Positive workplace cultures prioritize employees’ health and well-being, encourage respect and trust among all, and forgive mistakes. They promote employee happiness and retention, improve team performance, and enhance talent while effective leadership enables engineering managers to capture the full potential of employees’ skills and knowledge. Previous research demonstrates that happier employees are more engaged and productive. This article proposes a conceptual model of culture from the perspective of organizational leadership theory. In particular, the model is derived from a longitudinal study of complexity leadership and represents culture at three scales: societal (macro), organizational (meso), and team (micro). At each level, culture is conceived as a set of actively promoted or discouraged behaviors, what might be called active culture . We also propose that employee happiness is largely influenced by the form and interplay of leadership and these layered cultures. Our aim is to provide practical implications for engineering managers wanting to develop business or team culture, leadership, and employee happiness while seeking to promote productivity and engagement.

Since the beginning of the quality revolution a number of decades ago, there has been a growing realization that the most successful teams are teams of empowered employees who make the right decisions for the business based on information at hand. Successful organizations in many fields are finding that their leaders need to move beyond conventional planning and directing people skills to coaching and mentoring. At the same time, team members have to take on more ownership and responsibility for solving problems aligned with the organizational direction.

Background: As researchers race to understand the nature of COVID-19 transmission, healthcare institutions must treat COVID-19 patients while also safeguarding the health of staff and other patients. One aspect of this process involves mitigating aerosol transmission of the SARS-CoV2 virus. The U.S. Centers for Disease Control and Prevention (CDC) provides general guidance on airborne contaminant removal, but directly measuring aerosol clearance in clinical rooms provides empirical evidence to guide clinical procedure. Aim: We present a risk-assessment approach to empirically measuring and certifying the aerosol clearance time (ACT) in operating and procedure rooms to improve hospital efficiency while also mitigating the risk of nosocomial infection. Methods: Rooms were clustered based on physical and procedural parameters. Sample rooms from each cluster were randomly selected and tested by challenging the room with aerosol and monitoring aerosolized particle concentration until 99.9% clearance was achieved. Data quality was analysed and aerosol clearance times for each cluster were determined. Findings: Of the 521 operating and procedure rooms considered, 449 (86%) were issued a decrease in clearance time relative to CDC guidance, 32 (6%) had their clearance times increased, and 40 (8%) remained at guidance. The average clearance time change of all rooms assessed was a net reduction of 27.8%. Conclusion: The process described here balances the need for high-quality, repeatable data with the burden of testing in a functioning clinical setting. Implementation of this approach resulted in a reduction in clearance times for most clinical rooms, thereby improving hospital efficiency while also safeguarding patients and staff. (C) 2021 The Authors. Published by Elsevier Ltd on behalf of The Healthcare Infection Society. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Many life saving devices come with significant risk which must be mitigated through a defined system design process. A seamless integration of the design and development process and the safety risk management process will allow devices to be safety used on humans. The development process is described in ISO 13485, the international standard for the development of medical devices. ISO 14971 is the international standard for the evaluation of the safety risk of a medical device. A system engineering approach to the design of medical devices provides a holistic approach to ensuring these devices are safe for their intended use. Universities and companies hoping to use their devices in clinical trials on patients are required to follow a well-defined process incorporating design and development planning, design input, design output, design review, design verification, and design validation. The safety risk management process must be carefully overlaid on top of this standard development process. This paper will describe acceptable development processes, including agile and evolutionary design. It will also describe the methodology used to develop devices intended for clinical trials on patients, prior to commercialization. It will briefly describe the requirements of clinical trials performed on humans and will cover the key elements of the safety risk management process.

Healthcare is shifting from traditional hospital-centric care to a more virtual, distributed care that heavily leverages the latest technologies around artificial intelligence, deep learning, data analytics, genomics, home-based healthcare, robotics, and three-dimensional printing of tissue and implants. In the future, fundamental shifts will reshape the healthcare industry. Healthcare will be delivered as a seamless continuum of care, away from the clinic-centered point-of-care model and with a greater focus on prevention and early intervention.

A case study using a balanced scorecard approach to strategic management is described for an engineering development organization supporting a major academic healthcare center. While balanced scorecards are well described in the literature, this paper shows how one organization, the Mayo Clinic Division of Engineering, has applied these principles to develop an effective means of capturing and tracking the execution of tactics tied to our strategic plan. The challenges of developing a set of operational objectives and a framework for balancing the organization's strategic objectives, operational objectives, ongoing business processes, and project portfolio will be described.

Implantable medical devices are commonly used in research studies, clinical trials, and direct patient care and have been for many years. Researchers have targeted the application of these devices on specific application domains such as neural prosthetics, cardiac rhythm, and implantable drug delivery. This study proposes a configurable electronics implantable platform based on core capabilities that can be applied across various application domains. This platform provides a combination of general purpose capabilities such as programmable interval, bi-directional radio-frequency wireless communication for data transmission and control, configurable front-end circuitry to provide electrical stimulation and electrophysiology pre-amplifiers, analog-to-digital and digital-to-analog conversion capability, a core computational engine (microprocessor or FPGA), scalable input-output manifold options, data compression and variable bandwidth features, and single-use or wirelessly rechargeable battery variants. These capabilities will be configurable into custom, application-specific devices which can be used for a variety of acute and chronic studies.

Many organizations struggle when trying to align innovation efforts with their strategic plans. In fact, often the focus on productivity negatively impacts a company's ability to innovate. This paper discusses this tension and identifies a mechanism for aligning innovation efforts with the strategy of the organization. It will also discuss the challenges of assigning value to innovation activities and provide some straightforward metrics which can be used to quantify the results.

Corporate culture often becomes an excuse for discrimination. Developing a fair and unbiased approach to hiring can often alleviate some unintended consequences of the hiring process. This paper provides recommendations for establishing a fair and equitable hiring process.

Physicians and researchers require systems that provide real-time collection of physiological data sets to explore new diagnostics and therapies. Implantable devices used to monitor a variety of physiological parameters and administer therapies lend themselves to the development of customizable platforms that can be applied to individualized disease treatment. Radio frequency (RF) communication can provide a reliable data path allowing through-body communication. Here, RF propagation is analyzed in a saline phantom to characterize signal loss through free space when varying the distance between the transmitting and receiving antennas and the type and size of antennas, to find the highest received power to the lowest transmitted power. Two testing environments were constructed: dry and 0.9% saline. Four frequencies (400 MHz, 700 MHz, 900 MHz, and 2.5 GHz) and four antenna types (quarter-wave ground plane, horizontal half-wave dipole, single loop, and coiled loop) were implemented in the system.

A system to evaluate and follow morphologic changes in number, size, shape and other histological measurements of transverse myelinated fiber profiles in nerves and fiber tracts has proven to be a useful analysis tool. Applications of the system include the enumeration and sizing of peripheral nerves and central nervous system tracts for the morphologic study of development, aging, regeneration, neurotoxicity, pathologic conditions, also, the morphometric assessment of intra-epidermal nerve fiber densities, IENFD. The primary aim of the system is to provide both an operator-interactive and automated method for the detection, sizing and measurement of myelinated fibers. The system, Imaging System for Nerve Morphometry, was shown, to provide the specific functionality required to perform morphometric studies of peripheral nerve, compared to commercial systems which perform a more general estimate of histological features. The system consists of the tissue preparation process, a video camera-ready microscope capable of various resolutions, and a computer system for image acquisition, data analysis, data display and statistical analysis. The morphometric measurements obtained from this system have been used for quality control by clinical nerve pathologists, in the study of human peripheral neuropathies and the clinical assessment of IENFDs. In assessment of test retest reproducibility of periodically-sampled nerves, high degrees of reproducibility were achieved for most morphometric measurements.

Medical innovation is often delayed by the difficulty in developing cooperation among practicing physicians, academics and medical device developers. In Rochester, Minnesota, the Mayo Clinic Division of Engineering has excelled at integrating these specialties, facilitating medical device innovation for the past 60years. In 1948, Mayo Clinic combined an instrument shop with an engineering design services team and created the Division of Engineering. This enabled a unique partnership between physicians, researchers, and product developers. Early innovations from this team include the Mayo heart-lung machine, cardiac monitoring, advances in aero-medicine, surgical stereotaxy, and early transfusion equipment. Today, the Mayo Division of Engineering consists of mechanical, chemical, electrical, biomedical, and software engineers, machinists, and a scientific glass-blower. The division works in close collaboration with project proponents (primarily physicians) within the clinical environment to analyze problems, propose designs, and deliver a clinical solution. From custom 3-D models for support pre-surgical planning to endoscopic heart valve repair devices, the team identifies opportunities and delivers systems that can be quickly translated into medical practice.