How to overcome regulatory and ethical challenges regarding medical device - Pubrica
                     HOW TO OVERCOME  
REGULATORY AND 
ETHICAL  CHALLENGES 
REGARDING  MEDICAL 
DEVICE
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, Pubrica 
 Group: www.pubrica.com
Email: [email protected]
Today's Discussion
Outline In-Brief
Introduction
Ethics and the Purpose of Therapeutic Goods 
Regulation  Problems of Evidence about Devices
New Challenges
Questioning Current 
Approaches  Limitations of 
the Study  Conclusion
In-Brief
Biotechnological advancements in medical devices can intensify risks  
and introduce new types of risk, despite their potential to greatly benefit  
health. Therapeutic products control is our primary tool for handling these 
 threats. As these developments advance, the current regulatory  
approach is likely to be called into question.
Introduction
The below are the top ten ethical questions,  
in order of priority, as viewed by the  
participants:
(1)Equity of resources, (2) Patients' Rights,  
(3Patient Safety, (4) ) Confidentiality of the  
patients, (5)Ethics of privatisation, (6)Conflict 
 of terests, (7)Dealing with the opposite sex,  
(8)Informed Consent, (9) Beginning and end  
of life, and (10) Healthcare team ethics.
Therapeutic products regulation has two roles, Ethics and 
 which are often at odds with one another. the  Purpose 
Control strives to preserve the public's health  of  
and welfare while enabling or also promoting  Therapeutic  
useful technologies to enter the market as  
soon as possible. Goods  
Regulation
The expectation that suppliers show proof of a  
product's protection and efficacy is a  
significant part of how modern systems meet  
these goals.
Contd...
On the one side, this safeguards people from consuming goods that are harmful or  
ineffective.
On the other hand, it implies that market success must be founded on sound  
science, with quality creativity rewarded.
If evidentiary expectations are too uncertain, regulators' ability to protect patients  
may be endangered; if they are too high, patients may be denied access to new  
developments unnecessarily.
Problems  
of The immense ethical challenge with consumer  
Evidence  regulation is that we currently tolerate a high risk  during the business acceptance period due to  
about  data gathering issues and the operational
requirements of a regulatory report writing  
Devices framework related to products, not that the stakes 
 have been measured appropriately.
Another hand, many buyers conclude that the  
commodity on the market has been adequately  
tested for protection and efficacy.
Emerging innovations add to the complexity of New  
these  already complicated problems. I'll write to two of Challenge
them.
1. First, machines are becoming more computerised,  s
with many, such as pacemakers and insulin pumps, 
 incorporating automation into their operations.
It has various advantages, including automation of  tasks 
for smoother management; improved calibration  of 
equipment to patients' needs; a collection of  
physiological data of therapeutic significance; and  
remote, therefore more effective, system modification.
Contd...
The use of software in or as a diagnostic system exacerbates current problems while 
 also adding new ones.
It ensures that devices may be updated ever more regularly.
These changes can affect the functionality of devices already in use by patients or 
 even implanted in their bodies.
It would become much more challenging to ensure the technologies remain secure 
 and prosperous as they grow.
Contd...
Manufacturers will be held more responsible for device functionality in the long term.
Software introduces additional types of risks, such as predicting how functionality will  
be compromised when used in combination with various technical technologies and  
when applied to multiple clinical scenarios.
Another significant and relatively recent danger concerns cybersecurity: the threat of  
computers being compromised and used to damage their owners.
Customisation, once again, creates new problems.
Contd...
Given the unparalleled simplicity with which this manufacturing method can be used, 
 it could be impossible for regulators to keep track of all applications.
2. Increased system customisation, especially by 3D printing and computer-aided 
 design, is a second evolving possibility.
Implants often used, such as artificial hips, can now be designed in proportions more  
closely matched to individual conditions.
Personalised models can even be explicitly modelled on patient physiology.
Contd...
It seems to help patients on the surface; however, gathering rigorous proof of protection  
and usefulness for custom devices is much more complex than standardised devices.
Customisation is profoundly at odds with the most substantial evidence for regulatory  
purposes, created from populations of study subjects that undergo a standardised  
intervention.
As a result, customisation exacerbates the difficulty of finding good data for devices.
Custom instruments have typically been used by testing laws or legal exemptions in 
 the past.
The more customisation is used, the less suitable this becomes.
Questioning 
If technological advancements continue to pressure  
 Current  the existing system, it's worth considering any other  
Approaches options for interface control.
Some innovations can eliminate inequities, such as  
using 3D printing to include lower-tech electronics in  
low-income nations.
Still, this potential will not be appreciated as long as  
the research is incentivised today.
Healthcareresearch is focusedmainly on  
commercially  viable goods thatcan disregard  
changes  may be achieved by societal or
sthtrautctural change.
Contd...

Limitations  
of the 
The willingness to generalise the findings is a  Study
critical drawback.
First, the report excluded smaller underserved rural 
 hospitals, which may have revealed a different  
medical data collection of ethics concerns, even  
though equality in resource availability was  
identified as one of the top five problems.
Contd...
Second, despite the study's efforts to include  
non-clinicians, male clinicians' dominance in  
the survey may have tainted the findings and  
conclusions.
It may also clarify why no ethical concerns  
about paramedical personnel and their  
interactions with doctors were raised.
Conclusion
The central ethical issues as alleged by the participants were:
(1) Patients' Rights, (2) Equity of resource distribution, (3)  
Confidentiality of patients, (4) Patient Safety, (5) Conflict of  
Interests, (6) Ethics of privatisation, (7) Informed Consent, (8)  
Dealing with the opposite sex, (9) Beginning and end of life,  
and (10) Healthcare Team Ethics.This collection, however,  
was not exhaustive.
This study's findings were meant to be compared to those of  
another task. Since the differences in culture and healthcare  
systems, discrepancies were predicted.
Contd...

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