When most medical device engineers hear the term “Design Verification” they think of one thing: testing. While it is true and very likely that Design Verification will involve testing, there are other acceptable verification activities. Design Verification activities can include tests, inspections, and analyses. The purpose of Design Ver…[Read more]

When most medical device engineers hear the term “Design Verification” they think of one thing: testing. While it is true and very likely that Design Verification will involve testing, there are other acceptable verification activities. Design Verification activities can include tests, inspections, and analyses. The purpose of Design Verification…[Read more]

Verification is a theoretical exercise designed to make sure that no requirements are missed in the design, whereas validation is a practical exercise that ensures that the product, as built, will function to meet the requirements.The purpose of Design Validation shall prove the medical device meets the User Needs and intended uses.

ECO gives the chance for a team to see a mistake and have a chance to correct that mistake and document the change. This allows for teams to document changes carefully and also make sure the same mistakes do not repeat again. These changes are essential and are review by the project manager. He/she then reviews them and tries to make sure the…[Read more]

One of the most famous Six Sigma tools called DMAIC (Define, Measure, Analyze, Improve and Control) offers a structured approach for resolving organizational management-related issues. DMAIC can be understood as a troubleshooting-cum-improvement focused approach utility tool.

However, relying exclusively on Six Sigma means maintaining a…[Read more]

Gantt charts are a valuable tool to have in project planning arsenal. Managers use them to perform a variety of project management (PM) functions, including:
-Visualize the critical path.
-Set baselines for project scope, budget and schedule—three metrics that are later used to measure project success.
-Track project progress after kickoff.

The design review meetings were held with the head of the departments and each of the changes were reviewed and if anyone had any input to what else should be added or if any other changes should be made. These were very short meetings at my internship since it is a small company and not many people come into the office.

At Prosidyan, the engineers redline the latest version of a document online using track changes. Before redlining, the engineer will create a DCO(document change order) with new revision and why changes are being made.The document record must be attached to a change notice document type in order to be considered as design change request. The…[Read more]

Risk–benefit analysis is analysis that seeks to quantify the risk and benefits and hence their ratio. Analyzing a risk can be heavily dependent on the human factor. A certain level of risk in our lives is accepted as necessary to achieve certain benefits.
To date, manufacturers haven’t addressed risk very well as part of product design qua…[Read more]

I do not agree with this statement of the book. I do not think medical device companies “lack transparency and proper clinical trials”. None of the medical devices will be in the market if they were not good. The FDA does a very through job ensuring everything is proper and is safe for the consumer to use. Maybe the book is talking about something…[Read more]

I think that all the companies should go forward with the initial planning of the the project. Once the project is proposed, there is a chance the company might getting funding. It not, it was always a good risk to take and continue with the project because it will earn back the money that was spent on it and possibly even more after a few years.…[Read more]

The past summer, I did an internship with Prosidyan. They are a medical device company which create and produce bone graft substitutes. The company’s customers were mainly doctors/surgeons at hospitals. We would send the material to the hospitals around the country and the some other countries also to use the bone graft substitute for spinal s…[Read more]

The classification should not and will not change when the material is changed. Of course a PMA will be needed will filling out the paperwork but even if it is a new material, the class will not differ. This is because there is a similar product and it does similar things. Before using the material, the material being created will have to go…[Read more]

Project proposal should be done with extensive research of the device you are proposing along with how it will help the consumer. It should include the market gap between the competitors and how money it will bring to the company. Project proposal should be clear and straightforward so that anyone can understand it. It should provide a clear idea…[Read more]

Regardless of the project’s type, size and scope, it is important to create a high-performance quality plan template that includes all the tasks and activities required for setting up quality targets, assuring expected performance levels, controlling changes occurring in the project, and implementing the quality management process. Planning for p…[Read more]

I have had design control experience in the industry as well as in academics. In the industry, I have had only the chance to read through all the design controls. But when I took Dr. Simon’s class last semester, I learned much more and when he asked us to come with a new medical device and do all the paperwork behind it. Along with that, for…[Read more]

I have had a pleasure interning with two companies in the past two years. My project managers for both companies have had a management style of giving me enough freedom to finish the work they have given me in however long it took me but at the same time they also they made sure I wasn’t wasting my time. My managers have never pressured me to f…[Read more]

These skills are important because if you are not able to communicate with others, how is it possible to get work done? At a job, you need to keep everyone posted about what you are doing and if you need help, you should be able to ask. If you keep to yourself and not talk to anyone else, it may cost you your job no matter how qualified you are.…[Read more]

It’s not in the engineering world where you need to know how to convey your ideas, I believe it is something that every single person should know how to do. If you don’t know how to talk to others or be able to say what is on your mind, it is every hard for you get anywhere in this world which is all technology dependents right now. It is a shame…[Read more]

I think that the big companies should keep the low priorities projects. When they do that there will be more benefits from it since all of the projects are completed no matter how small or low priority they are. The projects have been past the assigning stage in a company because they thought it was good idea so therefore it should be completed.…[Read more]