Effective Medical Devices Research Articles

A review of human factors and infusion pumps: lessons for procurement

Integrating advanced technologies like medical devices in healthcare is crucial for addressing critical challenges, but patient safety must remain the top priority. In modern clinical settings, medical devices, such as infusion devices used to administer fluids and drugs, carry risks from use errors, requiring a focus on usability and human factors engineering (HFE). Despite the significance of integrating HFE into technology selection processes, it is often overlooked. A review of five key articles demonstrates how applying HFE principles in procurement strategies can enhance device usability and patient safety. Although designed to reduce medication errors, infusion devices can still cause over-infusion or delays, indicating the need for improved safety features that must be considered in the context of sociotechnical systems. The reviewed studies suggest incorporating HFE in design, purchasing, and implementation to address these issues. The studies highlight various HFE methodologies, showing a wide variation in design, deployment, interpretation, and reporting. This comprehensive examination underscores the importance of standardised evaluations to ensure safer and more effective medical devices, emphasizing the essential role of HFE in advancing patient safety within healthcare settings.

Comparative Analysis of Blood Transfusion Accuracy and Hemolysis Rate of Transfusion Cartridge Set Between Conventional Infusion Pumps and Cylinder-Type Infusion Pumps.

Infusion pumps are critical in delivering fluids, including medications and blood products, in controlled amounts. However, conventional pumps can cause hemolysis and other issues such as flow variations and infection risks, especially during blood transfusions. To address these limitations, a novel cylinder-type infusion pump, the Anyfusion H-100, was developed, which includes a specialized blood transfusion cartridge set that combines syringe and peristaltic infusion methods. This study evaluates the accuracy and hemolysis rates of the Anyfusion H-100 compared to conventional pumps, aiming to confirm its viability as a safe and effective medical device for blood transfusions. This study evaluated six different infusion rates (10-180 cc/hr) and conducted 57 transfusion trials, 20 of which used a 1:1 blood-saline dilution. Blood transfusion accuracy was measured using research-grade packed red blood cells, and hemolysis rates were assessed before and after transfusion by chi-square tests and independent sample t-tests. Anyfusion demonstrated an average transfusion error rate of 3.77%, compared to 4.00% for the Terufusion, with no statistically significant difference in hemolysis rates (p = 0.697). Bland-Altman plots confirmed their equivalent performance, with hemolysis rates of 0.566 ± 0.095% for Anyfusion and 0.518 ± 0.126% for Terufusion. Anyfusion provides an accurate and reliable blood transfusion performance comparable to that of Terufusion, with no significant difference in hemolysis rates; its integration of syringe and infusion methods shows a potential for safer and more efficient transfusion practices, especially in pediatric and emergency settings.

Regulatory Quality in the International Circulation of Medicinal Products

Since 2014, the World Health Organization has been implementing a large-scale project to strengthen and develop national regulatory systems, which is aimed at increasing the availability of safe, effective and high-quality medicines and medical devices for the population of all countries, but primarily low- and middle-income countries. The project analyzes the maturity of national regulatory systems using a global benchmarking tool developed based on various regulatory authority assessment systems and has undergone extensive discussion and pilot testing; the results of national authorities that have reached high levels of maturity are published. A WHO List of Regulatory Authorities is also being formed, replacing the previously used concept of "stringent regulatory authorities". This List is recommended for use in regulatory reliance procedures by national regulatory authorities, purchasing structures of various levels and status: commercial, public, state or international. The regulatory quality of drug regulation is one of the critical factors of any national healthcare system. At the global level, it is directly related to goals 1,3,8,9 and 11 of sustainable development defined by the UN. The WHO project under consideration to assess maturity) of the regulatory system of the pharmaceutical sector is fundamentally different from similarly focused projects carried out in the past. First of all, the project focuses not on legal and regulatory/methodological documents, but on institutional and procedural aspects, i.e. on the structure and functions of regulatory bodies. Along with this, the project can have a significant impact on global pharmaceutical markets.

Thirty-five Years of Reporting of Sex and Race in Clinical Studies of U.S. FDA-Authorized Orthopaedic Devices.

At the U.S. Food and Drug Administration (FDA), the mission of the Center for Devices and Radiological Health (CDRH) is to ensure that all patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Although the CDRH has observed enrollment differences in some clinical trials, no systematic analysis has been conducted regarding enrollment differences in baseline demographics, to our knowledge. The CDRH has summarized information on study participants and their baseline demographics in public-facing documentation for all authorized medical devices that involved orthopaedic clinical studies from 1985 to 2020. Descriptive analyses and exploratory statistical testing have been conducted to investigate the reported percentages by sex and race compared with those reported in the U.S. National Census and the American Joint Replacement Registry (AJRR), respectively. We identified 94 submissions and corresponding combined clinical trials from 261 original clinical study arms with 34,193 participants. Most of the submissions reported age and sex, while only 36 submissions (38.3%) reported racial demographics. Among the 88 trials providing enrollment by sex, the female enrollment percentage ranged from 22.2% to 88.7%, with a mean of 55.0%. In the submissions that reported racial data (38.3%), White and Black patients had a mean enrollment of 89.2% (range, 64.8% to 98.7%) and 6.2% (range, 0.4% to 20.7%), respectively. The enrollment for other minority groups ranged from 0% to 3.0%. These clinical trials have shown numerically lower female representation (55.0%) but higher White representation (89.2%) than what has been reported in the AJRR. The other racial groups have participated much less than their corresponding percentages in the U.S. population, but they are similarly represented in the AJRR. The clinical trials supporting the FDA's authorization of orthopaedic devices had a wide range of sex and racial enrollments. It appears that female enrollment mirrors the percentage of women in the U.S. population. However, despite prior efforts, some racial groups are still underrepresented. The FDA has made a commitment to advancing health equity as part of the 2022-2025 Strategic Priorities of the CDRH. We hope that the results of this study will help health-care professionals make informed clinical decisions when using medical devices.

Current Application of the Medical Device Single Audit Program (MDSAP) as a Global Regulatory Reliance Framework for the Inspection of Medical Devices.

The globalization and rapid advancements in medical technologies necessitate the harmonization of international regulatory frameworks to ensure the efficient and timely clinical application of medical products, including pharmaceuticals and medical devices. Regulatory reliance, a critical component of this harmonization process, is a powerful tool that provides efficient access for economic entities and regulatory authorities, promoting predictable decision-making and accelerating approvals. The Medical Device Single Audit Program (MDSAP) serves as a regulatory reliance framework for medical device inspections. Implemented by countries including Japan, the United States, Canada, Australia, and Brazil, MDSAP allows third-party certification bodies, recognized by these regulatory authorities, to conduct audits on medical device manufacturers. The outcomes of these audits are shared with the regulatory authorities, who use them for regulatory assessments and decision-making. Since transitioning to its implementation phase in 2017, MDSAP has been widely utilized in various countries. This review provides an overview of the adoption and utilization of MDSAP in major countries, exploring the program's impact on regulatory processes and its potential as a method of regulatory reliance to facilitate timely access to effective and safe medical devices.

Enhanced specific surface area and mechanical property of silk nanofibers aerogel for potential hemostasis applications

Biopolymer aerogel is a new type of material with potential applications in the biomedical field. Silk fibroin is of particular interest as a raw material with good biocompatibility and degradable. However, the low mechanical strength and small specific surface area of silk fibroin aerogels limit its further development. Herein, a fast water absorption, highly specific surface area and mechanically strong of aerogels were prepared using low crystal silk fibroin nanofibers (SNF), sol-gel process, solvent exchange and supercritical carbon dioxide (CO2) drying method. The resulting Aero-Sc displayed highly specific surface area (251 m2/g), porosity (97.6 %) and water absorption capacity (1200 %). Furthermore, with rapid water absorption and stronger erythrocyte adhesion, the Aero-Sc showed highly effective hemostasis in vitro. In vivo, animal experiments on rat liver hemorrhage model confirmed that SNF aerogels have a less blood loss (312 ± 29 mg) and faster hemostatic time (92 ± 13 s) than commercially gelatin sponge (p < 0.05). The unique properties of silk fibroin nanofibers aerogel developed in this study has great potential to be a safe and effective hemostatic medical device.

Early Experience With the Iliac Branch Endoprosthesis (IBE) in Managing Iliac Aneurysms.

Aim The objective of this study is to evaluate the feasibility of using iliac branch endoprosthesis (IBE) devices and to examine their short-term outcomes. Materials and methods This was a descriptive, retrospective observational study involving 15 patients diagnosed with either aortoiliac or isolated iliac artery aneurysms and treated with an IBE device. Data were collected for patients who received IBE devices at Glan Clwyd Hospital in Rhyl, United Kingdom, from February 2020 to May 2023. Results Most patients presented with asymptomatic aneurysms; 86.7% (n = 13) had bilateral common iliac artery (CIA) aneurysms. The mean diameter of the CIA was 38.7 ± 8.8 mm, and the mean diameter of the abdominal aortic aneurysm (AAA) was 39.8 ± 23 mm. For the indications of IBE use, 60% (n = 9) of the patients had iliac aneurysms reaching the intervention threshold, 20% (n = 3) had AAA reaching the threshold, and 20% (n = 3) had aortoiliac aneurysms reaching the threshold. The majority of patients underwent bilateral femoral access (86.7%; n = 13), while 13.3% (n = 2) required both femoral and brachial access. Technical success was achieved in all cases. Aside from 20% (n = 3) of cases where the sac size remained static, the majority of patients (80%; n = 12) experienced sac regression. All patients were free from buttock claudication. A type II endoleak was observed in 33.3% (n = 5) of patients. No reinterventions were reported. The mean primary patency was 30.9 ± 0.7 months, and the follow-up period ranged from 12 to 36 months. Conclusions IBEs are an effective medical device, demonstrating a high rate of technical success, minimal need for additional procedures, and a low incidence of complications while maintaining a satisfactory rate of primary patency.

Navigating challenges in new product development: Strategies for reducing failure rates in the medical device industry

New product development (NPD) in the medical device industry is critical for advancing healthcare technology and improving patient outcomes. Due to high usage of automated processes and applications in healthcare, the medical devices are not limited to products but have expanded to software as medical device. However, the failure rate of NPD projects in this sector remains high due to various challenges. This article explores the complex NPD process, which includes concept development, feasibility studies, design, and development, verification and validation, regulatory approval, and commercialization. Major reasons for project failures are identified, such as regulatory challenges, Change Management issues, market misalignment, communication failures, and insufficient risk management. Addressing these failure points requires a multifaceted approach. Regulatory pathways should be navigated with careful planning and compliance, and market needs must be thoroughly understood through comprehensive research. Resource allocation should be optimized to avoid constraints, and effective communication channels should be established to align all project participants. Finally, implementing rigorous risk management strategies, such as Failure Modes and Effects Analysis (FMEA), can help mitigate potential risks early in the development process. By adopting these strategies, medical device companies can improve their NPD processes, reduce the failure rate of projects, and bring innovative and effective medical devices to market successfully.

Comparative study on physicochemical properties of macroporous hydroxyapatite coatings on 316L stainless steel implants using sol-gel and inverse opal templating

This study focuses on enhancing metallic implant biocompatibility by fabricating a three-dimensional ordered macroporous hydroxyapatite (HAP) architecture through inverse opal technology. Utilizing colloidal crystal templates on 316L stainless steel, specifically with polystyrene and polymethyl methacrylate, successful fabrication was achieved through H2O2 plus H2SO4 etching. The calcination process at different temperatures (350, 500 and 700°C) resulted in distinct HAP structures, and the sample was calcined at 500°C (HAP500), exhibiting superior physicochemical properties, including enhanced crystallinity, surface roughness and wettability. Biological experiments demonstrated that HAP500 significantly promoted mesenchymal stem cell adhesion and proliferation compared to HAP350 and bare 316LSS, suggesting its potential as a highly effective medical device for bone implantation.

Healthcare Providers’ Readiness to Address Medical Device Cybersecurity within the Irish Healthcare System

Medical devices that can diagnose and treat critically ill patients have become sophisticated and complex. Device manufacturers have been developing these systems to meet market requirements as technology evolves. Combining medical devices and ICT into a distributed medical device IT system can be a solution to incorporating continuous monitoring from the patient bedside to interoperability with a clinical information system. These technology innovations aim to manage patient data and configure medical devices into networked systems that can provide functionality and safety. The implementation of a medical device network solution allows a healthcare provider to take advantage of managing the flow of information to improve clinical work practices and implement a system that can be interoperable with other clinical information systems. International Electrotechnical Commission (IEC) 80001-1 was developed to assist healthcare providers in identifying and managing the risks associated with medical devices sharing the same IT network with other systems and software. This standard defines roles, responsibilities, and activities in relation to the management of risk with medical devices on an IT network. This study aims to determine if the standard International Electrotechnical Commission (IEC) 80001-1 is being implemented and determine familiarity with regulations and appropriate standards and guidance for an effective medical device security risk-management program with Irish healthcare providers. A literature review highlighted the restrictions healthcare providers face in adopting and implementing IEC 80001-1 and the security threats and risks present when integrating medical devices and IT networks. The study research was conducted with clinical engineering members of the Biomedical and Clinical Engineering Association of Ireland (BEAI). This survey targeted BEAI members due to their wealth of experience, knowledge, and skill level in supporting complex medical device systems. An online anonymous survey was created to determine knowledge, awareness, and familiarity with IEC 80001-1 and other medical device security risk-management guidelines. The study research results revealed low knowledge, awareness, and familiarity among research participants with IEC 80001-1 and guidelines on medical device security risk management. These results were consistent with the literature review that a key to the success of standard adoption is collaboration between stakeholders and a multidisciplinary approach to compliance.

Micrometer-thick and porous nanocomposite coating for electrochemical sensors with exceptional antifouling and electroconducting properties

Development of coating technologies for electrochemical sensors that consistently exhibit antifouling activities in diverse and complex biological environments over extended time is vital for effective medical devices and diagnostics. Here, we describe a micrometer-thick, porous nanocomposite coating with both antifouling and electroconducting properties that enhances the sensitivity of electrochemical sensors. Nozzle printing of oil-in-water emulsion is used to create a 1 micrometer thick coating composed of cross-linked albumin with interconnected pores and gold nanowires. The layer resists biofouling and maintains rapid electron transfer kinetics for over one month when exposed directly to complex biological fluids, including serum and nasopharyngeal secretions. Compared to a thinner (nanometer thick) antifouling coating made with drop casting or a spin coating of the same thickness, the thick porous nanocomposite sensor exhibits sensitivities that are enhanced by 3.75- to 17-fold when three different target biomolecules are tested. As a result, emulsion-coated, multiplexed electrochemical sensors can carry out simultaneous detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid, antigen, and host antibody in clinical specimens with high sensitivity and specificity. This thick porous emulsion coating technology holds promise in addressing hurdles currently restricting the application of electrochemical sensors for point-of-care diagnostics, implantable devices, and other healthcare monitoring systems.

Accelerated simulation methodologies for computational vascular flow modelling.

Vascular flow modelling can improve our understanding of vascular pathologies and aid in developing safe and effective medical devices. Vascular flow models typically involve solving the nonlinear Navier-Stokes equations in complex anatomies and using physiological boundary conditions, often presenting a multi-physics and multi-scale computational problem to be solved. This leads to highly complex and expensive models that require excessive computational time. This review explores accelerated simulation methodologies, specifically focusing on computational vascular flow modelling. We review reduced order modelling (ROM) techniques like zero-/one-dimensional and modal decomposition-based ROMs and machine learning (ML) methods including ML-augmented ROMs, ML-based ROMs and physics-informed ML models. We discuss the applicability of each method to vascular flow acceleration and the effectiveness of the method in addressing domain-specific challenges. When available, we provide statistics on accuracy and speed-up factors for various applications related to vascular flow simulation acceleration. Our findings indicate that each type of model has strengths and limitations depending on the context. To accelerate real-world vascular flow problems, we propose future research on developing multi-scale acceleration methods capable of handling the significant geometric variability inherent to such problems.

The "Big Three" in biocompatibility testing of medical devices: implementation of alternatives to animal experimentation-are we there yet?

Biocompatibility testing ensures the safety of medical devices by assessing their compatibility with biological systems and their potential to cause harm or adverse reactions. Thus, it is a critical part of the overall safety evaluation process for medical devices. Three primary types of biocompatibility tests-cytotoxicity, irritation, and sensitisation assessment-are standard for nearly all medical devices. However, additional biocompatibility tests, such as genotoxicity, systemic toxicity, hemocompatibility, and implantation studies, may also be necessary, depending on the device's nature and intended use. The testing is partly conducted in vitro, but the industry still heavily relies on animal experiments. Compared to other industrial sectors, implementing alternatives in medical device biocompatibility testing has been notably slower. This delay can be attributed to the absence of specific validation processes tailored to medical devices and the resulting hesitation regarding the predictive capacity of these alternative methods despite their successful applications in other domains. This review focuses on the progress and obstacles to implementing new approach methodologies in the areas of cytotoxicity, irritation and sensitisation testing of medical devices. While challenges persist in adopting these innovative methods, the trend towards embracing alternatives remains robust. This trend is driven by technological advancements, ethical considerations, and growing industrial interest and support, all collectively contributing to advancing safer and more effective medical devices.

Evolution of the Chronic Venous Leg Ulcer Microenvironment and Its Impact on Medical Devices and Wound Care Therapies.

Studies have reported that the constituents of the wound microenvironment are likely to have critical roles in the degradation and fate of the polymeric matrix and the compounds dissolved in the wound dressing matrix. Thus, chronic wound assessment and the design of effective medical devices and drug products for wound care partly rely on an in-depth understanding of the wound microenvironment. The main aim of this review is to identify and discuss the different stages of chronic wound progression, focusing on the changes in the biochemical composition of the wound microenvironment, with particular attention given to venous leg ulcers (VLUs), as they are one of the most prevalent chronic wound aetiologies. The pathophysiology of venous ulcers is detailed, followed by a thorough review of what is known about the VLU microenvironment and its changes as a function of the evolution of the VLU. Simulating conditions for VLU are then discussed with the view of highlighting potentially relevant simulating media as a function of VLU evolution for a better assessment of biological safety, in particular medical devices intended to be in contact with these wounds.

The Crucial Role of Microbiological Testing in Ensuring Safety and Efficacy of Medical Devices: An Overview

Microbiological testing is a critical aspect of the development and evaluation of medical devices, as it plays a vital role in ensuring their safety and efficacy. This article highlights the importance of microbiological testing in medical device development and the various types of tests that are commonly performed. Microbiological testing is essential for assessing the potential risks associated with medical devices, such as bacterial contamination or infections. Testing can also help to identify potential sources of contamination during the manufacturing process and to monitor the efficacy of sterilization methods. In addition, microbiological testing is crucial in determining the appropriate usage and maintenance procedures for medical devices. By providing accurate and reliable data, microbiological testing can aid in the development of safe and effective medical devices, while also ensuring compliance with regulatory standards. Overall, this article emphasizes the critical role of microbiological testing in the development and evaluation of medical devices, and highlights its significance in maintaining patient safety and improving health care outcomes.

Assessing the Biodegradability of PHB-Based Materials with Different Surface Areas: A Comparative Study on Soil Exposure of Films and Electrospun Materials.

Due to the current environmental situation, biopolymers are replacing the usual synthetic polymers, and special attention is being paid to poly-3-hydroxybutyrate (PHB), which is a biodegradable polymer of natural origin. In this paper, the rate of biodegradation of films and fibers based on PHB was compared. The influence of exposure to soil on the structure and properties of materials was evaluated using methods of mechanical analysis, the DSC method and FTIR spectroscopy. The results showed rapid decomposition of the fibrous material and also showed how the surface of the material affects the rate of biodegradation and the mechanical properties of the material. It was found that maximum strength decreased by 91% in the fibrous material and by 49% in the film. Additionally, the DSC method showed that the crystallinity of the fiber after exposure to the soil decreased. It was established that the rate of degradation is influenced by different factors, including the surface area of the material and its susceptibility to soil microorganisms. The results obtained are of great importance for planning the structure of features in the manufacture of biopolymer consumer products in areas such as medicine, packaging, filters, protective layers and coatings, etc. Therefore, an understanding of the biodegradation mechanisms of PHB could lead to the development of effective medical devices, packaging materials and different objects with a short working lifespan.

Significance of ISO 10993 Standards in Ensuring Biocompatibility of Medical Devices: A Review

This review paper aims to highlight the crucial role of ISO 10993 standards in ensuring the biocompatibility of medical devices. The use of medical devices has increased rapidly over the years, and it is essential to ensure that these devices do not cause adverse reactions or harm to patients. Biocompatibility testing is a critical aspect of medical device development and is mandated by regulatory bodies worldwide. ISO 10993 standards provide guidelines for evaluating the biocompatibility of medical devices, which includes various tests such as cytotoxicity, sensitization, and irritation. This paper discusses the importance of biocompatibility testing, the different types of ISO 10993 tests, and the challenges faced by the medical device industry in implementing these standards. The review also emphasizes the significance of appropriate material selection, manufacturing processes, and sterilization methods to ensure the biocompatibility of medical devices. Ultimately, the paper highlights the importance of adhering to ISO 10993 standards in designing safe and effective medical devices that benefit patients and healthcare providers alike.

Imidazolium Salts for Candida spp. Antibiofilm High-Density Polyethylene-Based Biomaterials

The species of Candida present good capability to form fungal biofilms on polymeric surfaces and are related to several human diseases since many of the employed medical devices are designed using polymers, especially high-density polyethylene (HDPE). Herein, HDPE films containing 0; 0.125; 0.250 or 0.500 wt% of 1-hexadecyl-3-methylimidazolium chloride (C16MImCl) or its analog 1-hexadecyl-3-methylimidazolium methanesulfonate (C16MImMeS) were obtained by melt blending and posteriorly mechanically pressurized into films. This approach resulted in more flexible and less brittle films, which impeded the Candida albicans, C. parapsilosis, and C. tropicalis biofilm formation on their surfaces. The employed imidazolium salt (IS) concentrations did not present any significant cytotoxic effect, and the good cell adhesion/proliferation of human mesenchymal stem cells on the HDPE-IS films indicated good biocompatibility. These outcomes combined with the absence of microscopic lesions in pig skin after contact with HDPE-IS films demonstrated their potential as biomaterials for the development of effective medical device tools that reduce the risk of fungal infections.

HH model based smart deep brain stimulator to detect, predict and control epilepsy using machine learning algorithm

BackgroundEpilepsy is the most common neurological disorder in the world. To control epilepsy, deep brain stimulation is one of the widely accepted treatment techniques. However, conventional deep brain stimulation technique provides continuous stimulation without optimizing the stimulation parameters, resulting in adverse side effects and unexpected death. Hence, understanding the dynamic behavior of brain neural networks at a cellular level is required for patient-specific epilepsy treatment. Considering the underlying mechanism of a single neuronal shift in the brain neural network, computational model-based techniques have a new face for healthcare, which aims to develop effective medical devices for preclinical investigations. New methodThis paper discusses the design of a Smart Deep Brain Stimulator (SDBS) using the Hodgkin-Huxley (HH) conductance-based cellular model of brain neurons to automatically detect, predict and regulate epilepsy against patient-specific conditions. Epileptic activity is simulated as a spike train of action potential due to sodium and potassium channel conductance variations in the single-neuron HH model. The proposed SDBS consists of three components:- i) seizure detection using bagging and boosting-based ensemble machine learning classifiers, ii) channel conductance prediction using Long Short Term Memory-Recurrent Neural Network (LSTM-RNN) based Deep Neural Network (DNN) for updating model parameters of brain neuron, and iii) model-based intelligent control of epileptic seizure with Nonlinear Autoregressive Moving Average-L2 (NARMA-L2) Controller and Nonlinear Model Predictive Controller (NMPC). ResultsFor effective treatment, improving the overall accuracy and efficiency of SDBS is essential. For epilepsy detection, the ensemble bagging machine learning algorithm provides better accuracy of 92.7% compared to the ensemble boosting algorithm. LSTM-RNN deep neural network model with four layers predicts the variations in channel conductance with Root Mean Square Error (RMSE) of 0.00568 and 0.009081 for sodium and potassium channel conductance, respectively. From the closed-loop performances of SDBS with an intelligent control scheme, it is observed that SDBS with NMPC provides efficient and accurate stimulation with minimum energy consumption. From a stability point of view, SDBS with NMPC provides better stability than SDBS with NARMA-L2 Controller. Comparison with existing methodThe proposed SDBS is designed to generate accurate stimulation pulses for epilepsy patients with specific conditions depending on the neuronal activity of a single neuron. Moreover, it will also adapt to the dynamic condition of epilepsy patients. The existing deep brain stimulator continuously provides stimulation pulses without adapting to the patient’s conditions. ConclusionThe proposed SDBS could provide patient-specific treatment based on sodium/potassium channel conductance variations of brain neurons. It will help increase the use of deep brain stimulation techniques and reduce sudden death. Furthermore, the proposed technique will be extended to neural network models with larger neuronal populations to improve the practical feasibility.

Systems and processes for regulation of investigational medical devices in Uganda.

In many parts of the world, medical devices and the processes of their development are tightly regulated. However, the current regulatory landscape in Uganda like other developing countries is weak and poorly defined, which creates significant barriers to innovation, clinical evaluation, and translation of medical devices. To evaluate current knowledge, systems and infrastructure for medical devices regulation and innovation in Uganda. A mixed methods study design using the methods triangulation strategy was employed in this study. Data of equal weight were collected sequentially. First, a digital structured questionnaire was sent out to innovators to establish individual knowledge and experience with medical device innovation and regulation. Then, a single focus group discussion involving both medical device innovators and regulators to collect data about the current regulatory practices for medical devices in Uganda. Univariate and bivariate analysis was done for the quantitative data to summarize results in graphs and tables. Qualitative data was analyzed using thematic analysis. Ethical review and approval were obtained from the Makerere University School of Biomedical Sciences, Research and Ethics Committee, and the Uganda National Council for Science and Technology. A total of 47 innovators responded to the questionnaire. 14 respondents were excluded since they were not medical device innovators. Majority (76%) of individuals had been innovators for more than a year, held a bachelor's degree with a background in Engineering and applied sciences, and worked in an academic research institute. 22 of the 33 medical device innovators had stopped working on their innovations and had stalled at the proof-of-concept stage. Insufficient funding, inadequate technical expertise and confusing regulatory landscape were major challenges to innovation. The two themes that emerged from the discussion were "developing standards for medical devices regulation" and "implementation of regulations in practical processes". Legal limitations, lengthy processes, and low demand were identified as challenges to developing medical device regulations. Efforts have been taken by government to create a pathway for medical device innovations to be translated to the market. More work needs to be done to coordinate efforts among stakeholders to build effective medical device regulations in Uganda.