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 things confidential. I read an example on a website that really helped me understand the difference so I’d like to share it with you. Let’s say you have…[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 participate in these forums. It was helpful to read other peoples’ comments and opinions for when I was struggling to understand a certain…[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 to be promoted from a lower level position. I think I wouldn’t mind starting even at the lower management level but then over time with…[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 for smaller teams where everyone works in the same division: people you need and other resources are easily accessible to…[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 own departments’ parts and send to him as he is the one responsible for putting it all together and submitting to the professor at the…[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 this week’s lecture that there are 4 ways in which this can be done: Accepting the risk, avoiding the risk, transferring…[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 with it. FDA not only focuses on the benefit, but also pays close attention to the…[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 these situations can be controlled or avoided and monitoring the…[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 and meets the customer needs. Design verification and validation falls under the design output category of design…[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 opportunity to expose ourselves to multiple projects that fall within the different tracks of BME. I feel like capstone gave me a good understanding of how…[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 address any design issues early on before it gets to the point where it’s unavoidable to make changes without…[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. The primary source for design inputs is usually the end users. Besides these people there are other sources…[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 representation of your schedule with horizontal bar charts that you can easily follow. You can prioritize your tasks by setting a critical path…[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 device recalls. Having good design controls during product development stage decreases the chances that the…[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 follow but also have the chance to interact with doctors and the FDA regarding the clinical studies that we are conducting.…[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 patient will soon die, it makes perfect sense for them to want to approach experimental drugs as a last chance at survival. At that…[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 products’ safety and effectiveness to the FDA. Just as there are healthy people who are…[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 marketed might be a good strategy for companies selling products that are not health related. However,…[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 to physicians’ offices to introduce the product and convince them why they should work with your company…[Read more]

I am choosing J&J to do a SWOT analysis.

Strengths
They provide to three different segments: consumer products, pharmaceuticals and medical devices. This helps them have a higher presence in the market compared to some other companies that provide only to one segment. They are a trusted brand among the medical practitioners and the consumers.…[Read more]