Verbal contracts do have their place in the field, but shouldn’t be realized on too heavily. As was mentioned, verbal agreements have a lack of traceability, which is important in compliance with regulatory agencies. A lack of a paper trail…   Read more»

Loopholes will always exist in every area where there are restrictions. As mentioned, the cost of a “gift” is a bit irrelevant if the intent behind the gift stays the same. If the goal of implementing this limit is to…   Read more»

NDAs are indeed a necessary tool to protect a company or person’s IP, however they are used aggressively. Maybe this isn’t a bad thing, but in the medical device field, one mess-up or leak in information can cause competitive disadvantages…   Read more»

Matrix organization is successful only when everyone’s perspective is aligned to a single, shared goal. Clear boundaries between each manager is important for determining when a manager runs out of authority. Defining boundaries through principles is important because it removes…   Read more»

I think that speaking up to a project lead depends greatly on how you phase what you want to say, instead of the content of what you want to say. Many things which require speaking up have valid foundations when…   Read more»

Design controls are process-driven, while project management is behavior-driven. Design controls rely heavily on regulatory, while project management is primarily more business oriented. Dealing with both of these seamlessly can be difficult in a project team. Many of the design…   Read more»

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 solutions for mistake-proofing can backfire. Introducing slots in designs for easy installation is good,…   Read more»

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 can make a device safer on paper,…   Read more»

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 challenge the design of a…   Read more»

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»