Mistake-proofing shouldn't be intrusive in a way which disrupts workflow. The best types of mistake-proofing are ones which are seamlessly integrated into non-mistake-proofed workflows. Overly rigid s...

One thing which I think is also important to consider is the user's perception of the device if the device is "over-engineered" to mitigate risk. For the actual device, implementing all these features...

To build upon what was mentioned in the post before mine, FMEAs are only as effective as the team who constructed it. Relying on checklists can be the result of inexperience and/or the reluctance to c...

What contributed to the Therac-25 incidents was a reliance on old code as mentioned in previous posts. Engineers possibly assumed their code from previous projects was fine as is. With AI entering med...

Following design controls intentionally is important for efficiency, even if it feels like it's there just for compliance. A lot of it feels like regulatory checkboxes, but it can benefit a project te...

As briefly mentioned, sectioning off the DDP by "departments" will allow the file to be filtered to view what is relevant to an individual or team. Filtering changes based on the specific sector the c...

To coordinate between risk and verification validation results, a dynamic risk assessment system can be used to consider the results. Verification and validation can uncover problems with a device rel...

FDA and ISO should begin to change their requirements. All of their requirements were written where the submissions were done in concrete steps. Many AI models have algorithms that can change after th...

Engineers should "fight" for an ideal design in a way which describes their design as a benefit to the business. In design, usually user needs will complement business goals. For example, designing a ...

There is a conflict when it comes to honest/proper communication and using the nocebo or placebo effect as a therapeutic tool. Patients entering a clinical trial will develop their own expectations fo...

Clinical trials are indeed very long and very expensive because of the ethics, regulatory demands, and demands for solid results which go into each clinical trial. Simplifying clinical trials might no...

As mentioned, a blinded study is a bit difficult to have honest conversations with the patient as it could compromise the study integrity. If a patient learns about which treatment they are receiving,...

Effective promotion and ethical communication relies heavily on how well the science is communicated. As was mentioned, marketing campaigns should be more closely aligned with the science, however not...

One factor that hasn't been really mentioned which is important for medical device marketing is being able to capture the trust of the consumer, whether it be prospective patients or physicians. Story...

To answer the question of what should the threshold of misunderstanding be, if you define a misunderstanding to be critical based on a risk that it poses to consumers through misunderstanding marketin...