Question 1

Compose and write a compelling need statement for a specific area within the biomedical field. Examine the importance and significance of this statement. Justify why it addresses a critical and pressing issue. Ensure that this problem is complex enough to allow for subproblems decomposition.

(15 marks)

Question 2

Draw an input and output diagram of this problem with functional decomposition (similar to that given in Figure 2.1, in Study Unit 2). Explain these diagrams.

(10 marks)

Question 3

Propose THREE (3) novel concepts that could potentially solve or address the problem stated in Question 1. Analyze how each concept functions and assess its feasibility to produce the desired outcome to address the problem.

(15 marks)

Question 4

Critically evaluate the novelty of each concept by conducting an external search. Provide references or web links to highlight existing solutions and offer an overview of how they compare to your proposed ideas.
(15 marks)

Question 5

Identify an existing biomedical device that is widely recognized as the solution or gold standard in this field. Discuss the innovativeness of this device, in terms of its design, functionality and impact within the area.
(10 marks)

Question 6

Create a Pugh method selection matrix (referencing Figure 2.3 in Study Unit 2), using the aforesaid device stated in Question 5 as the baseline solution. Analyze and compare the baseline solution with your three proposed concepts, by ranking and scoring them based on four key requirements for your concepts.
(15 marks)

Question 7

Evaluate the stakeholder analysis for your winning concept (referencing to Section 2.11 in Study Unit 1 for guidance).
(10 marks)

Question 8

Evaluate the market analysis for your winning concept (referencing to Section 2.12 in Study Unit 1 for guidance).
(10 marks)