Currently, my team is in the middle stages of our product development project. We have all submitted first drafts of our documents to each other for review, so that we can make required editations before we advance. I am in…   Read more»

In starting my own company, I think the functional matrix organization structure makes then most sense. Having departments structured and separated by function would allow every aspect of the development process to be completed efficiently. Additionally, there will be cross-talk…   Read more»

I don’t have an abundance of experience operating in different organization types, however I do feel that the most effective in my opinion would be a rigidly organized structure. While the “everyone does a little bit of everything” sounds good…   Read more»

Much of what we have learned about risk management uses terms like “minimize” and “as much as possible” due to the nature of risk. Risk is something that can never completely go away. Some amount of risk will be present…   Read more»

Post-Market surveillance is important for medical devices of all classifications, and additionally all products in general. This goes back to the statement that risk management does not have a specific timeline, because it should be performed in conjunction with every…   Read more»

Quantifying risk in product development is incredibly important for the project to stay on track successfully. This is not always an easy task, which is why there are methods like the SWOT analysis method. This takes an in depth look…   Read more»

You have encompassed just about all of what goes into risk assessment with the two categories of “how often the failure occurs” and “severity of the failure.” However, both of these could be expanded upon to get a better idea…   Read more»

As a project manager, the main this I would be looking for in a risk assessment meeting is input and feedback from everyone. Obviously as the project manager, I would have a good idea of the risk assumed by each…   Read more»

Determining the sample size for validation protocols seems to be a somewhat neglected, but very important task. The biggest reason this task proves to be difficult is the ability to properly analyze risk and quantify how many employees are required….   Read more»

From my experience working on a Gantt Chart, the most important thing to consider is the relationship between tasks. Many tasks depend on other tasks completion before they can be finished, or even started. This is a crucial aspect of…   Read more»

Design verification and validation are very similar, and I struggled to grasp why they needed to be separated into two distinct phases as well, when they seem be almost the same thing. What I have learned is that verification checks…   Read more»

Design Controls organize everything about a product, and the product development stages. The importance of proper design controls stems back to the importance of communication. Design controls play a major role in every aspect of product development because it is…   Read more»

Obviously, I think all parts of the DDP are essential. If they were not, by now they would likely be obsolete. However, out of all of them, I agree, the Communication management is the most essential aspect. Communication is key…   Read more»

Design Controls are important for any product development project. However, just any Design Controls thrown together haphazardly and insufficiently will not suffice. Design Controls are the blueprints and building blocks fro everything else in the product development process.  Design controls…   Read more»

The Design Input Document is the foundation of any product development project. It contains the basic functionality requirements and details of the product. Because of the amount of information that needs to be in the Design Input Document, there are…   Read more»

Placebo Controlled Trials are incredibly important to the validity of research done in clinical settings. To answer your question of why they are necessary, many subjects in a study would be greatly influenced by the group of the study they…   Read more»

Informed consent is crucial in clinical trials and medical research. Like stated in the question, this could end up being a disservice to the larger scientific field in the instance that a person such as Henrietta Lacks were to check…   Read more»

For most cases, single blind studies suffice for removing bias from the study. As the main reason for skewed data would stem from if subjects knew whether or not they had been given a placebo. However, in many cases, researchers…   Read more»

Marketing is absolutely all about manipulation. Product development works tirelessly to create something that is new, useful, innovative, etc, but if there is no marketing plan to get the target audience to know about and want to buy this product,…   Read more»

Marketing in today’s digital age seems to have become more effective than ever. A large percentage of the population has a smartphone at our immediate disposal in which we look at somewhere around 40 times per day. With social media…   Read more»