Process,Material,and Regulatory Considerations for 3D Printed Medical Devices and Tissue Constructs

Three-dimensional(3D)printing is a highly automated platform that facilitates material deposition in a layer-by-layer approach to fabricate pre-defined 3D complex structures on demand.It is a highly promising technique for the fabrication of personalized medical devices or even patient-specific tissue constructs.Each type of 3D printing technique has its unique advantages and limitations,and the selection of a suitable 3D printing technique is highly dependent on its intended application.In this review paper,we present and highlight some of the critical processes(printing parameters,build orientation,build location,and support structures),material(batch-to-batch consistency,recycling,protein adsorption,biocompatibility,and degradation properties),and regulatory considerations(sterility and mechanical properties)for 3D printing of personalized medical devices.The goal of this review paper is to provide the readers with a good understanding of the various key considerations(process,material,and regulatory)in 3D printing,which are critical for the fabrication of improved patient-specific 3D printed medical devices and tissue constructs.

Research on Patent Situation of Medical Devices in China

Objective To study the patent situation of medical device industry in China based on patent data.Methods The analysis function of the patent search software incoPat was used to analyze the patent situation from two perspectives:The overall situation and the technical level.Results and Conclusion At present,China’s medical device industry is developing rapidly under the leadership of enterprises as the main body of innovation,but only 16%of patents are authorized.In addition,the technology distribution of medical device industry is mainly related to diagnostic,surgical and identification medical devices and implantable devices,accounting for 59%of the main technology distribution,and their technical effects are mainly related to improving convenience,reducing complexity,and improving safety.The quality of patents related to medical device industry in China is low,the technology distribution is not rich enough,and the level of technical efficacy is low.

Quasi-Static, Poiseuille Flow of Analgesics from an Elastomeric Pump: Theoretical Determination of Infusion Times and Toxicity Conditions

Background: Elastomeric pumps (elastic balls into which analgesics or antibiotics can be inserted) push medicines through a catheter to a nerve or blood vessel. Since elastomeric pumps are small and need no power source, they fit easily into a pocket during infusion, allowing patient mobility. Elastomeric pumps are widely used and widely studied experimentally, but they have well-known problems, such as maintaining reliable flow rates and avoiding toxicity or other peak-and-trough effects. Objectives: Our research objective is to develop a realistic theoretical model of an elastomeric pump, analyze its flow rates, determine its toxicity conditions, and otherwise improve its operation. We believe this is the first such theoretical model of an elastomeric pump consisting of an elastic, medicine-filled ball attached to a horizontal catheter. Method: Our method is to model the system as a quasi-Poiseuille flow driven by the pressure drop generated by the elastic sphere. We construct an engineering model of the pressure exerted by an elastic sphere and match it to a solution of the one-dimensional radial Navier-Stokes equation that describes flow through a horizontal, cylindrical tube. Results: Our results are that the model accurately reproduces flow rates obtained in clinical studies. We also discover that the flow rate has an unavoidable maximum, which we call the “toxicity bump”, when the radius of the sphere approaches its terminal, unstretched value—an effect that has been observed experimentally. Conclusions: We conclude that by choosing the properties of an elastomeric pump, the toxicity bump can be restricted to less than 10% of the earlier, relatively constant flow rate. Our model also produces a relation between the length of time that the analgesic fluid infuses and the physical properties of the fluid, of the elastomeric sphere and the tube, and of the blood vessel into which the analgesic infuses. From these, we conclude that elastomeric pumps can be designed, using our simple model, to control infusion times while avoiding toxicity effects.

Design of Fine Life Cycle Prediction System for Failure of Medical Equipment

The inquiry process of traditional medical equipment maintenance management is complex,which has a negative impact on the efficiency and accuracy of medical equipment maintenance management and results in a significant amount of wasted time and resources.To properly predict the failure of medical equipment,a method for failure life cycle prediction of medical equipment was developed.The system is divided into four modules:the whole life cycle management module constructs the life cycle data set of medical devices from the three parts of the management in the early stage,the middle stage,and the later stage;the status detection module monitors the main operation data of the medical device components through the normal value of the relevant sensitive data in the whole life cycle management module;and the main function of the fault diagnosis module is based on the normal value of the relevant sensitive data in the whole life cycle management module.The inference machine diagnoses the operation data of the equipment;the fault prediction module constructs a fine prediction system based on the least square support vector machine algorithm and uses the AFS-ABC algorithm to optimize the model to obtain the optimal model with the regularized parameters and width parameters;the optimal model is then used to predict the failure of medical equipment.Comparative experiments are designed to determine whether or not the design system is effective.The results demonstrate that the suggested system accurately predicts the breakdown of ECG diagnostic equipment and incubators and has a high level of support and dependability.The design system has the minimum prediction error and the quickest program execution time compared to the comparison system.Hence,the design system is able to accurately predict the numerous causes and types of medical device failure.

Balancing the customization and standardization:exploration and layout surrounding the regulation of the growing field of 3D-printed medical devices in China

Medical devices are instruments and other tools that act on the human body to aid clinical diagnosis and disease treatment,playing an indispensable role in modern medicine.Nowadays,the increasing demand for personalized medical devices poses a significant challenge to traditional manufacturing methods.The emerging manufacturing technology of three-dimensional(3D)printing as an alternative has shown exciting applications in the medical field and is an ideal method for manufacturing such personalized medical devices with complex structures.However,the application of this new technology has also brought new risks to medical devices,making 3D-printed devices face severe challenges due to insufficient regulation and the lack of standards to provide guidance to the industry.This review aims to summarize the current regulatory landscape and existing research on the standardization of 3D-printed medical devices in China,and provide ideas to address these challenges.We focus on the aspects concerned by the regulatory authorities in 3D-printed medical devices,highlighting the quality system of such devices,and discuss the guidelines that manufacturers should follow,as well as the current limitations and the feasible path of regulation and standardization work based on this perspective.The key points of the whole process quality control,performance evaluation methods and the concept of whole life cycle management of 3D-printed medical devices are emphasized.Furthermore,the significance of regulation and standardization is pointed out.Finally,aspects worthy of attention and future perspectives in this field are discussed.

Integrity Assessment of Medical Devices for Improving Hospital Services

The present study examines the various techniques being used to maintain the integrity of the medical devices,and develops a quantitative framework to list these in the sequence of priority.To achieve the intended objective,the study employs the combined procedure of Fuzzy Analytic Network Process(ANP)and Fuzzy Technical for Order Preference by Similarities to Ideal Solution(TOPSIS).We selected fuzzy based decision making techniques for assessing the integrity of medical devices.The suggested methodology was then used for classifying the suitable techniques used to evaluate the integrity of medical devices.Different techniques or the procedures of integrity assessment were ranked according to their satisfaction weights.The rating of the options determined the order of priority for the procedures.As per the findings of the study,among all the options,A1 was assessed to be the most likely option.This means that the integrity of medical devices of A2 is the highest amongst all the chosen alternatives.This analysis will be a corroborative guideline for manufacturers and developers to quantitatively test the integrity of medical devices in order to engineer efficacious devices.The evaluations undertaken with the assistance of the planned procedure are accurate and conclusive.Hence instead of conducting a manual valuation,this experimental study is a better and reliable option for assessing the integrity of the medical devices.

Accuracy and Electromagnetic Safety Evaluation of a Portable Electromagnetic Localization System for Micro Invasive Medical Devices in Vivo

Aiming at localizing the telemetric capsule for detecting gastrointestinal physiological parameters in vivo accurately,a portable alternating current(AC)electromagnetic localization system is designed.To verify the feasibility of the method,the model and construction of the localization system are detailed.And static and dynamic accuracy of the localization system are tested by experiments.Next,we compare the simulating results of the electromagnetic radiation aroused by the localization system with the electromagnetic safety standards of human(ICNIRP guidelines and IEEE standard C95.1-1991).Finally,in terms of the results of the static and dynamic experiments,conclusions are drawn that the accuracy of portable positioning system is high(less than 10 mm)enough to satisfy the localization need of the micro invasive medical devices in vivo,and there is no harm of electromagnetic radiation to human.

Design and Realization of Signal Processing Platform of Multi-Parameter Wearable Medical Devices

This paper presents a design of new type of multi-parameter wearable medical devices signal processing platform. The signal processing algorithm has a QRS-wave detection algorithm based on LADT, wavelet transformation and threshold detection with TMS320VC5509 DSP system. The DSP can greatly increase the speed of QRS-wave detection, and the results can be practical used for multi-parameter wearable device detection of abnormal ECG.

Application of Real-World Evidence in Regulatory Decision-Making for Medical Devices

Objective To understand the real-world study(RWS)and its application in domestic and foreign pharmaceutical device regulatory decision-making,so as to promote its further application in the decision-making of medical devices supervision in China.Methods Literature analysis and comparative analysis were used to compare the real-world evidence(RWE)and randomized controlled trials to obtain the development status of medical devices in China and the United States.Results and Conclusion It is found that the application of RWS in the field of medical devices has many advantages,which can make up for the deficiencies of traditional clinical data.In addition,the RWE has a wide range of applications in the field of medical devices in China.In recent years,the RWE has received extensive attention in the medical field in the United States.The FDA has issued related guidelines,and its applications have gradually formed a complete system.Research on RWE will become the development trend of clinical evaluation of medical devices in the future.While attaching importance to the development of the RWE,China should learn from the specifications of relevant foreign organizations to improve its development in the field of health.

Knowledge, Perception and Attitude of Pharmacists, Nurses and Doctors about Home-Care Medical Devices in Sharjah and Ajman, UAE

Background: Medical Equipments are designed to aid in the diagnosis;monitoring or treatment of medical conditions. Upgrades in technology also help continuously educate healthcare professionals. Where previously the use of devices like “mercury sphygmomanometers” is common place, they are now being replaced by either aneroid or “mercury-free” devices. It indicates the development of technology in this area. However, trends show that healthcare professionals still seem to trust “old school” equipment a lot more. Thus, it would be motivating to see why healthcare professionals have such engraved perceptions regarding medical equipment and to be able to investigate their knowledge about current medical devices and what their thoughts are on new technology available in this area. Objectives: This research is designed with an aim to gauge perception and knowledge of targeted HCPs on the risks, benefits, issues, usage and perception on the difference between older medical equipment and the newer ones with state of the art technology available in the market. Methods: A cross-sectional study using a 34 item questionnaire was used to survey a convenient sample of nurses, pharmacists and doctors across community practices in Ajman and Sharjah, UAE. Conclusion: Discouraging HCP’s from a long standing bias towards certain brands may lead towards better therapeutic outcomes for patients. Also, comments from HCP’s prove that HCP’s in these Emirates really do care for their patients and overall improvement of the health care industry.

Cytotoxicity Tests for Evaluating Medical Devices: An Alert for the Development of Biotechnology Health Products

The risks and damages related to the use of products, technologies and services of sanitary interest can be due to defects or manufacturing failures. Certain products already contain a certain degree of risk, which requires strict quality control in their production, distribution and use, as well as in the disposal of their waste in the environment. With continuous development in science and technology, medical devices must undergo intradermal irritation and testing for sensitization, cytotoxicity, and acute systemic toxicity. In health care, biotechnology aims to provide technology-based products or processes related to energy, food, and health, which are capable of stimulating new businesses, expanding exports, integrating the value chain and stimulating new demands for innovative products and processes, taking into account health policies. The present article was prepared by a bibliographical survey of the electronic databases PubMed, Lilacs, and Bireme. Cell culture testing can be successfully employed, as it is reproducible, rapid, sensitive, and financially accessible for performing in vitro toxicity testing. Thus, it has been possible to optimize the development phase of new products by decreasing animal use or even replacing them in certain tests. Some in vitro assays validated by the Organization for Economic Cooperation and Development in the area of health products have already replaced animal testing.

Mechanical Design of Long-Term Body-Adhered Medical Devices to Maximize On-Body Survival

Long-term, body-adhered medical devices rely on an adhesive interface to maintain contact with the patient. The greatest threat to on-body adhesion is mechanical stress imparted on the medical device. Several factors contribute to the ability of the device to withstand such stresses, such as the mechanical design, shape, and size of the device. This analysis investigates the impact that design changes to the device have on the stress and strain experienced by the system when acted on by a stressor. The analysis also identifies the design changes that are most effective at reducing the stress and strain. An explicit dynamic finite element analysis method was used to simulate several design iterations and a regression analysis was performed to quantify the relationship between design and resultant stress and strain. The shape, height, size, and taper of the medical device were modified, and the results indicate that, to reduce stress and strain in the system, the device should resemble a square in shape, be short in height, and small in size with a large taper. The square shape experienced 17.5% less stress compared to the next best performing shape. A 10% reduction in device height resulted in a 21% reduction in stress and 24% reduction in strain. A 20% reduction in device size caused a 7% reduction in stress and 2% reduction in strain. A 20% increase in device taper size led to a negligible reduction in stress and a 6% reduction in strain. The height of the device had the greatest impact on the resultant stress and strain.

System for the Management of the Continuity of Use of Medical Devices in Hospitals

The Technical Services and the Medical Administration of the Hospitals of Trieste have been working for years to ensure the optimal functioning of the Surgery, Intensive Care, Diagnostics and Research Services offered to the Patients and to the University in an 800-bed hospital complex, transforming and innovating the buildings and support installations. We have dedicated special attention to the technologies necessary to guarantee the continuity of the power supply to the electromedical devices, increasingly numerous in highly specialized hospitals. We report the power of the generator sets and the UPS and our opinion that their power must be related to the overall consumption of the hospital, with a reserve margin.

Report on Cardiovascular Health and Diseases in China 2023:An Updated Summary

Since 1990,China has made considerable progress in resolving the problem of“treatment difficulty”of cardiovascular diseases(CVD).The prevalent unhealthy lifestyle among Chinese residents has exposed a massive proportion of the population to CVD risk factors,and this situation is further worsened due to the accelerated aging population in China.CVD remains one of the greatest threats to the health of Chinese residents.In terms of the proportions of disease mortality among urban and rural residents in China,CVD has persistently ranked first.In 2021,CVD accounted for 48.98%and 47.35%of deaths in rural and urban areas,respectively.Two out of every five deaths can be attributed to CVD.To implement a national policy“focusing on the primary health institute and emphasizing prevention”and truly achieve a shift of CVD prevention and treatment from hospitals to communities,the National Center for Cardiovascular Diseases has organized experts from relevant fields across China to compile the“Report on Cardiovascular Health and Diseases in China”annually since 2005.The 2024 report is established based on representative,published,and high-quality big-data research results from cross-sectional and cohort population epidemiological surveys,randomized controlled clinical trials,large sample registry studies,and typical community prevention and treatment cases,along with data from some projects undertaken by the National Center for Cardiovascular Diseases.These firsthand data not only enrich the content of the current report but also provide a more timely and comprehensive reflection of the status of CVD prevention and treatment in China.

Metal-Halide Perovskite Submicrometer-Thick Films for Ultra-Stable Self-Powered Direct X-Ray Detectors

Metal-halide perovskites are revolutionizing the world of X-ray detectors,due to the development of sensitive,fast,and cost-effective devices.Self-powered operation,ensuring portability and low power consumption,has also been recently demonstrated in both bulk materials and thin films.However,the signal stability and repeatability under continuous X-ray exposure has only been tested up to a few hours,often reporting degradation of the detection performance.Here it is shown that self-powered direct X-ray detectors,fabricated starting from a FAPbBr_(3)submicrometer-thick film deposition onto a mesoporous TiO_(2)scaffold,can withstand a 26-day uninterrupted X-ray exposure with negligible signal loss,demonstrating ultra-high operational stability and excellent repeatability.No structural modification is observed after irradiation with a total ionizing dose of almost 200 Gy,revealing an unexpectedly high radiation hardness for a metal-halide perovskite thin film.In addition,trap-assisted photoconductive gain enabled the device to achieve a record bulk sensitivity of 7.28 C Gy^(−1)cm^(−3)at 0 V,an unprecedented value in the field of thin-film-based photoconductors and photodiodes for“hard”X-rays.Finally,prototypal validation under the X-ray beam produced by a medical linear accelerator for cancer treatment is also introduced.

Research perspective and prospective of additive manufacturing of biodegradable magnesium-based materials

Biodegradable metals such as magnesium(Mg)and its alloys have attracted extensive attention in biomedical research due to their excellent mechanical properties and biodegradability.However,traditional casting,extrusion,and commercial processing have limitations in manufacturing components with a complex shape/structure,and these processes may produce defects such as cavities and gas pores which can degrade the properties and usefulness of the products.Compared to conventional techniques,additive manufacturing(AM)can be used to precisely control the geometry of workpieces made of different Mg-based materials with multiple geometric scales and produce desirable medical products for orthopedics,dentistry,and other fields.However,a detailed and thorough understanding of the raw materials,manufacturing processes,properties,and applications is required to foster the production of commercial Mg-based biomedical components by AM.This review summarizes recent advances and important issues pertaining to AM of Mg-based biomedical products and discusses future development and application trends.

美国FDA医疗器械监管数字化转型的进展分析及eSTAR模板的应用

目的:深入剖析美国FDA数字化转型背景、组织架构、战略重点,在医疗器械监管方面的具体措施,以及在加强医疗器械上市前审查计划方面的进展,以期对我国信息化引领的医疗器械技术审评的现代化起到一定的启示作用。方法:对FDA近年来在数字化转型方面的战略规划及进展进行概述,重点介绍基于可扩展标记语言(Extensible Markup Language,XML)格式的eSTAR模板,分析所依托的语言优势,提高数据标准化、数据系统兼容性,便于数据读取处理分析,有效提高审评过程的一致性、完整性及效率。受理不仅是对资料完整性的审核,也是对数据格式/数据标准的筛选过程,经筛选纳入FDA内部数据库,以便后期调用及统计分析,将数据转化为监管工具。结果与结论:我国医疗器械技术审评注册申报信息化平台迭代升级和数据库构建,应积极应用先进的电子信息技术和基础设施,进一步优化上市前审查流程并节省时间和资源,促进数据读取处理分析共享,将监管数据转变为监管证据和监管新工具,加速数据驱动型数字化转型,提高服务响应速度,提升服务质量。

Proof of concept of a self-tightening needle-less suture using a NiTi shapememory alloy

Among surgical procedures,suturing is considered simple.However,in some situations,suturing is not easy or feasible.Here,we present proof of concept of a new self-tightening needle-less suture made of a NiTi alloy.The new device is designed to overcome two demanding steps of traditional suturing:needle introduction and manual knotting.Our novel suture is composed only of a short NiTi wire that is able to change shape by exploiting a thermoelastic phase transition.This shape change is achieved by increasing the temperature from that of the operating room(e.g.,20-22℃)to 32℃using warm water.Suturing consists of two steps:suture introduction,in which the suture is in an open configuration,and shape recovery(i.e.,closed configuration).The closed configuration is maintained at human body temperature thanks to peculiar pseudoelastic properties of the NiTi material.Finally,thermal and functional characterization verified the simplicity and effectiveness of the proposed device.

Advances in Medical Applications of Additive Manufacturing

In the past few decades,additive manufacturing(AM)has been developed and applied as a cost-effective and versatile technique for the fabrication of geometrically complex objects in the medical industry.In this review,we discuss current advances of AM in medical applications for the generation of pharmaceuticals,medical implants,and medical devices.Oral and transdermal drugs can be fabricated by a variety of AM technologies.Different types of hard and soft clinical implants have also been realized by AM,with the goal of producing tissue-engineered constructs.In addition,medical devices used for diagnostics and treatment of various pathological conditions have been developed.The growing body of research on AM reveals its great potential in medical applications.The goal of this review is to highlight the usefulness and elucidate the current limitations of AM applications in the medical field.