Medical Device Courses | knm7 | Activity

knm7 replied to the topic "Engineer vs. Manager" -

Thu, 27 Apr 2023 19:31:58 -0400

Personally, I think I would choose to stay as an engineer and just eventually become one of the senior/lead engineers in the lab. I have seen what management goes through and I don’t think I would find any fulfillment in… Read more»

knm7 replied to the topic "What’s Your Motivator?" -

Thu, 27 Apr 2023 19:11:08 -0400

Something that motivates me to do my best in school or work is thinking about what I am trying to achieve in my career and my end goal. I use my aspirations of eventually finding a cure for neurodegenerative diseases… Read more»

knm7 replied to the topic "Quick, Fast, Good? Pick Two" -

Thu, 27 Apr 2023 19:05:00 -0400

In my opinion, I would choose to have a good and fast clinical trial. To buy good quality items could sometimes come at a higher cost, which sometimes makes it hard to find a cheaper item around the same quality…. Read more»

knm7 replied to the topic "What should the project team learn from the failure project" -

Fri, 21 Apr 2023 17:55:03 -0400

If a project fails, where it failed should be looked at. For each of the individuals on the team, constructive criticisms should be given by management to help the employees reflect on some possible issues. I also believe a group… Read more»

knm7 replied to the topic "Motivation" -

Fri, 21 Apr 2023 17:38:20 -0400

I believe that it should be a balance of both. You don’t want to cause your employees to become demotivated based on issues happening in the workplace but you should also want employees that are able to motivate themselves and… Read more»

knm7 replied to the topic "Why Do People Leave?" -

Fri, 21 Apr 2023 17:32:38 -0400

I think there is a combination of reasons that people leave companies but it really depends on the individual. Some people don’t mind having a lower compensation but the issue could be how management treats them and other employees or… Read more»

knm7 replied to the topic "Specifications: A double edged sword?" -

Thu, 13 Apr 2023 19:25:42 -0400

If you are creating specifications for a product, I think you should still take into account a range for the product that will be incorporated with your project. If you make the specifications too general, it can create confusion and… Read more»

knm7 replied to the topic "Vendor Decision" -

Thu, 13 Apr 2023 19:14:20 -0400

Having multiple vendors is always a good plan in case the main backup vendor can not fully their side of the contract. For this weeks simulation, I chose to only go with one alternative vendor as to save time on… Read more»

knm7 replied to the topic "Deadlines and SOP's" -

Thu, 13 Apr 2023 19:09:02 -0400

I don’t think reactive management is always a bad thing when it comes to deadlines. If the SOPs are able to help alleviate most of the problems, I think having some one review the SOPs that can delay the project… Read more»

knm7 replied to the topic "Personnel evaluation when succeeding project but delaying." -

Sun, 09 Apr 2023 22:02:47 -0400

I believe that sometimes bad planning could be a major issue in product developments and can lead to a lot of delays. Bad planning could be a number of issues such as not scheduling enough time for testing, or assigning… Read more»

knm7 replied to the topic "Different results from each test companies." -

Sun, 09 Apr 2023 21:55:46 -0400

If a product passes at one company and not at another, I think you need to investigate the practices at both companies. If there are some missing procedures in place or faulty data, this can cause major issues when it… Read more»

knm7 replied to the topic "Project manager responsibilities" -

Sun, 09 Apr 2023 13:43:50 -0400

Project management should definitely be more involved in every step. Since they are the one initiating the project, they need to understand every step that is occurring and observe certain steps to understand what is happening in the process. I… Read more»

knm7 replied to the topic "Managing a Hectic Workplace" -

Wed, 22 Mar 2023 02:32:49 -0400

I feel as a project manager, there should be some general understanding of what each group is doing and try to do some research in case a problem arises. I feel like doing meetings with certain individuals to give you… Read more»

knm7 replied to the topic "Project plans flexibility" -

Wed, 22 Mar 2023 02:23:39 -0400

I think that the schedule should be more flexible since you would have to adapt if any major delays arise or unexpected issues occur. Being flexible with the schedule is extremely important when it comes to projects because a lot… Read more»

knm7 replied to the topic "Project Manager's Authority for Monitoring and Controlling Projects" -

Wed, 22 Mar 2023 02:18:06 -0400

I think project managers have the right to change the project as long as it doesn’t change the entirety of the idea., If the change will cause a change in function or will exclude something major that the stakeholders were… Read more»

knm7 replied to the topic "Project manager priority" -

Fri, 10 Mar 2023 20:49:15 -0500

Ideally, there would be a balance of priorities between the shareholders and the project team but that normally doesn’t occur. In most situations, the stakeholders have most of the say especially with timeline so that they are able to get… Read more»

knm7 replied to the topic "Mapping- Gantt Chart" -

Wed, 08 Mar 2023 14:56:12 -0500

I definitely think Gantt charts are extremely important in the development of scheduling a project and the timeline from start to finish. This tool is also extremely helpful into creating deadlines for each department so that a finished product can… Read more»

knm7 replied to the topic "Time vs. Money" -

Wed, 08 Mar 2023 14:49:10 -0500

I agree with a lot of the previous comments stating that the time is more important than money. With some projects, making sure to take the time to do the proper testing and that there is enough data for the… Read more»

knm7 replied to the topic "Assessing & Evaluating Risks of a Medical Device" -

Thu, 02 Mar 2023 04:39:26 -0500

I would definitely try to compare the product to what is already on the market to get an idea of possible risks that could potentially be detrimental to my product. To assess any risks, research is key step. If you… Read more»

knm7 replied to the topic "Penalization for Going Over Budget and Time?" -

Thu, 02 Mar 2023 03:22:12 -0500

I don’t think anyone should be penalized for going over budget or past a deadline when related to a project. In the field, there are many times where upper management would go over budget with projects such as building additions… Read more»

knm7 replied to the topic "Problem with the Vendors" -

Thu, 02 Mar 2023 03:06:12 -0500

I agree with the previous posts on how a new vendor should be found. I definitely think that the vendor should be notified first to make sure that they are aware of the large influx of defective materials. If that… Read more»

knm7 replied to the topic "Project Slack Time" -

Sun, 19 Feb 2023 15:43:56 -0500

Slack time is extremely important to account for project members being sick, going on vacation, weekends, holidays, or possible delays. It extremely important especially when having complex projects related to medical devices as well as other fields of the medical… Read more»

knm7 replied to the topic "Revising a Gantt Chart" -

Sun, 19 Feb 2023 14:12:19 -0500

While listening to Dr.Simon’s lectures, he mentions that you have to take into account the work schedule of your employees, holidays, vacation time, and if your project members are working on multiple projects. When you don’t take these things into… Read more»

knm7 replied to the topic "Are Missed Milestones really Bad?" -

Sun, 19 Feb 2023 13:53:42 -0500

In my opinion, missing a milestone can either be detrimental or just a minor setback but it just depends on what milestone is missed. I would say if the milestone was some initial testing to see if there is any… Read more»

knm7 replied to the topic "Project Manager Changes" -

Fri, 17 Feb 2023 15:57:02 -0500

I think when a new project manager takes over there is a sort of tension between the employees and the project manager. Since they are new to the team, it is a little difficult to form relations with the employees… Read more»

knm7 replied to the topic "Difference in communication when working from home" -

Fri, 17 Feb 2023 15:30:56 -0500

During the pandemic, I was one of the employees at my company that had to continue working at the office. Yet sometimes this would cause issues because other parts of the company could work from home and it was difficult… Read more»

knm7 replied to the topic "Risk Management impact" -

Fri, 17 Feb 2023 15:23:09 -0500

Risks are normally considered to have a negative connotation due to the fact that it is always referred to as the possible hazards there are within a project or an action. Most companies will assess a lot of the risks… Read more»

knm7 replied to the topic "Leaders: Nature or Nurture?" -

Sun, 12 Feb 2023 20:07:06 -0500

I tend to think that there are no natural leaders but develop those abilities based on those around them and the experiences they face. In my opinion, they are nurtured to have these traits and are able to grow their… Read more»

knm7 replied to the topic "Experiments" -

Sun, 12 Feb 2023 19:35:13 -0500

When dealing with failures during testing, I believe that reviewing what went wrong, altering the testing procedure and keeping a level head is extremely important. Keeping a level head is extremely important in the field especially when failures happen because… Read more»

knm7 replied to the topic "Dividing the Workload" -

Sun, 12 Feb 2023 19:29:05 -0500

In my opinion, I tend to favor that each person has their own individual section than creating groups to divide up the work. In a group there always tends to be people that tend to carry more of the workload… Read more»

knm7 replied to the topic "Design Control Process" -

Wed, 01 Feb 2023 17:57:19 -0500

If I was able to ever be apart of the design control process, I would want to be apart of design verification. To me, design verification seems really interesting since its testing the design of the product. I think testing… Read more»

knm7 replied to the topic "Flaw in the design process" -

Wed, 01 Feb 2023 17:35:22 -0500

Even with the FDA regulations and procedures, I think there is always room for improvement but they do try to update the guidelines as more information comes out. Yet I think most of the responsibility should fall on the device… Read more»

knm7 replied to the topic "Design Verification Testing" -

Wed, 01 Feb 2023 17:21:22 -0500

As the previous posts have stated, the verification testing should have specifications that should be met with listed tolerances. Even how the product is made should be specified, such as machinery used, speeds, materials, and even the shape. The procedure… Read more»

knm7 replied to the topic "Roles of the Regulatory Department" -

Tue, 24 Jan 2023 19:37:31 -0500

Since I am more interested in research and testing, I would choose the product development phase. I feel like I would enjoy this part of the regulatory department because I would like to be more involved in how the product… Read more»

knm7 replied to the topic "FDA ethics" -

Mon, 23 Jan 2023 20:08:40 -0500

I know that the FDA has to do in-depth research to justify that use of toxic substances in small amounts but at the same time, I read many articles and saw that it wasn’t antifreeze but just a component that… Read more»

knm7 replied to the topic "Sizes of Project Teams" -

Mon, 23 Jan 2023 19:46:51 -0500

In my opinion, I don’t think that it is harder to get other group members to agree on final product decisions if there is open communication and everyone has a similar understanding. Even if group members come from different backgrounds,… Read more»

knm7 replied to the topic "Should Interpersonal skills be more valuable than technical skills?" -

Thu, 19 Jan 2023 20:16:51 -0500

Although I think interpersonal skills are extremely important within the engineering field, I feel like technical skills are just as important. In my opinion, 70% interpersonal skill has more of a meaning in saying that you need to use this… Read more»

knm7 replied to the topic "Project Deadlines" -

Thu, 19 Jan 2023 20:04:36 -0500

While I do agree that you need to set reasonable deadlines to make sure that individuals can meet them without rushing or overworking themselves, sometimes that isn’t very possible. Within my field of regenerative medicine, I have seen where engineers… Read more»

knm7 replied to the topic "How would you handle team conflict as a Project manager?" -

Thu, 19 Jan 2023 19:50:59 -0500

In my opinion, being a project manager means to not only have an in-depth knowledge of the project but also having an understanding of the employees that you are in charge of and working with. Sometimes there can be conflicts… Read more»