My company uses many of the tools mentioned above to identify and manage risk. As the professor also mentioned, risk can be associated with the design as well as the manufacturing of the device. Risk can also just be associated with the way that the device will be used. From a functional standpoint, the QA department conducts a functional analysis…[Read more]

Another factor to consider when making benefit-risk determination suggested by FDA in this guidance document is whether the device is a novel technology addressing an unmet medical need. This means that the device has a breakthrough technology by providing a clinically meaningful advantage over existing technologies, posing less risk than an…[Read more]

I also work as an R&D engineer for a medical device company, and one thing I have noticed in my company is a lack of brainstorming to identify potential risks. I have found that many times our QA department just uses a lot of data from previous projects and automatically applies it to the new device since most of our devices are quite similar in…[Read more]

Just to add to what was mentioned by several people, they mentioned doing design verification early and often. However, design verification cannot be performed until the design is frozen, which does not happen early in a project. However, you can do characterization at any time throughout the design process to assess the design to make sure you…[Read more]

As Prof. Simon mentioned in his lecture, the validation process consists of design validation and process validation. In a design validation, you assess whether the product meets all of the user needs, and this validation is usually conducted by a selected group of end users. The key to a successful design validation is first of all getting good…[Read more]

For orthopedic devices, such as spinal implants, knee implants, and hip implants, the verification protocols are usually defined by ASTM standards which govern how these devices must be tested. For each type of device, FDA provides guidance on the modes of testing which should be conducted on the device, and ASTM standards dictate how each of…[Read more]

In my company, the customer needs, business requirements, and test plan are all housed within one document, called the DIOVV (Design Input, Output, Verification, Validation). the customer needs are listed as user needs in this document, which the product development then translates into design outputs (business requirements) with acceptance…[Read more]

FDA is looking to make sure that all required elements of a design control system are in place, but more importantly, they are looking to see if the products that companies are developing are following the design control procedures. I believe that an important element of having a complete design control system is how well the company adheres to it…[Read more]

I agree that consistently updating all DHF documents throughout the project is very critical. I have found from my experience that it is very easy to let these things slip, especially in very dynamic projects with frequently changing team members. In fact, I heard of one project where they did not update their project team assignment form, and an…[Read more]

I think I would like working for the sponsor that actually plans out the clinical trial. As an engineer, this role would fit me the best, because it would be my role to come up with the clinical protocol, and essentially plan various aspects of the clinical trial. There is a lot of responsibility associated with this role, because clinical trials…[Read more]

I think this is a very interesting topic that you have raised. However, I do not agree that whoever writes the protocol or pays for the study should own any potential IP coming out of the clinical trial. I think it is a very gray area who owns the IP, but it could be either the sponsor, the investigator, or a combination of both, ultimately…[Read more]

I think the use of placebos are important. As Dr. Simon also mentioned in his lecture, the placebo effect is a very real thing, and in order to know how effective the drug or device is, the investigator must also have a good understanding of how big of an impact the placebo effect is having on the treatment. If they don’t use a placebo, the…[Read more]

I agree with the above posts summarizing what vision and mission statements are, and I would like to add to reshamn’s post regarding Stryker. As a Stryker employee, I agree that I am not aware of a vision statement. However, if you ask any Stryker employee, they will definitely know what our mission statement is. If you walk into any Stryker…[Read more]

I agree with the above posts regarding the definition of EI. EI is very important for selling. As mentioned in the lecture, building relationships with the customer is extremely important, and in order to build a good relationship it will require a certain level of EI. In my company some of the sales reps who sell the most product only sell to 2…[Read more]

I have witnessed the fifth “P” of marketing in my company. Rather than the sales reps doing most of the interaction with the surgeons, our marketing department is also very much focused on engaging the customer. They run several different programs to do this. For example, every week they bring surgeons into the office and present on the product…[Read more]

The difference between public and private companies is public companies have shares that can be publicly traded on the stock market, whereas the private companies are not traded publicly on the stock market.

Public:
Pro: focused on increasing the value of the company to make it more desirable for investors
Con: must disclose corporate financial…[Read more]

I researched Amazon and these were my findings as of June 2017:

Gross Profit Margin: 38.98%
Operating Profit Margin: 2.31%
Net Profit Margin: 1.28%
ROE: 8.28%
ROA: 2.19%
ROI: 4.58 %

The gross profit margin is relatively high, and has improved compared to the last several years. However, the operating profit margin and net profit margin are…[Read more]

I have several suggestions that I believe could improve the relationship between R&D and quality. First, R&D tends to be quite ignorant when it comes to what the quality procedures are all about. They just see them as dragging out and holding back the development of their product. There needs to be more collaboration between the departments, where…[Read more]

In my company, looking at the overall big picture, I would say quality and R&D both have the same end goal. We are devoted to developing quality products to make healthcare better. However, the method of reaching that goal is what causes the distinction between R&D and quality. I agree with most people’s opinion that R&D and quality often seem to…[Read more]