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 medical devices now, what is stopping engineers from…   Read more»

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 team if it is followed. In business, there…   Read more»

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 change came from allows the document…   Read more»

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 relating to its design controls, and being able to update a…   Read more»

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 their initial training and these changes are most…   Read more»

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 medical device which takes into account rather…   Read more»

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 for their treatment even prior to receiving a full…   Read more»

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 not directly be possible, however optimizing clinical trials in a…   Read more»

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, it pretty much ruins the study. To…   Read more»

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 everyone may be well-versed with the technical or pharmacological aspects of…   Read more»

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. Storytelling in order to oversimply a product has its…   Read more»

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 marketing content, then yes, that is an appropriate way…   Read more»

For long-term goals in order to remain an established company, going public is almost a requirement in my mind. A private company when it goes public should hit the ground running. As in, the company should already have some momentum…   Read more»

Negative cash flow is definitely more influential than profit itself when evaluating when companies fail. Getting to a negative cash flow indicates numerous poor financial decisions; it is never the result of one mess-up. A medical device can remain unprofitable,…   Read more»

One critical factor which could be overlooked with “extremely” innovative technologies would be the payback period. Payback period is the length of time estimated to break even from the development of a project. Tracking this period of time is important…   Read more»

Some of the communication troubles between QA and QC because integration of the two is tricky due to the nature of how they deal with quality. QA focuses on being more proactive, while QC is more reactive. QA is there…   Read more»

Adding on with a specific example of incomplete documentation missing which leads to a failed audit is the lack of “assumed” process in the documentation. In cases where employees work at a company for a fair amount of time, they…   Read more»

Specifically when comparing QA/QC in the development stages of medical devices versus in the post-market surveillance, companies should adapt their strategies in a way which makes the process quicker without sacrificing effectiveness. The QA/QC in the development stages tend to…   Read more»

I agree that engineers should have a layer of responsibility for regulatory basics. Understanding of FDA regulations is important for proper design of medical devices, but with constantly changing guidelines, having a perfect understanding of regulatory regulations for engineers is…   Read more»

I do think that if a reform is needed on the classification of medical devices in the FDA, the time to do it should be in the near future before too many problems arise in classifying “in between” medical devices. Less…   Read more»