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Medical Standards and Professional Engagement

Medical Standards and Professional Engagement

Academic year 2023-24

MODULE: PDE 2910     TITLE: Medical Standards and Professional Engagement

MODULE LEADER:

COURSEWORK B ASSIGNMENT

Topic: Strategy for design and manufacture of a novel low-cost mechatronic device for wheelchair stability assessment

SUBMISSION DEADLINE: 19 February 2024 (Monday), 23.59

COURSEWORK WEIGHTING: 40% of your module mark This coursework is a part of your summative assessment. This is an individual coursework.

SUBMISSION INSTRUCTIONS:

Submit your coursework via the Turnitin submission link on UniHub by 23.59

on 19 February 2024 (Monday). The submission link will close automatically after the specified deadline. ONLY submissions via the TurnitIn link will be considered. Late submission is not allowed. Anonymous marking will be applied. Your submission DOES NOT NEED to include your name and SID. Do not use font sizes smaller than 10pt.

ASSESSMENT:

Your submission will be assessed by your supervisor and another tutor with expertise in the topic. The preliminary grade and feedback on your report will be available on UniHub in the feedback area of your TurnitIn submission. YOUR GRADES WILL BE GIVEN IN MIDDLESEX 20 POINT SCALE. PLEASE

DISREGARD THE PERCENTAGE SYMBOL. Remember that until the results are formally published by the University, the grades are indicative only. They can go up or down as a result of an external examiner’s scrutiny.

CONSULTATION ARRANGEMENTS:

1.  Coursework objective

The aim of this coursework is to assess the following learning outcomes as specified in the module narrative for PDE2910:

Assessment B: An individual activity to propose a strategy for design of a new medical device that complies with the existing legislation and safety requirements and generate a Product Design Specification from a brief for a proposed new device to assess learning outcomes 2 and 3. (40%)

Learning outcome 2: Undertake risk assessment and specify safety critical examinations required for the commissioning and continued use of medical devices

Learning outcome 3: Discuss the importance of legislation, standards, guidelines and requirements for compliance of medical devices.

2.  Coursework Scenario:

A multi-disciplinary team at Robin Valley Hospital* was awarded funding from the hospital’s research programme to develop a low-cost mechatronic device that can establish the boundaries of static stability for wheelchairs. [1] The new device was needed for the daily work of their rehabilitation engineering department. Previously, the rehabilitation engineering department utilised a pass-fail testing approach known as the tilt test. The procedure entailed positioning the wheelchair and its occupant on a designated ramp that was progressively elevated from its horizontal position. (Figures 1 and 2) The stability was evaluated by verifying if the wheelchair could remain steady until it reached the specified inclination angles (12 degrees for manual wheelchairs and 16 degrees for motor-propelled wheelchairs) [6]. The disadvantages of this approach are that the user may experience discomfort if the wheelchair tips over, and the measurement procedure can take a considerable amount of time [2, 3].

After six months of work on the new project, the research team built a prototype device consisting of a mechanical construction with an electromotor-powered ramp and outfitted with several sensors. A microcontroller carried out all testing procedures automatically. An appropriate GUI and an encrypted wireless connection were used for visualisation and recording test results. [4-6]. The new measurement device collected information about the tipping angles by tilting automatically the ramp of the device forward, rearward, and sideways. It estimated the tipping angles without reaching the exact points of fall and provided recommendations to staff about the stability of the tested human-wheelchair system.

The prototype of the new wheelchair stability testing device was initially tested for 6 months in the rehabilitation engineering department of Robin Valley Hospital. The tests confirmed its effectiveness. The hospital staff and the wheelchair users quickly adapted to the new control

algorithm. The new system produced precise and much more clear measurements, and the time for tests was significantly reduced.

During the second year of project development, the initial concept was improved further. Ten additional prototype devices were manufactured and evaluated for six months at five collaborating institutions. The analysis of the test results confirmed the efficacy of the new device.

After the completion of the research project, the obtained research results were transferred to Advance Rehab Company, a small but innovative organisation that consented to manufacture the new device. A team of specialists was assembled and asked to propose a strategy for market research, development, and mass production of the new product. The team consisted of experts from the Advance Rehab company, specialists from the Robin Valley Hospital, and academic staff from the nearby Goldfinch University.

Please note:

* The scenario above is for educational purposes only and is not related to any specific products, businesses, or genuine health care organisations.

3.  Your task

Write an essay of 2500 words (+/-20%) to propose a strategy for design of the new wheelchair stability assessment device that was introduced in the scenario above. The strategy that you propose must comply with the existing legislation and safety requirements. Generate a Product Design Specification for the device introduced in the above scenario.

In your essay, you need to:

  1. discuss the 4 P’s of marketing for the wheelchair stability assessment device;
  2. describe how QFD analysis can be utilised for transforming customer requirements into technical specifications needed for the design phase of the new wheelchair stability assessment device. You need to support your answer with a simple House of Quality diagram for the device from the above-presented scenario;
  3. suggest a Product Design Specification (PDS) for the intended device for wheelchair stability assessment. Your PDS should include design requirements that will help the design team in the development of a product that is novel, attractive to customers, and has good market prospects to compete with other existing products. Determine if the design requirements you propose are criteria or constrains;
  4. explain the process for developing a design concept for the new device and comment on how brainstorming techniques might help. Make a suggestion for how to hold a brainstorming session to generate design ideas for the new product. Comment on the team’s structure (explain who should be invited to brainstorming sessions and why their expertise is required). Describe the procedure for selecting the best design concept. Give an example of the selection of the best design idea for the wheelchair stability assessment device.
  5. discuss medical device legislation and electrical equipment safety for the wheelchair stability assessment device;
  6. discuss the FMEA of the new wheelchair stability assessment device. Include a short example of the FMEA analysis of the new device for wheelchair stability assessment.

4.  Keep in mind:

  • Your answers should focus on the organisation of the design process for the wheelchair stability assessment device presented in Section 2. For this coursework, it is not required for you to create an engineering solution for a wheelchair stability assessment device. You are not required to conduct a background search on existing products or find existing engineering solutions for wheelchair stability assessment devices. INSTEAD: Your objective is to do the tasks 1-6 listed in Section 3 above.
  • When you prepare your essay, use the lecture materials as a primary source of reference. Additionally, look for additional information on your own (relevant scientific research papers and books, patents, legislation documents, etc.). Evidence your literature search by using an appropriate list of references. Seek to cite high-quality literature sources.
  • Your answers must be related to the coursework scenario. It will not be sufficient if you submit general answers that simply repeat the basic theory discussed in class. Instead, provide answers that demonstrate that you understand the theory and can creatively apply your theoretical knowledge to the given coursework scenario.
  • You must also demonstrate knowledge of current legislation applicable to the specific device. You must concentrate on the legislation enacted in the United Kingdom.
  • This coursework is part of your summative assessment for this module. It is expected that you will create it on your own. It is not envisaged that you will prepare your coursework in cooperation with the academic team (for example, you prepare a very rough version of your essay or just a tiny portion of it, send it to the tutor, expecting the tutor to read, change and improve it, and provide detailed feedback on it, then you slightly improve the initial version and ask the academic tutor for new detailed checks and feedback, and so on). However, you could schedule a meeting with the tutor to discuss your coursework writing progress, ask questions, and obtain general directions and ideas.
  • The presented scenario does not refer to any real enterprises and their practices, products, or individuals. It is prepared for educational purposes only.
  • You need to ensure that your essay is well-structured. Make sure your essay has a brief introduction, clearly structured sections with your discussions on each topic, a short conclusion, and a list of references. To see how a well-structured document looks like, you can look at examples in places like peer-reviewed journals. Ensure that the length of your essay is within the stated boundaries. In order to demonstrate that your essay is within the required length, it is a good idea to include a text box displaying the exact word count.

5.  Marking scheme

The 4 P’s of marketing for the intended new product 20%
Considering customer requirements: QFD analysis. 15%
A brief Product Design Specification for the device that will be designed 15%
Concept development process: brainstorming, constraints, criteria, concept selection   15%
Medical device legislation and electrical equipment safety relevant to the intended new product   15%
FMEA of the intended new device. Provide an example to demonstrate how FMEA can be applied to the intended new product.     10%
Report quality: Introduction, structure, conclusion, list of references, length 10%

This assignment accounts for 40% of the overall grade for the PDE2910 module.

REFERENCING:

References are an important means of supporting your own ideas. Include citations for all sources of information reviewed. Literature and pertinent legislative documents ought to be cited using the Harvard referencing system. Numerous publications and websites offer comprehensive guidelines regarding the format and application of Harvard style. One good example of Harvard style is provided in “Ultimate Guide to Harvard Referencing – Cite This For Me” at https://www.citethisforme.com/harvard-referencing. Additionally, you could refer to section “Q&A regarding Coursework B, A, and C” on UniHub for PDE2910, where you will find helpful tutorials on Harvard style referencing.

PLAGIARISM:

Plagiarism is committed when the work of others is not acknowledged. Plagiarism and cheating are violations of university regulations and will be dealt with accordingly.

2023-24    PDE2910    Coursework B: Strategy for design and manufacture of a novel low-cost mechatronic device for wheelchair stability assessment

Criterion Wgt 1-4 5-8 9-12 13-16 17-18 19
Product Design Specification (PDS)   15% PDS is reviewed to a high standard. PDS is very well presented. PDS is relevant to the specific device but lacks detail. PDS is not supported by research and is not focused on the specific device. PDS is largely missing. There is no PDS.
Discussion on the 4 P’s of marketing for the intended new product     20% The discussion of the four P’s of marketing is focused on the specific new device and thoroughly reviewed. The 4 P’s of marketing are very well presented. The discussion of the 4 P’s of marketing is relevant to the given device, but it lacks detail. The discussion of the 4 P’s of marketing is not supported by research and is not focused on the given device. The discussion of the 4 P’s of marketing is largely missing. The 4 P’s of marketing are not commented.
    QFD analysis     15% The discussion of QFD analysis is relevant to the specific device and reviewed to a high standard. The discussion of QFD analysis is relevant to the specific device and very well presented. The discussion of QFD analysis is relevant to the specific device but lacks detail and academic rigour. The discussion of QFD analysis is not supported by research and is not focused on the particular device. QFD analysis discussion is largely missing. There is no QFD analysis discussion.
Concept development process: brainstorming, constraints, criteria, concept selection       15% A comprehensive and well-thought-out discussion of the concept development process A good overview of the concept development process. The discussion of the concept development process is limited in detail and scope. Some discussion of concept development is provided, although it is quite limited in detail and scope. There is very little discussion of the concept development process. There is no discussion of the concept development process.
Medical device legislation and   15% A thorough and well- considered review of the relevant A well-thought-out overview of the appropriate A discussion of the legislation and electrical equipment Some discussion of the legislation and the safety of electrical equipment is It is provided very little discussion of the legislation There is no discussion of the legislation
electrical equipment safety   legislation and electrical equipment safety. legislation and the safety of electrical equipment. safety is provided; however, it is limited in detail and scope. provided. It is relevant to the given device, but it is very limited in scope and detail. and electrical equipment safety; the discussion is too general and mostly not related to the given device. and electrical equipment safety.
    FMEA of the intended new device       10% It is provided a comprehensive and well-thought-out discussion of the FMEA, which is supported by a well- presented risk assessment example that refers to the device from the coursework scenario. The FMEA and risk assessment were thoroughly discussed. It is given an example that is relevant to the device in the coursework scenario. The FMEA discussion is limited in scope and detail. You have provided some discussion of the FMEA, though it is very limited in detail and scope. / An FMEA example is not provided. There was very little discussion of the FMEA and risk assessment. There is no discussion of FMEA and risk assessment.
    Report quality: Introduction, structuring, conclusion, list of references, length       10% The report is structured in a very comprehensive way and written in standard English with correctly formatted citations and references. High- quality, peer- reviewed research articles are included in the reference list. The report is well- structured, written in standard English, and has typically good formatting. A good selection of relevant references. The report is well- structured, but it lacks some elements of conventional English. Some citations and references are poorly formatted. The report lacks adequate structure. It has a generally poor English level. There are few citations that consist mainly of web addresses; there are citations; there are few unproperly formatted citations; or there are no quality references; or, your paper is much larger than the size indicated in the coursework brief. There has been little attempt to structure the report according to the provided instructions, and the English is of a poor standard. There are no references. There has been no attempt to arrange the report properly. There are no references to literature sources, and/or there is no list of references.

This assignment accounts for 40% of the overall grade for the PDE2910 module.

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