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.

Prions:a threat to health security and the need for effective medical countermeasures

Prions are infectious conformations of certain naturally occurring proteins.These misfolded proteins can struc­turally alter healthy protein,creating misfolded copies that repeat the process and form protein aggregates that lead to neuronal cell death.Although years can pass from initial prion infection to clinical presentation of symp­toms,onset of symptoms is typically followed by rapid neurological decline resulting in death.Prion diseases have been characterized in animals ranging from sheep and cattle to cervids and humans,with notable cross-species infections such as the variant Creutzfeldt-Jakob disease.Thus,prions present a health risk with the potential to disrupt major food sources as well affect human health through animal to human and human to human trans­mission events.While human to human prion transmission is rare and the immediate risks for a prion-facilitated pandemic are low,prions are a class of pathogens for which we are underprepared.In addition,prions,and prion disease-like approaches,have also been discussed in the context of biological weapons and toxins,adding another layer of complexity surrounding biosecurity and biodefense.These threats underscore the need for increased scrutiny and research on prions.Here,pharmaceutical and nonpharmaceutical prion-specific interventions are discussed.Recent advances in prion therapeutic development are also briefly highlighted,and a set of policy rec­ommendations are given that aims to provide high level suggestions for the prevention and mitigation of prion diseases.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Issues concerning Migrant Workers' Participation in the New Rural Cooperative Medical System and Countermeasures——Based on the Survey in Wenjiang District and Jintang County, Chengdu City

We conduct questionnaire survey of migrant workers in Wenjiang District and Jintang County of Chengdu City,respectively,using the method of key-point investigation and the sampling survey. We describe the status quo of the sample migrant workers' participation in the New Rural Cooperative Medical System,analyze the issues concerning migrant workers' participation in the New Rural Cooperative Medical System,and put forward the countermeasures and recommendations as follows: using many types of medical insurance; establishing universal reimbursement points in strange land and premium-paying system for migrant workers; making the proportion of reimbursement open and transparent; establishing and improving medicare security system for migrant workers.

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.

Investigation and Countermeasures of Medical Staff’s Demand for Nursing Workers in Chifeng

In order to understand the current demand of the medical staffs for nursing workers in Chifeng and to explore the practical management mode of nursing workers,150 doctors and nurses were randomly selected from general tertiary hospitals in Chifeng to participate in a questionnaire survey.The objective of this study was to investigate the demand of nursing workers in tertiary hospitals in Chifeng and the satisfaction of medical staffs toward the existing nursing work.The results of the investigation were analyzed to provide countermeasures and suggestions for the nursing work in Chifeng.

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.