I think it makes perfect sense that there are rules and laws that prevent these things from continuing to happen. As Dr. Simon mentioned in this week’s lecture, there are products out there that could give better results for patients…   Read more»

NDA is not a substitute for a patent. Patents give you a solid proof of ownership of an idea or a product itself whereas an NDA is just a contract that is signed by two people who promise to keep…   Read more»

This course was definitely beneficial in giving us an idea of what to expect when we go out into the real world. Dr. Simon did a good job in keeping us all engaged throughout the semester by asking us to…   Read more»

I agree with @jr377 that in order to move up to the upper level positions, you would have to be promoted from a middle level position. Similarly, in order to move up to the middle level position, you would need…   Read more»

There are advantages to each type so it’s good to go over those first before you make a decision to be part of one. From a project manager’s standpoint, functional structure gives you the least power. This structure is good…   Read more»

We are planning on having weekly meetings to make sure everyone is on track. So far, we have completed the DID and DDP. Our project manager created a document where we wrote down the date we expect to finish our…   Read more»

When developing a new product or device, there is always a risk that things might go wrong. In order to effectively deal with and overcome these risks, companies need to come up with risk management plans. Dr. Simon mentioned in…   Read more»

Risk-benefit assessment is the foundation for FDA’s decision making process in terms of its medical device regulations. This assessment helps to determine whether the advantages a medical device brings to the public outweighs the risks that it might have associated…   Read more»

Medical device companies are required to have an established risk management process in compliance with ISO14971. This process includes identifying hazardous situations that may come up with the medical device being developed, evaluation of these hazardous situations, ways in which…   Read more»

All of the design meetings held throughout the design and development stages were to ensure that the product design inputs met the product design outputs. This means that your final product functions in the way that it was intended to…   Read more»

I’m so glad that we have capstone as a required class. I think it would be really nice if we got to do a capstone project for each year that we are in college. That way we would have the…   Read more»

Design reviews are technical meetings held by a group of people who are working on the same project where the design for that particular project or product is evaluated against all of its requirements. These meetings help to identify and…   Read more»

Establishing solid design inputs are essential to the success of a project. Each and every single requirement to a product needs to be clearly stated and understood by everyone working on that project so that it can be developed correctly….   Read more»

Gantt chart allows you to create an outline of the tasks involved in a project and the time period in which those tasks need to be completed in order to finish the project on time. It gives you a visual…   Read more»

Design controls are necessary documentations required by the FDA to ensure that a product is in compliance with regulations, is safe and meets customer needs. In 1984, FDA identified lack of design controls as one of the major causes of…   Read more»

I think I would want to work for the sponsor company as the person putting the clinical protocols together. It seems like it would be an interesting position where not only would I get to prepare procedures for people to…   Read more»

Right to try law allows terminally ill patients to have access to drugs that are not yet approved by the FDA. If all other treatments have been attempted and resulted in failure and there is a high chance that the…   Read more»

Clinical studies do come with risks but they are an important part of drug and medical device development processes. After getting favorable results from pre-clinical trials, companies need to further their studies and go into clinical trials to prove their…   Read more»

Marketing is the activity of promoting, distributing and selling your product to a customer. It takes a good communicator to convince people into buying your products over others’. I think the whole manipulating the customer to buy what is being…   Read more»

I think the way it works is that the companies have certain employees that they send out to conferences where they give presentations to physicians who might be interested in their products. Another way is to send sales representatives directly…   Read more»