Activity | srg36 | Medical Device Courses

srg36 replied to the topic "Discussion Topic: Beyond experimental design issues" – 5 years, 10 months ago

First of all, I think that the decision to outsource to this university just because a team member has connections there is a poor decision. In a best case scenario (which is probably what was assumed when making this decision),… Read more»
srg36 replied to the topic "Discussion Topic: Brand new biomaterial" – 5 years, 10 months ago

As the others have mentioned already, referencing the Toxicity Table from ISO 10993, there are different tests required for different applications. Therefore, if you know what application you are planning to use the biomaterial for, you just reference the corresponding… Read more»
srg36 replied to the topic "Obstacles while working on a project" – 5 years, 10 months ago

I worked on a project that was so volatile during the execution phase that it really did not follow any plan, and eventually it was cancelled. It really was a complete failure. One of the main contributing factors was that… Read more»
srg36 replied to the topic "Discussion Topic: Project Management in a medical device setting" – 5 years, 10 months ago

Many of the posts above mention the regulatory aspect of project management as a greater challenge in the medical device industry. I do agree with this, but I would like to expand on what ao242 mentioned about globalization. Many companies… Read more»
srg36 replied to the topic "Professions in Academia and the Industry" – 5 years, 10 months ago

I have been working as a Product Development Engineer for 2 years in the medical device industry. My team is focused on designing implants and instruments for spine surgery. Overall, I really enjoy my work. Although certain projects that I… Read more»
srg36 replied to the topic "Discussion Topic: Academia vs. Industry" – 5 years, 10 months ago

I have only been working in industry, so I cannot speak to the differences between academia and industry. However, I can speak to what I have experienced in industry. My job is very structured, in that I am assigned to… Read more»
srg36 replied to the topic "Discussion Topic: Practical vs. Informational courses" – 5 years, 10 months ago

I think that the answer to this question is highly dependent on the individual, depending on what they are looking to get out of their MS degree. For me personally, I think that a 50/50 ratio would be better, and… Read more»
srg36 posted a new topic "Overworked Americans vs. Motivation" – 5 years, 10 months ago

It is a well known fact that Americans work more hours per week on average than most other countries in the world. Do you think that Americans are putting more hours in because they are more motivated, or because they… Read more»
srg36 posted a new topic "Simulation 3" – 5 years, 10 months ago

In this simulation we are learning about ways to boost sagging sales. In my company, we are a large OEM that sells directly to the customer, and when we have sagging sales, the first thing we do is an depth… Read more»
srg36 posted a new topic "Product Obsolescence" – 5 years, 10 months ago

As a company launches more and more products and their portfolio becomes larger and larger, it can become very cumbersome to manage such a large portfolio. Several of their products may be in the decline phase of the product life… Read more»
srg36 posted a new topic "Process Validation vs. Verification" – 5 years, 10 months ago

In the lecture for this topic Dr. Simon explained the difference between process validation and process verification. Process validation is definitely the preferred method, as it ensures the process is highly controlled and ultimately results in a more efficient manufacturing… Read more»
srg36 posted a new topic "Gauge R&R Challenges" – 5 years, 10 months ago

I’m interested to know if anyone with experience in industry has experience with performing validations on measurement systems, such as Gauge R&Rs (Gauge Repeatability and Reproducibility). Similar to how the process used to produce the part needs to be validated,… Read more»
srg36 posted a new topic "Simulation 1: Faulty Quality System" – 5 years, 10 months ago

In the first simulation this week, we are requesting changes to documents in the Quality System hierarchy. The hierarchy laid out in this simulation is the Quality Manual on the top, followed by Quality System Procedures (QSP), followed by Work… Read more»
srg36 posted a new topic "Does your company use ECOs?" – 5 years, 10 months ago

For those of you who work in industry, I am curious whether your company uses ECOs or another similar form of documentation to execute a change to a product. My company uses the CCF (Change Control Form) process, and personally,… Read more»
srg36 posted a new topic "Documents that are equivalent to a DSD" – 5 years, 10 months ago

Hello everyone, In the topic this week we spent a lot of time learning about the DSD document, a very important document in the DHF. However, in my company, we do not fill out a DSD. Instead, we fill out… Read more»
srg36 posted a new topic "Family Businesses" – 5 years, 10 months ago

I have a question about family businesses. Say for example someone started a sole proprietorship, and down the road the business grows and is successful, and that person wants to pass the business on to his 2 sons as he… Read more»
srg36 posted a new topic "Multiple Project Managers for one project" – 5 years, 10 months ago

I’m wondering if any of you have experience working on a project where there were multiple project managers who each were responsible for different portions of the project rather than just one project manager who managed the entire project. If… Read more»
srg36 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

I have been working as an engineer for 3 years and enjoy what I am doing. I still am not sure if I want to take a technical or managerial career path. I think I would like to gain some more technical experience over the next several years, but I could see myself transitioning into a managerial role sometime in the future.
srg36 replied to the topic Disconnect in rewarding motivation in the forum Project Management Application: Clinical Trial 6 years, 11 months ago

I think there is another very important aspect to this topic that I would like to bring up. I think it is important that managers recognize what type of work motivates their employees, and give them more opportunities to do that type of work. For example, if an employee really likes technical work, the manager should give that person opportunities…[Read more]
srg36 replied to the topic Cost and Time of Device Clearance/Approval in the forum Clinical Trials for Medical Devices 6 years, 11 months ago

The division of the company that I work for only submits 510k applications, and the FDA cost associated with submitting a 510k is $10,566. In 2016, the average time to get 510k clearance was 177 days. Just recently, my company received 510k clearance for a device 65 days after submitting the 510k. However, this came as a shock to us, because it…[Read more]
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