While a patent is a federal document providing ownership of an idea, NDA which is non disclosure agreement is just a simply contract between two people. NDA can provide people with a level of protection and NDA is not as…   Read more»

I think I am very lucky to take this course before I graduate. I always hope that I can learn some information about medical device company before finding job since Lack of knowledge in the industry always make me nervous….   Read more»

Generally speaking, most contacts can be either written or oral and legally enforceable, however there are several types of agreements which have to be in writing. I listed them below. 1. Real estate sales 2. Agreements to pay someone else’s…   Read more»

If I were to start up a medical device company, I will choose matrix type organization. One of the reasons is that because the matrix structure is more dynamic because it allows employees to communicate more readily across the boundaries,…   Read more»

I would like to work in matrix type organization. As mentioned in the video, the matrix organization structure is a combination of two or more types of organizational structures, such as the projectized organization structure and the functional organization structure.This…   Read more»

I found a few tips for avoiding dysfunction of team project on the internet. 1. Size, Go with smaller teams—the bare minimum necessary to get the work done. The typical project team size is five to nine members. If you…   Read more»

I do not have experience. But I searched about it online and found that for risk identification, the project team should review the program scope, cost estimates, schedule (to include evaluation of the critical path), technical maturity, key performance parameters,…   Read more»

I found that the ALARP concept contains legal interpretation of the regulatory process that promotes financial consideration in higher regard than of the requirements of safety and performance of medical devices. Contradicting this approach, AFAP requires that all ventures of…   Read more»

The differences between medical device and pharmaceuticals are, firstly, Medical devices are based on biomedical engineering and, as a general rule, either permanently or temporarily replace a body function. By contrast, pharmaceuticals are medicines, designed to engage the body’s chemistry….   Read more»

I will mainly talk about customer input sources. Every organization actually has two different types of customers: Internal Customers and External Customers.Most people are familiar with their external customers – these are your end users and even your intermediate users…   Read more»

I have less experience on writing protocols but I searched about this online and found that sample sizes are calculated based on the magnitude of effect that the researcher would like to see in his treatment population (compared with placebo)….   Read more»

I searched about the Korean Regulatory System The Ministry of Health and Welfare (MHW) is the primary healthcare agency regulating the importation of medical devices. Under Korea’s Medical Devices Act, the Korea Food and Drug Administration (KFDA), an agency under…   Read more»

Regardless of the device classification, Design Controls are a critical component to medical device product development. Design Controls demonstrate you have designed and developed a medical device that meets user needs, is safe and effective. The relationship between Design Controls…   Read more»

In my opinion, the most important phase is scope management plan. scope management plan is the collection of processes used to ensure that the project includes all the tasks required to complete the project while excluding all work which is…   Read more»

I think insufficient design control would, firstly, waste money and energy, since engineers spent time and money on useless design. It is also kind of financial loss for the company. Moreover. It is also damage the image of company if…   Read more»

I‘d like to play a role of investigator，since I love research. I’d love to study whether the drug I am working on is safety when people taking it. This role is very important because investigators should be responsible for the…   Read more»

I think double blind test is better. Since some scientists are dishonest, they often have pressures comes from billion dollar drug companies and the fight of research grants, so they want to have positive results. Therefore they may give the…   Read more»

Clinical trials are risky, but I do not agree to inhibit doing clinical trials, since it is very important for research. In my opinion, a strategy should be required for reducing the risk comes from clinical trials. For example, participants…   Read more»

I select a company that design ophthalmological surgical tools, the name is NovOculi. NovOculi employs a method involving iontophoresis, an ionic dye, and a wavelength-specific laser to accomplish effective refraction without the troublesome destruction of epithelium. Strengths Patented technology: they…   Read more»

There is a pretty clever way of marketing i met before, that is drawing a lottery and introduce the products as a prize. I agree with that using social media is a good way of marketing, but actually some medical…   Read more»