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.

Bioinspired Functional Surfaces for Medical Devices

Medical devices are a major component of precision medicine and play a key role in medical treatment,particularly with the rapid development of minimally invasive surgery and wearable devices.Their tissue contact properties strongly affect device performance and patient health(e.g.,heat coagulation and slipperiness on surgical graspers).However,the design and optimization of these device surfaces are still indistinct and have no supporting principles.Under such conditions,natural surfaces with various unique functions can provide solutions.This review summarizes the current progress in natural functional surfaces for medical devices,including ultra-slipperiness and strong wet attachment.The underlying mechanisms of these surfaces are attributed to their coupling effects and featured micronano structures.Depending on various medical requirements,adaptable designs and fabrication methods have been developed.Additionally,various medical device surfaces have been validated to achieve enhanced contact properties.Based on these studies,a more promising future for medical devices can be achieved for enhanced precision medicine and human health.

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.

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.

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.

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.

A review of the bio-tribology of medical devices

Numerous medical devices have been applied for the treatment or alleviation of various diseases.Tribological issues widely exist in those medical devices and play vital roles in determining their performance and service life.In this review,the bio-tribological issues involved in commonly used medical devices are identified,including artificial joints,fracture fixation devices,skin-related devices,dental restoration devices,cardiovascular devices,and surgical instruments.The current understanding of the bio-tribological behavior and mechanism involved in those devices is summarized.Recent advances in the improvement of tribological properties are examined.Challenges and future developments for the prospective of bio-tribological performance are highlighted.

Key considerations on the development of biodegradable biomaterials for clinical translation of medical devices:With cartilage repair products as an example

With the interdisciplinary convergence of biology,medicine and materials science,both research and clinical translation of biomaterials are progressing at a rapid pace.However,there is still a huge gap between applied basic research on biomaterials and their translational products-medical devices,where two significantly different perspectives and mindsets often work independently and non-synergistically,which in turn significantly increases financial costs and research effort.Although this gap is well-known and often criticized in the biopharmaceutical industry,it is gradually widening.In this article,we critically examine the developmental pipeline of biodegradable biomaterials and biomaterial-based medical device products.Then based on clinical needs,market analysis,and relevant regulations,some ideas are proposed to integrate the two different mindsets to guide applied basic research and translation of biomaterial-based products,from the material and technical perspectives.Cartilage repair substitutes are discussed here as an example.Hopefully,this will lay a strong foundation for biomaterial research and clinical translation,while reducing the amount of extra research effort and funding required due to the dissonance between innovative basic research and commercialization pipeline.

Medical Devices Standardization System in China

The standardization system is imperfect since the complexity of the medical devices and the specialty of the medical device industry in China. This paper describes the present situation of medical devices standardization system in China,reviews and discusses the advantages and problems of the medical devices standardizatiom. It also presents some comments and suggestions to perfect the medical devices standardization system for enhancing the quality control of medical devices and for promoting the development of medical devices industry.

Analysis of intellectual properties on animalderived regenerative, implantable medical devices

This article analyses and summarizes issues of intellectual property involved in animal-derived regenerative,implantable medical devices(ADRIMD)in order to better understand global trends in patent applications and disclosures,the legal status of patent families(i.e.sets of patents filed in various countries to protect a single invention),and International Patent Classification topics such as main assignee and core expertise.Analysis of research trends will enhance and inform the decision-making capacity of researchers,investors,government regulators and other stake-holders as they undertake to develop,deploy,invest in or regulate ADRIMD.

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.

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.

Internet of Medical Things (IoMT): Overview, Taxonomies, and Classifications

Recent research efforts have created rapid advances in the field of the Internet of Things (IoT) in terms of communication protocols, sensing technologies, computing capabilities, next-generation wireless technologies, big data and AI techniques, and on-device, edge, cloud processing. These advances created a paradigm shift and generated a wide range of potential opportunities for a new major field known as the Internet of Medical Things (IoMT), as well as subfields like mobile Health (mHeatlh) and digital or electronic Health (eHealth). This paper provides an overview of the Internet of Medical Things and presents a classification to define the primary users and their roles and involvement in smart healthcare systems. The paper then presents taxonomy on the deployment scales of different healthcare environments, from personal healthcare to widescale connected healthcare systems. The overview also discusses the n-tier architecture of IoMT, then presents a set of taxonomies and classifications on the different medical devices used in healthcare systems as well as non-medical devices used to provide context-aware information about the surrounding environment. The paper then concludes the overview by presenting the different healthcare-related applications and services, a comparison between traditional and smart healthcare systems, and the different obstacles and challenges in the field of IoMT to guide the development of new services and devices. Many survey papers in the literature focused on similar points;however, up to our knowledge, this is the first paper to present taxonomies and classifications for these IoMT essential topics. The presented taxonomies and classifications provide the manufacturers of medical devices and the developers of healthcare services a deeper understanding of the healthcare systems’ landscape to address different requirements and demands.

Preparation of Air Film for Medical Infusion Device and Study on Air Permeability and Water Resistance

Polypropylene melt-blown nonwoven was used as the substrate for the preparation of an air film. The nonwoven was immersed in the casting solution at first,and then respectively placed in the first coagulation bath,the second coagulation bath and the finishing liquid containing fluorine additive aqueous solution of 20 g/L. At last,the high temperature drying was carried out to obtain the air permeable and water resistant air film. With analyses and comparisons of the isopropanol alcohol content,the residence time of air,the composition of the first coagulation bath and the residence time of the first coagulation,the optimum parameters were found and the air film had an air permeability of 4. 7 L/min,a water blocking pressure of 16 kPa,a contact angle of 134. 2°,and a mean pore size of 2. 089 1 μm.

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.

Report on Cardiovascular Health and Diseases in China 2022:an Updated Summary

In the past 30 years,the accessibility and quality index of medical care have made remarkable progress in China,ranking the first among middle-income countries.Many cardiovascular technologies are at or near the world's leading level,and significant progress has been achieved in China solving the problem of“treatment difficulty”of cardiovascular diseases(CVD).However,due to the prevalence of unhealthy lifestyles among Chinese residents,a huge population with CVD risk factors,accelerated population aging,and other reasons,the incidence and mortality rate of CVD are still increasing,and the turning point of the decline in disease burden has not appeared yet in China.In terms of proportions of disease mortality among urban and rural residents,CVD still ranks the first.In 2020,CVD accounted for 48.00%and 45.86%of the causes of death in rural and urban areas,respectively;two out of every five deaths were due to CVD.It is estimated that the number of current CVD patients in China is around 330 million,including 13 million stroke,11.39 million coronary heart disease,8.9 million heart failure,5 million pulmonary heart disease,4.87 million atrial fibrillation,2.5 million rheumatic heart disease,2 million congenital heart disease,45.3 million peripheral artery disease,and 245 million hypertension cases.China has entered a new stage of transformation from high-speed development to high-quality development,and the prevention and control of CVD in China should also shift from previous emphasis on scale growth to strategies focusing more on strategic and key technological development in order to curb the trend of increasing incidence and mortality rates of CVD.

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.

Integrated Product Development in Rhinoplasty:A Case Study

The 3D simulation in preoperative design for nasal plastic surgery was studied to help patients see the postoperative effects and reduce medical disputes.The study developed and clinically tested an innovative design for surgical guides for nasal plastic surgery,which showed positive results in patient satisfaction and accuracy in achieving the preoperative simulated effect.The study also investigated the process of designing and producing nasal prostheses and how patient feedback could be obtained using third-party social media voting.Patient satisfaction information was collected and evaluated using the Likert scale,and the data statistical analysis was carried out with the SPSS19.0 software.More than 94.1% of the patients were satisfied with the postoperative results.The study provides a good reference case for the integration of knowledge and skills from the medicine,design,and engineering fields in the development of medical devices.

FDA MAUDE database analysis of titanium middle ear prosthesis

Purpose:Partial ossicular replacement(PORP)and total ossicular replacement prostheses(TORP)are used to restore ossicular chain function.Despite favorable auditory outcomes,these interventions have associated risks and complications.This study examines the FDA MAUDE database for ossicular chain prosthesis adverse events to highlight complications,interventions,and root cause analysis(RCA)findings.Materials and methods:The MAUDE database was searched for Medical Device Reports(MDRs)relating to PORPs and TORPs from 2010 to 2020.MDR event descriptions were reviewed,and adverse events were identified as a device issue,patient issue,and/or packaging issue that occurred intraoperatively or postoperatively.Results:Our search identified 70 MDRs which included 110 reported adverse events.Events consisted of 63 device issues,often due to device breaks and displacements,39 patient issues,including common complaints of hearing loss and erosion,and 8 packaging issues.When comparing PORPs and TORPs,TORPs had more reported device issues whereas PORPs had more packaging issues.Intraoperative device issues were commonly resolved by completing the procedure with a backup device and most postoperative device issues required additional surgery.For devices returned to the manufacturer,RCA determined that most breaks were caused by modification and/or mishandling or that the product met specifications with an undetermined cause for the break.Conclusion:Device issues were the most common adverse events and frequently required subsequent intervention.Displacement occurred more often with TORPs and was associated with changes in hearing or erosion.The findings of this study are purely descriptive and may not have direct clinical relevance.