Background
Title: A Study on the Design of a Wireless Pacemaker: Measuring the Ergonomics Performance Level
Majorly the project focuses on establishing whether the wireless pacemaker, that is currently being developed further, could potentially be harmful to the designated patients. Therefore, it will serve to inform the design engineers on the ergonomic aspect that is part of measuring the performance level of the device.
- To establish the ergonomic performance level of the wireless pacemaker
- To provide a standard criteria of safety tests of the device
- To provide a basis for redesign of the device, by ensuring all ergonomic aspects are captured thereafter
- What are the unique features of performance that the new pacemaker could be having?
- How does the new pacemaker compare with the old wired one?
- Are there any improvements made since it was first designed?
- What are the success and failure rates among the patients who have used the new device?
- What are the concerns raised by both medics and patients?
There has been an outcry from different patients and medics about the ergonomic aspects of the new pacemaker which uses no wires to operate (Karrouze, 2007). Some patients reportedly developed holes on their heart after they used the new device. Besides, the old one proved unhealthy for use since the patients recorded highest probability of developing chest and heart infections after its use (CBS news.com, 2017). Notably, engineers responded by designing and developing the wireless pacemaker which requires no surgery to be performed, though it has not gained greater acceptability among the medics and patients. Admittedly, it is against that backdrop that this research was informed to investigate the likely cause of its low acceptability. Therefore, the research will focus on establishing the ergonomic aspects of the new design.
Notably, a lot of research interests have ensued. According to Graham-Rowe (2011) the wireless pacemaker eliminates the leads in the heart hence it is becoming a significant breakthrough in the cardiology field. Graham-Rowe opines that the new device causes less health risk as it does not produce any heat since it uses the ultrasound which then gets converted to electricity to power the device. However, some medics have remained skeptical about its safety. According to Smith (2016) there has been hacking claims on the new device; in fact it is being suspected that the new device could be highly susceptible to malicious attacks that may put the lives of the patients in great danger. Allegedly, the device is not encrypted or authenticated in the wireless protocol hence could substantially be exploited by running its functionality down to 50% (Smith, 2016). Furthermore, Halperin et al (2013) launched an enquiry in the form of a research to ascertain the levels of privacy and security of the wireless implantable devices like the new pacemaker. They were stunned by the revelations; that the critical data transfers were open for interception by the attackers, and then they would use an attack programme to destruct the transmission hence leading to malfunctioning. However, the biggest challenge was how to opine these facts without causing further damage on both patients’ and medics confidence level; nevertheless, the paper focuses on the technical aspects of the IMDs (implantable Medical Devices) without being specific on the wireless pacemaker. However, on the positive side, the device has successfully been tested on the mouse. Laughner et al (2013) developed a comparative study on the battery powered and wireless pacemakers. They concluded that the wireless pacemaker if successfully designed and operated could lower the mortality rates induced by the battery powered pacemakers from a high of 40% to a low of 10%.
Data Collection Techniques
The essential data collection techniques shall involve both primary and secondary sources. We intend to use a minimum of one month to collect, collate, analyze and present the analyzed findings. In the first two days of the first week, we will be involved in planning the tasks and then making arrangements how to go about all these. We shall call to book appointments in some of the reputable research centers in order to interrogate some of the breakthroughs in this arena. Therefore, wide consultations with the experts and experienced cardiologists will also be done. Additionally, we shall conduct interviews and administer questionnaires to both selected patients and medics. On the secondary sources, we will adopt both online and offline interrogation of the available relevant journals, books, publications and articles; this would greatly help in formulating the conceptual framework. Lastly, simulation of both the wireless and battery-powered pacemakers shall be done. This will also involve the use of matlab software to analyze the results.
Table 1: The Gantt chart
Time schedule |
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Activity |
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Day3,4 |
Day 5 |
Day1,2 |
Day3,4 |
Day 5 |
Day1,2 |
Day3,4 |
Day5 |
Day1,2 |
Day3,4 |
Day 5 |
Planning & scheduling |
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Data collection |
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Interviews |
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Questionnaires |
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Simulation |
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Secondary sources |
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Expert opinion |
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Analysis |
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Matlab tests analysis |
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Report preparation |
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Presentation |
Once the data is collected, we will analyze and report the findings. However, we are likely to face some challenges in the course of this study. For instance, the research touches on a more sensitive and even personal topic that is health. We are likely to have a situation where the findings based on scientific collection techniques, indicates a damaging picture on the device. However, we will chose to remain factual but not blunt on the medical consequences of our research. Certainly, as one of the objectives, we intend to uncover the design flaws on the device so that appropriate redesign can be done thereafter. Furthermore, we may want to make the research more rigorous by expanding the research sample, however due to budgetary constraints, we shall be limited in our endeavor. Risk Assessment, Health & Safety Issues, and Ethical Issues:
Like medics, engineers and scientists also have an ethical responsibility in ensuring the systems and products they design meet the minimum ethical standards. Additionally, we are aware of the sensitivity of this topic and we shall endeavor to remain factual in analysis and findings. For example, one misleading statement can cause irreparable damage on the confidence level of the patients and even medics. As engineers, we bear the responsibility to ensure safety, health, ethical conduct and privacy in the use of this device are maintained at all times.
However, it should be noted that this research will not involve interrogation of all design aspects of the new pacemaker. There are a dozen aspects that must be integrated in the design and development of such IMDs. We shall focus on the ergonomic aspects of the device which mainly include the safety, wellbeing, privacy and security of use. Certainly, therefore, in future another research study should be launched to examine the different design aspects of the device.
References
Cbsnews.com. (2017). “Wireless” pacemaker brings new hope for heart failure patients. [online] Available at: https://www.cbsnews.com/news/wireless-pacemaker-brings-new-hope-for-heart-failure-patients/ [Accessed 24 Dec. 2017].
Graham-Rowe, D. (2017). New Pacemaker Needs No Wires. [online] MIT Technology Review. Available at: https://www.technologyreview.com/s/426164/new-pacemaker-needs-no-w [Accessed 24 Dec. 2017].
Halperin, D. (2008). Pacemakers and Implantable Cardiac Defibrillators: Software Radio Attacks and Zero-Power Defenses.Online Journal. [Accessed 24 Dec 2017]
Karrouze, A. (2007). Learn all about cardiac pacemakers and defibrillators Implantable Cardiac Pacemakers and Defibrillators: All you Wanted to Know Anthony WC Chow, Alfred E Buxton ISBN:9780727915665 Blackwell, 2006 184 pages, £36.99. British Journal of Cardiac Nursing, 2(3), pp.152-152.
Laughner, J., Marrus, S., Zellmer, E., Weinheimer, C., MacEwan, M., Cui, S., Nerbonne, J. and Efimov, I. (2013). A Fully Implantable Pacemaker for the Mouse: From Battery to Wireless Power. PLoS ONE, 8(10), p.e76291.
Smith, M. (2017). St Jude calls easily hackable pacemaker claims ‘false and misleading’. [online] CSO Online. Available at: https://www.csoonline.com/article/3113059/security/st-jude-calls-easily-hackable-pacemaker-claims-false-and-misleading.html [Accessed 24 Dec. 2017].