Selvam College of Technology
(Autonomous),
“A” Grade by NAAC, UGC recognized 2(f) Status, Approved by AICTE – New Delhi, Affiliated to Anna University
Namakkal – 03. www.selvamtech.edu.in
DEPARTMENT OF BIOMEDICAL ENGINEERING
CBM353 MEDICAL DEVICE DESIGN
SEM/YEAR:V/III
Practice Test I- Question paper (Total Marks: 40)
DATE:..25
PART A (5X2=20marks)
Q1.A Startup team is developing a wearable device to monitor
heart rate in elderly patients. During the early design stage, they
skip detailed user interviews and fail to identify key user
challenges. How could proper problem identification have
impacted the success of this medical device?
Q2.A medical device company is designing a portable insulin
delivery system. Initially, the design team worked in isolation
without conducting brainstorming sessions. How might including
brainstorming have benefited the product development process?
Q3.A company developed a novel handheld diagnostic device after
years of research but did not file for any intellectual property (IP)
protection. Later, a competitor released a similar product and
captured the market. How could IP protection have changed the
outcome for the original developer?
Q4.A medical start-up launched an advanced wound care device in
hospitals, but sales remained low despite clinical effectiveness. Feedback
revealed that the device was not covered under any insurance
reimbursement scheme. Analyze the potential long-term consequences of
a lack of reimbursement for the sustained adoption of this medical device
within the healthcare system
PART B(2X15=30 MARKS)
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