There are multiple strategies that medical device companies utilize to roll out their devices. Medical device companies utilize strategies that are focused on marketing products towards medical professionals and utilizing academic and medical conferences in order to spread the word…   Read more»

One grand strategy that is frequently used in medical devices and technology companies is product development. Product development deals with the company investing heavily in research and development in order to launch new and innovative products to market. The overall…   Read more»

Interesting video with of course an exaggerated view but definitely touches on a lot of the concepts discussed in this weeks topic. Due to the lack of technical expertise each department was not able to focus in on the problem…   Read more»

Netflix financials and state of company. P/E ratio: 244.39 Gross Margin: 31.72 Operating Margin: 4.3 ROI: 3.49 Revenue: 8.83 Billion Market Cap: 86.13 Billion Share Price: $199.49 EPS: 0.15 vs 0.16 expected (July 2017) From these financials it is clear…   Read more»

Public vs Private companies, the largest difference between the two is that private companies are not publicly traded, while public companies have shares traded on exchange funds available to the public. The main reason a company chooses to go public…   Read more»

For positions out of school I believe it is more important in determining the type of experience you will receive from the company and the depth of your role, rather than the type of company. Initially you want to gain…   Read more»

My current role dealing with engineering change controls involved document control and properly maintaining records of changes in manufacturing of medical device and pharmaceutical products. This information is used for regulatory filings, quality control, health authority filings, and audits. The…   Read more»

The dynamic is interesting and I have a middle ground perspective between the two fields. As a Process Engineer in my companies manufacturing and science technology group my role deals in bridging the gap between R&D and manufacturing, therefore I…   Read more»

Quality can definitely burdensome for medical and pharmaceutical companies and is a key driving factor in the high cost of delivering good products to the consumers. For a portion of my role as a Process Engineer we have teams dedicate…   Read more»

The user fees increase could be a benefit for the industry as it has the potential to increase the regulatory timeline for FDA. This can allow for drugs and medical devices to reach market quicker and aide thousands of patients…   Read more»

A recent prominent recall that happened was part of Johnson & Johnson’s orthopedic subdivision Depuy Synthes. In this situation J&J was found negligent in properly informing consumers that their metal on metal hip implant (Pinnacle Hip implant) had a design…   Read more»

An antibiotic hip stem would be considered a combination product “as defined by 21 CFR 3.2 (e)”. The primary mode of action of this hip stem would be to provide similar functionality and support of a hip and the antibiotic…   Read more»

Within industry research the main advantage is the resource and workflow that is in place to deliver finished products. For example, currently my role is that of a Process Engineer and the main task of my group is working in…   Read more»

While working in industry I did come across a situation very similar to this, in which our company was conducting animal studies for a product under development. The constraint that we had was we had to conduct the trial at…   Read more»

Personally I am more interested in doing research that can be developed into product in a useful time frame. I do not agree that the hard line is between academic doing long term research and industry doing short term research….   Read more»

A milestone failure within the medical device industry can be viewed as a learning opportunity and improvement area no matter what stage of the project planning phase it occurs in. With that being said if the failure is to occur…   Read more»

Personally within industry I have used Microsoft Project for creating project timelines. Microsoft Project’s functionality to integrate with different functional teams is crucial for project planning and execution. One recent project I was working on dealt with lab validation and…   Read more»

For a medical device project I agree that the manager must provide the balance of executive deadlines and taken into consideration the overall safety of the users. However, the role of the manager should not be limited to a business…   Read more»

I was recently made aware of this ratio as I was attempting to create a schedule so that I would be able to take all 4 courses that you provide in my curriculum. I would disagree with the 3 to…   Read more»

The biggest difference that I see for academia and industry is the structured projects present within industry and the unstructured projects you can choose within academia. Within industry for the most part the projects you are assigned are limited in…   Read more»