Early feasibility studies in the United States: Focus on electrophysiology.

The care of patients with heart rhythm disorders is often dependent on technologies developed to address their unique clinical needs. Although much innovation occurs in the United States, recent decades have seen a significant proportion of early clinical studies performed outside the United States, driven largely by costly and time-inefficient processes seemingly inherent to the United States research ecosystem. As a result, the goals of early patient access to novel devices to address unmet needs and efficient technology development in the United States remain incompletely realized. This review will introduce key aspects of this discussion, organized by the Medical Device Innovation Consortium, in an effort to broaden awareness and encourage engagement by stakeholders in an effort to address central issues and therefore further a growing effort to shift Early Feasibility Studies to the United States for the benefit of all involved.

Innovations in indwelling urethral catheterisation.

The indwelling urethral catheter remains an integral part of contemporary medical care, despite its significant design shortcomings. Urethral catheterisation is responsible for well-recognised complications including catheter-associated urinary tract infection (CAUTI), catheter-associated urethral injury (CAUI), catheter blockage, and bladder mucosal irritation. In this narrative review, we provide an update on current innovations in urethral catheter design, aimed at safeguarding against these complications. There is an obvious need to improve catheter technology and urologists should support the translation of innovations into clinical practice.

Budget Impact Analysis of Minimally Invasive versus Open Transforaminal Lumbar Interbody Fusion for Lumbar Degenerative Disease: A European Hospital Perspective.

Purpose: When traditional therapies fail to provide relief from debilitating lower back pain, surgeries such as transforaminal lumbar interbody fusion (TLIF) may be required. This budget impact analysis (BIA) compared minimally-invasive (MI)-TLIF versus open (O)-TLIF for single-level fusion from an Italian hospital perspective. Methods: The BIA compared costs of 100 MI-TLIF and 100 O-TLIF procedures from an Italian hospital perspective over a one-year time horizon. The base case included costs for length of hospital stay (LOS), blood loss, and sterilizing surgical trays. The scenario analysis also included operating room (OR) time and complication costs. Base case inputs were from the Miller et al meta-analysis; scenario analysis inputs were from the Hammad et al meta-analysis. The device costs for MI-TLIF and O-TLIF procedures were from Italian tender prices for Viper Prime™ System and Expedium™ Spine System, respectively. Results: Base case deterministic analysis results showed cost savings of €207,370 for MI-TLIF compared with O-TLIF. MI-TLIF costs were lower for LOS (€215,277), transfusion for blood loss (€16,881), and surgical tray sterilization (€28,232), whereas device costs were lower for O-TLIF (€53,020). The probabilistic result was similar, with MI-TLIF resulting in savings of €211,026 (95% credible interval [CR]: €208,725 - €213,327). All 1000 base case probabilistic sensitivity analysis runs were cost saving. Deterministic scenario analysis results showed cost savings of €166,719 for MI-TLIF. MI-TLIF costs were lower for LOS (€190,813), transfusion for blood loss (€16,881), surgical tray sterilization (€28,232), and complications (€2076), whereas O-TLIF costs were lower for OR time (€18,263) and devices used (€53,020). Conclusion: Despite the increase incremental cost for medical device innovation and OR time, this study demonstrates the economic savings of MI-TLIF compared to O-TLIF from a European hospital perspective. The findings will be useful to policy and hospital decision makers in assessing purchasing, funding and reimbursement decisions.

Robotics in interventional endoscopy-evolution and the way forward.

The integration of robotics into gastrointestinal (GI) endoscopy represents a transformative advancement and bears the potential to bridge the gap between traditional limitations by offering unprecedented precision and control in diagnostic and therapeutic procedures. This review explores the historical progression, current applications and future potential of robotic platforms in GI endoscopy. Originally designed for surgical applications, robotic systems have expanded their reach into endoscopy, potentially enhancing procedural accuracy and reducing ergonomic strain on practitioners. Natural Orifice Transluminal Endoscopic Surgery (NOTES) emerged as a promising technique, leveraging natural orifices to perform minimally invasive surgeries. Despite its initial potential, several factors, including limitations of the available instrumentations and lack of reliable closure techniques, hindered its widespread adoption and progress. Conventional endoscopic tools often fall short in terms of triangulation, traction and degrees of freedom, necessitating the adoption of robotic interventions. Over recent decades, robotic endoscopy has significantly evolved, focusing on both diagnostic and complex therapeutic procedures such as endoscopic sub-mucosal dissection (ESD) and endoscopic full-thickness resection (EFTR). Various robotic platforms demonstrate enhanced safety and efficiency in GI procedures. As the field progresses, the emphasis on clinical validation, advanced training and the exploration of new applications remains crucial. Continuous innovation in robotic technology and endoscopic techniques promises to overcome existing limitations, further revolutionizing the management of GI diseases and improving patient outcomes.

Translating medical device innovations to market - a Ugandan perspective.

There is a disparity between low and middle-income countries (LMICs) and high-income countries (HICs) in translating medical device innovations to the market, affecting health care service delivery. Whereas medical technologies developed in HICs face substantial challenges in getting to the bedside, there are at least clear pathways in most of the major markets, such as the UK, the EU, and the USA. Much less is known about the challenges that innovators of medical technologies face in LMICs. The aim of this study was to map out current bottlenecks in medical device innovation in Uganda, a LMIC in Sub-Saharan East Africa.A cross-sectional survey was carried out using a digital questionnaire. Twenty-one individuals completed the questionnaire, with the majority being medical device innovators (n = 12). Only one of these had undertaken all the innovation stages, up to clinical validation. Very few innovators had established companies, and/or acquired intellectual property. It is evident from similar studies that challenges in medical device translations are multidimensional, and hence interdisciplinary collaborations are key to accelerating translation processes, especially for LMICs.

Introduction and validation of an automatic and low-cost three-dimensional facial imaging system: a comparison to direct anthropometry and Vectra H1.

Background: Three-dimensional (3D) imaging is a powerful tool for the analysis of soft tissue morphology. 3D photogrammetry outperforms conventional photogrammetric methods and gains popularity among plastic surgeons. However, commercial 3D imaging systems bundled with analytical software are costly. This study intends to introduce and validate an automatic, low-cost, and user-friendly 3D facial scanner. Methods: An automatic and low-cost 3D facial scanning system was developed. The system consisted of a 3D facial scanner running automatically on a sliding track and a 3D data processing tool. Fifteen human subjects underwent 3D facial imaging by the novel scanner. Eighteen anthropometric parameters were measured on the 3D virtual models and compared with caliper measurements (the gold standard). Further, the novel 3D scanner was compared to the commonly used commercial 3D facial scanner Vectra H1. Heat map analysis was used to evaluate the deviation between the 3D models obtained by the two imaging systems. Results: The 3D photogrammetric results were highly correlated with the direct measurement results (P<0.001). The mean absolute differences (MADs) were less than 2 mm. Bland-Altman analysis indicated that, for 17 of the 18 parameters, the largest differences within the 95% limits of agreement margin were within the 2.0 mm clinical acceptance. Heat map analysis showed the average distance between the 3D virtual models was 0.15 mm, with a root mean square of 0.71 mm. Conclusions: The novel 3D facial scanning system is proven to be highly reliable. It provides a good alternative to commercial 3D facial scanners.

Impact of Health Care Reform on Technology and Innovation.

The medical device industry has long been subject to criticism for lack of price transparency and minimal regulations surrounding device approval, which have functioned as barriers to providing quality and cost-effective care. Recent health care reforms aimed at overcoming these barriers, including improving market approval regulations, increasing postmarket surveillance, and using comparative effectiveness research, have drastically changed industry practices. These reforms have also prompted increasingly cost-aware health care practices, which have encouraged new trends in medical device innovation such as frugal innovation and deinstitutionalization. This article explores the challenges faced by industry, physicians, and patients in light of these reforms.

The Barrow Innovation Center Case Series: A Novel 3-Dimensional-Printed Retractor for Use with Electromagnetic Neuronavigation Systems.

OBJECTIVE: The Barrow Innovation Center consists of an educational program that promotes interdisciplinary collaboration among neurosurgery, legal, and engineering professionals to foster the development of new medical devices. This report describes a common issue faced during the placement of ventricular shunts for the treatment of hydrocephalus and the solution to this problem that was developed through the Barrow Innovation Center. METHODS: Neurosurgery residents involved in the Barrow Innovation Center presented the problem of ferromagnetic retractors interfering with pinless image-guidance systems at a monthly meeting. Potential solutions were openly discussed by an interdisciplinary committee of neurosurgeons, patent lawyers, and biomedical engineers. The committee decided to pursue development of a novel self-retaining retractor made of nonferromagnetic material as a solution to the problem. RESULTS: Each retractor design was tested in the cadaver laboratory for size and functionality. A final design was chosen and used in a surgical case requiring ventriculoperitoneal shunt placement. The new retractor successfully retracted the scalp without interfering with the electromagnetic image-guidance system. CONCLUSIONS: Through the interdisciplinary Barrow Innovation Center program, a newly designed, 3-dimensional-printed skin and soft-tissue retractor was created, along with an innovative universal shunt retainer. Through this integrated program dedicated to surgical innovation (i.e., the Barrow Innovation Center), the process of developing and implementing new technology at our institution has been streamlined, creating a culture of innovation within the neurosurgery training program.

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

PURPOSE: The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. METHODS: This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. RESULTS: Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P < .001). CONCLUSIONS: Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval.