Developing tomorrow's innovative surgical solutions

Designers are increasingly becoming aware of the potential use and integration of smart materials and technologies within their designs. One of the critical steps towards building innovative surgical solutions will be to link physicians and product designers utilising the appropriate materials and technologies to provide tangible improvements in patient care and treatment

Disruptive design innovation: reflections on the relationship of design, science and art

The title of designer conveys a large number of historical, cultural, philosophical drivers and working practises that effectively range from the traditional engineer through to the individual interested in personal expression. The considerable differences originate and have evolved for a variety of reasons. The range is from capitalist necessity through to social inclusion. Today, the designer needs to have the ability to understand significant changes in technology, art and science as well as being an astute observer of human behaviour. Ultimately, the designer will need to convert ideas into objects and systems that people can understand and use. It is important to consider serendipitous design and disruptive design as it often involves risk taking and may be unpredictable in character. Disruptive design innovation can improve a design in ways that the customer or a market does not expect. The authors suggest a refreshing approach to design that is inclusive in purpose to enrich the act of designing and advocate a greater correlation between the art, sciences and design in reflecting the values, virtues and methods of working and the principles that guide the methodologies and processes which can be correlated into a coherent whole and with a clearer focus

Exchange Rate Policy in Small Rich Economies

We look at the exchange rate policy choices and outcomes for small rich economies. Small rich economies face significant policy challenges due to proportionately greater economic volatility than larger economies. These economies usually choose some form of fixed exchange rate regime, particularly in the very small economies where the per capita cost of independent monetary policy is relatively high. When such countries do choose a free or managed floating regime, they appear to derive no benefit from those regimes; their exchange rate volatility seems to rise without any significant change in fundamental economic volatility. Thus, for these countries, floating exchange rates seem to create problems for policy makers without solving any.Small economies, Exchange rate regimes

Tracheal intubation: improving first pass success with smart material solutions

Airway management and intubation procedures continue to challenge anaesthetists. With current equipment not always providing an optimum solution, this can lead to potential serious complications if an airway is not secured quickly. Improvements in airway devices need to be discussed, designed, tested, and implemented. The implementation of the appropriate smart technologies and materials present an opportunity to resolve key issues with bougie-guided intubation. It is suggested that the development of a novel steerable bougie could improve current tracheal intubation practice. This proposition is grounded on using the appropriate research and design development strategies combined with a structured methodological approach

PRM4 – a review evaluating the validity of motion-based gaming platforms to measure clinical outcomes in clinical research

OBJECTIVES: Motion-based video game platforms provide the capability to track 3D body movements and may offer a versatile, easy to use and low-cost approach to measuring objective clinical outcomes. We reviewed published validation studies comparing clinical outcomes derived from video game platforms to gold-standard approaches. METHODS: We categorized studies in our review into three areas of application and summarized validation findings. We confined our review to studies using the Microsoft Kinect platform due to the volume of work in this area. RESULTS: Gait and balance: Five validation studies reported varied findings. One study in MS reported good correlation of most parameters with ClinROs; and a second study reported good validation of walk test parameters in Stroke patients. A treadmill test in healthy volunteers found Kinect underestimated joint flexion and over-estimated extension; and a further study was able to detect gait disturbances in MS during a speed-walking test compared to healthy volunteers although correlation to clinician assessment was modest (r=0.447). Kinect use during a battery of balance and dexterity tests in PD accurately measured the timing (ICCs: 0.940- 0.999) and gross spatial characteristics of clinically relevant movements, but spatial accuracy for smaller movements, such as toe tapping (ICC = 0.038), was poor. Upper extremity movement: Eight studies reported good validity in measurement of shoulder range of motion (r’s > 0.8, ICCs > 0.864). Spirometry: One study reported strong correlation of spirometry parameters (r>0.866) estimated using multiple sensors to generate a 3D image of the chest. CONCLUSIONS: Motion-based video gaming platforms offer potential for low-cost assessment of movement and mobility in large-scale clinical trials without reliance on specialist centers. Studies report good validity in some application areas. The ability to provide the level of accuracy needed in more rapid and finer movements requires more validation work

Performance analysis for difficult airway equipment: standardising for success

Equipment design and selection can contribute to the success or failure of difficult airway management. However, evaluative systems for providing the relative performance data for bougie introducers to help inform these choices do not exist outside of bespoke studies. This paper discusses the design development of an innovative tip pressure and shape retention testing system. Working with a design activity model, a set of stringent criteria to inform the manufacture of the testing systems were produced. Once implemented, this testing method can inform future equipment selection to improve procedure success rates and thereby reduce patient complications

Enhancing the measurement of clinical outcomes using Microsoft Kinect

There is a growing body of applications leveraging Microsoft Kinect and the associated Windows Software Development Kit in health and wellness. In particular, this platform has been valuable in developing interactive solutions for rehabilitation including creating more engaging exercise regimens and ensuring that exercises are performed correctly for optimal outcomes. Clinical trials rely upon robust and validated methodologies to measure health status and to detect treatment-related changes over time to enable the efficacy and safety of new drug treatments to be assessed and measured. In many therapeutic areas, traditional outcome measures rely on subjective investigator and patient ratings. Subjective ratings are not always sensitive to detecting small improvements, are subject to inter- and intra-rater variability and limited in their ability to record detailed or subtle aspects of movement and mobility. For these reasons, objective measurements may provide greater sensitivity to detect treatment-related changes where they exist. In this review paper, we explore the use of the Kinect platform to develop low-cost approaches to objectively measure aspects of movement. We consider published applications that measure aspects of gait and balance, upper extremity movement, chest wall motion and facial analysis. In each case, we explore the utility of the approach for clinical trials, and the precision and accuracy of estimates derived from the Kinect output. We conclude that the use of games platforms such as Microsoft Kinect to measure clinical outcomes offer a versatile, easy to use and low-cost approach that may add significant value and utility to clinical drug development, in particular in replacing conventional subjective measures and providing richer information about movement than previously possible in large scale clinical trials, especially in the measurement of gross spatial movements. Regulatory acceptance of clinical outcomes collected in this way will be subject to comprehensive assessment of validity and clinical relevance, and this will require good quality peer-reviewed publications of scientific evidence

Monitoring and alleviating the effects of pressure related injuries for spinal surgery–a need for improvement?

The development of pressure injuries (PIs) is a common complication arising during surgery. Monitoring and alleviating PIs is currently not possible during lengthy spinal and orthopaedic surgeries, especially if a patient requires x-rays. We interviewed surgical staff to gain an understanding of attitudes regarding current methods and approaches for the management of PIs to allow the development of new devices based on staff feedback. Interviewees provided insights regarding the possible design of a new device used to monitor and alleviate pressure injuries in a surgical environment. From the interviews we derived key themes, including current devices/systems, current risk assessment/scales, and design considerations. As a result, we identified critical design requirements and an appropriate product design specification. Background: Complications can arise when perioperative staff are monitoring a patient’s health status during surgery, including the development of pressure injuries (PIs). It is important to reduce the incidence rates of developing PIs intraoperatively, and thereby mitigate both increased costs and negative impacts to patients and care providers. Current pressure relief supports offer limited monitoring abilities throughout the perioperative environment. Aim: The aim of this study is to establish clear design requirements and a product design specification that enables a new closed-loop product solution to be developed with real-time pressure monitoring during surgery. Method: We conducted semi-structured interviews with nine different clinical staff members involved in the perioperative environment. We conducted the interviews over a two-week period with two major teaching hospitals within the East Midlands, UK. Questions focused on healthcare professionals’ perceptions of current methods and their approaches to managing PIs. We recorded and transcribed participants’ data using NVivo software. Conclusion: The interview data identified a need for an improved method to manage and monitor PIs. We established that the incorporation of live feedback to reduce the prevalence of PIs is a critical design priority. Based on the interviews, we developed design criteria and a product design specification (PDS). Interview transcripts suggest a new device design should focus on a novel radiolucent pressure redistribution solution capable of reducing PIs intraoperatively while incorporating live feedback

Meaningful change: defining the interpretability of changes in endpoints derived from interactive and mHealth technologies in healthcare and clinical research

Immersive, interactive and mHealth technologies are increasingly being used in clinical research, healthcare and rehabilitation solutions. Leveraging technology solutions to derive new and novel clinical outcome measures is important to the ongoing assessment of clinical interventions. While demonstrating statistically significant changes is an important element of intervention assessment, understanding whether changes detected reflect changes of a magnitude that are considered meaningful to patients is equally important. We describe methodologies used to determine meaningful change and recommend that these techniques are routinely included in the development and testing of clinical assessment and rehabilitation technology solutions