Podcast
Questions and Answers
What distinguishes design from research?
What distinguishes design from research?
- Design is a purely creative process.
- Design typically integrates existing knowledge. (correct)
- Design involves generating new theories.
- Design requires only theoretical knowledge.
Which statement best represents the relationship between design and research?
Which statement best represents the relationship between design and research?
- Design may involve some research but is fundamentally distinct. (correct)
- Design processes eliminate the need for research.
- Design is entirely dependent on research outcomes.
- Research is the primary method used in design.
In what scenario might research be necessary for a design task?
In what scenario might research be necessary for a design task?
- When the task requires a historical overview of design.
- When the task focuses on aesthetic improvement.
- When solving a problem that has multiple solutions.
- When creating new concepts without existing references. (correct)
Which of the following is NOT typically considered a part of the design process?
Which of the following is NOT typically considered a part of the design process?
What is a common misconception about design tasks?
What is a common misconception about design tasks?
Which aspect is essential in correctly understanding biomedical device design?
Which aspect is essential in correctly understanding biomedical device design?
What is the purpose of the example requirements given for an ECG?
What is the purpose of the example requirements given for an ECG?
Which specification aligns with the requirement of displaying differential voltages of +/- 5 mV?
Which specification aligns with the requirement of displaying differential voltages of +/- 5 mV?
During which stage is performance evaluation performed in the Product Development Life Cycle?
During which stage is performance evaluation performed in the Product Development Life Cycle?
What is the role of developers in the design process as mentioned in the content?
What is the role of developers in the design process as mentioned in the content?
Why are specifications like 'the ECG A/D converter shall have at least 10-bit real resolution' important?
Why are specifications like 'the ECG A/D converter shall have at least 10-bit real resolution' important?
What tool is suggested for evaluating electronic, mechanical, thermal, and radiation behavior?
What tool is suggested for evaluating electronic, mechanical, thermal, and radiation behavior?
Which of the following is NOT a typical aspect covered by specifications in the design process?
Which of the following is NOT a typical aspect covered by specifications in the design process?
What is indicated by the requirement stating that a 20µV peak-to-peak sinusoidal signal shall yield a visible ECG trace?
What is indicated by the requirement stating that a 20µV peak-to-peak sinusoidal signal shall yield a visible ECG trace?
What are the three axes used to assess the success of a project?
What are the three axes used to assess the success of a project?
Which of the following is NOT a reason for IT project failure according to the Bull Survey?
Which of the following is NOT a reason for IT project failure according to the Bull Survey?
How is risk management characterized in the medical design field?
How is risk management characterized in the medical design field?
What percentage of IT projects fail due to delays, according to the Bull Survey?
What percentage of IT projects fail due to delays, according to the Bull Survey?
What is a major reason for project failure that relates to risks?
What is a major reason for project failure that relates to risks?
Which of the following aspects is integral in project management to ensure success?
Which of the following aspects is integral in project management to ensure success?
Which option best describes the relationship between project performance and costs?
Which option best describes the relationship between project performance and costs?
Which of the following statements about project management practices is true?
Which of the following statements about project management practices is true?
What is the primary question a business plan must answer regarding product sales?
What is the primary question a business plan must answer regarding product sales?
What does 'differential competitive advantage' refer to?
What does 'differential competitive advantage' refer to?
Which element is considered essential for evaluating a product's market performance?
Which element is considered essential for evaluating a product's market performance?
What is meant by 'product marginal cost'?
What is meant by 'product marginal cost'?
Which relationship is emphasized in the context of performance, cost, and price?
Which relationship is emphasized in the context of performance, cost, and price?
What critical point is reached when a company sells a certain quantity of its product?
What critical point is reached when a company sells a certain quantity of its product?
What does 'feature investment' involve?
What does 'feature investment' involve?
What happens to business profitability after reaching the break-even point?
What happens to business profitability after reaching the break-even point?
What is the relationship between the effort required to become an expert in a specific project and the experience already gained in similar projects?
What is the relationship between the effort required to become an expert in a specific project and the experience already gained in similar projects?
Which of the following aspects can be part of know-how to reduce costs in product design?
Which of the following aspects can be part of know-how to reduce costs in product design?
What type of patent permits the reservation of patents almost worldwide?
What type of patent permits the reservation of patents almost worldwide?
What does a patent protect?
What does a patent protect?
What is one way to simplify patent investigation?
What is one way to simplify patent investigation?
Which of the following is NOT typically included in the category of know-how?
Which of the following is NOT typically included in the category of know-how?
Which type of patent is specifically issued within the United States?
Which type of patent is specifically issued within the United States?
What is the effect of know-how on the development process of a product?
What is the effect of know-how on the development process of a product?
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Study Notes
Design and Research
- Design is primarily about integrating existing knowledge rather than generating new knowledge.
- Research may be a part of a design task when necessary.
Product Development Life Cycle
- The Waterfall Model outlines the sequential stages of product development.
- Example requirements for an ECG include:
- Displaying differential voltages of +/- 5 mV.
- A 20µV peak-to-peak sinusoidal signal yielding a visible trace.
Design Specifications
- Developers create design specifications responding to defined requirements.
- Example specification for an ECG related to the requirement for displaying voltages:
- The A/D converter must have at least 10-bit resolution.
Performance Evaluation
- Performance evaluation employs tools like CAD for simulations of electronic, mechanical, and thermal behavior.
- Market-driven products ensure they meet consumer needs and expectations.
Business Context for Design
- To succeed, a product must demonstrate a "differential competitive advantage" over competitors.
- ‘Perceived performance’ is crucial for consumer decision-making.
Cost-Related Business Terms
- Product Marginal Cost (PMC) pertains to increased production costs due to feature implementation.
- ‘Feature investment’ refers to the additional investment needed to develop new features.
- Understanding cost structures is essential for pricing and profitability.
Profitability Considerations
- The break-even point indicates when profit starts to accrue after sales.
- Gross profit increases with the quantity of products sold beyond the break-even volume.
Project Management in Design
- Designing medical products follows project management principles focusing on time, cost, and performance.
- Effective project management can enhance the probability of project success.
Common Project Failures
- Based on IT management surveys, common failures include:
- Delays: 75%
- Excessive costs: 55%
- Failure to meet performance and quality benchmarks: 37%
Risk Management
- Essential for ensuring patient and user safety in medical designs.
- Unexpected risks can lead to project failures; thus, comprehensive risk management strategies are necessary.
- Knowledge from previous projects enhances expertise and reduces risks in new projects (Learning Curve principle).
Intellectual Property Rights
- "Know-how" reduces costs, risks, and development time via established designs, algorithms, and software.
- Intellectual property encompasses hardware diagrams, specific algorithms, and coded interfaces.
- Three main types of patents include international, US, and EU patents.
Patent Overview
- Patents grant exclusive rights for inventions that are new, useful, and non-obvious.
- Online resources facilitate simple patent searches for prior art and related innovations.
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