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…   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…   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…   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…   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….   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…   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…   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…   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,…   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…   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…   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…   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…   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…   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…   Read more»

I agree with the general consensus in the above posts that the quality assurance process and quality control process is very important to ensure a device will be safe and reliable for the end user. However, I also agree with…   Read more»

I recently worked on a product that was recalled voluntarily by our company. I want to make the distinction between a voluntary recall and an FDA mandated recall. A voluntary recall is when a company’s post market surveillance of a…   Read more»

A de Novo is a classification process using a risk-based strategy for new, novel devices that have not been classified as of yet. The new ruling in 2014 streamlined the process by creating an alternative pathway that does not require…   Read more»

The question was raised whether the current 510(k) process is ensuring that the medical devices released to the market are safe and effective. The Institute of Medicine (IOM) investigated this question and found that the current 510(k) process is flawed…   Read more»

I work in Product Development, and what I would say is that in industry, timing can determine the success or failure of a product, therefore I believe that industrial research is approached in a different way. Taking the example of…   Read more»