Impact of the COVID-19 pandemic on international cutaneous squamous cell carcinoma incidence: A systematic review and meta-analysis.

Background: Non-melanoma skin cancer (NMSC) is the most common cancer globally in white ethinicity populations, and cutaneous squamous cell carcinoma (cSCC) is the second most common subtype. The COVID-19 pandemic severely impacted public and private healthcare systems. Many studies have reported reduced cancer diagnoses during the pandemic.

Characterizing continuous positive airway pressure (CPAP) Belly Syndrome in preterm infants in the neonatal intensive care unit (NICU).

Objective: Reproducibly define CPAP Belly Syndrome (CBS) in preterm infants and describe associated demographics, mechanical factors, and outcomes.

Study Design: A retrospective case-control study was conducted in infants <32 weeks gestation in the Stanford Children's NICU from January 1, 2020 to December 31, 2021. CBS was radiographically defined by a pediatric radiologist.

Development and validation of a novel fetal vesico-amniotic shunt, the vortex shunt.

Fetal lower urinary tract obstruction (LUTO) is a severe malformation associated with an up to 80% mortality risk as well as significant renal and pulmonary morbidity in survivors. Fetal vesico-amniotic shunts (VAS) bypass the bladder obstruction, improve amniotic fluid volume and enhance in-utero pulmonary development. VAS has been shown to reduce respiratory morbidity and mortality in the neonatal period without proven benefit on long-term renal and bladder function.

Novel Umbilical Catheter Securement and Protection Device for Umbilical Line Securement during Laparotomy.

Objective: Umbilical catheter malposition rate is high. We compared a Novel Umbilical Securement Device (NUSD) to standard methodologies for neonatal invasive care unit patients undergoing laparotomy.

Study Design: Retrospective study was performed on infants undergoing laparotomy from April 2019 to January 2023.

Using an Accelerated Undergraduate Needs Finding Course to Build Skills, Inspire Confidence, and Promote Interest in Health Technology Innovation.

Many undergraduate educational experiences in biomedical design lack clinical immersion-based needs finding training for students. Convinced of the merits of this type of training for undergraduates, but unable to offer a quarter-long course due to faculty and administrative constraints, we developed an accelerated block-plan course, during which students were dedicated solely to our class for 3 weeks. The course focused on the earliest stages of the health technology innovation process-conducting effective clinical observations and performing comprehensive need research and screening.

Innovation versus Experimentation: An Application of Ethical Frameworks to the Acceptance of Fluorescence-Guided Pediatric Surgery.

Innovation is essential to the advancement of the field of pediatric surgery. The natural skepticism toward new technologies in pediatrics leads to frequent confusion of surgical innovation and research. Using fluorescence-guided surgery as an archetype for this ethical discussion, we apply existing conceptual frameworks of surgical innovation to understand the distinction between innovation and experimentation, acknowledging the spectrum and "grey zone" in between.

A Novel Method for Administering Epinephrine during Neonatal Resuscitation.

Objective: This study aimed to determine if prefilled epinephrine syringes will reduce time to epinephrine administration compared with conventional epinephrine during standardized simulated neonatal resuscitation.

Study Design: Timely and accurate epinephrine administration during neonatal resuscitation is lifesaving in bradycardic infants. Current epinephrine preparation is inefficient and error-prone.

A Stepwise Replicable Approach to Negotiating Value-driven Supply Chain Contracts for Orthobiologics.

Introduction: Orthobiologics are increasingly used to augment healing of tissues. Despite growing demand for orthobiologic products, many health systems do not enjoy substantial savings expected with high-volume purchases. The primary goal of this study was to evaluate an institutional program designed to (1) prioritize high-value orthobiologics and (2) incentivize vendor participation in value-driven contractual programs.

Optimizing Orthopaedic Trauma Implant Pricing Through a Data-Driven and Surgeon-Integrated Approach.

Objective: To determine whether market-based pricing could be coupled with surgeon integration into negotiation strategies to achieve lower pricing levels for orthopaedic trauma implants. A secondary aim was to identify specific types of implants that may offer larger opportunities for cost savings.

Methods: Market pricing levels were reviewed from 2 industry implant databases.

The utility of Endoscopic Functional Luminal Imaging (EndoFLIP) in the diagnosis and management of children with achalasia.

Background: Per-oral endoscopic myotomy (POEM) has is an alternative treatment to laparoscopic Heller myotomy for children with achalasia. The EndoFLIP functional luminal imaging system is used to measure esophagogastric junction (EGJ) distensibility pre- and post-POEM. Previous adult studies have established a correlation between obstructive symptoms and Distensibility Index (DI).

The Value of Scientific Publications in Surgical Device Innovation.

Background: Clinical trials represent a significant risk in the commercialization of surgical technologies. There is incentive for companies to mitigate their regulatory risk by targeting 510K over Premarket Approval (PMA) pathways in order to limit the scope, complexity and cost of clinical trials. As such, not all companies will publish clinical data in the scientific literature.

Somatization in dermatology.

Medically unexplained dermatologic symptoms, such as pruritus, numbness and burning are known as somatization. These cutaneous symptoms can be very difficult to treat because of an absence of an objective explanation and they may not fit neatly into any known dermatological or psychiatric condition. These disorders are more commonly encountered in primary care and in dermatology, rather than in psychiatry.

Does healthcare system device volume correlate with price paid for spinal implants: a cross-sectional analysis of a national purchasing database.

Objectives: Amid continuously rising US healthcare costs, particularly for inpatient and surgical services, strategies to more effectively manage supply chain expenses are urgently necessary. Across industries, the 'economy of scale' principle indicates that larger purchasing volumes should correspond to lower prices due to 'bulk discounts'. Even as such advantages of scale have driven health system mergers in the USA, it is not clear whether they are being achieved, including for specialised products like surgical implants which may be more vulnerable to cost inefficiency.

Development and in-vitro characterization of a novel fetal vesicoamniotic shunt - The Vortex shunt.

Objectives: To develop and test a novel vesicoamniotic shunt (VAS) to treat fetal lower urinary tract obstruction (LUTO), decrease dislodgement and optimize shunt deployment in-vitro.

Methods: Vesicoamniotic shunt design objectives included: (1) robust and atraumatic fixation elements, (2) kink resistant conduit to adjust to fetal movement and growth, (3) one-way pressure valve to facilitate bladder cycling, and (4) echogenic deployment visualization aids. The force to dislodge the novel Vortex shunt was compared with existing commercially available shunts in a bench-top porcine bladder model.

Enhancing person-centred care in inpatient mental health settings through supported person-side handover: a multi method study.

Background: Many nursing contexts have introduced bedside handover, where the person in care participates in the transfer of clinical information, with benefits for person, carers, and clinicians. This type of handover has been implemented across a number of mental health settings, but there is limited evidence regarding implementation approaches or of practice change. This study reports the development and evaluation of a co-produced education and support package.

Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables.

Objective: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices.

Methods: On August 5, 2020, a group of innovators, engineers, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting.

Quantification of US Food and Drug Administration Premarket Approval Statements for High-Risk Medical Devices With Pediatric Age Indications.

Importance: Medical device companies submit premarket approval (PMA) statements to the US Food and Drug Administration (FDA) for approval of the highest-risk class of devices. Devices indicated for the pediatric population that use the PMA pathway have not been well characterized or analyzed.

Objective: To identify and characterize high-risk devices with pediatric age indications derived from PMA statements.

The Value of Surgical Data-Impact on the Future of the Surgical Field.

The combination of computing power, connectivity, and big data has been touted as the future of innovation in many fields, including medicine. There has been a groundswell of companies developing tools for improving patient care utilizing healthcare data, but procedural specialties, like surgery, have lagged behind in benefitting from data-based innovations, given the lack of data that is well structured. While many companies are attempting to innovate in the surgical field, some have encountered difficulties around collecting surgical data, given its complex nature.

The design and evaluation of a novel algorithm for automated preference card optimization.

Background: Inaccurate surgical preference cards (supply lists) are associated with higher direct costs, waste, and delays. Numerous preference card improvement projects have relied on institution-specific, manual approaches of limited reproducibility. We developed and tested an algorithm to facilitate the first automated, informatics-based, fully reproducible approach.