Medical device development takes several years to complete, and drug development can take over a decade to complete. The clinical trial process has become more complex and expensive, as mentioned. Challenges include the need for more procedures & tests, longer…   Read more»

GCP is absolutely necessary because innovation is useless, if the methods used to essentially prove the device are not sound. While GCP does involve much more extra paperwork, that causes things to take much longer and also cost more money,…   Read more»

I agree with you, that trust is absolutely vital in a clinical study, not only to attract and retain participants, but to also ensure that the patients report honestly. I believe that the best way to build to maintain trust…   Read more»

I understand the concern about the risks involved in clinical studies, but I believe that human clinical trials are absolutely necessary and ultimately do far more good than harm. Without them, there would be no safe or effective medical devices,…   Read more»

For the protection of human research subjects, regardless of the type of research, there is 45 CFR 46, which pertains to the Department of Health and Human Services. This regulation was also adopted by other agencies and departments, which is…   Read more»

An important guideline for medical companies is ensuring data integrity in clinical research. This is where the ALCOA+ principle (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) comes in, and what CRAs look for regarding documents and…   Read more»

Along with everything else, everyone has mentioned, biomedical engineers also help with making sure that what a clinical trial measures actually matters. The study has to show specific results that show whether a device worked or not. Engineers help translate…   Read more»

While GCP regulations can slow development, the FDA has several programs in place that see to expedite the wait time. In class when learning about the specific pathways that medical products can take, we also learned about Investigational Device Exemption…   Read more»

I think biomedical engineers play a role in the entire feedback system that determines whether a clinical trial can evolve efficiently. In Dr. Simon’s materials, we can see how each subsystem of a process is reliant on controlled inputs and…   Read more»

I love this topic regarding the psychological aspects of clinical research. Dr. Simon and the provided protocol template discuss the importance of reducing bias in study development and how that is done with blinding, randomization, and standardization. Usually, these effects…   Read more»

I agree with both of you that the complexity of clinical research makes everything more time-consuming and stems from the ethical and regulatory layers. After reading the clinical trial protocol that Dr. Simon provided, I can see how much coordination…   Read more»

Clinical research in medical device development is complex because it involves multiple layers of scientific, ethical, and regulatory challenges. Each device must be tested rigorously to ensure it is safe and effective for human use, which requires carefully designed studies…   Read more»

Trust is the secret ingredient that underpins every successful clinical trial in medical device development. Participants must trust researchers to protect their safety, privacy, and well-being throughout the study. Similarly, regulators and clinicians need confidence that the data collected are…   Read more»

The regulatory process for medical device development is often seen as either a gold standard for safety or a paperwork nightmare for innovators. On one hand, strict regulatory frameworks such as those enforced by the FDA ensure that only safe,…   Read more»