired intellectual property. It is evident from similar studies that challenges in medical device translations are multidimensional, and hence interdisciplinary collaborations are key to accelerating translation processes, especially for LMICs.

In traditional infusion processes, issues such as untimely medication replacement and patients’ difficulty in continuously monitoring their medication levels are prevalent. This study presents the design of a smart infusion automatic medication replacement device aimed at automating infusion management through three key modules: high-precision liquid level monitoring, automated medication replacement, and a smart control system. By monitoring liquid levels in real time, the system eliminates the need for patients to constantly check their medication levels, accurately controlling the amount of medication dispensed and transmitting monitoring signals within safe thresholds. The rotational medication replacement mechanism stores and precisely replaces medicine bottles, optimizing usage and minimizing waste. Automated settings for liquid level monitoring and the plug-and-push system replace the need for manual assessment of medication completion and input quality, ensuring consistent dosage and high-quality delivery. The rotational mechanism also reduces the time needed for refilling and decreases the labor intensity for healthcare providers. A stabilization and calibration mechanism ensures bottles remain centered, preventing issues with internal pressure changes and loosening of the piercing tool. By replacing repetitive manual adjustments with automated processes, healthcare professionals can focus more on patient care rather than the cumbersome medication replacement procedures. The smart infusion automatic medication replacement device enhances the quality of infusion therapy for patients and alleviates the repetitive workload of medical staff.

In recent years, the biomedical startup industry has flourished, and yet, it still faces challenges in adapting to changing market demands. Meanwhile, the widespread use of single-use medical devices generates significant waste, posing threats to environmental sustainability. Addressing this issue has become a critical challenge for humanity today. The study aimed to delve into the specific difficulties faced by Taiwanese biomedical entrepreneurs during the innovation and development of medical devices from a sustainability perspective and to explore solutions. This study collected first-hand experiences and insights from Taiwanese biomedical entrepreneurs through a literature review and expert questionnaires. It employed Interpretive Structural Modeling to analyze the development stages and interrelationships of biomedical device startups for building sustainable biomedical innovation. The Clinical Needs Assessment is revealed as the most influential factor, shaping Regulatory Feasibility Evaluation, Clinical Trial Execution, and Market Access Compliance. Our findings provide a structured problem-solving framework to assist biomedical startups in overcoming challenges while incorporating energy-saving and carbon reduction processes to achieve environment sustainability goals. The results of this study show that biomedical innovation practitioners should prioritize integrating sustainability considerations directly into the earliest stage of a Clinical Needs Assessment.

Objectives: As recent public and private initiatives have sought to increase the transparency of physician-industry financial relationships (including calls for restricting collaboration), it is important to understand the extent of physicians' contributions to new medical devices. We quantify the contribution of information from physician-founded startup companies to 170 premarket approval (PMA) applications filed by 4 large incumbent medical device manufacturers over the period 1978—2007. We ask: Are incumbents more likely to incorporate information from physician-founded firms than nonphysician-founded firms? Methods: We matched the text in 4 incumbent medical device firms' PMAs (Medtronic, Johnson & Johnson, Boston Scientific, and Guidant) to the text in patent applications of 118 startup companies that received investment from these incumbents between 1978 and 2007. We use a text-matching algorithm to quantify the information contribution from physician and nonphysician-founded startups to incumbent firms' PMAs. We analyze correlates of backward citations and degree of overlap between incumbents' PMAs and startups' patents using negative binomial and tobit regressions. Findings: On average, physician-founded companies account for 11% of the information in PMAs, compared with 4% from nonphysician-founded companies. Regression results show that incumbents are significantly more likely to cite physician-founded companies' patents and to incorporate them into new devices. Conclusions: Physicians are an important source of medical device innovation. The results suggest that restrictions on financial relationships between providers and industry, while potentially improving patients' trust, may result in reduced medical innovation if physicians found fewer startups or if incumbent firms reduce investments in physician-founded startups.

This study presents a comprehensive approach to the redesign of auto-injection syringe systems, employing the TRIZ problem-solving framework along with Ishikawa analysis. The proposed design aims to address common challenges, including usability issues, high production costs, complex assembly procedures, and hygiene considerations. By leveraging the TRIZ methodology, this work successfully identified and addressed technical contradictions, leading to the development of an innovative auto-injection syringe. This design incorporates a recyclable polypropylene random copolymer, which not only reduces manufacturing costs but also promotes environmental sustainability. Replacing flexible springs with inexpensive rubber bands enhances the design's affordability and usability. This change lowers costs and improves user-friendliness, allowing patients to operate the system more easily while upholding performance standards. According to engineering validations carried out through static and dynamic simulations in NX Nastran, the design safely withstands up to 10 N of applied force, with its maximum stress levels remaining below 5.2 MPa, well within the material’s 27.5 MPa yield strength. While prior studies have reported ergonomic or functional improvements, they often lack a systematic engineering approach to address design contradictions. This study fills that gap by uniquely integrating the TRIZ and Ishikawa approaches to develop an optimized, user-friendly, and sustainable autoinjector. As a result, our new design meets user needs and adheres to the industry’s safety and efficacy standards. This research underscores the effectiveness of integrating the aforementioned methodologies to create practical and efficient solutions for patients requiring regular self-injection, thereby contributing to improved healthcare outcomes and a more sustainable medical device industry. Este estudio presenta un enfoque integral para el rediseño de sistemas de jeringas autoinyectables, empleando el marco de resolución de problemas TRIZ junto con el análisis Ishikawa. El diseño propuesto busca abordar desafíos comunes, incluidos problemas de usabilidad, altos costos de producción, procedimientos de ensamblaje complejos y consideraciones de higiene. Aprovechando la metodología TRIZ, este trabajo logró identificar y resolver contradicciones técnicas, lo que condujo al desarrollo de una innovadora jeringa autoinyectable. Este diseño incorpora un copolímero aleatorio de polipropileno reciclable, lo cual no solo reduce los costos de fabricación, sino que también promueve la sostenibilidad ambiental. La sustitución de resortes flexibles por bandas elásticas económicas mejora la asequibilidad y la facilidad de uso del diseño. Este cambio reduce los costos y mejora la usabilidad, permitiendo que los pacientes operen el sistema con mayor facilidad sin comprometer los estándares de rendimiento. Según validaciones de ingeniería realizadas mediante simulaciones estáticas y dinámicas en NX Nastran, el diseño soporta hasta 10 N de fuerza aplicada de manera segura, con niveles máximos de tensión que se mantienen por debajo de los 5.2 MPa, muy por debajo del límite elástico del material, que es de 27.5 MPa. Si bien han reportado mejoras ergonómicas o funcionales, los estudios anteriores a menudo carecen de un enfoque sistemático de ingeniería para abordar contradicciones de diseño. Este estudio llena ese vacío al integrar de manera única los enfoques TRIZ e Ishikawa para desarrollar un autoinyector optimizado, fácil de usar y sostenible. Como resultado, nuestro nuevo diseño satisface las necesidades del usuario y cumple con los estándares de seguridad y eficacia de la industria. Esta investigación subraya la eficacia de integrar las metodologías mencionadas para crear soluciones prácticas y eficientes para pacientes que requieren autoinyecciones regulares, contribuyendo así a mejorar los resultados sanitarios y a una industria de dispositivos médicos más sostenible.

The integration of robotics into gastrointestinal (GI) endoscopy represents a transformative advancement and bears the potential to bridge the gap between traditional limitations by offering unprecedented precision and control in diagnostic and therapeutic procedures. This review explores the historical progression, current applications and future potential of robotic platforms in GI endoscopy. Originally designed for surgical applications, robotic systems have expanded their reach into endoscopy, potentially enhancing procedural accuracy and reducing ergonomic strain on practitioners. Natural Orifice Transluminal Endoscopic Surgery (NOTES) emerged as a promising technique, leveraging natural orifices to perform minimally invasive surgeries. Despite its initial potential, several factors, including limitations of the available instrumentations and lack of reliable closure techniques, hindered its widespread adoption and progress. Conventional endoscopic tools often fall short in terms of triangulation, traction and degrees of freedom, necessitating the adoption of robotic interventions. Over recent decades, robotic endoscopy has significantly evolved, focusing on both diagnostic and complex therapeutic procedures such as endoscopic sub-mucosal dissection (ESD) and endoscopic full-thickness resection (EFTR). Various robotic platforms demonstrate enhanced safety and efficiency in GI procedures. As the field progresses, the emphasis on clinical validation, advanced training and the exploration of new applications remains crucial. Continuous innovation in robotic technology and endoscopic techniques promises to overcome existing limitations, further revolutionizing the management of GI diseases and improving patient outcomes.

When traditional therapies fail to provide relief from debilitating lower back pain, surgeries such as transforaminal lumbar interbody fusion (TLIF) may be required. This budget impact analysis (BIA) compared minimally-invasive (MI)-TLIF versus open (O)-TLIF for single-level fusion from an Italian hospital perspective. The BIA compared costs of 100 MI-TLIF and 100 O-TLIF procedures from an Italian hospital perspective over a one-year time horizon. The base case included costs for length of hospital stay (LOS), blood loss, and sterilizing surgical trays. The scenario analysis also included operating room (OR) time and complication costs. Base case inputs were from the Miller et al meta-analysis; scenario analysis inputs were from the Hammad et al meta-analysis. The device costs for MI-TLIF and O-TLIF procedures were from Italian tender prices for Viper Prime™ System and Expedium™ Spine System, respectively. Base case deterministic analysis results showed cost savings of €207,370 for MI-TLIF compared with O-TLIF. MI-TLIF costs were lower for LOS (€215,277), transfusion for blood loss (€16,881), and surgical tray sterilization (€28,232), whereas device costs were lower for O-TLIF (€53,020). The probabilistic result was similar, with MI-TLIF resulting in savings of €211,026 (95% credible interval [CR]: €208,725 - €213,327). All 1000 base case probabilistic sensitivity analysis runs were cost saving. Deterministic scenario analysis results showed cost savings of €166,719 for MI-TLIF. MI-TLIF costs were lower for LOS (€190,813), transfusion for blood loss (€16,881), surgical tray sterilization (€28,232), and complications (€2076), whereas O-TLIF costs were lower for OR time (€18,263) and devices used (€53,020). Despite the increase incremental cost for medical device innovation and OR time, this study demonstrates the economic savings of MI-TLIF compared to O-TLIF from a European hospital perspective. The findings will be useful to policy and hospital decision makers in assessing purchasing, funding and reimbursement decisions.

Artificial intelligence-based medical devices (AIMDs) have emerged as transformative technologies in modern health care. However, comprehensive analysis of recent approval trends and characteristics of AIMDs in China remains limited. This study aimed to provide an up-to-date overview of AIMDs approved in China up to June 2025. We conducted a search of the Drugdataexpy database to identify AIMDs approved up to June 30, 2025, using artificial intelligence-related keywords in the \"structural composition\" and \"intended use\" fields. After manual verification and exclusion of non-AIMDs, we collected key characteristics, including name, manufacturer, approval date, risk class, clinical evaluation pathway, medical specialty, data source, review pathway, and algorithm type. Statistical analysis encompassed descriptive statistics and trend analysis. We used the Fisher exact test and Pearson chi-square test to assess the associations between risk class and categorical variables. A total of 154 AIMDs were identified since the first approval in 2020, with annual approvals increasing from 9 in 2020 to 45 in 2024 (a 49.53% compound annual growth rate), although the 20 approvals in the first half of 2025 suggest a potential moderation in pace. Most AIMDs (123/154, 79.9%) were categorized as class III, and the risk class was significantly associated with approval year (P=.03), manufacturer location (P=.03), and medical specialty (P=.004). Of the 123 class III devices, 19 (15.4%) were approved through innovation review, and 2 (1.6%) each were approved through priority and emergency approval. Deep learning was the dominant algorithm (143/154, 92.9%). Radiology dominated the field (106/154, 68.8%), with computed tomography serving as the primary data source (96/154, 62.3%), particularly for applications in pulmonary nodule detection and cardiovascular assessment. Clinical trials were the primary evaluation pathway for 76.6% (118/154) of all AIMDs. This approach was predominant for class III devices (116/123, 94.3%), whereas most class II devices (21/31, 67.7%) used a clinical exemption pathway. Market concentration was evident, with the top 4 manufacturers accounting for 38.3% (59/154) of all approvals and geographically clustered in major innovation hubs such as Beijing, Shanghai, Shenzhen, and Hangzhou. China's AIMD ecosystem is experiencing growth, heavily focused on radiology and computed tomography-based solutions within a risk-proportionate regulatory framework. The market is characterized by significant manufacturer and geographic concentration.

Musculoskeletal pain significantly impacts quality of life and daily functioning. Light-based therapies, including those using red and infrared wavelengths, have shown potential in pain management due to their anti-inflammatory and tissue healing properties. CURAPOD, a pain management device developed by Litemed, uses a combination of visible red and infrared light for noninvasive pain relief. This study aimed to assess the safety and efficacy of Litemed's pain management device (CURAPOD) in managing acute and chronic musculoskeletal pain at various pain sites, in comparison with a placebo, and to evaluate its efficacy across different skin types. In a double-blinded, randomized, placebo-controlled, multicentric study, 240 participants (aged 18-60 years) with acute or chronic musculoskeletal pain were enrolled and treated with either the test or control device for 30 minutes. The test device contains 7 LEDs designed to emit a combination of visible red and infrared radiation, while the control device emits visible light of the red spectrum. Pain intensity was subjectively measured at baseline, at 30 minutes after treatment, and at time windows of 8 to 12 hours and 21 to 24 hours after treatment. A greater number of participants reported a reduction in pain (of up to 60%) in the treatment group than in the placebo group. Repeated measures ANOVA revealed significant effects of time (F3,684=282.37; P<.001) and treatment group (F1,228=662.12; P<.001), indicating that the relief experienced may be more sustained in the treatment group. No significant effects of pain site (F5,228=0.169; P=.97) or skin type (F5,228=0.8; P=.55) were observed, suggesting consistent action across anatomical locations and skin types. No significant adverse events were reported. The device appears to be safe and viable as a nonpharmacological adjunct for managing acute and chronic musculoskeletal pain. Treatment with the device showed short-term pain reduction, with reports of up to 60% pain reduction within 30 minutes of use and sustained self-reported relief in pain for up to 20 hours after treatment. No significant effects of pain sites or skin type on reduction in visual analog scale scores were observed, suggesting broad applicability. However, these results must be interpreted with caution while considering the limitations inherent to the study methodology and short-term follow-up. These findings should be interpreted as evidence of short-term analgesic response rather than definitive clinical effectiveness. Further investigation through rigorously designed randomized controlled trials and longitudinal studies is necessary to definitively establish the efficacy of the device, the durability of its action, and the potential integration of CURAPOD into pain management strategies.

Stairclimbing wheelchairs offer enhanced mobility for users navigating multilevel environments, yet limited research addresses the ergonomics of lever propulsion-based stair climbing mechanisms. Comprehensive ergonomic assessment integrating both subjective user feedback and objective biomechanical analysis is essential for optimizing assistive device design for comfort and usability. This pilot study aims to assess the ergonomic design of a transformable stair-climbing wheelchair through a dual-methodology approach, evaluating plane surface movement accessibility and quantifying muscle activation patterns during lever-propelled stair-climbing operations using surface electromyography (sEMG). This 2-part study involved anthropometric measurements from 20 male participants to establish design parameters using 5th and 95th percentile values. Part A assessed plane surface movement with 9 participants (7 healthy, 2 with paraplegia) navigating a simulated urban course featuring a 5° ramp, a 90° turn, and narrow passages across 3 trials. Task completion times and subjective ride easiness ratings were recorded. Part B used a Taguchi-based fractional factorial design to evaluate 3 ergonomic factors, including torso angle (λ), lever distance (L), and lever orientation (ψ), across 7 healthy participants. Maximum voluntary contraction (MVC) was measured for 4 muscles, including biceps brachii long head (BBL), triceps brachii long head (TBL), brachioradialis, and posterior deltoid (PDT). In Part A, the ramp and 90° turn proved most challenging due to the wheelchair's 65 kg weight and large turning radius (~1450 mm). Driving control scored highest (6/10), while comfort scored lowest due to the tilted seat design. In Part B, a straight torso (λ=0°) consistently reduced muscle strain, particularly for brachioradialis. A lever distance of approximately 50 mm and a neutral to slightly supinated orientation (ψ=0°-30°) optimized muscle effort. Interaction effects revealed high strain configurations (λ=45°; L=100 mm; ψ=-30°) exceeding 75 MVC, while optimal settings reduced strain to approximately 50 MVC. Optimal ergonomic parameters of λ=0°, L=37.5 mm, and ψ=15° are recommended to minimize fatigue and enhance user comfort. Design improvements should prioritize weight reduction, compact form factor for maneuverability, and adjustable seat tilt. The modular wheelchair design permits customization for diverse user populations. Future research should include larger, gender-diverse participant groups and real-world validation studies.