Biomedical Devices Design and Troubleshooting Chapter 1

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Questions and Answers

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?

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?

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?

Conducting laboratory experiments. Signup and view all the answers

What is a common misconception about design tasks?

They do not require any research. Signup and view all the answers

Which aspect is essential in correctly understanding biomedical device design?

Design combines various disciplines of knowledge. Signup and view all the answers

What is the purpose of the example requirements given for an ECG?

To define the performance metrics for ECG functionality. Signup and view all the answers

Which specification aligns with the requirement of displaying differential voltages of +/- 5 mV?

The ECG A/D converter shall have at least 10-bit real resolution. Signup and view all the answers

During which stage is performance evaluation performed in the Product Development Life Cycle?

Performance evaluation stage. Signup and view all the answers

What is the role of developers in the design process as mentioned in the content?

They perform design specifications and implementations. Signup and view all the answers

Why are specifications like 'the ECG A/D converter shall have at least 10-bit real resolution' important?

They guide the manufacturing process to align with performance expectations. Signup and view all the answers

What tool is suggested for evaluating electronic, mechanical, thermal, and radiation behavior?

CAD - computer aided design. Signup and view all the answers

Which of the following is NOT a typical aspect covered by specifications in the design process?

Financial estimation of the project's budget. Signup and view all the answers

What is indicated by the requirement stating that a 20µV peak-to-peak sinusoidal signal shall yield a visible ECG trace?

The ECG must display low amplitude signals effectively. Signup and view all the answers

What are the three axes used to assess the success of a project?

Performance, Cost, Time Signup and view all the answers

Which of the following is NOT a reason for IT project failure according to the Bull Survey?

Insufficient User Training Signup and view all the answers

How is risk management characterized in the medical design field?

A critical aspect for ensuring safety Signup and view all the answers

What percentage of IT projects fail due to delays, according to the Bull Survey?

75% Signup and view all the answers

What is a major reason for project failure that relates to risks?

Unexpected risk occurrence Signup and view all the answers

Which of the following aspects is integral in project management to ensure success?

Defining rules, processes, and best practices Signup and view all the answers

Which option best describes the relationship between project performance and costs?

Performance must be achieved within cost constraints Signup and view all the answers

Which of the following statements about project management practices is true?

They should adapt based on project specifics. Signup and view all the answers

What is the primary question a business plan must answer regarding product sales?

Why should customers buy our product and not those of our competitors? Signup and view all the answers

What does 'differential competitive advantage' refer to?

The factor that makes a product more appealing than competitors' products. Signup and view all the answers

Which element is considered essential for evaluating a product's market performance?

Perceived performance. Signup and view all the answers

What is meant by 'product marginal cost'?

An increase in production cost due to new features. Signup and view all the answers

Which relationship is emphasized in the context of performance, cost, and price?

They are strictly related. Signup and view all the answers

What critical point is reached when a company sells a certain quantity of its product?

They achieve the break-even point. Signup and view all the answers

What does 'feature investment' involve?

An investment in developing a specific product feature. Signup and view all the answers

What happens to business profitability after reaching the break-even point?

The business becomes profitable. Signup and view all the answers

What is the relationship between the effort required to become an expert in a specific project and the experience already gained in similar projects?

Inversely proportional Signup and view all the answers

Which of the following aspects can be part of know-how to reduce costs in product design?

Algorithm development Signup and view all the answers

What type of patent permits the reservation of patents almost worldwide?

International patents Signup and view all the answers

What does a patent protect?

Exclusive rights for new, useful, and non-obvious inventions Signup and view all the answers

What is one way to simplify patent investigation?

Utilizing the Internet Signup and view all the answers

Which of the following is NOT typically included in the category of know-how?

Employee training programs Signup and view all the answers

Which type of patent is specifically issued within the United States?

US patents Signup and view all the answers

What is the effect of know-how on the development process of a product?

It reduces cost, risk, and development time Signup and view all the answers

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.

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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Description

Explore the foundational concepts of biomedical device design and troubleshooting in this introductory chapter from BME520. Understand the key principles and importance of biomedical systems in engineering, paving the way for more advanced applications. Perfect for students and professionals in the field of biomedical engineering.