Strategic management and organizational culture of medical device companies in relation to corporate performance.

AIMS: Strategies focus on securing the competitiveness of medical device corporations by strengthening their organizational capabilities, which, in turn, ensure their continuous development. This study aims to investigate both management strategies and organizational culture, which may affect the performance of these companies, and analyzes the influence of education and training investment. MATERIALS AND METHODS: We used data from the 3rd to 6th Human Capital Corporate Panel surveys by the Korea Research Institute for Vocational Education and Training as well as data from the Korea Information Service and 6,112 workers and 260 companies were analyzed. For the analysis, management strategy and organizational culture were set as independent variables, and corporation performance was set as the dependent variable. Additionally, investment in education and training was set as a control variable between the independent and dependent variables. Corporate performance was analyzed by dividing into organizational satisfaction and organizational commitment. RESULTS: Differentiation strategy and innovative culture had a positive (+) effect on organizational satisfaction, while cost leadership strategy and hierarchical culture had a negative (-) effect. On the other hand, in the case of interaction with education and training investment, cost leadership strategy and hierarchical culture had a positive (+) effect, while differentiation strategy and innovation culture had a negative (-) effect. In organizational commitment, innovation culture had a positive (+) effect, and hierarchical culture had a negative (-) effect. In the case of interaction with investment in education and training, only the hierarchical culture had a positive (+) effect. CONCLUSIONS: The innovation culture positively influenced the performance of medical device companies. Furthermore, cost leadership strategy, hierarchical culture, education and training investment improved the corporate performance of these companies. To enhance corporate performance, these companies should create an innovation culture and invest in education and training in accordance with the organizational culture.

COVID-19 has proven the excellence of Korea's medical devices, and the medical device industry is expected to continue to grow due to the increase in chronic disease and non-face-to-face treatment. However, the current medical device industry is monopolized by global companies with capital and technological prowess. To overcome this, Korean medical device companies are developing innovative medical devices centered on start-ups, but now is the time to strategically respond to them in order to compete with global companies. In general, companies establish management strategies for survival and growth by analyzing threats and opportunities based on the market environment to maintain the optimal organization according to market competition, government policies, and changes in consumer needs. Strategies are often established based on the culture of the organizations that make up the company. When it comes to strategy establishment, the medical device industry has special characteristics compared to other industries. The medical device industry is based on advanced technology and puts patient safety first, requiring continuous product upgrades. Therefore, it is an essential industry for employees to invest in education and training. The analysis shows the effectiveness of investment in education and training according to the management strategy and organizational culture of medical device companies. It was confirmed that when medical device companies create an Innovation culture, their performance improves. It also shows that when medical device companies adopt a cost leadership strategy, they need to increase their investment in education and training to improve corporate performance.

Invited Commentary: Undiagnosed and Undertreated-the Suffocating Consequences of the Use of Racially Biased Medical Devices During the COVID-19 Pandemic.

While medical technology is typically considered neutral, many devices rely upon racially biased algorithms that prioritize care for White patients over Black patients, who may require more urgent medical attention. In their accompanying article, Sudat et al. (Am J Epidemiol. 2023;XXX(XX):XXX-XXX) document striking inaccuracies in pulse oximeter readings among Black patients, with significant clinical implications. Their findings suggest that this resulted in racial differences in delivery of evidence-based care during the coronavirus disease 2019 (COVID-19) pandemic, affecting admissions and treatment protocols. Despite the medical community's growing awareness of the pulse oximeter's significant design flaw, the device is still in use. In this article, I contextualize Sudat et al.'s study results within the larger history of racial bias in medical devices by highlighting the consequences of the continued underrepresentation of diverse populations in clinical trials. I probe the implications of racially biased assessments within clinical practice and research and illustrate the disproportionate impact on patients of color by examining 2 medical tools, the pulse oximeter and pulmonary function tests. Both cases result in the undertreatment and underdiagnosis of Black patients. I also demonstrate how the social underpinnings of racial bias in medical technology contribute to poor health outcomes and reproduce health disparities, and propose several recommendations for the field to rectify the harms of racial bias in medical technology.

How New Mexico Leveraged a COVID-19 Case Forecasting Model to Preemptively Address the Health Care Needs of the State: Quantitative Analysis.

BACKGROUND: Prior to the COVID-19 pandemic, US hospitals relied on static projections of future trends for long-term planning and were only beginning to consider forecasting methods for short-term planning of staffing and other resources. With the overwhelming burden imposed by COVID-19 on the health care system, an emergent need exists to accurately forecast hospitalization needs within an actionable timeframe. OBJECTIVE: Our goal was to leverage an existing COVID-19 case and death forecasting tool to generate the expected number of concurrent hospitalizations, occupied intensive care unit (ICU) beds, and in-use ventilators 1 day to 4 weeks in the future for New Mexico and each of its five health regions. METHODS: We developed a probabilistic model that took as input the number of new COVID-19 cases for New Mexico from Los Alamos National Laboratory's COVID-19 Forecasts Using Fast Evaluations and Estimation tool, and we used the model to estimate the number of new daily hospital admissions 4 weeks into the future based on current statewide hospitalization rates. The model estimated the number of new admissions that would require an ICU bed or use of a ventilator and then projected the individual lengths of hospital stays based on the resource need. By tracking the lengths of stay through time, we captured the projected simultaneous need for inpatient beds, ICU beds, and ventilators. We used a postprocessing method to adjust the forecasts based on the differences between prior forecasts and the subsequent observed data. Thus, we ensured that our forecasts could reflect a dynamically changing situation on the ground. RESULTS: Forecasts made between September 1 and December 9, 2020, showed variable accuracy across time, health care resource needs, and forecast horizon. Forecasts made in October, when new COVID-19 cases were steadily increasing, had an average accuracy error of 20.0%, while the error in forecasts made in September, a month with low COVID-19 activity, was 39.7%. Across health care use categories, state-level forecasts were more accurate than those at the regional level. Although the accuracy declined as the forecast was projected further into the future, the stated uncertainty of the prediction improved. Forecasts were within 5% of their stated uncertainty at the 50% and 90% prediction intervals at the 3- to 4-week forecast horizon for state-level inpatient and ICU needs. However, uncertainty intervals were too narrow for forecasts of state-level ventilator need and all regional health care resource needs. CONCLUSIONS: Real-time forecasting of the burden imposed by a spreading infectious disease is a crucial component of decision support during a public health emergency. Our proposed methodology demonstrated utility in providing near-term forecasts, particularly at the state level. This tool can aid other stakeholders as they face COVID-19 population impacts now and in the future.

Physiology of repeated mixed gas 100-m wreck dives using a closed-circuit rebreather: a field bubble study.

PURPOSE: Data regarding decompression stress after deep closed-circuit rebreather (CCR) dives are scarce. This study aimed to monitor technical divers during a wreck diving expedition and provide an insight in venous gas emboli (VGE) dynamics. METHODS: Diving practices of ten technical divers were observed. They performed a series of three consecutive daily dives around 100 m. VGE counts were measured 30 and 60 min after surfacing by both cardiac echography and subclavian Doppler graded according to categorical scores (Eftedal-Brubakk and Spencer scale, respectively) that were converted to simplified bubble grading system (BGS) for the purpose of analysis. Total body weight and fluids shift using bioimpedancemetry were also collected pre- and post-dive. RESULTS: Depth-time profiles of the 30 recorded man-dives were 97.3 ± 26.4 msw [range: 54-136] with a runtime of 160 ± 65 min [range: 59-270]. No clinical decompression sickness (DCS) was detected. The echographic frame-based bubble count par cardiac cycle was 14 ± 13 at 30 min and 13 ± 13 at 60 min. There is no statistical difference neither between dives, nor between time of measurements (P = 0.07). However, regardless of the level of conservatism used, a high incidence of high-grade VGE was detected. Doppler recordings with the O'dive were highly correlated with echographic recordings (Spearman r of 0.81, P = 0.008). CONCLUSION: Although preliminary, the present observation related to real CCR deep dives questions the precedence of decompression algorithm over individual risk factors and pleads for an individual approach of decompression.

Dry heat sterilization as a method to recycle N95 respirator masks: The importance of fit.

In times of crisis, including the current COVID-19 pandemic, the supply chain of filtering facepiece respirators, such as N95 respirators, are disrupted. To combat shortages of N95 respirators, many institutions were forced to decontaminate and reuse respirators. While several reports have evaluated the impact on filtration as a measurement of preservation of respirator function after decontamination, the equally important fact of maintaining proper fit to the users' face has been understudied. In the current study, we demonstrate the complete inactivation of SARS-CoV-2 and preservation of fit test performance of N95 respirators following treatment with dry heat. We apply scanning electron microscopy with energy dispersive X-ray spectroscopy (SEM/EDS), X-ray diffraction (XRD) measurements, Raman spectroscopy, and contact angle measurements to analyze filter material changes as a consequence of different decontamination treatments. We further compared the integrity of the respirator after autoclaving versus dry heat treatment via quantitative fit testing and found that autoclaving, but not dry heat, causes the fit of the respirator onto the users face to fail, thereby rendering the decontaminated respirator unusable. Our findings highlight the importance to account for both efficacy of disinfection and mask fit when reprocessing respirators to for clinical redeployment.

Remote monitoring in telehealth care delivery across the U.S. cystic fibrosis care network.

BACKGROUND: Cystic fibrosis (CF) programs and people with CF (PwCF) employed various monitoring methods for virtual care during the COVID-19 pandemic. This paper characterizes experiences with remote monitoring across the U.S. CF community. METHODS: The CF Foundation (CFF) sponsored distribution of home spirometers (April 2020 to May 2021), surveys to PwCF and CF programs (July to September 2020), and a second program survey (April to May 2021). We used mixed methods to explore access, use, and perspectives regarding the use of remote monitoring in future care. RESULTS: By October 2020, 13,345 spirometers had been distributed, and 19,271 spirometers by May 2021. Programs (n=286) estimated proportions of PwCF with home devices increased over seven months: spirometers (30% to 70%), scales (50% to 70%), oximeters (5% to 10%) with higher estimates in adult programs for spirometers and oximeters. PwCF (n=378) had access to scales (89%), followed by oximeters (48%) and spirometers (47%), often using scales and oximeters weekly, and spirometers monthly. Over both surveys, some programs had no method to collect respiratory specimens for cultures associated with telehealth visits (47%, n=132; 41%, n=118). Most programs (81%) had a process for phlebotomy associated with a telehealth visit, primarily through off-site labs. Both PwCF and programs felt future care should advance remote monitoring and recommended improvements for access, training, and data collection systems. CONCLUSIONS: PwCF and programs experienced unprecedented access to remote monitoring and raised its importance for future care. Improvements to current systems may leverage these shared experiences to augment future care models.

Organic Photo-antimicrobials: Principles, Molecule Design, and Applications.

The emergence of multi-drug-resistant pathogens threatens the healthcare systems world-wide. Recent advances in phototherapy (PT) approaches mediated by photo-antimicrobials (PAMs) provide new opportunities for the current serious antibiotic resistance. During the PT treatment, reactive oxygen species or heat produced by PAMs would react with the cell membrane, consequently leaking cytoplasm components and effectively eradicating different pathogens like bacteria, fungi, viruses, and even parasites. This Perspective will concentrate on the development of different organic photo-antimicrobials (OPAMs) and their application as practical therapeutic agents into therapy for local infections, wound dressings, and removal of biofilms from medical devices. We also discuss how to design highly efficient OPAMs by modifying the chemical structure or conjugating with a targeting component. Moreover, this Perspective provides a discussion of the general challenges and direction for OPAMs and what further needs to be done. It is hoped that through this overview, OPAMs can prosper and will be more widely used for microbial infections in the future, especially at a time when the global COVID-19 epidemic is getting more serious.