BN5208

Biomedical Quality and Regulatory Systems

Mrinal Kanti, PhD

Department of Biomedical Engineering
National University of Singapore
 Schedule for todays interaction

• Practice questions to ensure clarity and understanding of

materials covered during last lecture
• Ethics case discussions relevant to medical devices
(informal setting, no slides needed )
• Weekly group presentations for Gps 5-8
The details of the CA quiz are:
• 25MCQ administered through Examplify (week 10)
• In-person exam
• 90 min duration
• Open book, but no internet (you may download all slides
and study materials on desktop)
• MCQs similar to the practice questions 
• No memorization needed (focus on understanding and
analysis and NOT on memorization)
 Practice questions
from previous week 
 VERY IMPORTANT HOUSEKEEPING INFO

• In line with blended/flipped classroom concept a short video

(zoom link) will be uploaded for week 6 and all students are
expected to see the video (10-15 min)
• During next lecture (week 6) we will discuss the practice
questions and students are expected to actively participate
and engage in deliberations
• I will bring some simulated, 3D-printed medical device
prototypes to explain critical concepts on medical device
design, biocompatibility and failures
• This exercise will help you further visualize how implants
function along with some very complex and relevant issues
Ethical case studies:
Medical Devices
 This week we will touch on a very interesting and important
(albeit at times not properly recognized) aspect of the medical
device industry…ETHICS…
I can say many of these cases don’t have a single answer. Ethics
is not always black or white but rather grey at times and allows
for discussion and engagement.

Hence, we should keep that spirit as we discuss these ethical

issues...I would like to encourage all groups to participate and
engage in constructive discussions and provide any other
options that may be feasible…
Case # Groups Ethical case studies
relevant to medical
Case 1 1

Case 2 2

Case 3

Case 4
3

4
devices
Case 5 5 Context: These are real-life ethical incidences drawn
Case 6 6 from my own experiences in the industry. I have
Case 7 7 excluded some of the sensitive information  to
ensure confidentiality
Case 8 8

Case 9 9

Case 10 10 Please critically evaluate individual cases and identify

Case 11 11 potential solutions or suggestions. The objective of
this exercise is to identify the ethical context involved
Case 12 12
and brainstorm about the potential and possible
Case 13 13
resolutions, in an informal setting. Thus, NO SLIDES
Case 14 14 ARE NECESSARY for this exercise.
Case 15 15 Everyone is encouraged to participate and contribute
to the discussions.
 Case 1

You are part of the Regulatory affairs of a medical device company

and your team receives a report from a sales personnel of a
potential life threatening adverse effect of one of your company's
‘top dollar making’ product

• What would you do?

• Would you proceed with unhindered and continued manufacture and sale
of the product?

9
 Case 2

You are part of the Regulatory affairs of a medical device

company and your team receives a report from a sales
personnel of a potential life threatening adverse effect of one of
your company's ‘top dollar making’ product

• If this event has occurred in a country where government

regulations are not stringent, will your response be any different
from another country where regulations are stringent

• What may be the consequences

10
 Case 3

Your company manufactures a class III, life saving/sustaining medical

device, which is the only device of its kind available in the market.
Recently you as a RA professional came to know of a adverse effect
(AE), which may result in the failure of the device eventually.

• As an ethical regulatory professional what do you do?

• Would you consider product recall if the AE is reported in:

a. 1 patient (out of 1000 patients who have the device)
b. 5% of patient
c. 90% of patients

AE: adverse event

 Case 4

Your company manufactures a class III, life saving/sustaining medical

device, which is the only device of its kind available in the market.
Recently you as a RA professional came to know of a adverse effect (AE),
which may result in the failure of the device eventually.
You report this to your management but they are more concerned about
the profits the product is bringing to the company (which also pays for
your salary and bonus)

• What do you do?

• Is ‘whistle blowing’ an option? What may be the consequences?

 Case 5

You as the regulatory person in charge of your team is going to

launch (start marketing) a new medical devices next month but you
were just informed that the clinicians involved in the clinical trials
have falsified some data or not obtained patient consent during
clinical investigation:

• What do you do

Also later you learnt that your team miscalculated some statistical data
in the already submitted document

• What do you do
 Case 6

As part of the RA team you become aware of an ‘off label use’ of

one of your company’s recently launched medical device by the
surgeon. While discussing it with the surgeon he was actually
quite happy with the eventual outcome of the procedure

• As part of RA team you are not very comfortable. What do you

do ?

• What may be your considerations ?

 Case 7

• SE Asian Minister of Health declares that the physiology of his

country’s population is significantly different from other Asian
populations
• Thus, a clinical trial will be required before your product can be
distributed in his country
• He will conduct the trial, determine the product’s safety and
efficacy for a non-negotiable fee of ‘X’
• That is the price of admission to “his” market

1. Will your company pay? Why? Why not?

2. What may be the implications?
 Case 8

Your company manufactures and sells an expensive artificial hip.

Although expensive it lasts for an average of 20 years and then needs to
be replaced. The company is under pressure to decrease the
manufacturing cost and make it more accessible to every patient.
Manufacturing suggested that a particular step in the manufacturing
process may be skipped. This will decrease the costs by 30% but will also
decrease the average life of the implant to 10 years.

• As a RA professional what would be your response

• What would be your considerations and if your company may have both
the products
 Case 9

A regulatory auditor from another country is scheduled to visit

your plant for an audit related to a ‘pending’ marketing
application. In his/her country it is customary/expected to give
gifts to visitors. If not it may offend the visitor:

• Should your company do so even if ‘much’ is at stake

• In this case how important is the monetary value of the gift or is

it more about ‘principle’ of the company on such issues
 Case 10

As a manufacturer of medical devices (implant), when are

you relieved of your responsibilities, pertaining to due
diligence, safety and performance of the device:

1. When the device is in the shelf/storage

2. When the device is implanted into the patient
 Case 11

A particular medical condition prevails in a small group of

patients worldwide (say < 100 patients). Do
manufacturers of medical devices have a social and moral
responsibility towards such patients:

• How relevant is cost/benefit ratio in such incidences?

Should it be applied at all?
• How does medical device regulators (like FDA/HSA)
address such issues
 Case 12

Your company’s medical device has been released to market. In early

commercial uses, there have been difficulties in using the device in
some cases. In one case the physician has found that one can “achieve
the desired outcome” by breaking a handle on the device and
manipulating it by hand in certain ways (not described in labelling).

As RA professional, you become aware of these cases

• How would you handle these cases?
• What are your considerations?
 Case 13

A leading physician and ‘key opinion leader’ organises an annual

scientific conference focused on new technologies and procedures.
You have a new, unapproved, device undergoing premarketing
authorisation review by the regulatory authority following a clinical
investigation (in which the physician participated). She wishes to
present information on your device and study at the upcoming
conference.

• May she?
• What are your considerations?
 Case 14

May an ‘approved’ medical device be ‘displayed’ in a trade fair ?

May the device be used to diagnose patients in the trade fair ? Is the
diagnosis done at the trade fair ‘clinically relevant’?

• What are the considerations?

• How may they be addressed ?
 Case 15

Involvement of robots and AI/sophisticated programs are getting more

and more prevalent during surgical procedures. During one such
intervention the robotic arm involved in a critical invasive procedure
fails. Although rare, such untoward incidences may give rise to serious
ethical issues. In that context what would be the responsibility of :

• Surgeon
• Manufacturer of the device
• Hospital/clinic
 References

• Raps.org
• Wong et al. Med Dev RA in Asia
• MDRA program, 2015/16
Thank you for
your attention 
Post-lecture
presentations
 Lets learn together on the following
Medical device controversies

• Therac-25 (Group 5)
• HeartWare Ventricular Assist Device (HVAD) controversy
(Group 6)
• The Pip implant scandal (Group 7)
• DePuy Hip implant controversy (Group 8)

• 7-8 minutes (max) per group followed by QnA/discussion

• 2-3 members can present the post lecture presentations and the rest of the team may present the final
presentations (only 1 presentation per person)
• Please save your presentation in a thumb drive if possible for quick transition

Objective: To encourage individual and peer-to-peer learning which is typically followed in an industrial setting where small groups working
together come up a potential suggestion/brainstorm
Suggestions for expected deliverables/domains that may be covered

In your presentation you can discuss on issues like;

1. The background of this scandal

2. How and why it happened
3. What effect the scandal/controversy had on medical device
regulations? Can such occurrences be prevented in the future?
4. What role did the regulatory authority play in the
controversy? Were there any shortcomings on their part?
5. How was ethics compromised in your opinion?
6. Any other relevant/interesting findings from your research
on the topic…