How to overcome regulatory and ethical challenges regarding medical device?

June 8, 2021
What data to Extract for systematic review?
June 4, 2021
How healthcare professionals can use EBP in assessment & diagnosis
June 11, 2021

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.


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 Interests, (7)Dealing with the opposite sex, (8)Informed Consent, (9) Start and end of life, and (10) Healthcare team ethics.

Ethics and the prospect of therapeutic goods regulation

Therapeutic products regulation has two roles, which are often at odds with one another. Control strives to preserve the public’s health and welfare while enabling or also promoting useful technologies to introduce in the market as soon as possible. The expectation that suppliers show proof of a product’s protection and efficacy is a significant part of how modern systems meet these goals. 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 evidence about devices

The immense ethical challenge with consumer regulation is that we currently tolerate a high risk during the business acceptance period due to data gathering issues and the operational requirements of a regulatory report writing 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.

New challenges

Emerging innovations add to the complexity of these already complicated problems. I’ll write to two of them.

  1. First, machines are becoming more computerised, 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.

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.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. Given the unparalleled simplicity with which this manufacturing method can be used, it could be impossible for regulators to keep track of all applications.

  • 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. 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 current approaches

If technological advancements continue to pressure the existing system, it’s worth considering any other 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. Healthcare research is focused mainly on commercially viable goods that can disregard changes that may be achieved by societal or structural change.

Limitations of the study

The willingness to generalise the findings is a 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.

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.


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.


  1. Gibbs JN, et al. 2014. 510(k) statistical patterns. Medical Device and Diagnostic Industry, 2 Dec,
  2.  Roger WA, Hutchison K. 2017. Hips, knees, and hernia mesh: When does gender matter in surgery? International Journal of Feminist Approaches to Bioethics 10(1):148-174.
  3. Hutchison K, Sparrow R. 2017. Ethics and the cardiac pacemaker: More than just end-of-life issues. Europace, online first doi:10.1093/europace/eux019.

 IMDRF Software as a Medical Device (SaMD) Working Group. 2014. “Software as a Medical Device”: Possible Framework for Risk Categorisation and Corresponding Considerations. International Medical Device Regulators Forum,

Comments are closed.

Order Now
close slider

    Order Now