Biomedical Devices Innovation: Mission and Concept Design

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.

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Expert Answers on Above Biomedical Device Innovation

Mission statement and strategic focus

The mission has been to develop a non-invasive monitoring device that allows for early detection of chronic diseases in community and home settings.
Strategic focus area: This strategic focus area is the remote patient monitoring for chronic diseases especially diabetes.
Alignment with startup success criteria: According to the statistics provided by World Health Organisation, chronic diseases have a significant impact on the Global death level and remote level monitoring is a significant area in the health care segment that is gaining rapid attention. The value that the proposed device will provide includes early detection, and lower overall healthcare cost. It is highly feasible and it will be available in the form of wearable and can be easily scaled globally specially across the developing economies.

Unstructured interview transcript

Interviewer: Thanks for giving your time and discussing your health concerns. Can you tell me about monitoring your diabetes level daily?
Interviewee: Well I have to check my glucose several times in a day which is quite painful and inconvenient.
Interviewer: Does it have any impact on your daily life condition?
Interviewee: Yes sometimes it is so inconvenient that I have to skip the process.
Interviewer: Is there any way it can be made simpler?
Interviewee: A painless and automatic process can be great in dealing with the situation.
Interviewer: How do you rate a wearable device that will update you about your Glucose level without any pain?
Interviewee: That will be great but the cost factor needs to be considered.

Why do the questions demonstrate good interview practice?

The questions above are mainly based on open ended questions which allows the respondent to provide detailed responses, and there are no any misleading questions to avoid any kind of biasness.

Need statement

The primary need of the patient suffering from diabetes is to get a tool that allows them to monitor their diabetes level without any kind of pain. Additional needs include allowing people to monitor their levels remotely and patients need affordable devices to reduce their health care expenses.
Comparison and selection: Based on the above analysis, strong market demand along with clear pain point are the primary reasons for selection of need one above.

Three novel concepts using scamper

The concept one is a type of smart skin patch which is the kind of wearable device to monitor the Glucose level continuously. The second concept is Smartwatch glucose monitor that combines Smartwatch and a multi functional wearable. The third concept is smartphone based optimal scanner that utilises phone sensors to scan glucose level.

User requirements and pugh matrix

The user expects accurate results, comfortable and affordable, and also allows easy ease of use.
Pugh selection matrix: Among the three options available such as patch, watch and scanner, the highest weighted score based on the criteria of accuracy, comfort, cost and ease is Patch and it is therefore recommended.

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