Scribd
Upload
30 views

Lecture 4

This document discusses 15 ethical case studies related to the medical device industry. It provides context for the cases, which involve real issues encountered in the industry. Participants are divided into groups to critically evaluate the cases and identify potential solutions. The objective is to consider the ethical issues and brainstorm possible resolutions through discussion. No slides are required, as the goal is informal engagement on complex topics with no single right answer. The cases cover issues like adverse events, data integrity, marketing and costs, responsibilities, gifts, and special patient populations. Participants are encouraged to discuss options and implications rather than make definitive judgments.

Uploaded by

Yong Hao Jordan Jin
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
30 views

Lecture 4

This document discusses 15 ethical case studies related to the medical device industry. It provides context for the cases, which involve real issues encountered in the industry. Participants are divided into groups to critically evaluate the cases and identify potential solutions. The objective is to consider the ethical issues and brainstorm possible resolutions through discussion. No slides are required, as the goal is informal engagement on complex topics with no single right answer. The cases cover issues like adverse events, data integrity, marketing and costs, responsibilities, gifts, and special patient populations. Participants are encouraged to discuss options and implications rather than make definitive judgments.

Uploaded by

Yong Hao Jordan Jin
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 21

BN5208

Biomedical Quality and Regulatory Systems

Mrinal Musib, PhD


Department of Biomedical Engineering
National University of Singapore
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

Case 6 6
Context: These are real-life ethical incidences drawn
Case 7 7
from my own experiences in the industry. I have
Case 8 8 excluded some of the sensitive information  to
Case 9 9 ensure confidentiality
Case 10 10

Case 11 11
Please critically evaluate individual cases and identify
Case 12 12 potential solutions or suggestions. The objective of
Case 13 13 this exercise is to identify the ethical context involved
Case 14 14 and brainstorm about the potential and possible
resolutions, in an informal setting. Thus, no slides
Case 15 15
are necessary for this exercise.
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?

4
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

5
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

• 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 7

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 8

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 9

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. Once the device leaves the manufacturing facility to the


hospital
2. When the device is in the shelf/storage
3. When the device is implanted into the patient
4. When the patient has used the implant for some time
Case 10

Does a class III medical device has a expiry date during:


1. Shelf life
2. Once implanted

• So what if it’s a class II device, then? Say X-ray machine, CT


Scan etc
• What about warranty period for such devices
Case 11

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 he 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 12

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 13

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 14

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
Case 15

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
References

• Raps.org
• Wong et al. Med Dev RA in Asia
• MDRA program, 2015/16
Post-lecture presentations: Lets
learn together

Transcyte (Group 1)
Carticel (Group 2)
Transdermal nicotine patch (Group 3)
Lets learn together
• Inspiration/unmet medical need
• Target audience
• Current gold standard
• Commercial aspect/considerations
• Product details
• Principle and mechanism (how it functions)
• Clinical trials ?
• Issues with FDA ?
• Limitations and Side Effects
• The next better thing…
• Any other relevant and interesting aspect you wish to share

10-12 minutes per group followed by QnA/discussion

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

21

You might also like