As many users of this post have said, biotechnology companies tend to look at the rewards more than the risks. I do think that there are some companies that actually do take into account the risks, but they only take…   Read more»

There are some cases where the risk management team is the project team. From my experience from my undergraduate senior project, my project team was the risk management team because it was our project. We knew the project all the…   Read more»

As we have learned from this week’s lecture, hazards are a potential problem posed to you. It is just there and it does not do anything to you. These can include biohazard, chemical, electrical, or mechanical hazards. A hazardous situation…   Read more»

As most users have said here, yes, I do feel safer knowing that medical devices include verification and validation testing. That goes to show that these companies and those building the device have the people’s health and safety in their…   Read more»

I do think that these 4 columns are enough information in a design matrix. Design inputs, design specifications, verification, and validation are the most important and basic information to include in a design matrix. They are all correlated to each…   Read more»

I think that verification and validation can be conducted simultaneously, but that depends mostly on what design input it is for the device. Most of the time, verification testing is done first and validation testing is done later in the…   Read more»

Design inputs, control, or requirements are targeted for the intended use of the device in terms of the user and patient needs. Design control helps to indicate the user needs and the specifications associated with it to provide the correct…   Read more»

The Design History File consists of many documentations, figures, protocols, appendices, and miscellaneous items. For any medical devices, simple or complex, they should be extremely detailed to note everything that was done from the initial design to the finished product….   Read more»

Design teams should incorporate customer feedback into the design process very early on. They should not wait until the last minute to look or ask for feedback when time is ticking away and the deadline for the finished product is…   Read more»

Artificial intelligence has been up on the rise as of recent years, but it seems to be slowly taking over this past year. I have not seen this much use of AI until this year. AI can be used to…   Read more»

Clinical experiments require human testing and this is usually done after preclinical trials have passed in animals and are deemed safe to perform on human testing. It is more involved than animal testing as it has more risks and precautions…   Read more»

Reading all of the responses, I would like to disagree that the placebo effect cannot have any negative effects on a clinical trial. I think that placebo effects can skew data results in pharmaceutical drug research and testing even if…   Read more»

Generally, almost every company is going to be affected by external factors like the weather, politics, economy, competitors, and collaborators. There is really no escape as external factors are factors you cannot change, and these include opportunities and threats. These…   Read more»

People who are designated in branding control the product’s image. I feel like I may be able to do a good enough job in that department. I do not have much confidence in my skills to say that I will…   Read more»

In terms of marketing, we all have seen those drug commercials on TV where it is usually a patient describing their story and how this medication saved their lives, while the doctor on screen agrees and explains what it does….   Read more»

First and foremost, I think it would depend on the business you want to build, the location, the size, and the need for your product or services. For example, if you are going into the food business, you need to…   Read more»

In research labs, it seems like creativity and productivity is easier to achieve than in corporations. For example, research students, facility mentors, or researchers in general have a common goal they are trying to achieve. They are given the opportunity…   Read more»

I believe that many business owners or those that go into entrepreneurship prefer an LLC over an LLP due to the flexibility over ownership with the business. Typically, LLCs are easier to form than LLPs. In this week’s lesson, we…   Read more»

I do not have much experience with the industry and medical devices for quality control, but I do have experience with our quality control department at a laboratory with how they maintain accurate results, as well as team management and…   Read more»

Every user has provided good points on who would be beneficial to be a panelist in a FDA advisory panel. I agree with torikul as they have highlighted generally the most important people that should be included. I would like…   Read more»