DEPARTMENT OF BIOMEDICAL ENGINEERING

CBM353 - MEDICAL DEVICE DESIGN

III YEAR / V SEMESTER
QUESTION BANK
UNIT – 1
Strategic Focus – observation and problem identification – Need statement development
- question bank
Strategic Focus and Observation
1. What is the purpose of strategic focus in the medical device design process?
2. Why is observing real-world clinical environments important in medical device
development?
3. How can ethnographic research contribute to the identification of unmet clinical
needs?
4. Describe how observation can help in understanding the workflow in a healthcare
setting.
5. What are the key characteristics of effective observation in a clinical environment?
Problem Identification
6. Why is problem identification critical in the early stages of medical device design?
7. How does problem identification differ from problem solving?
8. What are the common methods used to identify problems in clinical settings?
9. Give an example of how poor problem identification can lead to a failed medical
device.
10. What role does stakeholder analysis play in problem identification?
Need Statement Development
11. What is a need statement in the context of medical device design?
12. Describe the key components of a well-crafted need statement.
13. How does a need statement guide the design and development process?
14. What is the difference between a need statement and a solution?
15. Why is it important to avoid including solutions in a need statement?
Linking Observation to Need Statements
16. How can observations lead to the development of a need statement?
17. What are the challenges in translating observations into clear need statements?
18. Describe how interdisciplinary teams can improve the process of need statement
development.
19. What is the importance of verifying need statements with end-users?
20. How can a poorly defined need statement affect the outcome of a medical device
project?
Practical Application
21. Develop a need statement based on the observation of a common clinical procedure.
22. What steps would you take to refine a broad observation into a specific need
statement?
23. How can you ensure that a need statement is aligned with strategic business goals?
24. What is the role of market research in validating a need statement?
25. Provide an example of how an unmet need in healthcare has led to the development of
a successful medical device.
Evaluation and Refinement
26. How can stakeholder feedback be used to refine a need statement?
27. What tools or frameworks can assist in evaluating the relevance of a need statement?
28. Describe the process of prioritizing multiple need statements.
29. What are the common pitfalls in need statement development, and how can they be
avoided?
30. Why is it important to periodically revisit and revise need statements during the
design process?
Strategic Alignment
31. How does strategic focus influence the selection of which need statements to pursue?
32. Explain the relationship between a company's mission and the development of need
statements.
33. What is the role of competitive analysis in shaping need statements?
34. How can global health trends impact the development of need statements?
35. Why is it important to consider regulatory constraints when developing a need
statement?
Ideation and Brainstorming – concept screening, concept selection: intellectual property
basics – reimbursement basics – business models - question bank
Ideation and Brainstorming
1. What is the primary goal of the ideation phase in medical device design?
2. Name two techniques commonly used in brainstorming sessions.
3. How does brainstorming help in generating innovative solutions in medical device
design?
4. Why is it important to encourage diverse ideas during brainstorming?
5. What role does cross-functional collaboration play during the ideation phase?
Concept Screening
6. What is concept screening in the context of product development?
7. Describe the main objective of the concept screening process.
8. What criteria are typically used to screen concepts in medical device development?
9. Why is it important to involve a multidisciplinary team during concept screening?
10. How can early-stage concept screening help in reducing product development costs?
Concept Selection
11. Explain the difference between concept screening and concept selection.
12. What are the key factors to consider when selecting a concept for further
development?
13. Describe the purpose of a decision matrix in the concept selection process.
14. Why is it important to align concept selection with market needs and business goals?
15. How does risk analysis influence the concept selection process?
Intellectual Property (IP) Basics
16. What is intellectual property (IP) in the context of medical device design?
17. Name three types of intellectual property protections relevant to medical devices.
18. What is the purpose of a patent in protecting medical device innovations?
19. Explain the concept of "freedom to operate" in relation to intellectual property.
20. Why is it important to conduct a patent search before starting the development of a
new medical device?
Reimbursement Basics
21. What is reimbursement in the context of medical devices?
22. Name two key stakeholders involved in the reimbursement process for medical
devices.
 23. Explain the role of Medicare in the reimbursement of medical devices in the United
States.
24. What is a reimbursement code, and why is it important for medical devices?
25. How can reimbursement strategies influence the market success of a medical device?
Business Models
26. What is a business model, and why is it important for a medical device company?
27. Describe the difference between a product-based and a service-based business model.
28. What is the "razor and blades" business model, and how might it apply to medical
devices?
29. How does the subscription model work in the context of medical devices?
30. Why is it important to consider the scalability of a business model in the medical
device industry?
Linking Ideation to Business Models
31. How does the outcome of the ideation phase influence the choice of business model?
32. What role does market analysis play in refining a business model for a new medical
device?
33. Why is it crucial to consider reimbursement strategies during the concept selection
process?
34. Explain how intellectual property considerations can impact the selection of a
business model.
35. Describe how early-stage concept screening can align with long-term business
objectives.
Practical Application
36. Develop a concept screening checklist for a new wearable medical device.
37. What are the potential intellectual property risks associated with open innovation in
medical device development?
38. How would you approach concept selection if two equally viable concepts meet
different market needs?
39. Propose a business model for a new diagnostic medical device that leverages AI
technology.
40. Discuss the implications of a reimbursement denial on the business strategy of a
medical device company.
Evaluation and Decision Making
41. Why is it important to revisit and possibly revise the business model during product
development?
 42. What factors would you consider in deciding whether to file for a patent or keep a
technology as a trade secret?
43. How can the concept selection process help in identifying potential barriers to market
entry?
44. What is the significance of understanding payer policies in the reimbursement
process?
45. Explain how licensing intellectual property could be an alternative business strategy
for a medical device startup.
Strategic Integration
46. How does a strong IP portfolio enhance the competitive advantage of a medical
device company?
47. What is the importance of aligning the chosen business model with the regulatory
environment?
48. How can concept screening help in refining the business model for a medical device?
49. What are the strategic benefits of having a clear reimbursement pathway for a new
medical device?
50. Describe the relationship between a company's long-term vision and its approach to
ideation and concept selection.
PART - B

Strategic Focus, Observation, and Problem Identification

1. Discuss the importance of strategic focus in the early stages of medical
device development. How do observation and problem identification
contribute to the development of a need statement? Provide examples of
methods used for observing clinical practices and identifying unmet
needs, and explain how these observations are translated into actionable
need statements.
2. Analyze the process of problem identification in the context of medical
device innovation. Discuss how an effective need statement can guide the
design and development process. Provide a detailed example of a real or
hypothetical medical device development project, illustrating how the
need statement was derived from initial observations and problem
identification.
Need Statement Development
3. Explain the process of developing a need statement in the medical device
design process. Discuss the key components of a well-structured need
statement and how it guides the subsequent stages of product
 development. Illustrate your answer with an example of a need statement
that led to the successful development of a medical device.
4. Critically evaluate the role of a need statement in aligning the strategic
goals of a medical device company with market demands. Discuss how a
need statement influences the design process, concept generation, and
overall project focus. Provide examples of how need statements can be
refined over time as more information is gathered.
Ideation and Brainstorming – Concept Screening and Selection
5. Discuss the ideation and brainstorming process in the context of medical
device design. How do these activities contribute to the generation of
innovative concepts? Evaluate the methods used for concept screening
and selection, and explain how these methods ensure that the best ideas
are advanced to the development stage.
6. Critically analyze the role of concept screening and selection in medical
device innovation. Discuss the criteria used to evaluate concepts,
including feasibility, usability, regulatory considerations, and market
potential. Provide examples of tools or frameworks (e.g., Pugh matrix,
weighted decision matrix) used in the selection process and discuss their
effectiveness.
Intellectual Property Basics
7. Explain the importance of intellectual property (IP) in the medical device
industry. Discuss the different types of IP protection available, such as
patents, trademarks, and trade secrets, and how they can be strategically
used to protect innovations. Provide examples of how medical device
companies have successfully used IP to gain a competitive advantage.
8. Evaluate the challenges and strategies involved in securing intellectual
property rights for a new medical device. Discuss the process of
patenting, including prior art searches, patent applications, and the role of
patent claims. How does IP protection influence the overall business
strategy of a medical device company?
Reimbursement Basics
9. Discuss the role of reimbursement in the commercial success of a medical
device. Explain how reimbursement strategies are developed and the
factors that influence reimbursement rates, including the role of Medicare
and private insurers. Analyze how early consideration of reimbursement
issues can impact the design and development of a medical device.
 10.Critically evaluate the impact of reimbursement policies on the
innovation and development of medical devices. Discuss the processes
involved in obtaining reimbursement approval, including coding,
coverage, and payment determination. How do changes in reimbursement
policies affect the marketability and adoption of new medical devices?
Business Models
11.Analyze different business models used by medical device companies,
including traditional sales, leasing, subscription models, and outcome-
based models. Discuss the advantages and challenges of each model in
the context of bringing a new medical device to market. Provide
examples of how companies have successfully implemented these
models.
12.Discuss the factors that influence the choice of a business model for a
new medical device. Evaluate how the target market, regulatory
environment, and competitive landscape shape the business model
decision. Illustrate your answer with examples of medical devices that
have adopted innovative business models to achieve market success.
Prototyping – Final Concept Selection
13.Explain the role of prototyping in the medical device design process.
Discuss how prototypes are used to refine concepts, validate designs, and
gather user feedback. Evaluate the importance of iterative prototyping in
ensuring that the final concept selected is both feasible and aligned with
user needs.
14.Critically assess the process of final concept selection in medical device
development. Discuss the criteria used to evaluate and choose the final
design, including technical feasibility, user feedback, regulatory
requirements, and cost considerations. Provide examples of how
prototyping and testing have led to significant design improvements
before final selection.
Safety and Risk Management - Tools, Documents, and Deliverables
15.Discuss the importance of safety and risk management in the medical
device design process. Explain the tools and methods used to identify,
assess, and mitigate risks (e.g., FMEA, Hazard Analysis, Risk Matrix).
How do these tools ensure that safety considerations are integrated into
the design process from the earliest stages?
16. Evaluate the role of documentation and deliverables in the safety and risk
management process for medical devices. Discuss the key documents
required (e.g., Risk Management Plan, Risk Analysis Report, Design
History File) and their importance in regulatory submissions and ongoing
compliance. Provide examples of how effective documentation has
helped companies manage safety risks.