Based on the organizations discussed by Simon. I would choose to have a functional organization. It would allow me to have departments with people familiar with each project that is needed. This would allow for a cohesive workflow with one…   Read more»

I believe that the best organizational structure is functional and project-based. These two are strong because you can place people in groups/teams based on their specialty. This allows for optimal workflow and brainstorming because they are familiar with the task…   Read more»

I currently work in a functional organization. A group of scribes is selected to work on specific doctors only and we work together to complete all the charts necessary while other groups have other centers or facilities for doctors that…   Read more»

Medical device startups and manufacturers should take the PMS process as a holistic approach to maximize the gains including fewer medical device defects, improved user safety, and, in certain cases, decreased litigation risks. The essential tools of your PMS process…   Read more»

When dealing with risks for medical devices, there is always going to be an instance where risk is accepted. Any device has to accept some risks when a device is released for use. But you always want the benefits to…   Read more»

Yes, I believe that risk management is an important part of the planning phase, essentially it is very important in the whole aspect of making medical devices. Risk management is critical in avoiding unnecessary costs and mitigating unknown risks that…   Read more»

I think meeting minutes are very underrated. They are taken for granted and passed over quite often. Meeting minutes can be crucial to you if you happened to zone out or take your attention off of the meeting, even for…   Read more»

I believe the most important part of design control is the design verification phase. I chose this part of the process because the verification of the design is crucial to being a “good” product in my opinion. I think it…   Read more»

Regulation of medical devices is different across the world. Some places have very complex requirements while others have none at all. In the U.S., we have established Design Controls. Design controls designate the application of a formal methodology to the conduct…   Read more»

I believe that double-blind studies are beneficial. This is due to the fact that a researcher or overseer of the patient could have an impact on the patient if they know what is given. If the researcher develops a rapport…   Read more»

I feel that this law is very beneficial to those that are terminal and/or looking for the last hope to find a way to stop the progression of their disease. Making this a law is allowing people more hope. While…   Read more»

I think they are lots of risks and benefits when it comes to human clinical trials. Some of the most noticeable advantages are that it helps further research, a new drug could do less harm to the side as far…   Read more»

I think that it is very important for a salesperson to be knowledgeable in whatever aspect it is that they sell. Someone in sales for medical devices should definitely be well versed in some of the ways and rules that…   Read more»

You are currently developing a company to manufacturer dental tools. Who are you planning to sale to? (Physician, Hospital, Retailer) Explain your answer.   If I was to start a company that manufactured dental tools, I would plan to sell…   Read more»

When i think of a companies that are corporations, I never think of that corporation being specifically an “S-Corp” or a “C-Corp”. I just think of them as a corporation, can you please provide an example of each type of…   Read more»

The drug Aprotinin (Trasylol) has been banned in the U.S. but is still on the market in some European countries. The drug was used as a medication administered by injection to reduce bleeding during complex surgery, such as heart and liver surgery. Its main effect is the slowing down…   Read more»

De Novo is a classification process using a risk-based strategy for new, novel devices that have not been classified as of yet. This new ruling expediated the process by creating an alternative pathway that does not require submission of a…   Read more»

I think being a physician, you will face many challenges that you want to accomplish. Making medical devices can be a cumbersome task if not done the right way. Some of the biggest challenges a physician could face are money,…   Read more»

A common medical device that is used in hospitals that is essential to run a stability test on is some sterile and non-sterile medical devices. Sterile devices specifically need to be stability tested to ensure that sterilization does not break…   Read more»

I believe that animal research is looked at in such a negative light because of the negative association that people have of research labs/facilities from movies and TV. I think the population does not understand the cruel treatment that animals…   Read more»