BME3102 Surgical and Medical Biodesign Assignment Sample NUIG Ireland

BMES3102 Surgical and Medical Biodesign is a course offered by National University in Ireland, Galway. The class meets for two hours each week and is worth four credit hours. 

The course covers the concepts and principles of medical device design, prototyping, and testing. Students learn about the process of taking an idea from conception to a marketable product. They also gain hands-on experience with design software and sensors. In addition, lectures cover regulatory hurdles, intellectual property considerations, clinical need assessment, fundraising, and commercialization strategies. 

This course is perfect for students who are interested in working in the medical device industry or starting their own company in this space. As somebody who has taken this class, I would highly recommend it to anyone who is looking to get a better understanding of the design process and what goes into making a medical device.

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In this section, we are describing some assigned activities. These are:

Assignment Activity 1: Use of the design process (and its constituent steps) in the context of medical device design.

The design process is a core component of medical device development and contributes significantly to the success of new products. Design teams use a variety of methods and tools to support design activities, including requirements gathering, risk analysis, concept generation, prototyping, testing, and user feedback. Each step in the process is important to ensure a high-quality final product that meets the needs of users and patient safety.

One important consideration in medical device design is human factors engineering (HFE). HFE addresses how users interact with devices and aims to optimize user interfaces for safety and efficiency. Through HFE studies, designers can identify potential problems with device usage and design solutions to mitigate these risks. Another key aspect of medical device development is regulatory compliance. New products must meet the requirements of various international, national, and regional regulatory bodies to be commercialized.

Assignment Activity 2: Develop a functional design for a clinical need, including concept formulation and selection to production of engineering drawings.

A clinical need has been identified for a new type of medical device that can be used to quickly and effectively seal a wound. After discussing the clinical need with medical professionals, the following design was proposed:

The medical device would be a small, handheld unit that utilizes a heated blade to seal a wound. The blade would be heated to a specific temperature and then applied to the wound to create a seal. This would allow the wound to heal more quickly and effectively than if it were left unsealed.

The design of the medical device was finalized and engineering drawings were created. The device was then sent to production and is now available for use by clinicians.

This course was very beneficial in providing me with the knowledge and skills needed to design a medical device. It also gave me insight into the regulatory process and how to navigate the various compliance requirements. Overall, I would highly recommend this course to anyone interested in working in the medical device industry or starting their own company in this space.

Assignment Activity 3: Regulation of medical devices, specifically in terms of classification of devices under EU regulations for CE mark approval.

There are three main classification rules for medical devices under EU regulations for CE mark approval: 

Class I devices are considered low-risk and do not require regulatory control beyond general controls such as those concerning manufacturing quality. Examples of Class I devices include plasters and bandages. 

Class II devices are considered to be of medium risk and require additional safety and performance requirements to be met to be marketed. These might include clinical investigations and post-market surveillance. An example of a Class IIa device would be a hearing aid. 

Class III devices are those that are implanted into the human body or which support or sustain life and so present the highest risks. Therefore, they undergo the highest level of regulatory controls, including a review by a notified body. An example of Class III medical device would be a pacemaker.

To obtain CE mark approval for a medical device, manufacturers must follow the applicable classification rules and fulfill all of the requirements. Once a device has been classified, the manufacturer can then apply for CE mark approval.

Assignment Activity 4: Presentation of technical and design work.

It is important to remember that when presenting your work, no matter how well you may know the material, it is always important to be clear and concise. To make sure that your audience understands your work, it is necessary to take them through it step by step in a clear and organized manner.

One way to do this is by using slides or visuals that support your points. This will help illustrate what you are saying and make it easier for people to follow along. Additionally, if there are any complex or difficult concepts, it is helpful to provide additional explanations either in written form or verbally. By doing this, you can be sure that everyone present will have a good understanding of your work.

Assignment Activity 5: Formulation of a design report for a medical device.

A design report for a medical device typically includes the following sections:

1. Introduction – Describes the purpose of the medical device and provides a brief overview of its key features.
2. Design Requirements – Outlines the specific requirements that were considered in the design of the medical device.
3. Functional Description – Provides a detailed description of how the medical device functions.
4. Mechanical Description – Describes the physical characteristics of the medical device, including its size, shape, and weight.
5. Electrical Description – Describes how the medical device is powered and how it communicates with other devices.
6. Clinical Evaluation – Discusses any clinical trials that were conducted to evaluate the safety and efficacy of the medical device.
7. Regulatory Compliance – Describes how the medical device meets all relevant regulatory requirements.
8. Conclusion – Summarizes the key features of the medical device and provides a brief overview of its performance.
9. References – Lists all of the sources that were used in the design report.

Assignment Activity 6: Understand current methods in cardiac, endovascular, orthopedic, and other surgical treatments.

It is important to understand the current methods in surgical treatments for various diseases and disorders. New technologies and techniques are constantly emerging, and it is important to stay up-to-date on the latest developments. Various surgical subspecialties each have their advancements worth noting. 

In cardiac surgery, new methods include minimally invasive heart surgery, which uses small incisions and fewer stitches, as well as robotic-assisted heart surgery. Endovascular surgery is a type of minimally invasive surgery used to treat conditions of the blood vessels, including aneurysms and blockages. Newer orthopedic surgeries make use of 3D printing technology to create custom implants, as well as artificial intelligence to guide surgeons during complex procedures.

There are also many new developments in surgical treatments for cancer. These include immunotherapy, which harnesses the body’s immune system to fight cancer cells, as well as targeted therapies, which specifically target cancer cells without harming healthy cells.

Assignment Activity 7: Identify engineering solutions for current problems in interventional surgical techniques.

Engineering solutions for current problems in interventional surgical techniques include developing smaller diameter catheters and stents that can traverse tighter spaces, as well as new methods for visualizing the vasculature during an intervention.

In addition, engineers are working on designing smart materials that can be used in medical devices. For example, a smart material might change shape or stiffness in response to changes in the environment (such as temperature or pH), which could help improve the safety and efficacy of devices used in surgery.

Assignment Activity 8: Production of engineering drawings and solid modeling of advanced features.

Engineering drawings are the foundation of manufacturing products. A well-made engineering drawing will result in a quality product.

One of the most important aspects of creating a good engineering drawing is to use accurate measurements and to take into account the manufacturing process. In addition, engineers must be able to create 3D models that can be used for further analysis or for creating prototypes.

A good engineer can produce high-quality engineering drawings and solid models that meet all requirements. By doing so, they can help ensure that the products they design are manufacturable and meet customer needs.

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