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.

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.

New regulations for medical devices: Rationale, advances and impact on research and patient care

A series of events relating to inferior medical devices has brought about changes in the legal requirements regarding quality control on the part of regulators. Apart from clinical studies, register and routine data will play an essential role in this context. To ensure adequate use of these data, adapted methodologies are required as register data in fact represent a new scientific entity. For the interpretation of register and routine data several limitations of published data should be taken into account. In many cases essential parameters of study cohorts- such as age, comorbidities, the patients' risk profiles or the hospital profile- are not presented. Required data and evaluation procedures differ significantly, for example, between hip and spine implants. A "one fits for all" methodology is quite unlikely to exist and vigorous efforts will be required to develop suitable standards in the next future. The new legislation will affect all high-risk products, besides joint implants also contact lenses, cardiac pacemakers or stents, for example, the new regulations can markedly enhance product quality monitoring. Register data and clinical studies should not be considered as competitors, they complement each other when used responsibly. In the future follow-up studies should increasingly focus on specific questions, while global follow-up investigations regarding product complication rates and surgical methods will increasingly be covered by registers.

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.

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.

Efficacy of Over-the-Counter (OTC) Medical Device Products as a Tool in Clinical Weight Management

Background: Obesity is a significant public health challenge. Its prevalence is increasing at an alarming rate globally. Numerous slimming products crowd the market, with each offering a proprietary formulation with statements of alleged efficacy. Within the EU, one such class is Medical Device, featuring a range of marine- and vegetal-based fibers as the functional ingredient. Methods: An analysis was performed to investigate and compare the lipid binding performance of three medical devices consisting of: 1) a polyglucosamine;2) a vegetal opuntia extract;and 3) a vegetal opuntia extract with vitamins using an industry-standard, validated test method. 0.5 gr of material from each product was studied. Results: The polyglucosamine exhibited a lipid binding capacity (691.7 g/g) more than 20 times the vegetal opuntia extracts. A significantly higher standard deviation (±12.1) was reported for the polyglucosamine medical device vs. the vegetal opuntia extracts (±1.3 - 4.8). However, the standard deviation reported for the former is approximately 1.7% of the mean value obtained from double determination, significantly smaller than that 2.5% - 15% observed for the extracts. Conclusions: Analysis of lipid binding indicated the polyglucosamine exhibited a substantially higher capacity than the vegetal opuntia samples. Further studies are needed to validate these in vitro results.

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.

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.

Values of medical-grade smart wearable device onimprovement of individual healthTaking philips health watch as an example

Health is an inevitable demand to promote people's all-round development and to make foundation for economic and social development. Health and longevity of citizens is not only important symbols of national development and prosperity but also the common wish of the Chinese people. Actually,smart wearable technology is an emerging one and the application of some smart wearable devices such as health watch is the most promising one in the health industry. As new psychotherapy,cognitive behavioral therapy( CBT) can change the poor awareness by means of changing one's way of thinking,thus eliminating the unhealthy emotions and behaviors. In terms of health management,CBT enjoys such advantages as guidance,motivation,integrity and short therapy time. This paper introduces the improvement of smart wearable device guided by professional health management solutions on individual health by taking Philips health watch as an example,and the users can therefrom get full understanding of the relationship between smart wearable devices and health,thus improving their individual 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.

The Medical Device Industry Expects Acceleration of Going Overseas

As the Chinese medical device industry has been going overseas at an accelerated rate,medical device design,R&D,manufacturing and service have making progress towards an international leading level.Highend pharmaceutical products have entered the global market and play a more important role in foreign trade.The development model has also transitioned from commodity trade to technology transfer,capital transfer and medical service.

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.

Brief Talking about the Development of Medical Device Industry in China

With the continuous development of China’s economy and the improvement of Chinese’living standards,people’s awareness of health care has gradually increased,so the demand for medical devices products is also strengthen.In addition,China is gradually entering an aging society and policy support for the medical device industry.China’s medical device industry is developing rapidly.

Biodegradable Protection for Medical Devices with Medical Drugs Controlled Separation

With the aim of creating biodegradable materials for medical devices clinical appointments with high hemocompatibility we have developed a new polymer product.The basis of this product is plasticized by polyethylene glycol bacterial copolymer of hydroxybutyrate and oxovalerate. A well-known antitbrombotic supplement--acetylsalicylic acid has been added to improve hemocompatibility in the polymer. The results of our studies showed a controlled prolonged separation of acetylsalicylic acid from polymeric material in the blood. We studied in vitro the dynamics of liberation of acetylsalicylic acid from polymeric coatings. It was shown that the concentration of polyethylene glycol and the thickness of the polymer layer can affect the rate of diffusion of acetylsalicylic acid from polymer films.

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.

约定俗成——也谈MedicalDevices一词的翻译问题

约定俗成——也谈ＭｅｄｉｃａｌＤｅｖｉｃｅｓ一词的翻译问题ＡｃｃｅｐｔｅｄＴｈｒｏｕｇｈｃｏｍｍｏｎＰｒａｃｔｉｃｅ——Ｔｒａｎｓｌａｔｉｏｎｏｆ“ＭｅｄｉｃａｌＤｅｖｉｃｅｓ”北京新兴生物医学工程研究开发中心（北京１０００３７）蔡国方Ｂｅｉｊｉｎｇ...