Medical Device Development
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Questions and Answers

During the concept evaluation phase, which of the following items must be completed?

  • The product's architecture diagram (correct)
  • The product requirement documents
  • User interface requirements
  • A list of human factors to be considered

    • What is the purpose of the concept model?

  • To prove the core technology will work (correct)
  • To develop a design that includes the key product functions
  • To confirm product feasibility
  • To reduce implementation risks

    • Which phase of medical device development is concept evaluation?

  • Phase I
  • Phase III
  • Phase II (correct)
  • Phase IV

    • What is captured in the product requirements document (PRD)?

    <p>All of the features and physical attributes of the device</p> Signup and view all the answers

    Which phase of medical device development follows the Market Opportunity Evaluation phase?

    <p>Concept Evaluation</p> Signup and view all the answers

    What is the goal of the Market Opportunity Evaluation phase?

    <p>To understand the product, the user, and the market</p> Signup and view all the answers

    Which plans must be completed before leadership can make a go/no-go decision for developing a product?

    <p>Risk analysis plan, Risk management plan, Product development plan, Business review plan</p> Signup and view all the answers

    What is the next phase after the Market Opportunity Evaluation phase?

    <p>Concept Evaluation</p> Signup and view all the answers

    Which phase of the medical device development process focuses on understanding the product, the user, and the market?

    <p>Market Opportunity Evaluation</p> Signup and view all the answers

    What is the goal of the Market Opportunity Evaluation phase?

    <p>To understand the product, the user, and the market</p> Signup and view all the answers

    Which aspect is NOT considered in the product description during the Market Opportunity Evaluation phase?

    <p>Manufacturing process</p> Signup and view all the answers

    What are the five phases of medical device development?

    <p>Market Opportunity Evaluation, Concept Evaluation, Engineering Design Process, Verification and Validation, Manufacturing Transfer</p> Signup and view all the answers

    Which one of the following is a key aspect of software design for medical devices?

    <p>Separate SOP for software design</p> Signup and view all the answers

    What is the purpose of human factors engineering in the development of medical devices?

    <p>To ensure safe and accurate user performance</p> Signup and view all the answers

    What is one of the most common labeling deficiencies for medical devices?

    <p>Missing or unavailable use instructions</p> Signup and view all the answers

    What is a potential concern regarding the compatibility of a pacemaker with other devices?

    <p>Interference with hospital monitoring devices</p> Signup and view all the answers

    According to the text, what is the classification of software that controls life support equipment?

    <p>Class C</p> Signup and view all the answers

    Which standard is recognized by both the FDA and Europe's Medical Device Directive for medical device software development?

    <p>ISO 62304</p> Signup and view all the answers

    What is the purpose of integration testing in medical device software development?

    <p>To confirm the interaction of software subsystems</p> Signup and view all the answers

    What is the common practice for searching for defects in medical device software?

    <p>Using Monte Carlo simulations</p> Signup and view all the answers

    Which government agency heavily influences the coverage decisions of private payers for medical reimbursement?

    <p>CMS</p> Signup and view all the answers

    What is the potential impact if insurance companies and government healthcare providers do not provide reimbursement for a medical device?

    <p>The potential product market shrinks dramatically</p> Signup and view all the answers

    Which organization sets international standards for product standards, including those for medical devices?

    <p>ISO</p> Signup and view all the answers

    What is one of the key factors to consider in the product development plan for a medical device?

    <p>The manufacturing strategy</p> Signup and view all the answers

    Which phase of the medical device development process focuses on understanding the product, the user, and the market?

    <p>Concept evaluation</p> Signup and view all the answers

    What is the goal of the engineering design process phase in medical device development?

    <p>To design and develop the medical device</p> Signup and view all the answers

    Which plans must be completed before leadership can make a go/no-go decision for developing a product?

    <p>Concept evaluation plan</p> Signup and view all the answers

    What is one of the key aspects considered in the product description during the Market Opportunity Evaluation phase?

    <p>The expected users</p> Signup and view all the answers

    Which of the following is NOT a potential concern regarding the compatibility of a pacemaker with other devices?

    <p>Use of existing surgical tools for implantation</p> Signup and view all the answers

    Which of the following is a common labeling deficiency for medical devices?

    <p>Missing or unavailable use instructions</p> Signup and view all the answers

    What is the purpose of human factors engineering in the development of medical devices?

    <p>To ensure the design supports safe and accurate user performance</p> Signup and view all the answers

    Which one of the following is a key aspect of software design for medical devices?

    <p>Specific design practices</p> Signup and view all the answers

    Which ISO standard is recognized by both the FDA and Europe's Medical Device Directive for medical device software development?

    <p>ISO 62304</p> Signup and view all the answers

    What is the classification of software that controls life support equipment?

    <p>Class C</p> Signup and view all the answers

    What is the purpose of integration testing in medical device software development?

    <p>To evaluate the interaction of software subsystems</p> Signup and view all the answers

    What is the goal of the Market Opportunity Evaluation phase?

    <p>To understand the product, the user, and the market</p> Signup and view all the answers

    During the Engineering Design phase, what is the main challenge of engineering software?

    <p>Designing software that can be effectively evaluated</p> Signup and view all the answers

    When determining the product requirement specifications, what factor(s) does the development team consider?

    <p>The intended use of the device and indications for use</p> Signup and view all the answers

    What are the electromagnetic compatibility requirements for a medical device?

    <p>Susceptibility to electric impulses</p> Signup and view all the answers

    What safety requirements must a permanently implanted medical device meet?

    <p>Toxicity and biocompatibility analysis</p> Signup and view all the answers

    During the concept evaluation phase, what are the key items that must be completed?

    <p>The product's architecture diagram, user interface requirements, product requirement documents, software requirements, and a list of human factors</p> Signup and view all the answers

    What is the purpose of the concept model?

    <p>To prove the core technology will work</p> Signup and view all the answers

    What is the purpose of creating a breadboard during the proof of concept process?

    <p>To provide evidence that the technology works and to identify and reduce implementation risks</p> Signup and view all the answers

    What plans are drafted during the concept evaluation phase?

    <p>Risk analysis plan and business review plan</p> Signup and view all the answers

    Which one of the following is NOT considered during the specification setting phase in the design process?

    <p>Cost of implementing design changes</p> Signup and view all the answers

    What is the potential cost of implementing a design change if it is introduced in the design phase?

    <p>$100</p> Signup and view all the answers

    Why is careful specification setting important in terms of production costs?

    <p>It helps save money in the long run</p> Signup and view all the answers

    What is the purpose of the electrical design and control software in relation to temperature regulation?

    <p>To support proper temperature regulation</p> Signup and view all the answers

    What is the potential cost of implementing a design change if it is introduced later?

    <p>$100,000</p> Signup and view all the answers

    What is the purpose of having a complete specification in the design process?

    <p>To save time and money for developers</p> Signup and view all the answers

    Which section of the course introduces the concept of direct and indirect measurements?

    <p>Introduction to Measurements</p> Signup and view all the answers

    What is the purpose of using a gold standard diagnostic in medical testing?

    <p>To establish a benchmark for diagnostic tests</p> Signup and view all the answers

    What are indirect measurements often referred to as in clinical studies?

    <p>Surrogate endpoints</p> Signup and view all the answers

    In what type of medical condition is a gold standard test likely to be an indirect measurement?

    <p>Conditions that require an autopsy for a perfect diagnosis</p> Signup and view all the answers

    Which of the following is an example of an indirect measurement used as a diagnostic test?

    <p>Measurement of red blood cell count</p> Signup and view all the answers

    Which of the following is an example of a direct measurement used as a diagnostic test?

    <p>Measurement of cholesterol levels</p> Signup and view all the answers

    Which of the following is an example of a gold standard test for diagnosing a particular infectious agent?

    <p>Bacterial culture</p> Signup and view all the answers

    What is the purpose of constructing a standard curve in diagnostics?

    <p>To graph the relationship between jellybean weight and the number of jellybeans</p> Signup and view all the answers

    Which type of distribution is commonly seen in analyte concentrations associated with disease in a population sample?

    <p>Bimodal distribution</p> Signup and view all the answers

    What percentage of the population falls within a certain range of height measurements in a normal distribution?

    <p>68%</p> Signup and view all the answers

    What is the main challenge in differentiating the diseased population from the healthy population in a bimodal distribution?

    <p>Overlap between the two populations</p> Signup and view all the answers

    What is the ideal scenario for differentiating the diseased group from the healthy group in a test?

    <p>Clear separation with no overlap</p> Signup and view all the answers

    Which of the following best describes a bi-modal distribution?

    <p>A distribution with two different modes</p> Signup and view all the answers

    What is the advantage of a bi-modal curve that does not overlap?

    <p>It allows a diagnostic to determine who is healthy and who has the disease</p> Signup and view all the answers

    What is the accuracy of a test defined as?

    <p>The statistical difference between the result and the reference value or gold standard</p> Signup and view all the answers

    What is a false positive in a diagnostic test?

    <p>When someone who doesn't have a disease or condition tests positive for it</p> Signup and view all the answers

    Which of the following is NOT a key factor in the use of colorimetric assays?

    <p>The type of chemical element</p> Signup and view all the answers

    What is the purpose of a standard curve in colorimetric assays?

    <p>To correlate the degree of color change with a known analyte concentration</p> Signup and view all the answers

    What is the advantage of using a bi-model curve in diagnostic measurements?

    <p>It provides a clear distinction between normal and abnormal measurements</p> Signup and view all the answers

    What causes variations in diagnostic measurements?

    <p>All of the above</p> Signup and view all the answers

    Which one of the following best describes sensitivity in the context of a diagnostic test?

    <p>The ability of the test to correctly identify all individuals who have a disease.</p> Signup and view all the answers

    Which one of the following best describes specificity in the context of a diagnostic test?

    <p>The ability of the test to correctly identify healthy individuals.</p> Signup and view all the answers

    What is the formula for calculating sensitivity?

    <p>$\frac{A}{A + C}$</p> Signup and view all the answers

    What is the formula for calculating specificity?

    <p>$\frac{B}{B + D}$</p> Signup and view all the answers

    Which scenario illustrates high specificity and low sensitivity?

    <p>Testing for drunk driving</p> Signup and view all the answers

    What does sensitivity mean in the context of diagnostics?

    <p>Identifying everyone with a disease</p> Signup and view all the answers

    What does specificity mean in the context of diagnostics?

    <p>Rejecting everyone without a disease</p> Signup and view all the answers

    Which diagnostic test is described as having high specificity and low sensitivity?

    <p>Testing for drunk driving</p> Signup and view all the answers

    What is the opposite scenario to searching for a weapon at an airport?

    <p>Testing for drunk driving</p> Signup and view all the answers

    What is the result of searching for a weapon at an airport?

    <p>Most weapons are found, but many people are subjected to unnecessary searches</p> Signup and view all the answers

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