I also found these restrictions to be quite ridiculous, especially not being able to pay for the physicians spouse. However, I do understand why these regulations are in place and what they are preventing. As Professor Simon had mentioned in…   Read more»

Although recognized as a legal contract, I personally do not think verbal agreements, especially on behalf of a company, should be used. As Professor Simon had also mentioned in the video lecture, there are 5 parts every contract must have,…   Read more»

Being that the only experience in industry I’ve had is the position I currently hold at a medical device manufacturing company, I found this course to be immensely helpful and somewhat like a roadmap. Prior to this semester, I was…   Read more»

I agree that the size of the company and the product being produced plays a large role in deciding which is the best organizational structure. For smaller companies, I can see the benefits of having a functional structure because the…   Read more»

The medical device development company I currently work at has a functional organization type. As Professor Simon had explained in his lectures, this is where the company is structured into departments that are each run by a manager and the…   Read more»

Although it is rare you are able to directly chose each individual on your entire project team, I believe a diverse group who holds expertise in varying departments is necessary for a projects success. Depending on the organizational structure of…   Read more»

When identifying and analyzing risks, there are tools that can be used such as brainstorming, failure mode effects analysis (FMEA), fish bone diagrams etc. to help lay out why the risk is present, how failures can occur, the probability of…   Read more»

Within the risk management process, there are four stages which include analysis, evaluation, management, and measurement. Once we have identified and categorized each risk in the analysis, assigned probability of occurrence and considered severity in the evaluation, we move into…   Read more»

There are four ways to manage risk: avoidance, mitigation, acceptance, and transference. Transference is basically transferring the risk elsewhere and not commonly used in medical device development. However, one of the remaining three tactics must be considered in order to…   Read more»

Dr.Simon’s stress on the importance of meeting minutes is for good reason. To begin, meeting minutes are an all encompassing record of what took place during the meeting. This can include the date and time of the meeting, who attended,…   Read more»

I agree that one way to keep the DHF audit ready is to ensure the document is “living” and accurate to the product currently being produced. Although, I would like to bring up some of the risks associated when auditing…   Read more»

Design controls are an elemental piece of getting a well-thought out idea on a piece of paper to a manufactured reality. Design controls include nine parts: planning, input, output, review, verification, validation, transfer, design changes and the design history file….   Read more»

Although I have not had the opportunity to prepare a Gantt Chart for the company I work at in industry, I did have to include this in my senior design capstone proposal and got a brief introduction into what should…   Read more»

Outsourcing the design transfer can be beneficial in many ways, such as cost efficiency or a shorter time to market. However, and possibly bias because I am currently a supplier quality intern at a medical device manufacturing company, I believe…   Read more»

I would respectfully disagree that only medical devices have been proven to improve human health, and not pharmaceuticals. In addition, a drug does not need to cure a disease in order to be classified as effective or safe. Reducing side…   Read more»

I agree with the last statement that clinical studies are necessary for discovery, although I am conflicted with risking human lives for such advancements. It would not be possible to administer a treatment and have an understanding of its effects…   Read more»

I do believe that having a clinical background would be of benefit in certain roles, such as the Principle Investigator or the Study Coordinator. Mostly because these are individuals that would be dealing directly with the patients and reporting any…   Read more»

Rather than being considered separate entities, let us think of sales as a subcategory within product management. Product management is considered over the life cycle of a product. And once past the developmental stages, sales should be ready to commence….   Read more»

The function of product development is to plan how to develop a new product, actually manufacture it, and sell the product to consumers. There are a few moving parts that go into the development of a product, but most of…   Read more»

Advertising is a critical component of marketing, and if not executed effectively, could be the make or break of a product. Within the Four P’s of Marketing, advertising falls under promotion. There are many different ways to promote a product,…   Read more»