IEEE Engineering in Medicine and Biology Magazine最新文献

FDA-mandated design controls for medical devices provide a structured, systematic engineering paradigm that supports human-centered systems engineering. Engineering design controls are nothing more than the fundamental elements of classical systems engineering. The human focus is enabled through the iterative reidentification of stakeholders, reassessment of their NWDs, and reconciliation of their evolving/conflicting NWDs. The implementation of design controls and embedded risk management must begin prior to commercial development to reap the full benefit of the approach; partial approaches dilute or negate the effectiveness and efficiency of this nearly century-old systems engineering paradigm. Properly employing engineering design controls is a strategic business decision. The central value of this proposition is the reduction of economic, technical, and operational risks for both producers and consumers; regulatory compliance is a secondary benefit. Misuse or abuse of design controls only undermines long-term profitability and increases the risks to the consumer.

Wearable technology may provide an integral part of the solution for providing health care to a growing world population that will be strained by a ballooning aging population. By providing a means to conduct telemedicine-the monitoring, recording, and transmission of physiological signals from outside of the hospital-wearable technology solutions could ease the burden on health-care personnel and use hospital space for more emergent or responsive care. In addition, employing wearable technology in professions where workers are exposed to dangers or hazards could help save their lives and protect health-care personnel.

This article describes health technology assessment (HTA) as an evaluation tool that applies systematic methods of inquiry to the generation and use of health technologies and new products. The focus of this article is on the contributions of HTA to the management of the new product development effort in the biomedical organization. Critical success factors (CSFs) are listed, and their role in assessing success is defined and explained. One of the conclusions of this article is that HTA is a powerful tool for managers in the biomedical sector, allowing them to better manage their innovation effort in their continuing struggle for competitiveness and survival.

In this article, we focus on the least invasive interface: transcutaneous ES (TES), i.e., the use of surface electrodes as an interface between the stimulator and sensory-motor systems. TES is delivered by a burst of short electrical charge pulses applied between pairs of electrodes positioned on the skin. Monophasic or charge-balanced biphasic (symmetric or asymmetric) stimulation pulses can be delivered. The latter ones have the advantage to provide contraction force while minimizing tissue damage.

It is now more than 50 years since the time when clinical monitoring of individuals in the home and community settings was first envisioned. Until recently, technologies to enable such vision were lacking. However, wearable sensors and systems developed over the past decade have provided the tools to finally implement and deploy technology with the capabilities required by researchers in the field of patients' home monitoring. As discussed, potential applications of these technologies include the early diagnosis of diseases such as congestive heart failure, the prevention of chronic conditions such as diabetes, improved clinical management of neurodegenerative conditions such as Parkinson's disease, and the ability to promptly respond to emergency situations such as seizures in patients with epilepsy and cardiac arrest in subjects undergoing cardiovascular monitoring. Current research efforts are now focused on the development of more complex systems for home monitoring of individuals with a variety of preclinical and clinical conditions. Recent research on the clinical assessment of wearable technology promises to deliver methodologies that are expected to lead to clinical adoption within the next five to ten years. In particular, combining home robots and wearable technology is likely to be a key step toward achieving the goal of effectively monitoring patients in the home. These efforts to merge home robots and wearable technology are expected to enable a new generation of complex systems with the ability to monitor subjects' status, facilitate the administration of interventions, and provide an invaluable tool to respond to emergency situations.

The possibility of gathering reliable information about movement characteristics during activities of daily living holds particular appeal for researchers. Data such as this could be used to analyze the performance of individuals undergoing rehabilitation and to provide vital information on whether or not there is an improvement during a neurorehabilitation protocol. Wearable devices are particularly promising toward this aim, because they can be used in unstructured environments (e.g., at home). Recently, two different approaches in this area have become very popular and show promising performance: the use of inertial sensors together with advanced algorithms (e.g., Kalman filters) and the development of e-textile, in which the sensing technology is directly embroidered into the garment worn by the user.