Innovative medical devices

This research paper aims to explore the mechanical characteristics of polyamide PA12 (PA12) as a 3D material printed utilizing Selective Laser Sintering (SLS) and HP MultiJet Fusion (HP MJF) technologies in order to design and manufacture forearm orthoses. The study assessed the flowability of the materials used and compared the mechanical performance of PA12 with each other using tensile, flexure, and impact tests in five different fabrication orientations: X, Y, Z, tilted 45° XZ, and tilted 45° YZ...

Novel medical devices must conform to medical device regulation (MDR) for European market entry. Likewise, chemicals must comply with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh) regulation. Both pose regulatory challenges for manufacturers, but concordantly provide an approach for transferring data from an already registered device or compound to the one undergoing accreditation. This is called equivalence for medical devices and read-across for chemicals. Although read-across is not explicitly prohibited in the process of medical device accreditation, it is usually not performed due to a lack of guidance and acceptance criteria from the authorities...

Over the past decades, research on nanomedicines as innovative tools in combating complex pathologies has increased tenfold, spanning fields from infectiology and ophthalmology to oncology. This process has further accelerated since the introduction of SARS-CoV-2 vaccines. When it comes to human health, nano-objects are designed to protect, transport, and improve the solubility of compounds to allow the delivery of active ingredients on their targets. Nanomedicines can be administered by different routes, such as intravenous, oral, intramuscular, or pulmonary routes...

Rapid technological advancements have created opportunities for new solutions in various industries, including healthcare. One exciting new direction in this field of innovation is the combination of skin-based technologies and augmented reality (AR). These dermatological devices allow for the continuous and non-invasive measurement of vital signs and biomarkers, enabling the real-time diagnosis of anomalies, which have applications in telemedicine, oncology, dermatology, and early diagnostics. Despite its many potential benefits, there is a substantial information vacuum regarding using flexible photonics in conjunction with augmented reality for medical purposes...

The innovative technique of "presurgical lip, alveolus, and nose approximation" (PLANA) offers a new approach within the domain of presurgical infant orthopedics for infants born with cleft lip and palate. Presurgical lip, alveolus, and nose approximation introduces the utilization of the NoseAlign device in conjunction with medical adhesive tapes, designed to approximate and support displaced soft tissue nasolabial structures in patients with cleft, without an intraoral plate. The NoseAlign device, constructed from medical-grade silicone, consists of 2 tubular portions that fit into the nostrils, connected by a columella band...

The conventional metered dose inhaler (MDI) has long served as a cornerstone in the management of asthma and chronic obstructive pulmonary disease (COPD), affecting millions annually. Despite its advantages, a persistent challenge is seen in the form of patient education and the unchanged design of these inhalers since their inception in 1956. This lack of progress in MDI design has inadvertently contributed to incidences of foreign body inhalation. In this case presentation we report a 50-year-old male with a past medical history of asthma, who faced an incident of foreign body inhalation with use of his inhaler...

Research evidence shows that physical rehabilitation exercises prescribed by medical experts can assist in restoring physical function, improving life quality, and promoting independence for physically disabled individuals. In response to the absence of immediate expert feedback on performed actions, developing a Human Action Evaluation (HAE) system emerges as a valuable automated solution, addressing the need for accurate assessment of exercises and guidance during physical rehabilitation. Previous HAE systems developed for the rehabilitation exercises have focused on developing models that utilize skeleton data as input to compute a quality score for each action performed by the patient...

Blood glucose monitoring constitutes a pivotal element in the clinical management of Type 1 diabetes (T1D), a globally escalating metabolic disorder. Continuous glucose monitoring (CGM) devices have demonstrated efficacy in optimizing glycemic control, mitigating adverse health outcomes, and augmenting the overall quality of life for individuals afflicted with T1D. Recent progress in the field encompasses the refinement of electrochemical sensors, which enhances the effectiveness of blood glucose monitoring...

Introduction The authors examined if the transparency in industry payments to foot and ankle-trained orthopedic surgeons resulted in the following changes to the (1) median general payments to surgeons, (2) trend in median payments to surgeons across all subcategory payments, and (3) trend in median payments to surgeons in 11 regions of the United States. Methods A retrospective review of the Centers for Medicare and Medicaid Services (CMS) and Open Payments Database (OPD) was performed to identify all industry payments made by drug and medical device companies to orthopedic surgeons (N = 3,835) between January 1, 2014, and December 31, 2019...

INTRODUCTION: Expandable devices such as interbody cages, vertebral body reconstruction cages, and intravertebral body expansion devices are frequently utilized in spine surgery. Since the introduction of expandable implants in the early 2000s, the variety of mechanisms that drive expansion and implant materials have steadily increased. By examining expandable devices that have achieved commercial success and exploring emerging innovations, we aim to offer an in-depth evaluation of the different types of expandable cages used in spine surgery and the underlying mechanisms that drive their functionality...

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Neural probe engineering is a dynamic field, driving innovation in neuroscience and addressing scientific and medical demands. Recent advancements involve integrating nanomaterials to improve performance, aiming for sustained in vivo functionality. However, challenges persist due to size, stiffness, complexity, and manufacturing intricacies. To address these issues, we propose a neural interface utilizing freestanding CNT-sheets drawn from CNT-forests integrated onto thermally drawn functional polymer fibers...

The magnitude of the impact of technological innovations on healthcare expenditure is unclear. This paper estimated the impact of high-technology procedures on public healthcare expenditure for patients with ischemic heart disease (IHD) in Portugal. The Blinder-Oaxaca decomposition method was applied to Portuguese NHS administrative data for IHD discharges during two periods, 2008-2015 vs. 2002-2007 (N = 434,870). We modelled per episode healthcare expenditures on the introduction of new technologies, adjusting for GDP, patient age, and comorbidities...

Defining innovation in the field of medical devices can be extremely challenging due to the peculiarity of the products within this class. Short life-cycle, incrementality, learning curve effect, impact of the organizational setting, uncertainty of effect and level of evidence are only some of these aspects. A clear set of criteria to define innovation would be of paramount relevance in this field. Twelve criteria to define innovation were proposed to a multistakeholder panel within a consensus process. A Delphi method on two rounds was used to reach consensus...

BACKGROUND: Operating safely throughout the coronavirus disease 2019 (COVID-19) pandemic has required surgical centers to adapt and raise their level of readiness. Intuitively, additional expenses related to such adaptation may have resulted in an increase in the cost of surgical care. However, little is known about the magnitude of such an increase, and no study has evaluated the temporal variation in the costs of care throughout the pandemic. The aim of the current study was to evaluate the impact of COVID-19 on the cost of surgical and anesthetic care in a free-standing, pediatric ambulatory care center...

Introduction Since the passage of the Physician Payments Sunshine Act in 2010, the Centers for Medicare and Medicaid Services (CMS) started the National Physician Payment Transparency Program and Open Payments Database (OPD), which allowed for public access to financial disclosures between physicians and industry. Although orthopedic surgeons receive the highest average payments when compared to other specialties, there has been limited data evaluating these payments among the different orthopedic subspecialties...

Vitamins are crucial micronutrients found in limited quantities in food, living organisms, and soil. Since most vitamins are not produced within the human body, a lack of these essential nutrients can result in various physiological disorders. Analyzing vitamins typically involves costly, time-consuming methods, requiring skilled personnel, automated equipment, and dedicated laboratory setups. The pressing need is for the development of efficient, portable, and user-friendly detection techniques that are cost-effective, addressing the challenges associated with traditional analytical approaches...

As life expectancy increases and there is growing demand for BPH treatments, innovative technologies have been developed, allowing for swift recovery, symptom relief, low complication rates, and the possibility of performing procedures on an outpatient basis, often under local anaesthesia. This review aims to describe the outcomes of newly developed minimally-invasive surgical therapies (MIST) for BPH treatment in terms of functional voiding parameters and sexual function. These therapies are categorized into primarily ablative (Aquablation [Aquabeam]), non-ablative (Prostatic Urethral Lift (PUL, Urolift), temporary implantable devices [iTind]), and secondarily ablative procedures (convective water vapor ablation, Rezum, Prostate Artery Embolization [PAE])...

Since the 1960s, efforts have been made to develop new technologies to eliminate the risk of thrombosis in medical devices that come into contact with blood. Preventing thrombosis resulting from the contact of a medical device, such as an implant, with blood is a challenge due to the high mortality rate of patients and the high cost of medical care. To this end, various types of biomaterials coated with polymer-drug layers are being designed to reduce their thrombogenicity and improve their hemocompatibility...

Digital technologies have produced many innovations in care delivery and enabled continuity of care for many people when in-person care was impossible. However, a growing body of research suggests that digital health can also exacerbate health inequities for those excluded from its benefits for reasons of cost, digital literacy, and structural discrimination related to characteristics such as age, race, ethnicity, and socioeconomic status. In this paper, we draw on a political economy perspective to examine structural barriers to progress in advancing digital health equity at the policy level...