Word Count: Maximum 1500 words for the overall assignment excluding references. A cover page, introduction, or table of contents are not required.
Assignment 1 Guidelines
Word Count: Maximum 1500 words for the overall assignment excluding references. A cover page, introduction, or table of contents are not required.
Write a Short Review Paper on two therapeutic medical devices using the template provided. Select one Balloon Catheter and one Orthopaedic medical device type from the table below.
Balloon Catheter Devices Orthopaedic Devices
Occlusion balloon catheter Shoulder arthroplasty
Thrombectomy balloon catheter Finger arthroplasty
Sinuplasty balloon catheter Elbow arthroplasty
Neurological balloon catheter Ankle arthroplasty
Transcarotid balloon catheter (Transcarotid artery revascularization - TCAR) Prosthetic intervertebral disc
Include the following:
The device name and one image of the device.
Name the company that manufactures the device.
You must NOT currently work or have previously worked for the company
The company must have a presence in Ireland or UK (Pls confirm with me before you choose the company), either a manufacturing facility or a research and development (R&D) facility.
Device Description
Balloon Catheter: Include information such as the indication for use, matrix of sizes available, balloon material/type, balloon diameter, balloon length, introducer sheath compatibility (size), guidewire compatibility (size), balloon nominal pressure/volume, balloon rated burst pressure/volume, catheter working length etc.
Orthopaedic Device: General description.
Briefly describe the clinical need for the medical device.
A brief description of how the device functions in the body.
List the components and component materials of the device.
Balloon Catheter: Minimum of 5 components.
Orthopaedic Device: Minimum of 3 components.
Discuss why the materials are suitable for the device.
Discuss the device classification EU (Class I, IIa, IIb, III) or FDA (I, II, III) and reason for selection.
Describe a suitable sterilisation method for the device.
Describe the nature and duration of contact of the device with the body.
List four endpoints that should be evaluated as part of a biological evaluation of the device.
Include a minimum of six references (Harvard style).
Please note: A PTCA (coronary) and a Knee or Hip (arthroplasty) are not within the assignment scope
Assignment 1 Template (remove/replace text highlighted in yellow)
Name: Forename Surname
Student Number: Number
Word Count: xxxx words (max 1500 excluding references)
Device Name: Catheter Device
Insert image of device
Figure 1:
Company Name:
Balloon Catheter Device Description:
Clinical Need:
How the Device Functions in the Body:
Device Components and Materials:
Material Suitability:
Device Classification:
Sterilisation Method:
Nature and Duration of Contact:
Endpoints for Biological Evaluation:
References:
Device Name: Orthopaedic Device
Insert image of device
Figure 2:
Company Name:
Orthopaedic Device Description:
Clinical Need:
How the Device Functions in the Body:
Device Components and Materials:
Material Suitability:
Device Classification:
Sterilisation Method:
Nature and Duration of Contact:
Endpoints for Biological Evaluation:
References:
