Question 1 You wish to establish a biomedical device startup. Compose ONE (1) mission statement and identify ONE (1) strategic focus area, using considerations from Study Unit 1. Discuss your choices by explaining how well they align with the acceptance criteria that contribute to startup success. Provide references or weblinks where applicable.

Question 2 Create a script of an unstructured one-on-one interview to uncover the compelling needs which may be addressed by a biomedical device, aligning with your startup’s mission and strategic focus.

This script must present interviewer and interviewee dialogue. Descriptive paragraphs must also be given for providing other information, including (but not limited to) setting, and characters actions.

Examine and discuss how the interview script demonstrates good interviewing practice as outlined in Study Unit 1. Provide justification for your approach.

Question 3 Formulate and discuss one compelling need statement based on your interview. Then propose TWO (2) additional need statements that also align with your startup’s strategic focus and mission.

Compare all THREE (3) and justify which one to pursue, using evaluation considerations from Study Unit 1. A well-balanced need statement will score well across multiple dimensions, including (but not limited to): market analysis; stakeholder analysis; unmet pain points; cost and resource requirements; feasibility and risk; and time to achieve impact.

Question 4 Propose and discuss THREE (3) distinct and novel concepts that could address the selected aforesaid need statement. Use the SCAMPER technique, applying one or more elements per concept. For each concept, analyse and discuss how it functions, evaluate its novelty with reference to existing literature, and assess its feasibility across technical, financial, and regulatory aspects.

Your concepts should demonstrate both creativity and real-world viability. Provide references or weblinks where applicable.

Question 5 Design and discuss FOUR (4) user requirements related to your selected need and proposed concepts. Ensure each is clear and actionable neither too vague nor too specific as cautioned in SU2. Assign weights (1–5) to reflect importance and justify your weightings. Construct a Pugh selection matrix using a current gold standard or a commonly accepted alternative as the baseline. Rate each of your 3 concepts (+1 / 0 / –1) and calculate weighted scores as described in SU2 for your 3 concepts and the baseline method.