BME317 Biomedical Devices Innovation End-of-Course Assessment 2026 | SUSS

BME317 End-of-Course Assessment 2026

Instruction To Students:

1. This End-of-Course Assessment paper comprises NINE (9) pages (including the cover page).
2. Students must use the official answer template provided in Appendix A.
3. Before submitting your answers, you are required to complete the declaration section in the template by checking the appropriate boxes to confirm:
   • the originality of your work,
   • that the assignment has not been submitted to another course, and
   • your use (or non-use) of Artificial Intelligence (AI) tools, in accordance with the Academic Integrity Rules
4.  Submissions that do not use the prescribed template or that contain incomplete or inaccurate declarations may be subjected to penalties under the Academic Integrity Rules.
5. You are to include the following particulars in your submission: Course Code, Title of the ECA, SUSS PI No., Your Name, and Submission Date.
6. Late submission will be subjected to the marks deduction scheme. Please refer to the Student Handbook for details.

Instruction To Students:

ECA Submission Deadline:  Friday, 10 April 2026, 12 noon

BME317 ECA Questions

Question 1

Examine your biomedical device startup business and develop a 1-minute elevator pitch video designed to generate interest from potential investors. In the video, discuss your business and funding opportunity while speaking directly to the camera. Only you may appear in the video—no slides, props, or other visual aids are allowed. Your pitch must clearly address the following key elements:

• Company information
• Value proposition
• Problem or opportunity being addressed
• Your product
• Market size and growth potential
• Additional information that reinforces your credibility.
• Support and/or amount of funding you are asking.

The presentation must be no longer than 1 minute. Only content delivered within the first 60 seconds will be graded.

(25 marks)

Question 2

Discuss your proposed biomedical device startup idea (based on Question 1) using the Business Model Canvas (BMC). Incorporate all essential components outlined in Section 1.2 in Study Unit 4. Appraise and discuss how each component contributes to making your business viable, sustainable, and successful.

Your answer should not exceed 900 words.

(25 marks)

Question 3

Evaluate your biomedical device (as described in Question 1) and analyse how your device could qualify for intellectual property (IP) protection. Perform an IP search and identify THREE (3) similar existing patents or published applications. For each, explain how it might affect your device’s ability to obtain patent protection.

Assuming your startup is the first to invent and develop this biomedical device, propose TWO (2) patent claims that could protect your innovation. Justify the scope and originality of each proposed claim.

Your answer should not exceed 900 words.

(25 marks)

Question 4

Discuss your plan to prototyping your biomedical device startup (as described in Question 1), using figures where appropriate. Outline your planned proof-ofconcept testing, non-clinical testing, and clinical testing, clearly stating the objectives and expected outcomes of each stage.

Additionally, describe the key considerations involved in developing and testing biomedical device prototypes, with reference to the following:

• Safety precautions
• Relevant regulatory agencies and applicable regulations
• Hazard identification and risk management
• Use of animals (if applicable)
• Occupational health and laboratory safety
• Facilities and equipment requirements

Your answer should not exceed 900 words.

(25 marks)

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