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. After I take this course, I learned that working in the medical device company, just like what I thought before, is…[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 debts
3. Contracts that take longer than one year to complete
4. Real estate leases for longer than one…[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, creating a good, cooperative, work environment which helps to integrate the organization. Moreover,employees…[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 combination may help organizations achieve higher efficiency, readiness, and…[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 assign more people than needed, just to be safe, you might experience Parkinson’s law: Work expands to fill the time available for…[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, performance challenges, stakeholder expectations vs. current plan, external and…[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 safety must be addressed in the intent of the consumer and effectiveness…[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. Secondly, Medical devices have different efficacy d…[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 (dealers, distributors, brokers, etc).
If you’re in a regulated industry (an…[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). It is important to note variables such as prevalence, expected confidence level and expected treatment…[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 MHW, independently regulates all medical devices; only when KFDA requests l…[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 and regulatory submissions is strong. Design Controls are…[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 out of scope. The Scope Management Plan details how the project scope will be defined, developed, and…[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 the insufficient design caused problems on usage of the product. Furthermore, It would effect the market of the…[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 result of clinical trials. This role is also burdensome, since if something goes wrong, for example, patients have som…[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 drugs to the patients who have the better chance of recovery and even manipulate results, try to show 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 may do some blood test before clinical trials to make sure they are really suitable for joining the test.…[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 have patents on Non Invasive Corneal…[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 devices are for old people and not all old people are familiar with facebook and twitter. Lottery marketing strategy is the kind of…[Read more]

Emotional intelligence is the ability to identify and manage your own emotions and the emotions of others. I think highly of EI. People’s emotions plays a important role on the efficiency of work. For example, If you have bad mood, you might have less passion for you work. Moreover, you have Great EI also means you have the capability to identify…[Read more]