Development Of Medical Devices Research Articles

Achievements and prospects for the application of artificial intelligence technologies in medicine. Overview. Part 2

On a global scale, a radical transformation of the healthcare sector is taking place right before our eyes. The last few years have become a turning point in terms of the number of new directions, the emergence of innovative diagnostic and treatment methods, and the introduction of digital platforms. Digital medicine uses information and communication technologies to address the numerous problems associated with ensuring the quality and accessibility of medical care already available today. The rapid development of neural networks and artificial intelligence (AI) provides doctors with ample opportunities to predict the course of diseases and calculate the risks to the health of patients. Manufacturers of medical devices offer consumer a wide range of software and products with AI embedded. Despite the tremendous advances in the application of AI in medicine, the medical community is highly concerned about some of the intractable problems associated with the too rapid and ubiquitous use of these digital platforms. A highly trained neural network is an extremely complex computer program consisting of a large number of internal hidden layers with customizable parameters. The more complex the neural network and the number of computational operations it performs, the more difficult it is to understand the processes in its inner layers. The functioning of AI systems in a black box format makes explaining the results of its work a very non-trivial task. Therefore, in the future, research will certainly be required assessing the reliability of these systems and interpreting their decision-making processes which, will affect the neural networks of the latest generations.

Red Blood Cell Sublethal Damage: Hemocompatibility Is not the Absence of Hemolysis.

Blood is a complex fluid owing to its two-phase suspension of formed cellular elements within a protein-rich plasma. Vital to its role in distributing nutrients throughout the circulatory system, the mechanical properties of blood - and particularly red blood cells (RBC)-primarily determine bulk flow characteristics and microcirculatory flux. Various factors impair the physical properties of RBC, including cellular senescence, many diseases, and exposure to mechanical forces. Indeed, the latter is increasingly relevant following the advent of modern life support, such as mechanical circulatory support (MCS), which induce unique interactions between blood and artificial environments that leave blood cells with the signature of aging, albeit accelerated, and crucially underlie various serious complications, including death. Accumulating evidence indicates that these complications appear to be associated with mechanical shear forces present within MCS that are not extreme enough to overtly rupture cells, yet may still induce "sublethal" injury and "fatigue" to vital blood constituents. Impaired RBC physical properties following elevated shear exposure-a hallmark of sublethal injury to blood-are notable and may explain, at least in part, systemic complications and premature mortality associated with MCS. Design of optimal next-generation MCS devices thus requires consideration of biocompatibility and blood-device interactions to minimize potential blood complications and promote clinical success. Presented herein is a contemporary understanding of "blood damage," with emphasis on shear exposures that alter microrheological function but do not overtly destroy cells (ie, sublethal damage). Identification of key cellular factors perturbed by supraphysiological shear exposure are examined, offering potential pathways to enhance design of MCS and blood-contacting medical devices.

Proposal of a Bioinspired Patch for the Real-time Monitoring of Neurological Trauma

Neurological trauma, damage to the brain, spine, or nerves, can happen as a result of both neurosurgery and vehicle accidents. It may be risky to cause damage during surgery because of humans' ineffective capacity to repair neurons; as a result, the market may require a medical device specifically made to address this problem. The accessory limb model (ALM), one of the most typical regeneration models, has demonstrated that it has significant potential to improve regeneration outcomes and might be used for the regeneration of human brain tissues. Nowadays, many implanted medical devices interact with circuitry outside the body via cables or wireless RF telemetry. However, wires usually result in a huge chance to increase surgical difficulties such as wire breakage, infection, and electrical noise. Intrabody communication, as a result, became a preferable and safer way of communication in the design of implantable medical devices, and is used in the device introduced in this article.

A Comprehensive Review of Risk Management in the Medical Device Industry

The medical device industry is highly regulated, with a focus on ensuring the safety and effectiveness of medical devices. Risk management is a critical aspect of the medical device industry, involving the identification, assessment, and control of potential risks associated with medical devices. This paper provides a comprehensive review of risk management in the medical device industry, including its history, current regulatory framework, and key principles and processes. The paper examines the different types of risks associated with medical devices and explores various risk management techniques and tools used by medical device manufacturers. Additionally, the paper discusses the importance of post-market surveillance and risk monitoring, as well as the role of clinical evaluations in risk management. The paper concludes by highlighting emerging trends and future directions in risk management for the medical device industry. Overall, this comprehensive review provides a valuable resource for medical device manufacturers, regulators, and other stakeholders interested in risk management in the medical device industry.

Quantitative Benefit-Risk Assessment in Medical Product Decision Making: A Good Practices Report of an ISPOR Task Force

Benefit-risk assessment is commonly conducted by drug and medical device developers and regulators, to evaluate and communicate issues around benefit-risk balance of medical products. Quantitative benefit-risk assessment (qBRA) is a set of techniques that incorporate explicit outcome weighting within a formal analysis to evaluate the benefit-risk balance. This report describes emerging good practices for the 5 main steps of developing qBRAs based on the multicriteria decision analysis process. First, research question formulation needs to identify the needs of decision makers and requirements for preference data and specify the role of external experts. Second, the formal analysis model should be developed by selecting benefit and safety endpoints while eliminating double counting and considering attribute value dependence. Third, preference elicitation method needs to be chosen, attributes framed appropriately within the elicitation instrument, and quality of the data should be evaluated. Fourth, analysis may need to normalize the preference weights, base-case and sensitivity analyses should be conducted, and the effect of preference heterogeneity analyzed. Finally, results should be communicated efficiently to decision makers and other stakeholders. In addition to detailed recommendations, we provide a checklist for reporting qBRAs developed through a Delphi process conducted with 34 experts.

Lipid Deposition Profiles Influence Foreign Body Responses.

Fibrosis remains a significant cause of failure in implanted biomedical devices and early absorption of proteins on implant surfaces has been shown to be a key instigating factor. However, lipids can also regulate immune activity and their presence may also contribute to biomaterial-induced foreign body responses (FBR) and fibrosis. Here it is demonstrated that the surface presentation of lipids on implant affects FBR by influencing reactions of immune cells to materials as well as their resultant inflammatory/suppressive polarization. Time-of-flight secondary ion mass spectroscopy (ToF-SIMS) is employed to characterize lipid deposition on implants that are surface-modified chemically with immunomodulatory small molecules. Multiple immunosuppressive phospholipids (phosphatidylcholine, phosphatidylinositol, phosphatidylethanolamine, and sphingomyelin) are all found to deposit preferentially on implants with anti-FBR surface modifications in mice. Significantly, a set of 11 fatty acids is enriched on unmodified implanted devices that failed in both mice and humans, highlighting relevance across species. Phospholipid deposition is also found to upregulate the transcription of anti-inflammatory genes in murine macrophages, while fatty acid deposition stimulated the expression of pro-inflammatory genes. These results provide further insights into how to improve the design of biomaterials and medical devices to mitigate biomaterial material-induced FBR and fibrosis.

Development of Polyurethane/Peptide-Based Carriers with Self-Healing Properties.

In situ-forming gels with self-assembling and self-healing properties are materials of high interest for various biomedical applications, especially for drug delivery systems and tissue regeneration. The main goal of this research was the development of an innovative gel carrier based on dynamic inter- and intramolecular interactions between amphiphilic polyurethane and peptide structures. The polyurethane architecture was adapted to achieve the desired amphiphilicity for self-assembly into an aqueous solution and to facilitate an array of connections with peptides through physical interactions, such as hydrophobic interactions, dipole-dipole, electrostatic, π-π stacking, or hydrogen bonds. The mechanism of the gelation process and the macromolecular conformation in water were evaluated with DLS, ATR-FTIR, and rheological measurements at room and body temperatures. The DLS measurements revealed a bimodal distribution of small (~30-40 nm) and large (~300-400 nm) hydrodynamic diameters of micelles/aggregates at 25 °C for all samples. The increase in the peptide content led to a monomodal distribution of the peaks at 37 °C (~25 nm for the sample with the highest content of peptide). The sol-gel transition occurs very quickly for all samples (within 20-30 s), but the equilibrium state of the gel structure is reached after 1 h in absence of peptide and required more time as the content of peptide increases. Moreover, this system presented self-healing properties, as was revealed by rheological measurements. In the presence of peptide, the structure recovery after each cycle of deformation is a time-dependent process, the recovery is complete after about 300 s. Thus, the addition of the peptide enhanced the polymer chain entanglement through intermolecular interactions, leading to the preparation of a well-defined gel carrier. Undoubtedly, this type of polyurethane/peptide-based carrier, displaying a sol-gel transition at a biologically relevant temperature and enhanced viscoelastic properties, is of great interest in the development of medical devices for minimally invasive procedures or precision medicine.

Improvement of tensile and flexural properties of 3D printed PEEK through the increase of interfacial adhesion

Polyetheretherketone (PEEK) is the leading high-performance biocompatible thermoplastic for the replacement of metals in orthopaedic applications. PEEK processing using material extrusion (ME) Additive Manufacturing (AM) techniques such as Fused Filament Fabrication (FFF) highlight its potential for the manufacture of patient-specific load-bearing implantable medical devices. As a high temperature semi-crystalline polymer, the mechanical properties of PEEK 3D printed samples are significantly influenced by printing parameters, particularly the crystallinity and interfacial adhesion of 3D printed parts. Given these challenges, the printing parameters of nozzle temperature, zone heater temperature, layer height and extruder multiplier were selected and studied for their effects in the interfacial adhesion and thus consequent mechanical performance of PEEK 3D prints. Design of Experiment (DoE) studies were conducted where the Taguchi and ANOVA analysis were used to determine the optimal parameter combinations and respective contributions. Additionally, different infill configurations were used with the optimal parameters to lower the samples' void volume and increase interface bonding. Reductions of up to 65 % in void volume were obtained with an interlayer translation of the infill lines and the tested configurations yielded improvements in both the tensile and flexural properties of 3D printed PEEK. Furthermore, high-temperature annealing treatments produced further increases in the strength, stiffness and crystallinity of PEEK samples. With this, significant improvements in both the void volume and the tensile and flexural properties of PEEK prints were achieved in support of the use of 3D printed PEEK in the manufacture of custom-made and high performance implantable medical devices.

Resilience of a Supply Chain-Based Economic Evaluation of Medical Devices From an Industry Perspective

Health budget allocation choices are increasingly aided by medical technology's economic evaluation (EE). With thousands of new items launched each year, the medical device (MD) business is one of the most active domains of medical advancement among providers of innovation. Some of these considerations have to do with the specifics of how the gadget works. The paper examines the investment assessment of new medical devices from an industrial viewpoint. The strategy EE-MD presented should lead to more inventive and cost-effective surgical supplies for the medical industry. The study's purpose is to better the decision-making process for medical device development. Small and medium-sized firms are a crucial source of innovation for the future, and the research focuses mostly on them. Design economy and professional engineering literature are linked in the article. The proposed multi-attribute and team method to construct selection discusses the financial factor and provides a strong foundation for ongoing program management by identifying project-specific risks and strategic alliances.

Influence of PEGDA Molecular Weight and Concentration on the In Vitro Release of the Model Protein BSA-FITC from Photo Crosslinked Systems.

Novel 3D printing techniques enable the development of medical devices with drug delivery systems that are tailored to the patient in terms of scaffold shape and the desired pharmaceutically active substance release. Gentle curing methods such as photopolymerization are also relevant for the incorporation of potent and sensitive drugs including proteins. However, retaining the pharmaceutical functions of proteins remains challenging due to the possible crosslinking between the functional groups of proteins, and the used photopolymers such as acrylates. In this work, the in vitro release of the model protein drug, albumin-fluorescein isothiocyanate conjugate (BSA-FITC) from differently composed, photopolymerized poly(ethylene) glycol diacrylate (PEGDA), an often employed, nontoxic, easily curable resin, was investigated. Different PEGDA concentrations in water (20, 30, and 40 wt %) and their different molecular masses (4000, 10,000, and 20,000 g/mol) were used to prepare a protein carrier with photopolymerization and molding. The viscosity measurements of photomonomer solutions revealed exponentially increasing values with increasing PEGDA concentration and molecular mass. Polymerized samples showed increasing medium uptake with an increasing molecular mass and decreasing uptake with increasing PEGDA content. Therefore, the modification of the inner network resulted in the most swollen samples (20 wt %) also releasing the highest amount of incorporated BSA-FITC for all PEGDA molecular masses.

Dilemmas Encountered by Small and Medium-sized Orthopedic Medical Device Manufacturing Companies in Healthcare Reform Based on a Supply Chain Perspective: Taking a Manufacturer in Jiangsu Province as an Example

As China’s healthcare reform progresses, the medical device industry is receiving significant attention as an essential part of the healthcare delivery system. Current research on the supply and management of medical devices in the context of healthcare reform mainly focuses on the downstream of the supply chain to innovate the management model of orthopedic consumables in hospitals and realize competent healthcare. However, only a few studies have focused on medical device manufacturers upstream of the supply chain and proposed measures to improve supply chain performance. This paper takes a medium-sized customer medical device manufacturer in China as a case study. This study analyzes the problems revealed in its supply chain operation through literature research, case study analysis, and fieldwork. It proposes countermeasures for the continuous improvement of the industry against the background of healthcare reform. The study found that small and medium-sized medical device manufacturers were not using management information systems adequately and were suffering from the impact of healthcare reform by sticking to their old distribution models. For long-term growth, these small and medium-sized medical companies should focus on research and development, cater to market needs, integrate downstream distributors, and work with hospitals to establish a more transparent and efficient healthcare supply chain.

Catheters with Dual-Antimicrobial Properties by Gamma Radiation-Induced Grafting.

Dual antimicrobial materials that have a combination of antimicrobial and antifouling properties were developed. They were developed through modification using gamma radiation of poly (vinyl chloride) (PVC) catheters with 4-vinyl pyridine (4VP) and subsequent functionalization with 1,3-propane sultone (PS). These materials were characterized by infrared spectroscopy, thermogravimetric analysis, swelling tests, and contact angle to determine their surface characteristics. In addition, the capacity of the materials to deliver ciprofloxacin, inhibit bacterial growth, decrease bacterial and protein adhesion, and stimulate cell growth were evaluated. These materials have potential applications in the manufacturing of medical devices with antimicrobial properties, which can reinforce prophylactic potential or even help treat infections, through localized delivery systems for antibiotics.

Brush Polymer Coatings with Hydrophilic Main-Chains for Improving Surface Antibacterial Properties.

Polymer coatings with improved surface antibacterial properties are of great importance for the application and development of implantable medical devices. Herein, we report the design, preparation, and antibacterial properties of a series of brush polymers (Dex-KEs) with hydrophilic dextran main-chains and mixed-charge polypeptide (KE) side-chains. Dex-KEs showed higher bactericidal activity and antifouling and antibiofilm properties than maleic acid modified dextran (Dex-Ma), KE, Dex-Ma/KE blend coatings, and brush polymer coatings with hydrophobic main-chains (AcDex-KEs). They also showed negligible in vitro cytotoxicity toward different mammalian cells and good in vivo biocompatibility. Dex-KE-coated implants exhibited potent in vivo resistance to bacterial infection before or after implantation.

Multiphoton Lithography as a Promising Tool for Biomedical Applications

AbstractMultiphoton lithography (MPL) is a powerful and useful structuring tool capable of generating 2D and 3D arbitrary micro‐ and nanometer features of various materials with high spatial resolution down to nm‐scale. This technology has received tremendous interest in tissue engineering and medical device manufacturing, due to its ability to print sophisticated structures, which is difficult to achieve through traditional printing methods. Thorough consideration of two‐photon photoinitiators (PIs) and photoreactive biomaterials is key to the fabrication of such complex 3D micro‐ and nanostructures. In the current review, different types of two‐photon PIs are discussed for their use in biomedical applications. Next, an overview of biomaterials (both natural and synthetic polymers) along with their crosslinking mechanisms is provided. Finally, biomedical applications exploiting MPL are presented, including photocleaving and photopatterning strategies, biomedical devices, tissue engineering, organoids, organ‐on‐chip, and photodynamic therapy. This review offers a helicopter view on the use of MPL technology in the biomedical field and defines the necessary considerations toward selection or design of PIs and photoreactive biomaterials to serve a multitude of biomedical applications.

A COMPARATIVE STUDY OF MEDICAL DEVICES AND THEIR REGULATIONS IN US, EU, INDIA, AND CHINA

The usage of medical device is on the rise due to the rise in incidence rate of chronic diseases, irregular health check-ups, and sedentary lifestyles and also rising cases of obesity, diabetes, neuro-based disorders, heart diseases, and chronic diseases relating to lifestyle disorders. Availability of hassle free home monitoring medical devices that can be used even by patients with no knowledge about the technical aspects made their way into patient homes. Even in the presence of restraining factors such as high cost and reimbursement issues, the opportunities for medical device professionals lie in the technological advancements and usage of internet of medical things in modern healthcare and the latest trend toward developing smart medical devices with fast development in (AI) and (ML). The usage of medical devices is on the rise due to medical device development is undergoing a huge technological advancement due to emergence 3D printing which allows development of devices designed specifically as per patient requirements. Medical devices like freestyle liber system by Abbott laboratories eliminate need for routine finger pricking as it has sensor that measures and records glucose levels through clothing of the consumer. Quickie Q300 M mini Wheelchair fits even in tight doorways, navigates restaurants, that are crowded and also in difficult living spaces. Harmonization of medical devices registration across the markets is essential to paue way for their easy approval and also in dealing with the withdrawn issues related to quality, safety, and performance. This review involves a comparative study of medical device regulations in four regions (US, EU, India and China).

Invited commentary: Comparison of visual discomfort experienced by surgeons in wireless versus conventional endoscopy in laparoscopic surgery.

In this study titled “A comparison of visual discomfort experienced by surgeons in wireless versus conventional endoscopy in laparoscopic surgery,” Xu et al. present a novel fifth-generation transmission wireless endoscopic system. They evaluated the visual discomfort in a small cohort of single-institution surgeons (n = 20) and compared its degree between conventional and wireless endoscopic laparoscopic surgeries (laparoscopic radical prostatectomy and laparoscopic radical cystectomy). Subjective questionnaires and objective physiological indicators were used to assess this outcome. They found no difference in visual discomfort between these technologies. For decades, the development of new medical and surgical devices has enabled the rise of state-of-the-art minimally invasive surgeries and enhanced the treatment efficiency of diseases. New technologies have affected every aspect of patient care. The introduction of laparoscopic, robotic, and endoscopic surgery in the urological field has allowed surgeons to push treatment boundaries and perform more challenging procedures in a less invasive manner. However, the “minimally invasive” laparoscopic approach is associated with greater perceived discomfort and musculoskeletal pain. [1] Notwithstanding the surgeons' burden associated with the laparoscopic surgery approach, [2] the technique is currently preferred over the open surgery technique for most cases, as it is associated with less pain, less bleeding, and shorter recovery time for patients. [3] In recent years, surgeons' ergonomic awareness has increased. Factors such as exposure and visualization, surgical instrumentation, and posture are key to avoiding musculoskeletal pain and long-term injury. [4] Thus, ergonomic integration and an appropriate operating room environment are paramount to ensure surgical efficiency, safety, and surgeon comfort. [5] The wireless innovative surgical device presented in the study may be comparable to the wired instrument in terms of visual discomfort; however, it may provide other essential benefits such as reduced physical exertion during surgery. Removing the camera wire from the surgical field confers a clear advantage in creating a clean and tidy terrain. The use of wireless devices in the operating room may aid in creating a better environment and improve surgeon ergonomics, ultimately translating into better procedures and outcomes. However, conclusions must be drawn with caution when introducing innovative technologies into the surgical setting. It is not possible to accept a technology of less-than-current standard. The benefits of the proposed instrument must outweigh its limitations to be validated and to eventually expand and change practice. This study did not measure crucial variables such as procedure duration, intraoperative complications, and surgical outcomes. The instrument's weight, battery autonomy, and grasp ergonomy are other important aspects that should be considered. Furthermore, the cost of the wireless device should meet the intersection between the need for improvement and availability of resources in the healthcare system. Today, the dramatic acceleration in the development of surgical instrument technology creates a unique need to rapidly adapt to the latest devices to stay at the forefront and continue moving forward in the field. However, such technologies require validation, and studies must collaborate to build the body of evidence necessary to shift from current practices toward new approaches.

Identification of Known Use-Related Problems in Artificial Intelligence Medical Imaging Devices

As Artificial Intelligence (AI) advances, it is included into more and more medical device systems to carry out these systems’ intended functions. Given AI’s ability to learn from real-world use and its capability to continuously improve performance, manufacturers of medical devices are utilizing AI to innovate their products to better assist health care providers. However, like application of other types of medical devices, the application of AI in medical care might pose different types of potential risks to the patients, the users themselves, and to the use environment. For manufactures to successfully ensure the safety of AI medical devices, it is crucial to identify known problems by investigating use-related, user interface, and user interaction in-cidents that have occurred in comparable medical devices. The objective of this study is to identify potential use-related problems of DeepView® Wound Imaging System that assesses the healing potential of thermal burn wounds by analyzing multispectral images with an ML algorithm. We use a variety of sources of information on reports and recalls of medical devices that are associated with deaths, serious injuries and mal-functions. After examining relevant reports and recalls, 19 use-related problems were identified. An in-depth analysis was then conducted, considering each identified use-related problem and determining how it relates to the specific features and functionality of DeepView® Wound Imaging System as well as identifying patterns and commonalities among them. The information gained from this analysis can be beneficial in enhancing the safety of AI medical devices by providing a deeper understanding of the reasons for failure, to avoid similar issues in the future, and ultimately to improve patient safety and public health.

A Study on Developing Safety and Performance Assessment Guideline for Electronic Warm-Acupuncture Apparatus

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity.Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was draftedResults: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety.Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

Heuristic evaluation of portable pulse oximeters for domiciliary use: Implications for its use in assessing medical device usability

Medical Device manufacturers must consider usability during medical device design to minimise the risk of harm associated with user error. However, devices are increasingly being incorporated into home care pathways and may be adopted in contexts unforeseen by manufacturers. In situations where devices are being used without supervision of a healthcare professional, device usability is more important. The first objective of this research was to use heuristic evaluation to assess the usability of pocket pulse oximeters used in National Health Service home pathways. The second objective was to investigate the value of heuristic evaluation as a tool to assess medical device usability. 10 heuristic evaluators independently assessed 5 portable pulse oximeters using 15 heuristics. The value of the heuristic evaluation in evaluating device usability was assessed. A total of 42 unique use problems were identified across all devices. 76% of use problems received the lowest severity score (1). We identified limitations in the methodology used and suggested modifications to improve the evaluation process. Heuristic evaluation pre-empted use problems and allowed for quantitative usability comparisons between devices. We found value in heuristic evaluation used to objectively identify device design flaws, particularly with the minor modifications suggested.

A four-prong approach for engaging biomedical engineering students

My involvement in a large medical imaging company for nearly 20 years shaped my approach to teaching biomedical engineering. These experiences are described in Medical Physics International Journal, 6,602–620, May 2021. At Boston University, I taught undergraduates using a four pronged approach. The first part included a “lessons learned” career overview lecture and discussion to incoming freshman. This talk emphasized shifting paradigms in medical device development and changing trends in research and development and how to best prepare for a biomedical engineering career by prudent course selection, practical experience and life-long networking. Second, I designed two ultrasound lab modules which were part of the mandatory physiology lab all juniors took. These laboratories provided condensed theory with hands-on experiments on imaging and Doppler processing/imaging and data analysis. Third, I taught ultrasound and medical imaging courses which included rigorous theory, applications and examples. My book, Diagnostic Ultrasound Imaging: Inside Out, second edition, is being used in ultrasound courses throughout the world. A new book and curriculum, coauthored with Peter Kaczkowski, and sponsored by Verasonics, is underway. Finally, for 15 years, I taught a usually two semester course in entrepreneurship, innovation and engineering design which culminated in a team-based senior project.