Going based on of the question proposed in the title of this post, Risk assessments are absolutely necessary for medical devices. Risk analysis or assessments are required not only in the US by the FDA, but also in the EU…   Read more»

As was already said before me, I think it is virtually impossible to completely eliminate risk. Even using a medical device in perfect conditions and following intended use protocols to a tee, there is still a possibility for risk to…   Read more»

I believe that in most scenarios it is ideal for the risk management team to be made up with members of the project team and those that belong to the risk management department. The individuals that are on the project…   Read more»

To answer your question, I do not believe it possible to entirely predict all real world failures of medical devices. The core problem of design controls is that they are created with what the designers or creators anticipate to occur…   Read more»

In reference to the title of the question, I do not think that there should necessarily a winner in regards to whether user needs or engineering viability are more important. The teams should instead come together and collaborate discussing what…   Read more»

I believe that you make a great point that the constant updating of the documents contents can become very confusing or lead to an overload of information as you say. The most important thing to do in this instance to…   Read more»

Teams can establish when they have done enough reviews by following the framework they initially created at the beginning of their design process. To ensure success, teams should plan to have a design review at each major milestone during the…   Read more»

I think that design controls ultimately help innovation because they make the design process more sustainable and efficient in the long run. Checkpoints such as design reviews allows the creator to ensure that the device is working as intended and…   Read more»

I think one the most obvious reasons for participants to volunteer or willing join a clinical study is the financial compensation (or equivalent) they may receive for their time in the study. Not all studies, but some do provide participants…   Read more»

I think whether or not you need a clinical background in this specific field is highly dependent on the role you are taking. For example principle investigators certainly should have clinical experience or come from a clinical background. These individuals…   Read more»

As mentioned by others before me, there is certainly a psychological element when companies design their branding whether that be their logos, colors, or websites. This is no different in the medical device industry, colors are not simply chosen at…   Read more»

Marketing and design are different disciplines within industry, but have commonality in the sense that they both strive to understand the people using their product. Design has to take into account human factors like ease of use and clinical applications,…   Read more»

I think for medical device companies the decision to go in the route of an S Corporation or C corporations depends on what the company values and their plans for growth or development. In the early stages of the company,…   Read more»

Having some exposure to the corporate veil from an engineering law class, I think the corporate veil is very important for owners of a company to be able to separate the liabilities of a company from their own personal assets….   Read more»

So I think to some degree there is definitely an moral question here over whether or not it is unethical for a company to withhold a medical device if it does not meet a 70-80%, especially if this device is…   Read more»

So, I believe that its hard to definitively say which should have more resources allocated to the other. Both are equally as important in my opinion to ensuring product safety of the device. Quality assurance is more proactive and prevents…   Read more»

I have always believed that QA and QC are fundamentally important for well functioning device and or company. My thought have not really changed after the lecture and they’ve really only been reinforced by the information provided in lecture. I…   Read more»