How to overcome regulatory and ethical challenges regarding medical device - Pubrica
                     How to Overcome Regulatory and Ethical 
Challenges Regarding Medical Device 
 
Dr. Nancy Agnes, Head, Technical Operations, Pubrica, [email protected] 
 
 
In Brief III. PROBLEMS OF EVIDENCE ABOUT DEVICES 
Biotechnological advancements in medical devices  
can intensify risks and introduce new types of risk, The immense ethical challenge with consumer 
despite their potential to greatly benefit health. regulation is that we currently tolerate a high risk 
Therapeutic products control is our primary tool for during the business acceptance period due to data 
handling these threats. As these developments gathering issues and the operational requirements of a 
advance, the current regulatory approach is likely to regulatory report writing framework related to products, 
be called into question. not that the stakes have been measured appropriately. 
 Another hand, many buyers conclude that the 
Keywords: Therapeutic products regulation, commodity on the market has been adequately tested 
regulatory writing, standardised devices, Healthcare for protection and efficacy. 
research, medical data collection. IV. NEW CHALLENGES 
  
I. INTRODUCTION Emerging innovations add to the complexity of these 
 already complicated problems. I'll write to two of them. 
The below are the top ten ethical questions, in order of 1. First, machines are becoming more computerised, 
priority, as viewed by the participants:(1)Equity of with many, such as pacemakers and insulin pumps, 
resources, (2) Patients' Rights, (3Patient Safety, (4) ) incorporating automation into their operations. It 
Confidentiality of the patients, (5)Ethics of has various advantages, including automation of 
privatisation, (6)Conflict of Interests, (7)Dealing with tasks for smoother management; improved 
the opposite sex, (8)Informed Consent, (9) Beginning calibration of equipment to patients' needs; a 
and end of life, and (10) Healthcare team ethics. collection of physiological data of therapeutic 
 significance; and remote, therefore more effective, 
II. ETHICS AND THE PURPOSE OF system modification. 
THERAPEUTIC GOODS REGULATION The use of software in or as a diagnostic system 
 exacerbates current problems while also adding new 
Therapeutic products regulation has two roles, which ones. It ensures that devices may be updated ever more 
are often at odds with one another. Control strives to regularly. These changes can affect the functionality of 
preserve the public's health and welfare while enabling devices already in use by patients or even implanted in 
or also promoting useful technologies to enter the their bodies. It would become much more challenging 
market as soon as possible. The expectation that to ensure the technologies remain secure and 
suppliers show proof of a product's protection and prosperous as they grow.Manufacturers will be held 
efficacy is a significant part of how modern systems more responsible for device functionality in the long 
meet these goals. On the one side, this safeguards term. Software introduces additional types of risks, 
people from consuming goods that are harmful or such as predicting how functionality will be 
ineffective. On the other hand, it implies that market compromised when used in combination with various 
success must be founded on sound science, with quality technical technologies and when applied to multiple 
creativity rewarded. clinical scenarios.Another significant and relatively 
If evidentiary expectations are too uncertain, regulators' recent danger concerns cybersecurity: the threat of 
ability to protect patients may be endangered; if they computers being compromised and used to damage 
are too high, patients may be denied access to new their owners. 
developments unnecessarily. Customisation, once again, creates new problems. 
 Given the unparalleled simplicity with which this 
 manufacturing method can be used, it could be 
 
Copyright © 2021 pubrica. All rights reserved  11  
 
impossible for regulators to keep track of all Custom instruments have typically been used by 
applications. testing laws or legal exemptions in the past. The 
2. Increased system customisation, especially by 3D more customisation is used, the less suitable this 
printing and computer-aided design, is a second becomes. 
evolving possibility. Implants often used, such as  
artificial hips, can now be designed in proportions V. QUESTIONING CURRENT APPROACHES 
more closely matched to individual conditions.  
Personalised models can even be explicitly If technological advancements continue to pressure the 
modelled on patient physiology. It seems to help existing system, it's worth considering any other 
patients on the surface; however, gathering options for interface control. Some innovations can 
rigorous proof of protection and usefulness for eliminate inequities, such as using 3D printing to 
custom devices is much more complex than include lower-tech electronics in low-income nations. 
standardised devices. Customisation is profoundly Still, this potential will not be appreciated as long as the 
at odds with the most substantial evidence for research is incentivised today. Healthcare research is 
regulatory purposes, created from populations of focused mainly on commercially viable goods that can 
study subjects that undergo a standardised disregard changes that may be achieved by societal or 
intervention. As a result, customisation exacerbates structural change. 
the difficulty of finding good data for devices. 
 
 
 
 
 
 
 
VI. LIMITATIONS OF THE STUDY different  medical data collection of ethics concerns, 
 even though equality in resource availability was 
The willingness to generalise the findings is a critical identified as one of the top five problems. 
drawback. First, the report excluded smaller 
underserved rural hospitals, which may have revealed a 
 
Copyright © 2021 pubrica. All rights reserved  22  
 
Second, despite the study's efforts to include non- also clarify why no ethical concerns about paramedical 
clinicians, male clinicians' dominance in the survey personnel and their interactions with doctors were 
may have tainted the findings and conclusions. It may raised. 
 
 
 
 
 
 
 
 
VII. CONCLUSION https://www.mddionline.com/510k-statistical-
 patterns. 
The central ethical issues as alleged by the participants 2.  Roger WA, Hutchison K. 2017. Hips, knees, and 
were: (1) Patients' Rights, (2) Equity of resource hernia mesh: When does gender matter in surgery? 
distribution, (3) Confidentiality of patients, (4) Patient International Journal of Feminist Approaches to 
Safety, (5) Conflict of Interests, (6) Ethics of Bioethics 10(1):148-174. 
privatisation, (7) Informed Consent, (8) Dealing with 3. Hutchison K, Sparrow R. 2017. Ethics and the 
the opposite sex, (9) Beginning and end of life, and (10) cardiac pacemaker: More than just end-of-life 
Healthcare Team Ethics.This collection, however, was issues. Europace, online first 
not exhaustive. This study's findings were meant to be doi:10.1093/europace/eux019. 
compared to those of another task. Since the differences 4.  IMDRF Software as a Medical Device (SaMD) 
in culture and healthcare systems, discrepancies were Working Group. 2014. "Software as a Medical 
predicted. Device": Possible Framework for Risk 
 Categorisation and Corresponding Considerations. 
REFERENCES International Medical Device Regulators Forum, 
 http://www.imdrf.org/docs/imdrf/final/technical/im
1. Gibbs JN, et al. 2014. 510(k) statistical patterns. drf-tech-140918-samd-framework-risk-
Medical Device and Diagnostic Industry, 2 Dec, categorization-141013.pdf. 
 
Copyright © 2021 pubrica. All rights reserved  33