Development Of Medical Devices Research Articles

A review of the literature on the new European Medical Device Regulations requirements for increased clinical evaluation

Purpose The European Union (EU) Medical Device Regulations (MDR) 2017/745 entered into force on May 2021 with changes related to strengthening the clinical evaluation requirements, particularly for high-risk devices. This study aims to investigate the impact of these strengthened requirements on medical device manufacturers by investigating the challenges they encounter while generating an MDR-compliant clinical evaluation report. Design/methodology/approach A systematic literature review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses method of peer-reviewed literature and various government jurisdictional reports and legislation. Findings The findings from the study understanding what constitutes sufficient clinical evidence poses the biggest challenge to the generation of an MDR-compliant clinical evaluation report. Resulting from the challenges they are facing, manufacturers of certain CE-marked medical devices are planning to remove (and have removed) devices from the EU market upon expiration of their certificate, and in the case of new and innovative devices, some manufacturers are planning to launch in other markets ahead of the EU. These challenges will lead to a potential shortage of certain medical devices in the EU and a delay in access to new devices, thereby negatively impacting patients’ quality of life. Practical implications This study provides a unique insight into the challenges currently experienced by medical device manufacturers as they transition to the MDR clinical evaluation requirements and the subsequent impact on the continued availability of medical devices in the EU. A limitation is the lack of literature analysing the regulations and their effects. Originality/value This study has both theoretical contributions in that, to the best of the authors’ knowledge, it is the first detailed and systematic review of the new MDR Regulations and has implications for practice as manufacturers and policymakers can leverage it alike to understand the challenges of the new MDR.

Distribution shift detection for the postmarket surveillance of medical AI algorithms: a retrospective simulation study

Distribution shifts remain a problem for the safe application of regulated medical AI systems, and may impact their real-world performance if undetected. Postmarket shifts can occur for example if algorithms developed on data from various acquisition settings and a heterogeneous population are predominantly applied in hospitals with lower quality data acquisition or other centre-specific acquisition factors, or where some ethnicities are over-represented. Therefore, distribution shift detection could be important for monitoring AI-based medical products during postmarket surveillance. We implemented and evaluated three deep-learning based shift detection techniques (classifier-based, deep kernel, and multiple univariate kolmogorov-smirnov tests) on simulated shifts in a dataset of 130’486 retinal images. We trained a deep learning classifier for diabetic retinopathy grading. We then simulated population shifts by changing the prevalence of patients’ sex, ethnicity, and co-morbidities, and example acquisition shifts by changes in image quality. We observed classification subgroup performance disparities w.r.t. image quality, patient sex, ethnicity and co-morbidity presence. The sensitivity at detecting referable diabetic retinopathy ranged from 0.50 to 0.79 for different ethnicities. This motivates the need for detecting shifts after deployment. Classifier-based tests performed best overall, with perfect detection rates for quality and co-morbidity subgroup shifts at a sample size of 1000. It was the only method to detect shifts in patient sex, but required large sample sizes (>30′000\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$> 30^{\\prime} 000$$\\end{document}). All methods identified easier-to-detect out-of-distribution shifts with small (≤300) sample sizes. We conclude that effective tools exist for detecting clinically relevant distribution shifts. In particular classifier-based tests can be easily implemented components in the post-market surveillance strategy of medical device manufacturers.

Sulfonation Treatment of Polyether-Ether-Ketone for Dental Implant Uses

There has been a recent uptake in the use of polyether-ether-ketone (PEEK), which is an organic thermoplastic polymer, in the manufacturing of various medical devices, implants, and equipment. Finding the best time and procedure for PEEK after sulfonation is the goal of this research. A total of 30 PEEK discs were sulfonated in this study by immersing them in concentrated (H2SO4) sulfuric acid for various durations and subsequently treated using various post-treatment techniques. Five experiments were carried out, aimed studying the effect of immersion time (5 s–2 min). The methods used as post-treatment were hydrothermal treatment, immersion in NaOH, and washing with acetone. The sulfonation time was measured, and the post-treatment techniques, surface characterizations, were conducted using scanning electron microscopy (SEM) (Electron Optics Instruments, LLC., West Orange, NJ, USA), atomic force microscopy (AFM) (AFM, Vía Burton, CA, USA), and hydrophilic properties. The results were confirmed by attenuated total reflectance-Fourier transform infrared spectroscopy (ATR-FTIR). The findings of this study demonstrate that sulfonating PEEK caused a structure with a porous network to form in every sample. As the sulfonation time increased, the porous structure became more noticeable and the concentration increased. As a consequence, the roughness of the surface increased notably, and the modified PEEK surface’s wettability improved noticeably. Hydrothermal treatment was determined to be the most successful way for eliminating the leftover sulfuric acid, and sulfonation for 2 min was determined to be ideal. By understanding the best post-treatment procedures and ideal sulfonation duration, a theoretical foundation for the production of sulfonated PEEK for orthopedic uses may be laid.

Designing the user interface of a ventilator under the constraints of a pandemic

Abstract This paper reports on the design of the GUI component of the PV1000, a fully-functional, cost-efficient pandemic ventilator developed during the COVID-19 pandemic. Our main objective in designing the user interface was to expose the rich features of the ventilator, which are on-par with many commercial medical devices, through an interface that is simple to use even by medical staff with little prior experience with ventilators. We present an agile development process which is intended to address the fast changing and potentially unclear requirements of a pandemic. This is to address the specific situation where domain experts as well as specific hardware have shortages, resulting in recurring changes in requirements. This occurs in conjunction with the collaboration of developers, not all of whom are familiar with the development of medical devices. Despite the pandemic situation, we have made a deliberate decision to use existing software engineering tools such as continuous integration. Additionally, we are employing a multi-platform development framework in order to utilise the resulting advantages, for example, if there are changes in requirements. We present and discuss the system, hardware and software architecture of the components that allow users to interact with the device. The focus here is on the dynamic generation of parts of the software architecture, which enables rapid adaptation to changing conditions on the part of the software. The user interface is evaluated through a user survey, where the majority of participants describe the interface as clear and intuitive. The entire ventilator was evaluated in one animal trial and fortunately never had to be used on humans. The next step is to convert the setup into an open source project that can be used as a research platform for ventilators.

Special Issue on Advanced Metal Cutting Technologies

Cutting technologies are utilized in many industrial sectors, such as automobile, aircraft, and medical-device manufacturing as well as dies and molds. Thus, the requirements for higher geometric accuracy, better surface integrity, and longer component service lifetimes have substantially increased. In addition, maintaining high machining efficiency while simultaneously reducing power consumption and CO2 emissions during machining is important for sustainable development. This special issue features 11 papers on the most recent advances in cutting technologies for metals and composite materials. - Reverse finishing characteristics of drilling surfaces - Machining error simulation for end milling - Visualization of cutting phenomena using a single-crystal diamond tool - Milling of TiB2 particle-reinforced high-modulus steel - Electrodischarge-assisted turning of carbon fiber-reinforced polymers - Suppression of chatter vibration during double-insert turning - Prediction of surface roughness components during turning - Microtome blades for high-precision tissue sectioning - Boiling of coolant near the cutting edge in high-speed machining - Residual stress during drilling of aluminum alloy - Effect of strain hardening on burr control during drilling This issue provides an understanding of recent developments in cutting technologies, aiming to inspire further research in this field. We deeply appreciate the careful work of all the authors and thank the reviewers for their diligent efforts.

A Preclinical Trial Protocol Using an Ovine Model to Assess Scaffold Implant Biomaterials for Repair of Critical-Sized Mandibular Defects.

The present work describes a preclinical trial (in silico, in vivo and in vitro) protocol to assess the biomechanical performance and osteogenic capability of 3D-printed polymeric scaffolds implants used to repair partial defects in a sheep mandible. The protocol spans multiple steps of the medical device development pipeline, including initial concept design of the scaffold implant, digital twin in silico finite element modeling, manufacturing of the device prototype, in vivo device implantation, and in vitro laboratory mechanical testing. First, a patient-specific one-body scaffold implant used for reconstructing a critical-sized defect along the lower border of the sheep mandible ramus was designed using on computed-tomographic (CT) imagery and computer-aided design software. Next, the biomechanical performance of the implant was predicted numerically by simulating physiological load conditions in a digital twin in silico finite element model of the sheep mandible. This allowed for possible redesigning of the implant prior to commencing in vivo experimentation. Then, two types of polymeric biomaterials were used to manufacture the mandibular scaffold implants: poly ether ether ketone (PEEK) and poly ether ketone (PEK) printed with fused deposition modeling (FDM) and selective laser sintering (SLS), respectively. Then, after being implanted for 13 weeks in vivo, the implant and surrounding bone tissue was harvested and microCT scanned to visualize and quantify neo-tissue formation in the porous space of the scaffold. Finally, the implant and local bone tissue was assessed by in vitro laboratory mechanical testing to quantify the osteointegration. The protocol consists of six component procedures: (i) scaffold design and finite element analysis to predict its biomechanical response, (ii) scaffold fabrication with FDM and SLS 3D printing, (iii) surface treatment of the scaffold with plasma immersion ion implantation (PIII) techniques, (iv) ovine mandibular implantation, (v) postoperative sheep recovery, euthanasia, and harvesting of the scaffold and surrounding host bone, microCT scanning, and (vi) in vitro laboratory mechanical tests of the harvested scaffolds. The results of microCT imagery and 3-point mechanical bend testing demonstrate that PIII-SLS-PEK is a promising biomaterial for the manufacturing of scaffold implants to enhance the bone-scaffold contact and bone ingrowth in porous scaffold implants. MicroCT images of the harvested implant and surrounding bone tissue showed encouraging new bone growth at the scaffold-bone interface and inside the porous network of the lattice structure of the SLS-PEK scaffolds.

Empowering Students in Medical Device Design: An Interdisciplinary Soft Robotics Course

AbstractExperiential learning in biomedical engineering curricula is a critical component to developing graduates who are equipped to contribute to technical design tasks in their careers. This paper presents the development and implementation of an undergraduate and graduate-level soft material robotics design course focused on applications in medical device design. The elective course, offered in a bioengineering department, includes modules on technical topics and hands-on projects relevant to readings, all situated within a human-centered design course. After learning and using first principles governing soft robot design and exploring literature in soft robotics, students propose a new advance in the field in a hands-on design and prototype project. The course described here aims to create a structure to engage students in fabrication and the design approaches taken by practitioners in a specific field, applied here in soft robotics, but applicable to other areas of biomedical engineering. This teaching tips article details the pedagogical tools used to facilitate design and collaboration within the course. Additionally, we aim to highlight ways in which the course creates (1) opportunities to engage undergraduates in design in preparation for capstone courses, (2) outward facing opportunities to connect with practitioners in the field, and (3) the ability to adapt this hands-on experience within a typical lecture structure as well as a hybrid online and in-person offering, thus expanding its utility in bioengineering departments. We reflect on course elements that can inform future design-based course offerings in soft robotics and other design-based multidisciplinary fields in bioengineering.

A Manufacturability Evaluation of Complex Architectures by Laser Powder Bed Fusion Additive Manufacturing

Abstract Additive manufacturing (AM) enables new possibilities for the design and manufacturing of complex metal architectures. Incorporating lattice structures into complex part geometries can enhance strength-to-weight and surface area-to-volume ratios for valuable components, particularly in industries such as medical devices and aerospace. However, lattice structures and their interconnections may result in unsupported down-skin surfaces, potentially limiting their manufacturability by metal AM technologies, such as laser powder bed fusion (LPBF). This study aimed to examine the correlation between down-skin surface area and the manufacturability of lattice structures fabricated using LPBF. Image processing algorithms were used to analyze down-skin surface areas of seven unique lattice designs and to devise quantitative metrics (such as down-skin surface area, discrete surface count, surface interconnectivity, down-skin ratio, over-print/under-print volumes, etc.) to evaluate LPBF manufacturability. The seven lattice designs were subsequently manufactured using maraging steel via LPBF and then examined using imaging using X-ray micro-computed tomography (XCT). The geometric accuracy of the lattice designs was compared with XCT scans of the manufactured lattices by employing a voxel-based image comparison technique. The results indicated a strong relationship between down-skin surface area, surface interconnectivity, and the manufacturability of a given lattice design. The digital manufacturability evaluation workflow was also applied to a medical device design, further affirming its potential industrial utility for complex geometries.

Comparison between a tubeless, on-body automated insulin delivery system and a tubeless, on-body sensor-augmented pump in type 1 diabetes: a multicentre randomised controlled trial.

This study compares the efficacy and safety of a tubeless, on-body automated insulin delivery (AID) system with that of a tubeless, on-body sensor-augmented pump (SAP). This multicentre, parallel-group, RCT was conducted at 13 tertiary medical centres in South Korea. Adults aged 19-69 years with type 1 diabetes who had HbA1c levels of <85.8 mmol/mol (<10.0%) were eligible. The participants were assigned at a 1:1 ratio to receive a tubeless, on-body AID system (intervention group) or a tubeless, on-body SAP (control group) for 12 weeks. Stratified block randomisation was conducted by an independent statistician. Blinding was not possible due to the nature of the intervention. The primary outcome was the percentage of time in range (TIR), blood glucose between 3.9 and 10.0 mmol/l, as measured by continuous glucose monitoring. ANCOVAs were conducted with baseline values and study centres as covariates. A total of 104 participants underwent randomisation, with 53 in the intervention group and 51 in the control group. The mean (±SD) age of the participants was 40±11 years. The mean (±SD) TIR increased from 62.1±17.1% at baseline to 71.5±10.7% over the 12 week trial period in the intervention group and from 64.7±17.0% to 66.9±15.0% in the control group (difference between the adjusted means: 6.5% [95% CI 3.6%, 9.4%], p<0.001). Time below range, time above range, CV and mean glucose levels were also significantly better in the intervention group compared with the control group. HbA1c decreased from 50.9±9.9 mmol/mol (6.8±0.9%) at baseline to 45.9±7.4 mmol/mol (6.4±0.7%) after 12 weeks in the intervention group and from 48.7±9.1 mmol/mol (6.6±0.8%) to 45.7±7.5 mmol/mol (6.3±0.7%) in the control group (difference between the adjusted means: -0.7 mmol/mol [95% CI -2.0, 0.8 mmol/mol] (-0.1% [95% CI -0.2%, 0.1%]), p=0.366). No diabetic ketoacidosis or severe hypoglycaemia events occurred in either group. The use of a tubeless, on-body AID system was safe and associated with superior glycaemic profiles, including TIR, time below range, time above range and CV, than the use of a tubeless, on-body SAP. Clinical Research Information Service (CRIS) KCT0008398 FUNDING: The study was funded by a grant from the Korea Medical Device Development Fund supported by the Ministry of Science and ICT; the Ministry of Trade, Industry and Energy; the Ministry of Health and Welfare; and the Ministry of Food and Drug Safety (grant number: RS-2020-KD000056).

Approach for contact medical device development via integrated testing, skeletal muscle modeling, and finite element analysis

Development of novel medical devices for the treatment of musculoskeletal pain associated with neuro-muscular trigger points requires a model for relating the mechanical responses of in vivo biological tissues to applied palliative physical pressures and a method to design treatments for optimal effects. It is reasonable to hypothesize that the efficacy of therapeutic treatment is proportional to the maximum tensile strain at trigger point locations. This work presents modeling of the mechanical behavior of biological tissue structures and treatment simulations, supported by indentation experiments and finite element (FE) modeling. The steady-state indentation responses of the tissue structure of the posterior neck were measured with a testing device, and an FE model was constructed using a first-order Ogden hyperelastic material model and calibrated with the experimental data. The error between experimental and FE-generated displacement-load curves was minimized via a two-stage optimization process comprised of an Optimal Latin Hypercube design-of-experiments analysis and a Bayesian optimization loop. The optimized Ogden model had an initial shear modulus (μ) of 5.16 kPa and a deviatoric exponent (α) of 11.90. Another FE model was developed to simulate the deformation of the tissue structures in the posterior neck adjacent to the C3 vertebrae in response to indentation loading, in order to determine the optimal location and angle to apply an indentation force for maximum therapeutic benefit. The optimal location of indentation was determined to be 28° lateral from the sagittal plane along the surface of the skin, measured from the centerline of the spine, at an angle of 8° counterclockwise from the surface normal vector. The optimized spatial orientation of the indentation corresponded to the average of the maximum principal strain across the deep muscle region of the model.

Healthcare Integrated Information System in Indonesia

The United States (US), leads the world in medical science and technology. Lead by clear definitions in almost all sectors of clinical research, training and governance practices. Likewise, the pharmaceutical and medical device (medical equipment) manufacturers are considered one of the leading in the world. Therefore, many of the definitions and rules have also been adopted into global regulations by the world health organization, the World Health Organization (WHO). Currently, these rules have been implemented into the health information system (HIS), which further rapidly being adopted and used in many countries. Nowadays, health facilities (HF) around the world have used HIS, which are basic or have reached an advanced level. This paper will describe how the development of HIS and applied products from utilization of information technology (IT) in Indonesia, along with the opportunities and challenges in the future.

Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections.

Smart GxP inspections have gained increasing attention due to the COVID-19 pandemic, which, understandably, made it challenging for regulatory authorities to conduct on-site inspections. Smart GxP inspections are an oversight approach developed by the SFDA to enable remote compliance assessments of establishments. In this type of inspection, appropriate technical methods and tools (such as livestreaming video) are used without requiring the presence of inspectors onsite, ensuring efficient utilization of resources and the efficiency of inspection process. The objective of this research is to examine and document the shared encounters involving remote inspections and evaluations carried out by SFDA from 2020 to 2022. This will be achieved through the evaluation of the accuracy of document evaluation and the extent to which the objectives of smart GxP inspections were met. Data were collected from local and international smart inspections reports conducted by SFDA between 2020 and 2022, covering medical device manufacturers, pharmaceutical manufacturing sites, warehouses, accreditation offices, scientific offices, and food manufacturing facilities. The results indicate that smart GxP inspections were effective in achieving visit objectives, showing a high degree of document evaluation accuracy. The findings of this study support the use of smart GxP inspections as a valuable alternative to on-site inspections, offering a practical solution to regulatory compliance during the pandemic and beyond. Although the SFDA recognizes the usefulness of smart inspections in upholding regulatory oversight in the face of various challenges, it does not endorse the complete replacement of conventional on-site inspection methods. The SFDA acknowledges significant limitations associated with the current technological resources used in remote regulatory assessments, and these limitations will be explored in the relevant sections.

Implementing Industry 4.0: An In-Depth Case Study Integrating Digitalisation and Modelling for Decision Support System Applications

The scientific community has shown considerable interest in Industry 4.0 due to its capacity to revolutionise the manufacturing sector through digitalisation and data-driven decision-making. However, the actual implementation of Industry 4.0 within complex industrial settings presents obstacles that are typically beyond the scope of mainstream research articles. In this paper, a comprehensive case-study detailing our collaborative partnership with a leading medical device manufacturer is presented. The study traces its evolution from a state of limited digitalisation to the development of a digital intelligence platform that leverages data and machine learning models to enhance operations across a wide range of critical machines and assets. The main business objective was to enhance the energy efficiency of the manufacturing process, thereby improving its sustainability measures while also saving costs. The project encompasses energy modelling and analytics, Fault Detection and Diagnostics (FDD), renewable energy integration and advanced visualisation tools. Together, these components enable informed decision making in the context of energy efficiency.

Leveraging AI for Enhanced Quality Assurance in Medical Device Manufacturing

The medical device sector adheres to strict regulatory frameworks, requiring precise adherence to quality assurance (QA) processes during the production process. Conventional quality assurance (QA) approaches, although successful, sometimes require substantial time and resource allocations, resulting in possible obstacles and higher expenses. The emergence of Artificial Intelligence (AI) in recent years has completely transformed quality assurance (QA) methods in different sectors, providing unparalleled prospects for improved productivity, precision, and scalability. This research examines the possibility of using AI technologies to enhance quality assurance processes in the manufacturing of medical devices. Manufacturers may improve product quality and streamline production workflows by utilising AI techniques like machine learning, computer vision, and natural language processing to automate and optimize important QA procedures. Artificial intelligence systems can analyse large amounts of data to find abnormalities, uncover flaws, and anticipate any problems in real-time. This allows for proactive intervention and reduces the chances of non-compliance hazards. In addition, AI-powered QA systems provide adaptive learning capabilities, constantly enhancing performance through feedback and adapting to changing regulatory needs. The incorporation of artificial intelligence (AI) into current quality management systems enables smooth and efficient sharing of data and compatibility, promoting a comprehensive approach to quality control throughout the whole production process.

Construction Practice of Medical Device Product Life Cycle Management Platform

Medical device product life cycle management is one of the core contents of medical device quality management system construction, spanning the entire process of enterprise core business activities including market, research and development, procurement, production, and services. Building a comprehensive and efficient life cycle management system facilitates the implementation of quality management systems. Taking the example of the construction of a unified product life cycle management platform for medical device hardware and software that has been launched and operated, this article describes the general principles and practical experience of constructing a medical device life cycle management platform, including requirements collection, system design, product selection, customization development and confirmation, as well as platform trial, acceptance commissioning, and operation and maintenance management.

Current state and prospects for the development of the domestic pharmaceutical industry

The main stages of the development of the Russian medical and pharmaceutical industry in 2010 are presented in the context of the dominance of large foreign companies producing medicines and medical devices in the pharmaceutical market. This reflects the political and economic restrictive measures illegally taken against Russia by the European Union, the United States of America, and some other unfriendly countries and has influenced the dynamics of the development of the medical and pharmaceutical industry in our country. To harmonize approaches to the production and quality control of medicines, this paper presents the stages of large-scale reforms on the transition of the Russian pharmaceutical industry to standards of good manufacturing practice and the implementation of state programs aimed at modernizing the industrial segment of the pharmaceutical industry. As part of the improvement of the standardization system of medicines, the study also presents the characteristics of the XIII, XIV, and XV editions of the State Pharmacopoeia of the Russian Federation published during the study period, in the development of which employees of the Military Medical Academy named after S.M. Kirov participated. The role and purpose of the creation of the developed Pharmacopoeia of the Eurasian Economic Union, approved by the Board of the Eurasian Economic Commission, is also reflected in this paper. This article describes the phased implementation of federal target programs, state programs, and other strategic plans and measures of nonfinancial support from the state, which have significantly expanded competencies in the field of development and production of medicines and medical devices and increased their output during the period analyzed. The development of medicines and increasing their production volumes with the help of pharmaceutical clusters, which acted as the “locomotives” of the industry, and various projects in establishing the production of innovative medical products with the help of the Industrial Development Fund, which increased the investment attractiveness of these sectors of the national economic complex, played an important role. The results revealed the essence of the changes concerning the revival of the activities of industrial pharmacies, considering a personalized approach to the treatment of patients. The study also presents an assessment of the Pharmaceutical industry Development Strategy for the period up to 2030.

Characterization of the layer, direction and time-dependent mechanical behaviour of the human oesophagus and the effects of formalin preservation.

The mechanical characterization of the oesophagus is essential for applications such as medical device design, surgical simulations and tissue engineering, as well as for investigating the organ's pathophysiology. However, the material response of the oesophagus has not been established ex vivo in regard to the more complex aspects of its mechanical behaviour using fresh, human tissue: as of yet, in the literature, only the hyperelastic response of the intact wall has been studied. Therefore, in this study, the layer-dependent, anisotropic, visco-hyperelastic behaviour of the human oesophagus was investigated through various mechanical tests. For this, cyclic tests, with increasing stretch levels, were conducted on the layers of the human oesophagus in the longitudinal and circumferential directions and at two different strain rates. Additionally, stress-relaxation tests on the oesophageal layers were carried out in both directions. Overall, the results show discrete properties in each layer and direction, highlighting the importance of treating the oesophagus as a multi-layered composite material with direction-dependent behaviour. Previously, the authors conducted layer-dependent cyclic experimentation on formalin-embalmed human oesophagi. A comparison between the fresh and embalmed tissue response was carried out and revealed surprising similarities in terms of anisotropy, strain-rate dependency, stress-softening and hysteresis, with the main difference between the two preservation states being the magnitude of these properties. As formalin fixation is known to notably affect the formation of cross-links between the collagen of biological materials, the differences may reveal the influence of cross-links on the mechanical behaviour of soft tissues.

Microenvironment-regulated dual-hydrophilic coatings for glaucoma valve surface engineering

Glaucoma valves (GVs) play an essential role in treating glaucomas. However, fibrosis after implantation has limited their long-term success in clinical applications. In this study, we aimed to develop a comprehensive surface-engineering strategy to improve the biocompatibility of GVs by constructing a microenvironment-regulated and dual-hydrophilic antifouling coating on a GV material (silicone rubber, SR). The coating was based on a superhydrophilic polydopamine (SPD) coating with good short-range superhydrophilicity and antifouling abilities. In addition, SPD coatings contain many phenolic hydroxyl groups that can effectively resist oxidative stress and the inflammatory microenvironment. Furthermore, based on its in situ photocatalytic free-radical polymerization properties, the SPD coating polymerized poly 2-methylacryloxyethylphosphocholine, providing an additional long-range hydrophilic and antifouling effect. The in vitro test results showed that the microenvironment-regulated and dual-hydrophilic coatings had anti-protein contamination, anti-oxidation, anti-inflammation, and anti-fiber proliferation capabilities. The in vivo test results indicated that this coating substantially reduced the fiber encapsulation formation of the SR material by inhibiting inflammation and fibrosis. This design strategy for dual hydrophilic coatings with microenvironmental regulation can provide a valuable reference for the surface engineering design of novel medical implantable devices. Statement of significanceSuperhydrophilic polydopamine (SPD) coatings were prepared on silicone rubber (SR) by a two-electron oxidation method. Introduction of pMPC to SPD surface using photocatalytic radical polymerization to obtain a dual-hydrophilic coating. The dual-hydrophilic coating effectively modulates the oxidative and inflammatory microenvironment. This coating significantly reduced protein contamination and adhesion of inflammatory cells and fibroblasts in vitro. The coating-modified SR inhibits inflammatory and fibrosis responses in vivo, promising to serve the glaucoma valves.

Bionic blink improves real-time eye closure in unilateral facial paralysis

Facial paralysis is the inability to move facial muscles thereby impairing the ability to blink and make facial expressions. Depending on the localization of the nerve malfunction it is subcategorised into central or peripheral and is usually unilateral. This leads to health deficits stemming from corneal dryness and social ostracization. Objective: Electrical stimulation shows promise as a method through which to restore the blink function and as a result improve eye health. However, it is unknown whether a real-time, myoelectrically controlled, neurostimulating device can be used as assistance to this pathological condition. Approach: We developed NEURO-BLINK, a wearable robotic system, that can detect the volitional healthy contralateral blink through electromyography and electrically stimulate the impaired subcutaneous facial nerve and orbicularis oculi muscle to compensate for lost blink function. Alongside the system, we developed a method to evaluate optimal electrode placement through the relationship between blink amplitude and injected charge. Main results: Ten patients with unilateral facial palsy were enrolled in the NEURO-BLINK study, with eight completing testing under two conditions. (1) where the stimulation was cued with an auditory signal (i.e. paced controlled) and (2) synchronized with the natural blink (i.e. myoelectrically controlled). In both scenarios, overall eye closure (distance between eyelids) and cornea coverage measured with high FPS video were found to significantly improve when measured in real-time, while no significant clinical changes were found immediately after use. Significance: This work takes steps towards the development of a portable medical device for blink restoration and facial stimulation which has the potential to improve long-term ocular health.

Building Medical Device Supply Chain Resilience With the US Food and Drug Administration

Medical device supply chain shortages have the potential to negatively impact patient care when patients and caregivers are unable to obtain the medical devices they need. The US Food and Drug Administration (FDA), specifically the Center for Devices and Radiological Health, received expanded authorities requiring medical device manufacturers to notify the FDA of any interruption or discontinuance of medical devices during or in advance of a public health emergency. The clinical community, in particular, healthcare technology managers, can provide additional information and perspective to the FDA by voluntarily reporting any device availability concerns. This will provide the FDA with more data about the current supply chain landscape and drive communication about the issue. Ultimately, improved information sharing will help ensure devices are available when and where they are needed to protect the health of the nation's patients and healthcare workers into the future.