Safety Of Medical Devices Research Articles

Ensuring Medical Device Safety: The Role of Standards Organizations and Regulatory Bodies.

Medical devices significantly enhance healthcare by integrating advanced technology to improve patient outcomes. Ensuring their safety and reliability requires a delicate balance between innovation and rigorous oversight, managed through the collaborative efforts of standards development organizations, standards accrediting organizations, and regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This article explores the historical evolution of medical device regulation, the role of standards organizations, and the impact of regulatory practices on device safety. Highlighting the critical need for stringent regulations, informed by instances where medical devices caused patient harm, we discuss the processes and collaborations between various international standards and regulatory frameworks that ensure device safety and effectiveness. This comprehensive review addresses the complexities of regulatory compliance and standardization, aiming to bridge the knowledge gap among healthcare providers and enhance the implementation of safety standards in medical technology.

Leveraging artificial intelligence to revolutionize medical device safety

Leveraging artificial intelligence to revolutionize medical device safety

The Analysis and Discussion of Risks Related to FDA Adverse Event of Continuous Glucose Monitoring System

Adverse events are one of the important bases for the re-evaluation of the safety and efficacy of medical devices. According to MAUDE, the U.S. Food and Drug Administration's (FDA) adverse event monitoring database, the factory-calibrated, integrated continuous glucose monitoring system (iCGM) received 130088 adverse events reports during the first half of 2023, ranking the second highest among all devices. In this paper, we conduct a multi-dimensional analysis of 130088 adverse events, summarize the main risk points of CGM products, and discuss these risk points accordingly. The analysis in this article can provide a reference for manufacturers, users, and regulators to provide risk management and control of CGM products

Investigating dexpanthenol transfer to the anterior segment from coated contact lenses and aqueous solution

Aims/Purpose: Dexpanthenol (Dxp) is a common excipient in topical formulations used in dermatology and ophthalmology. However, little is known about the absorption of Dxp into biological tissues. In this study we investigated the transfer of Dxp into the anterior segment – i.e. cornea and aqueous humor – first, from contact lenses (CL) following treatment with SOLOCARE AQUA® care solution and second, after administration of Bepanthen® and Siccaprotect® eye drops. All products contained approximately equivalent amounts of Dxp (2–3%).Methods: A bioanalytical method for the quantification of Dxp by UHPLC MS/MS was validated. The initial experiments evaluated the ad/absorption of Dxp from the SOLOCARE AQUA® care solution onto FDA class representative CL. Then, ex vivo porcine eye globes were mounted in an eye globe holder developed inhouse, with simulated tear flow, and Dxp uptake into the anterior segment from SOLOCARE AQUA® treated CL and eye drops was investigated.Results: Dxp ad/absorption in CL was correlated to exposure time and CL material. Following exposure to Dxp‐soaked CL and eye drops, transport of Dxp through porcine cornea to the aqueous humor was found in all experimental conditions. However, there was a statistically significant difference in the concentrations measured after CL application and eye drop instillation. Direct application of Dxp containing eye drops resulted in higher Dxp deposition in the anterior segment than the SOLOCARE AQUA® treated CL.Conclusions: In this benchmark study we investigated the deposition of Dxp in the anterior segment of excised porcine eyes from CL treated with a care solution and commercially available eye drops. Despite the excipient Dxp being classified as Generally Recognized as Safe (GRAS), the inferior absorption of the substance from SOLOCARE AQUA® washed CL compared to approved Dxp containing eye drops is considered preferable with regard to medical device safety.

Standard requirements for clinical very high energy electron and ultra high dose rate medical devices

Very High-Energy Electrons (VHEE) present a promising innovation in radiation therapy (RT), particularly for the treatment of deep-seated tumors using Ultra High Dose Rate (UHDR) within the framework of FLASH-RT. VHEE offers significant advantages, such as improved tumor targeting, reduced treatment times, and potential utilization of the FLASH effect, which may minimize normal tissue toxicity. However, the lack of an international technical standard for VHEE systems, especially for UHDR applications, remains a critical challenge. Current standards for radiation therapy equipment, such as IEC 60601-2-1 and IEC 60601-2-64, do not encompass VHEE technology. This regulatory gap underscores the need for developing a structured international standard to ensure the basic safety and essential performance of VHEE medical devices. Addressing this challenge requires overcoming complex dose delivery issues, such as the interaction of multiple fields and beam conformality and incorporating novel techniques like broad beam or pencil beam scanning. Establishing comprehensive regulatory standards is essential to ensure patient safety, consistent treatment practices, and the successful clinical integration of VHEE systems. These standards must encompass design guidelines, radiation protection protocols, and integration with existing oncology practices. Collaborative research and development efforts are crucial to formulating evidence-based guidelines, fostering the safe and effective use of VHEE in clinical settings. By addressing these challenges, VHEE technology has the potential to revolutionize cancer therapy, particularly for deep-seated tumors, while enhancing therapeutic outcomes for patients.

LOad Monitoring and Intervention System (LOMIS) to prevent diabetic foot ulceration: Study protocol for a multi-phased safety and performance evaluation of a novel medical device

Background Plantar foot pressure is a significant risk factor for ulceration in diabetic feet. However, foot pressure-based ulceration risk prediction has remained confined to the contribution of compressive pressure measured under controlled laboratory conditions for more than 30 years. This ignores the strong evidence that two important shear pressures are critical for tissue damage and ulceration genesis. It also prevents the cumulative effect of free-living behaviors on compressive and shear pressures from being integrated into predictive models of ulceration risk, and therefore risk prediction in real time. To address these fundamental limitations, the primary objective of this study was to assess the functionality of a novel LOMIS insole device that measures both shear and compressive pressure during daily activities over extended periods. The secondary objectives include assessing safety, validity, suitability, and feasibility as a clinical intervention. Methods Eighty patients with diabetes (aged 18–85 years, with feet classified as low, moderate, or high risk of ulceration) recruited from three clinical sites. Phase one includes a controlled walking assessment in the laboratory; Phase 2 pilots the device during participants’ free-living activities over five days, and phase three extends this to a three-month longitudinal study of compressive and shear pressure under real-life conditions. Discussion This is the first multi-center pilot study of a novel in-shoe pressure and shear measurement system that aimed to continuously measure the risk of foot ulceration. Through iterative testing to establish safety and functionality evidence, this study supports the development of digital healthcare technology and predictive foot ulceration risk models based on free-living data. Testing the feasibility and functionality of the LOMIS device in free-living circumstances will inform subsequent efficacy study designs and the pathway toward implementation in healthcare services. Trial registration ISRCTN87061146, Registered on 06/10/2022 https://www.isrctn.com/ISRCTN87061146 Protocol version 9, 12/02/2024

Off-the-Shelf Implant to Bridge a Urethral Defect: Multicenter 8-Year Journey From Bench to Bed.

To engineer an acellular mesh to reconstruct the urethra to replace the current surgical practice of using autologous tissue grafts. Cell based approaches have shown progress. However, these have been associated with high costs and logistical challenges. Acellular meshes were engineered using liquid collagen. They underwent in vitro, mechanical and bench testing by surgeons. Sixty-nine male New Zealand rabbits were used to refine the design. The final prototype based on the TissueSpan patented technology was then implanted again in a 2cm long urethral defect in 9 rabbits and in a 4cm long defect in 6 dogs. The TissueSpan technology platform allows for the manufacturing of tubular and rectangular meshes in different diameters and thicknesses. The tubular mesh acted as physical conduit to gap the urethral defect with a patent urethra demonstrated after 1month in both animal models. The mesh was absorbed within 1-3months. Spontaneous urothelial coverage of the mesh and smooth muscle cell migration into the surgical area was demonstrated even in a 4cm long urethral defect. A first in man clinical trial was subsequently initiated. The acellular mesh may have the potential to be an off-the-shelf product for substitution urethroplasty. Its mechanical properties allow surgeons to easily create a physical conduit while its material properties favor tissue remodeling. A large-scale clinical trial is still required to further confirm the safety, performance, and patient benefit of this new medical device.

Surprisingly fast self-healing coatings with anti-fog and antimicrobial activities via host-guest interaction

Dual functional coatings with anti-fog and antimicrobial performances greatly enhance the safety and reliability of medical detection devices, but are prone to mechanical damage, resulting in reduced performance and a shorter service lifespan. Herein, a semi-interpenetrating polymer network (SIPN) coating, featuring hydrophobic-hydrophilic balanced copolymers as bulk chains and host–guest inclusion compounds (HGICs) as cross-linkers, is reported, which demonstrates particularly effective anti-fog and antibacterial performances, along with a surprisingly fast self-healing capability under various scenarios. This HGIC-based coating displayed remarkable anti-fog capability over a wide temperature range from −20 ℃ to 85 ℃ and exhibited reliable antibacterial activities (≥98 %) against both gram-positive and gram-negative bacteria. Also, this coating showed extremely high self-healing ability (≥92 % recovery rate) within just 20 s, significantly outperforming traditional self-healing systems. These findings support the development of functional coatings that can highly maintain rapid self-healing performance while also providing anti-fog and antibacterial properties in medical detection devices.

A machine learning framework to adjust for learning effects in medical device safety evaluation.

Traditional methods for medical device post-market surveillance often fail to accurately account for operator learning effects, leading to biased assessments of device safety. These methods struggle with non-linearity, complex learning curves, and time-varying covariates, such as physician experience. To address these limitations, we sought to develop a machine learning (ML) framework to detect and adjust for operator learning effects. A gradient-boosted decision tree ML method was used to analyze synthetic datasets that replicate the complexity of clinical scenarios involving high-risk medical devices. We designed this process to detect learning effects using a risk-adjusted cumulative sum method, quantify the excess adverse event rate attributable to operator inexperience, and adjust for these alongside patient factors in evaluating device safety signals. To maintain integrity, we employed blinding between data generation and analysis teams. Synthetic data used underlying distributions and patient feature correlations based on clinical data from the Department of Veterans Affairs between 2005 and 2012. We generated 2494 synthetic datasets with widely varying characteristics including number of patient features, operators and institutions, and the operator learning form. Each dataset contained a hypothetical study device, Device B, and a reference device, Device A. We evaluated accuracy in identifying learning effects and identifying and estimating the strength of the device safety signal. Our approach also evaluated different clinically relevant thresholds for safety signal detection. Our framework accurately identified the presence or absence of learning effects in 93.6% of datasets and correctly determined device safety signals in 93.4% of cases. The estimated device odds ratios' 95% confidence intervals were accurately aligned with the specified ratios in 94.7% of datasets. In contrast, a comparative model excluding operator learning effects significantly underperformed in detecting device signals and in accuracy. Notably, our framework achieved 100% specificity for clinically relevant safety signal thresholds, although sensitivity varied with the threshold applied. A machine learning framework, tailored for the complexities of post-market device evaluation, may provide superior performance compared to standard parametric techniques when operator learning is present. Demonstrating the capacity of ML to overcome complex evaluative challenges, our framework addresses the limitations of traditional statistical methods in current post-market surveillance processes. By offering a reliable means to detect and adjust for learning effects, it may significantly improve medical device safety evaluation.

Development of a Medical Device Lifecycle Research Database at the MFDS

Abstract So-called big data are potentially useful in the healthcare field and are of interest to researchers, industry, and government agencies. Over the past 10 years, Europe, the United States, and Asia have been making efforts to collect and systematically manage information on the entire process from clinical trials to follow-up management of medical devices (MD). We developed MD lifecycle research database at the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea, consisting of 61 tables and 2,053 variables. The MFDS possesses statistical information on all MD, pharmaceuticals, foods, and human tissues produced and distributed. The information in the database is categorized according to four MD lifecycle phases-clinical trial, approval, production, and post-approval. For the clinical trial phase, the database contains information on planning and approval of clinical trial and non-clinical trial. The approval phase includes information on models, raw materials, quality, and changes, while the production phase stores information on production, import, export, supply and use. For the last step, follow-up management phase, provide information on post-marketing safety management, risk management, and administrative disposition. All four steps are linked based on primary key, so it is possible to understand information on the overall MD lifecycle. The MD Lifecycle Research Database will help strengthen the industry’s competitiveness in terms of cost-effectiveness in MD development and facilitate policy monitoring by improving its utilization in the public interest. This database contains information on all MD produced and distributed in Korea depending on the phases of the MD lifecycle, and data is easily accessible due to the lack risk of personal information exposure, so it can be widely used by individual researchers, industries, academia, and governments. Funding This research was supported by a grant (22063MFDS498) from ministry of food and drug safety in 2024. Key messages • We developed a medical device lifecycle database that enables tracking management according to the medical device lifecycle. • This database can be used as a scientific basis to ensure the safety, effectiveness, and efficiency of medical devices.

Impact of in-silico technologies in the development of high-risk medical devices on healthcare

Abstract This study examines the impact of in-silico technologies (IST), such as virtual cohorts and digital twins, on the development of high-risk medical devices within the healthcare sector. An iterative empirical approach combining a literature review, exploratory and in-depth interviews with stakeholders from academia, industry, regulators, healthcare professionals, and focus groups with patients across Europe, Japan, and the USA was employed to gain insight into the implications of IST on healthcare. The findings indicate that IST can reduce the time to market for medical devices, thereby facilitating faster, broader, and more equitable access for patients. The implementation of extensive early testing, optimized study designs and increased sample sizes in trials can facilitate the achievement of enhanced safety. The early identification of adverse effects can enhance the safety of medical devices and improve patient outcomes. Furthermore, IST may facilitate the inclusion of underrepresented groups, such as children, in clinical trials, thereby enhancing their representation in medical research. The reduction in costs associated with IST may facilitate innovation cycles. However, the impact on prices is contingent on competition. Furthermore, IST have the potential to reduce the need for animal testing. Nevertheless, several uncertainties and potential adverse effects have been identified. Physician training on new devices remains a bottleneck, which may limit the benefits of new products. Despite the advancements, a complete replacement of traditional clinical and preclinical trials with IST is not seen to be feasible. From a policy perspective, it is crucial to promote regulatory clarity by providing guidance for the usage of IST, to offer incentives for the adoption of IST, and to foster competition. These findings demonstrate the multifaceted potential benefits and challenges of IST, including enhanced safety, accessibility, and innovation in healthcare. Key messages • In-silico technologies can reduce time-to market of medical devices up medical device and improve safety for patients. • Challenges like physician training and regulatory guidance must be addressed to fully realize benefits of in silico technologies.

US FDA Advisory Panel Members’ Assessment of Premarket Approval Process and Suggestions for Improvement

The manufacturing and marketing of medical devices is regulated by the US Food and Drug Administration (FDA), and the FDA premarket approval (PMA) process evaluates the safety and effectiveness of medical devices. The PMA process includes a detailed scientific, regulatory and quality system review and is critical to ensure that novel devices are safe, effective, and meet the needs of patients. To survey current voting members serving on panels of the FDA's Medical Devices Advisory Committee to better characterize panel decision-making and identify steps for improvement. This qualitative survey study included 36 questions that were mailed to FDA device panelists regarding their opinions on the influence of sources of information, pivotal trial design, quality of evidence, panel composition and internal deliberative process, time allocation, and impartiality of the FDA. The survey was mailed to the members of all 18 FDA device panels in January and February 2017. Data were collected from January to May 2017 and analyzed from 2018 to 2019. Respondents read and returned the aforementioned paper survey, while nonrespondents did not. The main outcomes included panel members' perceptions, and their implications for process improvement. χ2 or Fisher exact tests were used to test differences between subgroups. Of 64 of 92 panel members who responded (69.6%), 38 of 64 (59.4%) were male, 3 of 63 (4.8%) were Black respondents, 46 of 63 (73.0%) were White respondents, and 36 of 60 (60.0%) were in academic practice. The mean (range) panel service was 6.8 (1-22) years with 3.9 (1-19) meetings attended. Overall, respondents considered information presented by the FDA unbiased, and 28 of 61 (45.9%) believed that pivotal trials were frequently well-designed, 55 of 62 respondents (88.7%) suggested FDA consult panel members preemptively regarding trial design and 54 of 64 (84.4%) regarding the device label. Most indicated that prior FDA approval of another device serving the same medical purpose (43 of 62 [69.4%]) or approval in other countries with comparable regulatory regimes, such as Canada and Europe (39 of 62 [62.9%]), would make them more likely to recommend approval. Respondents rated written information (50 of 60 [83.3%]), live presentations (43 of 58 [74.1%]), and prior professional knowledge (41 of 60 [68.3%]) as the most important sources of information in deciding whether to recommend approval. Additionally, 52 of 58 respondents (89.7%) recommended that a panel member-only executive session would allow more clarity and honesty in deliberations, and 33 of 59 (55.9%) believed a three-fourths majority appropriate for recommending approval, which would be a deviation from the current system in which an overall vote is reported without designation of a vote threshold. In this survey study of FDA device panel members, respondents wanted improved study designs, more relevant clinical data, including from other countries, involvement of panelists in study design and device label development, and inclusion of an executive session. Demographically, panels could be made more diverse.

Digital Certificate Management for Medical Devices

As the healthcare environment becomes increasingly digitally connected and cyber threats to healthcare technologies evolve, cybersecurity controls are necessary to ensure the safety and effectiveness of medical devices. Digital certificates are one such security control commonly utilized to secure various technologies and systems including medical devices. However, few academic resources describe the use of digital certificates in the unique context of medical devices. Additionally, digital certificate issues have the potential to impact the safety and effectiveness of medical devices and to negatively hinder the delivery of patient care. This article provides an introduction on the role of digital certificates to secure and manage access to medical devices, including potential issues and digital certificate management considerations.

Awareness Regarding Medical Device Safety among Physicians: A Knowledge, Attitude, and Practice Survey

Abstract Background: With the huge inflow of medical devices into the healthcare market, it is imperative to monitor the device safety throughout its period of usage, with the help of a systematic continual surveillance mechanism. Although the Materiovigilance Program of India has been formally introduced since 2015, there exists a dearth of awareness regarding its existence and functioning among the major stakeholders of patient safety. Addressing this gap, the study probes the awareness regarding materiovigilance among the doctors in eastern India. Methods: A cross-sectional questionnaire-based study was carried out using a 20-item structured survey tool to evaluate the knowledge, attitude, and practice of medical professionals regarding safety surveillance of medical devices. Responses obtained were statistically analyzed and interpreted. Results: Principal elements of medical device adverse event (MDAE) reporting were known to around 40% of respondents. However, the time frame for reporting an event/incident was found to be grossly unclear. Over 30% of respondents were aware of the effect of MDAEs and that its reporting could enhance patient safety. Items related to practice domains revealed that although around 50% of respondents of either category encountered MDAEs in their practice setup, only 10.95% of faculty and 6.41% of residents have reported it. Less than 5% of the respondents were ever trained on how to report MDAEs. The mean domain score for knowledge was on higher mark for the faculty, while that for attitude and practice domains were higher for the residents. Conclusion: There was a gross dearth of awareness regarding materiovigilance among the doctors. Enhanced sensitization regarding medical device safety surveillance in all healthcare levels can definitely help the situation ensuring patient safety.

Basic hydrophone measurements for biomedical ultrasound

Acoustic pressure measurements with hydrophones are critical to characterize safety and effectiveness of diagnostic and therapeutic medical ultrasound devices. This tutorial will cover (1) fundamental interactions between ultrasound and biologic tissues that determine thresholds for safety and effectiveness, (2) underlying physics of various hydrophone designs (e.g., membrane, needle, capsule, reflection-type fiber optic, Fabry-Perot interferometric fiber optic), (3) fundamental hydrophone specifications, such as sensitivity, directivity, and effective sensitive element size, all of which are frequency-dependent, (4) pros and cons of each hydrophone design for different applications, (5) how to characterize hydrophone measurement uncertainty, and (6) deconvolution methods to remove distortions in pressure measurements due to frequency-dependent sensitivity and spatial averaging artifacts.

A Study on Criminal Regulation to Ensure the Safety of Medical Devices: Also a Discussion on the Impact of the Artificial Intelligence in Medical Devices

A Study on Criminal Regulation to Ensure the Safety of Medical Devices: Also a Discussion on the Impact of the Artificial Intelligence in Medical Devices

Как обеспечить приоритет профилактических мероприятий в системе государственного контроля качества и безопасности медицинской деятельности: предложения.

In the article, based on the analysis of legislation, the authors formulated a number of proposals, the implementation of which will ensure the priority of preventive measures in the system of state control of the quality and safety of medical activities. It is noted that the priority of a preventive visit, as one of the most important preventive measures, in relation to control (supervision) measures, provided for by the Law on State Control No. 248-FZ, is primarily determined by the quality of the content of the preventive visit. The content of the preventive visit should allow the inspector of the supervisory authority in the field of health protection to identify during the preventive conversation the level of awareness of the controlled person about the mandatory requirements that this person is obliged to comply with. The step-by-step algorithm for carrying out a preventive visit in terms of monitoring the safety of medical devices presented in the article allows the inspector of the supervisory authority in the field of health protection to promptly and reliably obtain information about the level of awareness or lack of awareness of the supervised person about the established mandatory requirements for the activities carried out, and accordingly about their compliance or non-compliance by the supervised person.

Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership

BackgroundRecognizing the limitations of pre-market clinical data, regulatory authorities have embraced total product lifecycle management with post-market surveillance (PMS) data to assess medical device safety and performance. One method of proactive PMS involves the analysis of real-world data (RWD) through retrospective review of electronic health records (EHR). Because EHRs are patient-centered and focused on providing tools that clinicians use to determine care rather than collecting information on individual medical products, the process of transforming RWD into real-world evidence (RWE) can be laborious, particularly for medical devices with broad clinical use and extended clinical follow-up. This study describes a method to extract RWD from EHR to generate RWE on the safety and performance of embolization coils.MethodsThrough a partnership between a non-profit data institute and a medical device manufacturer, information on implantable embolization coils’ use was extracted, linked, and analyzed from clinical data housed in an electronic data warehouse from the state of Indiana’s largest health system. To evaluate the performance and safety of the embolization coils, technical success and safety were defined as per the Society of Interventional Radiology guidelines. A multi-prong strategy including electronic and manual review of unstructured (clinical chart notes) and structured data (International Classification of Disease codes), was developed to identify patients with relevant devices and extract data related to the endpoints.ResultsA total of 323 patients were identified as treated using Cook Medical Tornado, Nester, or MReye embolization coils between 1 January 2014 and 31 December 2018. Available clinical follow-up for these patients was 1127 ± 719 days. Indications for use, adverse events, and procedural success rates were identified via automated extraction of structured data along with review of available unstructured data. The overall technical success rate was 96.7%, and the safety events rate was 5.3% with 18 major adverse events in 17 patients. The calculated technical success and safety rates met pre-established performance goals (≥ 85% for technical success and ≤ 12% for safety), highlighting the relevance of this surveillance method.ConclusionsGenerating RWE from RWD requires careful planning and execution. The process described herein provided valuable longitudinal data for PMS of real-world device safety and performance. This cost-effective approach can be translated to other medical devices and similar RWD database systems.

Effects of Core Competitiveness on Strategic Alliance and Alliance Performance in Medical Device Industry

Along with the progress of economic development, the enhancement of national income, and the trend of population ageing in past years, people are annually increasing the medical expenses and enhancing the demands for medical devices. Being a part of healthcare, the requirements for the product safety and quality of medical devices are rather high. Manufacturers in the world therefore have to work hard to promote the competitiveness, attempting to achieve corporate goals and supply the best products to medical profession. Core competition combined resources are the sign of competitive advantage. Firms would build excellent competitive advantage through important resource combinations. A company tending to create competitiveness as well as build and lead new markets has to make investment earlier and continuously, apply the imagination to predict, develop, and investigate markets which have not been existed. The research focused on supervisors and employees in the medical device industry. The results reveal notable and positive effects of core competitiveness on strategic alliance and alliance performance, the understanding of how medical device firms apply strategic behavior in the competitive strategic means to reinforce the resource acquisition capability, and the reference for building the competitive advantage after strategic alliance and drafting appropriate competitive strategies for the business management of a domestic firm in medical device industry. It is expected to propose more specific suggestions for firms in medical device industry using core competitiveness in strategic alliance and dedicating to the promotion of competitive advantage.

Hybrid biofabricated blood vessel for medical devices testing

ABSTRACT Current in vitro and in vivo tests applied to assess the safety of medical devices retain several limitations, such as an incomplete ability to faithfully recapitulate human features, and to predict the response of human tissues together with non-trivial ethical aspects. We here challenged a new hybrid biofabrication technique that combines bioprinting and Fast Diffusion-induced Gelation strategy to generate a vessel-like structure with the attempt to spatially organize fibroblasts, smooth-muscle cells, and endothelial cells. The introduction of Fast Diffusion-induced Gelation minimizes the endothelial cell mortality during biofabrication and produce a thin endothelial layer with tunable thickness. Cell viability, Von Willebrand factor, and CD31 expression were evaluated on biofabricated tissues, showing how bioprinting and Fast Diffusion-induced Gelation can replicate human vessels architecture and complexity. We then applied biofabricated tissue to study the cytotoxicity of a carbothane catheter under static condition, and to better recapitulate the effect of blood flow, a novel bioreactor named CuBiBox (Customized Biological Box) was developed and introduced in a dynamic modality. Collectively, we propose a novel bioprinted platform for human in vitro biocompatibility testing, predicting the impact of medical devices and their materials on vascular systems, reducing animal experimentation and, ultimately, accelerating time to market.