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 experience in the industry and a proper role is the greatest step you can take to ensure that you are on the correct path. The…[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 best way to ensure that the information is…[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 deal with both departments on various issues. From my experience quality simply follows the…[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 to quality assurance and regulatory compliance when any changes are made to products. My role deals with…[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 in a more effective manner. There are also potential setbacks that can result from this move, as the increase in user…[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 flaw. The ASR hip implant was the first of the metal on metal hip implant’s recalled by…[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 portion would be considered an additional effect of the implant, and the CDRH would be responsible for this device. Also sin…[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 Manufacturing Science Technologies which is to translate research of products into a deliverable product through…[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 a specific test center that was pre-approved by the company and had a non-disclosure assigned. The test center was in Ohio…[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. While academics does have more research projects that may be beneficial long term there are many joint ventures between…[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 during an early stage, then this looks poorly on part of the project manager since it is their responsibility to do…[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 we had hired an outside contracting company to ensure proper…[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 aspect. In my experience a manager is most effective when they have technical expertise and experience in the…[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 7 ratio in practical courses vs informational courses because as stated above many of practical courses are filled with information we will utilize in…[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 scope to the business needs of the company. If the company is not headed in a direction of a…[Read more]

Currently I am working at Bristol Myers Squibb on a process characterization team focused on bridging the gap between R&D and manufacturing for commercial medical devices. I also have previous industry experience at Ethicon, where I worked mainly on design controls and verification/validation projects involving legacy products such as surgical…[Read more]

I don’t fully agree with the skepticism on lack of upper management willing to listen. While this is definitely an issue within any industry based off my experience it is in the minority of cases where these situations occur. This can mainly be attributed to the lack of leadership on upper management and a good indicator of this situation at…[Read more]

There can be many reasons to leave work, one of which as you stated would be limited praise/recognition. Many times people also feel that they would be better off in a different division if there is stagnation within their own division. Moreover, many times companies go through ups and downs and during certain phases management may decide on…[Read more]

Six Sigma certifications are intended to demonstrate that you have the capability of handling complex projects and the problems that may arise while working on them. Through my company I recently registered for lean six sigma yellow belt course, and based off the overview of the course it deals with waste reduction and time management in better…[Read more]

I was not part of a team that had a team member removed to work on another project completely. In my experience it usually isn’t a complete removal but the individual that is chosen to work on another project has to divide their time between their core responsibilities and the new project that they were selected to work on. This can cause problems…[Read more]