The Role of Soft Robotic Micromachines in the Future of Medical Devices and Personalized Medicine

Developments in medical device design result in advances in wearable technologies, minimally invasive surgical techniques, and patient-specific approaches to medicine. In this review, we analyze the trajectory of biomedical and engineering approaches to soft robotics for healthcare applications. We review current literature across spatial scales and biocompatibility, focusing on engineering done at the biotic-abiotic interface. From traditional techniques for robot design to advances in tunable material chemistry, we look broadly at the field for opportunities to advance healthcare solutions in the future. We present an extracellular matrix-based robotic actuator and propose how biomaterials and proteins may influence the future of medical device design.

Design Process for a Birthing Bed, Based on User Hierarchy: Promoting Improvement in User Satisfaction

The medical device design process has a responsibility to define the characteristics of the object to ensure its correct interaction with users. This study presents a proposal to improve medical device design processes in order to increase user acceptance by considering two key factors: the user hierarchy and the relationship with the patient’s health status. The goal of this study is to address this research gap and to increase design factors with practical suggestions for the design of new medical devices. The results obtained here will help medical device designers make more informed decisions about the functions and features required in the final product during the development stage. In addition, we aim to help researchers with design process didactics that demonstrate the importance of the correct execution of the process and how the factors considered can have an impact on the final product. An experiment was conducted with 40 design engineering students who designed birthing beds via two design processes: the traditional product design process and the new design process based on hierarchies (proposed in this study). The results showed a significant increase in the user acceptance of the new birthing bed developed with the hierarchical-based design process.

An industrial oriented workflow for 3D printed, patient specific orthopedic cast

The clinical use of 3D printed patient specific orthopaedic cast is of wide interest. However, design and production have problems such as production time, which can take up to 35 h, and standardized procedure considering that there are medical devices that must comply mandatory and/or voluntary standards. Moreover, the proposed procedures do not fully consider the traceability of this innovative medical device design to comply with standards and industrial proposes. The aim of this work is to propose a semi-automatic workflow for the production of the 3D printed orthopaedic casts. The procedure is oriented towards a reduction time in different phases (as scan setting, designing technique, printing orientation) of the production flow. The workflow is compliant with recognized quality standards for the production of additive manufactured medical devices. This approach offers the possibility to introduce new 3D printed medical devices in clinical practice as well as to design an optimized industrial workflow.

A User-Centered Medical Device Design Decision Making Approach Using Hybrid Rough Cooperative Game Model

With the advancement of new technologies and diverse customer-centered design requirements, the medical device design decision making becomes challenge. Incorporating multiple stakeholders’ requirements into the medical device design will significantly affect the market competitiveness and performance. The classic design decision making approaches mainly focused on design criteria priority determination and conceptual schemes evaluation, which lack the capacity of reflecting the interdependence of interest among stakeholders and capturing the ambiguous influence on the overall design expectations, leading to the unreliable decision making results. In order to relax these constraints in the medical device design, this paper incorporates rough set theory with cooperative game theory model to develop a novel user-centered design decision making framework. The proposed approach is composed of three components: 1) end/professional user needs identification and classification, 2) evaluation criteria correlation diagram and scheme value matrix establishment using rough set theory; and 3) fuzzy coalition utility model development to obtain optimal desirability considering users’ conflict interests. We used a blood pressure meter case study to demonstrate and validate the proposed approach. Compared with the traditional Technique for Order of Preference by Similarity to Ideal Solution (TOPSIS) approach, the proposed approach is more robust.

Using Task Models to Understand the Intersection of Numeracy Skills and Technical Competence With Medical Device Design

Task models are used in many different ways throughout the design and development of interactive systems. When the interactive systems are safety critical, task models can play an important role in ensuring system behaviours are consistent with user requirements, which may help to prevent errors. While task models can be used to describe a user’s goals and the steps required to achieve that goal, to understand where user errors may occur we also need to consider the users’ understanding of how to perform a task and how this relates to the system they are using. Our focus is on the use of medical devices such as syringe drivers and infusion pumps for intravenous medication, which forms a major part of hospital inpatient care throughout the world. While we might rely on software engineering and human factors techniques to ensure correctness of such devices, their use by medical personnel in practice includes other factors that are equally important. These include training medical personnel in the use of medical devices. Also numeracy education for medical staff to ensure that they are able to set up and perform the necessary calculations to convert prescribed medication into the appropriate values and measures for their delivery mechanisms. We have developed an approach that aims to bring together concepts of technology design (both functional correctness and usability concerns), numeracy and medication delivery competency. In order to do so we use task models as a common language that enables us to consider these different domains in a single way. We find that the ability to describe the two domains within a single process allows us to compare models of knowledge, tasks and use of devices, which can elicit potential mismatches and problems.

Reducing medical device alarms by an order of magnitude: A human factors approach

The intensive care unit (ICU) is one of the most technically advanced environments in healthcare, using a multitude of medical devices for drug administration, mechanical ventilation and patient monitoring. However, these technologies currently come with disadvantages, namely noise pollution, information overload and alarm fatigue—all caused by too many alarms. Individual medical devices currently generate alarms independently, without any coordination or prioritisation with other devices, leading to a cacophony where important alarms can be lost amongst trivial ones, occasionally with serious or even fatal consequences for patients. We have called this approach to the design of medical devices the single-device paradigm, and believe it is obsolete in modern hospitals where patients are typically connected to several devices simultaneously. Alarm rates of one alarm every four minutes for only the physiological monitors (as recorded in the ICUs of two hospitals contributing to this paper) degrades the quality of the patient’s healing environment and threatens patient safety by constantly distracting healthcare professionals. We outline a new approach to medical device design involving the application of human factors principles which have been successful in eliminating alarm fatigue in commercial aviation. Our approach comprises the networked-device paradigm, comprehensive alarms and humaniform information displays. Instead of each medical device alarming separately at the patient’s bedside, our proposed approach will integrate, prioritise and optimise alarms across all devices attached to each patient, display information more intuitively and hence increase alarm quality while reducing the number of alarms by an order of magnitude below current levels.