Discussion 3

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School

Northeastern University *

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6463

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Information Systems

Date

Oct 30, 2023

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docx

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Uploaded by JudgeLobsterPerson918

Discussion 3 Group 1: Primary response The role of users is essential in the process of controlling the design of new medical devices, and ignoring their needs can have significant consequences. This is true in all therapeutic areas, as medical devices are essential tools in healthcare. Ignoring the user's perspective can lead to serious consequences: • If a device is not user-friendly and does not conform to the workflow and training of healthcare professionals, it can lead to errors, misunderstandings, or misuse. The effectiveness of the medical device is an important factor to consider. • If a device is not designed to suit the user's needs and context, it may not function as intended. Inaccurate diagnosis, incorrect treatment, or suboptimal patient care can result from poor design which affects the overall effectiveness of the device. Ignoring user needs could lead to regulatory barriers, potentially delaying device approvals and market access. Inadequate consideration of user needs may expose the manufacturer to liability. When a device causes damage due to poor design the manufacturer may face lawsuits, product recalls, and financial consequences. Reputation and market share are also at stake. In the highly competitive medical device industry companies that prioritize user-centered design tend to outperform those that do not as healthcare professionals and organizations, healthcare providers prefer devices that fit their needs and improve patient care. To address the question of whether the therapeutic area matters the answer is that user-centered design is universally necessary, but the details may vary. Different therapeutic areas may require distinct design approaches taking into account the unique needs and contexts of users. So, although the basic principles of user-centered design apply to all therapeutic areas the methods and emphasis on specific user needs may vary. In summary, the role of users is central to the control of medical device design, and ignoring their needs can lead to disastrous consequences, regardless of the therapeutic field. Patient safety, effectiveness, compliance, regulatory compliance, liability, reputation, and market share are all at stake.

The drug manufacturers of TGN1412 could have done the below mentioned steps to make it safer: • Enhanced preclinical research: During the preclinical testing detailed study and extensive testing could have been conducted on animals such as non-human primates to ensure the drug’s safety and to recognize potential risks and side-effects by performing thorough in vitro studies on human tissues which are similar to target tissue. • Small dose in human trials: A smaller dose could have been administered in the initial human trial due to subtle differences between anthropoid and human targets that would have allowed for better observation and management of any untoward adverse effects. • Proper dosing interval between the subjects: An adequate interval between the dosing of one subject and the next should have been done because there was less time between 2 doses that were not sufficient for observation and management of possible side effects. • Allergy testing: If the allergy testing was conducted it would have been easier to anticipate the allergic response as TGN1412 interacts with cells involved in allergies and CD28 is expressed by cells responsible for allergies. As an FDA regulator, I would practice caution and conduct a detailed investigation to seek the adverse events during the TGN1412 clinical trial. I would have considered the following factors before faulting the manufacturer: If the investigation showed that the manufacturer has not conducted proper preclinical testing and has not followed the best practices in determining the initial dose, or has not evaluated the potential risks associated with the drug’s mechanism of action, it would be the fault of the manufacturer for inaccuracy and decision-making. The patient’s safety is of utmost significance, and the manufacturer should be accused of negligence or recklessness. Rather than blaming the manufacturer, I would move forward with a collaborative approach. I would work along with the manufacturer to understand where the process went wrong and will put joint efforts to identify areas of improvement in the process including preclinical testing,

dosing, and risk assessment. This kind of approach will be a learning curve to prevent recurrence in the future.

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