As an intern I noticed that the organization structure was Matrix. However, I noticed a pro and con about the structure. The consequence of having an Matrix organization is that people tend to ask everyone for an answer when an issue arises. Their’s no direct path for communication as to who to ask. The positive aspect of the matrix organization…[Read more]

My interpretation of AFAP is twofold: Businesses are doing just enough to be competitive or Businesses are going above and beyond to be the best. In the medical device realm to be the best is to have the require ISO, CDR , FDA etc regulations that allow them to be certified to sale and produce medical devices. Practical it is impossible to be…[Read more]

The regulations are written by people who do this for their career. That means they need a form of compensation. The fee(s) are used to compensate the employees who help write these regulations. These regulations show the quality of product that company is willing to pay for to have excellent quality for their medical devices. The saying goes…[Read more]

For medical devices there is an ISO standard which is ISO 14971. ISO 14971 is the Application of Risk Management to medical devices. In general, it states the specification for manufacturers to identify the hazards associated with medical devices, including in vitro diagnostic medical devices, to estimate and evaluate the associated risks, to…[Read more]

Being part of capstone instilled in me the practical and technical skills of writing a DDP and how you must use “shall” in the document. Also, if you make changes in one document say the DDP then you will have to make those changes in DSD. I understand why change orders are not favored.
Being part of NSF I learned the business approach to sel…[Read more]

At my internship theirs many design controls set in place to ensure we get good coatings on the ammunition we coat. For example after the bullets have been coated from a basket, I take three parts weigh them and then strip the coating from them. Afterwards, I weigh them again to evaluate the coating weight. Theirs a range for different bullets…[Read more]

From working at my internship I have had meetings in general and not at all related in terms of medical devices however, I notice that when meetings do take place they can be either exciting or boring. People from internship say that managerial meetings are boring. On the contrary when I was in the meeting it helps to understand everyone’s o…[Read more]

The regulations in the USA vs EU are stricter in terms of documentation. With that being said it seems that the FDA tends to expatriate the companies with documentation where EU is lenient. However, in terms of actual processes I believe Design Controls should be applied to every country that works in the medical device industry. These controls…[Read more]

I agree with the DID as being a rough blueprint to the customers input as @amd29 had stated. The example I disagree with because it does not compare to medical devices since their tends to be more regulations and scientific attributes associated with the field. The example is more for an interior designer then a engineer.
To answer more on the…[Read more]

When working in research one must have a lab notebook to document ones findings. There is not many rules to this living document however it should be clear and concise what you are doing for each experiment and/or discovery that you find. The document is also a reference to previous successes and problems you had in the past. I am sure if you had…[Read more]

The paradox seen here is people want a cure but they do not want to risk their lives for it. You ask the person given the clinical trials If they would risk their own life to save those for the future. They may say yes or they may say no. The ethical dilemma we face is if we do proceed with clinical trials then drugs will not be made because the…[Read more]

I notice that one critical step was missed this discussion was taking place. FDA demands animal testing prior to even having clinical trials being a thought. Data collection of the drugs on animals has to be analyzed for efficacy, toxicity, viability, etc.. Then after many trials on animals , next is testing the drug on humans during clinical…[Read more]

Going to give a brief summary of the general job responsibilities of a CRA. CRAs is health-care professional who performs many activities related to medical research. Some of those activities can be keeping the GCP’s for monitoring the clinical trials taking place, reviews case report forms (CRFs), communicates with clinical research c…[Read more]

Marketing to me was and still those tel-marketers calling me at 5:00 pm at night before eating dinner. They tend to be expatriating and annoying. However, It seems when it comes to medical devices the role of marketing is more people friendly and amiable, then receiving a call every day at 5:00 pm. Marketing of medical devices has to detailed yet…[Read more]

This is a fascinating factor to point out in branding. Sometimes people buy products just because of the color, which may sound absurd but it happens. From a website called HelpScout dot com, they go over the “ Psychology of Color in Marketing and Branding”. One fact is that color is too dependent on personal experiences which is uni…[Read more]

As Dr. Simon has mentioned in his lecture this week there is 15 grand strategies for marketing. The grand strategy which I will briefly talk on is the Turnaround strategy. From various resources the turnaround strategy is used when a firm has and is experiencing profit stagnation. One tactic to do this is to change the direction that a firm is…[Read more]

I choose Merck for the financial assessment: I found these results base doff Yahoo financial page for companies.
Doing a brief financially assessment off 2016 since some data isn’t up for 2017 yet.
Income Sheet:
Gross Profit : 26,444,000
Net Income : 3,920,000

Balance Sheet:
Total Assets: 95,377,000
Total Current Assets: 30,614,000
Total L…[Read more]

I have never thought to look at growth, revenue etc.. when even applying to a company. When I look for a job posting I typical look at the job based on requirements and the experience. I have already looked at the location and looked up the company but, with this question being raised I find it helpful to tune my scope based off my own…[Read more]

I researched largest private companies in America and found Cargil ranked 1 as well as it brings a revenue of $109.7 Billion dollars. For a company so “big” I have never heard of it before until last semester in Bio
materials class I took. When doing this week’s lecture what I notice I dislike about Private companies is that a corporation does…[Read more]