I believe that in order to be prepared for upper management, you need middle management experience. Middle management works with both upper management and lower levels of the company. As you mentioned, middle management works to fulfill the vision of upper management. In order for upper management to set the groundwork and vision, they have to…[Read more]

My team had their first meeting last Saturday. During this meeting we discussed everyones role and what documentation is necessary from each department. We discussed which documents should be completed as soon as possible because it is needed from other departments. We agreed that the DID should be done first. We also agreed that every person…[Read more]

Risk-benefit factors for assessment of medical device risk includes:
1) Severity of harm
2) Likelihood of risk
3) distribution of nonconforming devices
4) duration of exposure to population
5) False-positive or false-negative results
6) tolerance of risk
7) risk factors for healthcare professionals and caregivers

A few points for risk management: 1) ISO 14971, this standard is accepted throughout the world
2)FMEA is not risk management
3) establish a risk management policy and procedure
4)keep severity, probability, and risk levels simple
45use risk management as a tool during design and development as well as AFTER.
There are a lot of articles online…[Read more]

I read another article on risk management and it mentions other errors: 1) Lack of integration: silos between risk management and development 2) Understand and incorporate “intended use” in your risk management process 3) Failing to conduct and document risk-related activities in real time 4) Failing to document design controls or DHF 5) delaying…[Read more]

A validation is defined as conformation by examination that the particular requirements for a specific intended use can be fulfilled. Examples of when validations is required are sterile package sealing processes. An example of when a validation is not required is a manual cutting process. The following are examples of products that require…[Read more]

There are a lot of things that can go wrong when you have insufficient design controls. The obvious outcome would be a decrease in quality which can put your costumers in danger. Sometimes when the design control is too detailed, it can make it very difficult in the future to change a process. For example, we had an increase of defected parts with…[Read more]

I recently finished an internship with a medical device company and two of my projects involved drafting a validation. I have a few advices to successfully complete a validation.

1. Try to draft it asap and e-mail all the people you need approval from. This process takes so long since people can take awhile to get back to you.
2. Check for…[Read more]

One of the task I had to work on as an intern was validation. The first step for a successful validation is that everyone on the team does their part in a timely manner. For example, the team ensures the IQ and ect is complicated so the validation can be done as soon as possible. Another step to be successful is to look at previous validations or…[Read more]

Minutes for meetings has been very important and useful to me in the medical device industry. For example, I had to take minutes for a quarterly quality meeting that we had. In the meeting we discussed some important points that our site needed to focus on and improve. We also discussed some steps we should take and who to contact for help. My…[Read more]

I had to draft up the validation and protocol for two machines a few months ago. The plan used is known as Acceptable Quality Limit (AQL). It is a …”statistical method that is used to test the quality level that would be accepted by estimating a characteristic of the product population through a sample”. Other test used are t test, ANOVA, and more.

If I was involved in clinical research, I would want to be a clinical research coordinator. A clinical research coordinator’s job is to make sure everyone in the team is complying with all the rules and regulations. They also work with the companies to set a budget and are in charge of recruiting patients. They make sure everything is going…[Read more]

I believe placebo-controlled trials are very necessary. There is something known as the placebo effect which is when a placebo drug or treatment is not due to the actual drug/treatment but due to the patient’s belief. If patients knows what type of treatment they are about to receive, they may convince themselves that it is actually working. I do…[Read more]

If the job is more desk work related such as a statistician, bioinformatics, ect, a clinical background is not required. I believe a clinical background is necessary if you are are going to directly deal with patients.A principle investigator and clinical research associate should require a clinical background since these jobs entail dealing…[Read more]

The color of brands is extremely important in marketing and brand design. It is stated that, “…90% of snap judgements are made based solely on color.” In healthcare, the leading color used by brands is blue. Blue is associated with trust, peace, dependable, tranquil, and more. Healthcare companies that use blue as their brand design believe that…[Read more]

Marketing is when you get costumers and potential buyers interested in your company’s service or product.E Jerome McCarthy came up with 4 P’s of marketing:

1. Product: Some questions asked are who is the target for this product? Is the product a fit for the current market?

2. Price: What is an ideal price? What are your competitors price?

3.…[Read more]

A company I recently worked for is known as Zimmer Biomet, an orthopedic medical device company.

Mission statement: Lead the industry in delivering value to healthcare providers, patients and stockholders, while embracing our broader social responsibility.

Vision Statement/purpose: Restore mobility, alleviate pain and improve the quality of life…[Read more]

I recently read an article in WallStreetMojo with discusses the top differences between a private and public company. As mentioned several times above, a public company is able to sell their shares to the public (millions and millions of shareholders). A private company can sell their shares to only a few investors who are willing to buy. The…[Read more]

I believe a company’s type as well as their financial standings throughout the years is something to consider when deciding to work with them. I think this is extremely important when you have been working in the field for a few years and are deciding to move companies. You want to make sure the company you are working for is secure and that you…[Read more]

I researched the company Prudential Financial , Inc (2017)

Revenue: $59, 289
Return on Average equity: 16.0%
Operating Return on average equity: 13.0%
Benefits and expenses: 53, 202
Net Income (Loss): $7,974

Financial position:
Invested assest: $469, 871
Total assets: $831,921
Prudential Financial Inc equity: 54,069

Based on Prudential’s 2017…[Read more]