A verbal agreement could technically be an oral agreement or a written agreement, so in terms of the difference between the two there is virtually none as an oral agreement is a type of verbal agreement. If we are speaking…   Read more»

In terms of medical device contracts, the most common way to resolve conflict in contract laws often revolve around negotiations, mediations, and arbitration. These processes are not individual processes, and are instead a multi layered approach to resolve any conflict…   Read more»

Overall, I really enjoyed the course and the content provided to us. Where as capstone showed us more customer oriented elements of medical device development, I feel as though this class conveyed more of the industry elements and through the…   Read more»

As some have commented, I have not personally had the experience of working in industry and been able to be apart of a project team. However, with that said I think that I would ideally like to be in a…   Read more»

As with most things, I find it is often a balance of both and it not as clear cut as it may seem. Management provides structure to a project and is often the backbone of the quality and compliance aspects…   Read more»

I think the easiest way to avoid this scenario in this instance having “two bosses” as you put it is to essentially have each boss fill a particular role without stepping on the others feet. For example, I have two…   Read more»

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»