Medical Device Courses | ab2346 | Activity https://medicaldevicecourses.com/members/ab2346/activity/ Activity feed for ab2346. Fri, 24 Apr 2026 22:39:12 -0400 https://buddypress.org/?v= en-US 30 hourly 2 04f323dded8aa8c561893e0d6f3f46b5 ab2346 replied to the topic "Disconnect in rewarding motivation" - https://medicaldevicecourses.com/activity/p/18344/ Wed, 15 May 2019 21:47:29 -0400 A great part of a companies success is its employees. If a company only rewarded teams and not individuals, then all an employee has to do is seek to be in a very strong team. Essentially that employee wouldn’t have…   Read more»

]]> 29220cd1e2925b965ddbfb3b9b35bc78 ab2346 replied to the topic "Avoiding Tunnel Vision" - https://medicaldevicecourses.com/activity/p/18343/ Wed, 15 May 2019 21:47:29 -0400 I found that the best way to avoid this tunnel vision is to have thorough planning. Whenever starting a project, it is vital to examine all routes available. It is also important to explore each option individually and pick the…   Read more»

]]> 46230682c4e0f53a93469941e3ee21dc ab2346 replied to the topic "How was this class helpful" - https://medicaldevicecourses.com/activity/p/18342/ Wed, 15 May 2019 21:47:28 -0400 This class taught me a great deal. From the definition of a project, all the way to finalizing a project. I learned about risk assessment, about the project life cycle, about different departments and their roles. What was most intriguing…   Read more»

]]> 2aca6e31018b59d2ed279422416c6d5a ab2346 replied to the topic "How to make good relation with vendors" - https://medicaldevicecourses.com/activity/p/18292/ Wed, 15 May 2019 21:47:01 -0400 Establishing good relationships with vendors is critical to your company’s success. Without a strong relationship, you won’t be able to produce as much revenue as hoped for. Here are some tips to maintaining a good relationship with vendors: 1. Explain…   Read more»

]]> d15de89c3b782978ef28aefd5b995d13 ab2346 replied to the topic "Discussion Topic: Outsource vs. Insource the clinical trial" - https://medicaldevicecourses.com/activity/p/18291/ Wed, 15 May 2019 21:47:01 -0400 I agree with gingeranderson, a company should look at how much time, effort, and cost its going to take to in-source a clinical trial. They then should call a CRO and get a quote from it and compare the two….   Read more»

]]> ef2dd8fb6f7328ab084a4341aacf43ce ab2346 replied to the topic "Engineer vs. Manager" - https://medicaldevicecourses.com/activity/p/18290/ Wed, 15 May 2019 21:47:00 -0400 I would definitely pick an engineering role. This is because, engineering roles are a lot more interactive in terms of hands on projects and technical skills. An engineering role deals with the details and the analysis and everything that actually…   Read more»

]]> bfcc4f6e5c0a6f6660f69a88d23693a0 ab2346 replied to the topic "Changining staff" - https://medicaldevicecourses.com/activity/p/18218/ Wed, 15 May 2019 21:46:22 -0400 Filling a position of an employee that performed critical work for a project can be very challenging. This is especially because he/she is probably an expert in the tasks they perform for the project and know the most about whatever…   Read more»

]]> baf6412d0a3f5e94c01f4016eb9d3801 ab2346 replied to the topic "Deadlines and SOP's" - https://medicaldevicecourses.com/activity/p/18217/ Wed, 15 May 2019 21:46:22 -0400 I believe our company tackles this issue wisely. Each employee has a manager that practices reactive management. But each employee is assigned to a team and each team has a lead. That lead practices preventive management. This combination allows for…   Read more»

]]> 451d5ccd24dc996c8cfc4689d29d2559 ab2346 replied to the topic "Single Source/Dual Source" - https://medicaldevicecourses.com/activity/p/18216/ Wed, 15 May 2019 21:46:21 -0400 I don’t think that using the same supplier but a different coating would satisfy the dual source requirement. Using a different coating might not be as useful and productive because each coating has a different set of properties. These properties…   Read more»

]]> 54a21ba324a35131b59ff898b8dbe4ba ab2346 replied to the topic "planned value vs actual costs" - https://medicaldevicecourses.com/activity/p/18084/ Wed, 15 May 2019 21:45:16 -0400 In the monitoring and controlling phase, it is very important to keep track of unexpected growth. That growth can be in terms of monetary value. The project might go through a scope change that would require a larger sum of…   Read more»

]]> b3bddb2ffffcaf22d2a36c70d5f1cf61 ab2346 replied to the topic "Design Change Request" - https://medicaldevicecourses.com/activity/p/18080/ Wed, 15 May 2019 21:45:14 -0400 A change request at Lockheed Martin works in a very similar manner. First the person submitting the change request must log it on a special program and that program. That program will ask him a series of questions about the…   Read more»

]]> baafd4dab6624e4eabbad955aad94849 ab2346 replied to the topic "Estimating Project Timeline" - https://medicaldevicecourses.com/activity/p/18004/ Wed, 15 May 2019 21:44:33 -0400 We have a very efficient way of tackling this dilemma. Every two weeks each team sits in a room and looks through the work needed to be performed for the following two weeks. Based on this, we write tasks for…   Read more»

]]> 2a1c163eb395b94d308632961435dfeb ab2346 replied to the topic "Problem with the Vendors" - https://medicaldevicecourses.com/activity/p/18003/ Wed, 15 May 2019 21:44:32 -0400 The project manager should look at other vendors in a timely manner and contact them for a quote. He should also look at the all their track records and only contact the ones with a clean record. He could also…   Read more»

]]> 1fc5622f5b9e0a3755c7aa9cb6279c56 ab2346 replied to the topic "Meeting Deadlines with Research" - https://medicaldevicecourses.com/activity/p/17961/ Wed, 15 May 2019 21:44:11 -0400 To have the deliverables ready in time, as a manager, you need to take certain steps and plan ahead. First you need to be a very organized and communicative manager. You need to set deadlines, communicate with the different teams…   Read more»

]]> 9a11230c200f836d3894f389adba044f ab2346 replied to the topic "Most Important Phase" - https://medicaldevicecourses.com/activity/p/17938/ Wed, 15 May 2019 21:44:00 -0400 I would have to agree that the most important phase is the planning phase. It is what the other phases ride off of. In the planning phase, the project blooms. It is defined. In my company, during the planning phase,…   Read more»

]]> bad96ed26ec63b4670cd82569ab5a33c ab2346 replied to the topic "Overlapping activities" - https://medicaldevicecourses.com/activity/p/17937/ Wed, 15 May 2019 21:44:00 -0400 The planning phase in our company is crucial for any project. This is because the projects we take on are government funded projects and any mistake in the planning phase would risk us losing the entire project. This is why…   Read more»

]]> 0468ac66001f99079c2c1c22bf930ab4 ab2346 replied to the topic "Importance of Logging Work" - https://medicaldevicecourses.com/activity/p/17933/ Wed, 15 May 2019 21:43:58 -0400 Logging work is beyond important. In my company, we also write a lot of scripts so it’s very helpful to keep documentation on how to use each script. We also have to keep track of certain things we tested and…   Read more»

]]> 2ce35f0757c26078eb6ba5ac9e718066 ab2346 replied to the topic "Factors to look for while evaluating change request" - https://medicaldevicecourses.com/activity/p/17887/ Wed, 15 May 2019 21:43:34 -0400 The first thing that should be done when looking at change requests is the reason behind them. We receive a lot of change requests on projects we work on. Some of these requests are unnecessary because one parameter was overlooked…   Read more»

]]> fae8e5080a147ae22a0c00c08911c1d4 ab2346 replied to the topic "Communication and Responsiveness" - https://medicaldevicecourses.com/activity/p/17886/ Wed, 15 May 2019 21:43:34 -0400 I had a coworker that worked in the company for 14 years. Since the day I started working, she did nothing the entire time but talk to other coworkers and sit on her phone. She had no communication and wasn’t…   Read more»

]]> 13ef2c719734323fdf6c1e0335c8a639 ab2346 replied to the topic "Challenges PM face" - https://medicaldevicecourses.com/activity/p/17885/ Wed, 15 May 2019 21:43:33 -0400 Within my company, project managers go through numerous challenges. Some of the main challenges are communication, managing styles and organization. Communication is usually the main problem a project manager runs into. A project manager usually has to communicate across multiple…   Read more»

]]> 97709275f782b239ee4504959d33dcff ab2346 replied to the topic "Planning Phase" - https://medicaldevicecourses.com/activity/p/17776/ Wed, 15 May 2019 21:42:33 -0400 In the planning phase of a medical device, some more aspects that should be discussed are: stakeholders, roles and responsibilities, scope, schedule and cost, management plan, staffing plan, quality and risk. These are some very important terms to discuss in…   Read more»

]]> c93b30c8c8d55f4cd253af9a6256dfcb ab2346 replied to the topic "Unexpected Time Delays - miniSim" - https://medicaldevicecourses.com/activity/p/17775/ Wed, 15 May 2019 21:42:32 -0400 Delays in a project can be a major factor for the failure of it. There are multiple solutions around this however. The solutions are specific to what the time delays are caused by. But in general, most unexpected delays can…   Read more»

]]> cb35b3e5cb896dc305ddbb606e30b8d7 ab2346 replied to the topic "Risk Management Team" - https://medicaldevicecourses.com/activity/p/17774/ Wed, 15 May 2019 21:42:32 -0400 If a manager or team member has a personal connection to the project, and that project looks like it will not succeed, it can be very challenging to pull it off. If a risk management team decides that a project…   Read more»

]]> edefa094743396789f5a8d70499fcbb2 ab2346 replied to the topic "Experiments" - https://medicaldevicecourses.com/activity/p/17688/ Wed, 15 May 2019 21:41:47 -0400 I believe the most effective method for resolving an experiment failure is more testing. This gives you the opportunity to try out different parameters and see their interactions. It will become clear down the line which ones have the highest…   Read more»

]]> b694fb57f3f1a3413772b80f7bef45ee ab2346 replied to the topic "Determining project priority" - https://medicaldevicecourses.com/activity/p/17687/ Wed, 15 May 2019 21:41:46 -0400 I believe that in the case of prioritizing projects, a company shouldn’t move everyone from one project to the next according to prioritization. But they should decrease the number of employees working on a low priority project. The projects themselves…   Read more»

]]> 021753f6d7a1e60802d37224d2af1902 ab2346 replied to the topic "Design Review Meeting" - https://medicaldevicecourses.com/activity/p/17685/ Wed, 15 May 2019 21:41:45 -0400 I think the best way to get fast approval from the committee at the design review meetings is to present the proper material and hold them at the right times. For example, a design review should occur with each step…   Read more»

]]> 6fb191659893fcf51614a328f1c2151c ab2346 replied to the topic "Pros and Cons of the 3 Organizational Structures" - https://medicaldevicecourses.com/activity/p/17603/ Wed, 15 May 2019 21:40:59 -0400 I would personally pick matrix organization. This is because it incorporates more of the team aspect. Teams get a bigger say in the project and the outcome than managers and functional heads. The problem with matrix organization is that it…   Read more»

]]> cc2eab25fcfb5f66c847af7b8d163a8b ab2346 replied to the topic "Your Ideas about How to prepare/write a Successful Project Proposal" - https://medicaldevicecourses.com/activity/p/17602/ Wed, 15 May 2019 21:40:58 -0400 Writing a successful project proposal can be very tedious. This is because, you have to deliver something that might seem ingenious to you to others and have them see the same thing you see. To do so, I believe you…   Read more»

]]> 9e44861391cb3c0019b16deb10e21958 ab2346 replied to the topic "Best timing for validation and verification" - https://medicaldevicecourses.com/activity/p/17601/ Wed, 15 May 2019 21:40:58 -0400 I first want to emphasize what the difference between verification and validation is. Verification is intended to check if the product meets the design specifications. Validation is intended to ensure that the product meets the operational needs of the user….   Read more»

]]> 5092076f135f9b9eba0b88c9c2d19c53 ab2346 replied to the topic "Safety Recalls" - https://medicaldevicecourses.com/activity/p/17587/ Wed, 15 May 2019 21:40:51 -0400 Part of the FDA requirements is that labels and markings have to be correctly placed on the device. They have to be visible and clear for the user. If they’re not, then they’re breaking FDA compliance and must order a…   Read more»

]]> 0651d9442d5bb41b59551c9acfba987e ab2346 replied to the topic "Project Manager Skills" - https://medicaldevicecourses.com/activity/p/17586/ Wed, 15 May 2019 21:40:50 -0400 If I had to pick one skill a manager has to have to be successful, I would pick interpersonal skills. I’ve dealt with plenty of managers over the years. Only one stood out. This one is in the company I…   Read more»

]]> a4bfb214f50a9a117a827a568960824f ab2346 replied to the topic "Funding in Medical Devices Industry" - https://medicaldevicecourses.com/activity/p/17585/ Wed, 15 May 2019 21:40:50 -0400 I used to work in a the Department of Veterans Affairs in a group called War Related Illness and Injury Study Center (WRIISC). This group has a couple of biomedical engineers that make medical devices and test them on veterans….   Read more»

]]> 3c3ce34938c3173f8e6ccb5dcea83bad ab2346 replied to the topic "Interpersonal skills vs technical knowledge" - https://medicaldevicecourses.com/activity/p/17584/ Wed, 15 May 2019 21:40:49 -0400 I believe that technical knowledge in many cases is useless without interpersonal skills. For example, we have a saying at work that says, “A well performed analysis poorly communicated is a failure.” This means that no matter how much knowledge…   Read more»

]]> 9d405b73bd7e595b6f1c6f6bd4e7de0d ab2346 replied to the topic "Initiating a Project Idea" - https://medicaldevicecourses.com/activity/p/17583/ Wed, 15 May 2019 21:40:49 -0400 When you go to write an essay, the introduction is the hardest part. But the introduction is literally the most important part because it will present a layout for the rest of the essay. Initiating a project idea is like…   Read more»

]]> a274d9d88647f892431c665c22f44453 ab2346 replied to the topic "Flaw in the design process" - https://medicaldevicecourses.com/activity/p/17582/ Wed, 15 May 2019 21:40:48 -0400 A flaw in any design process can be detrimental. It could hold up work to be done for months or even worse, produce wrong results. To prevent this from happening, companies must test their devices repeatedly using different parameters to…   Read more»

]]> dccce1aa7784ee6a05f1cbadcdda51c4 ab2346 posted a new topic "Scope Growth" - https://medicaldevicecourses.com/activity/p/10800/ Wed, 15 May 2019 16:36:36 -0400 This week’s lecture slightly touched on scope growth and how it is one thing to watch out for as part of the monitoring and controlling phase. This is usually a very hard thing to monitor in big companies because of…   Read more»

]]> d49943d2754a29e8abcdea627b0ee7a6 ab2346 replied to the topic Disconnect in rewarding motivation in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10259/ Sun, 05 May 2019 22:56:14 -0400 A great part of a companies success is its employees. If a company only rewarded teams and not individuals, then all an employee has to do is seek to be in a very strong team. Essentially that employee wouldn’t have to do any work. That’s just one thought. It’s also important to reward individuals in order to create this sense of competition, even…[Read more]

]]> 0 6d5e25d284df6d39eda2190a456a31d5 ab2346 replied to the topic Avoiding Tunnel Vision in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10258/ Sun, 05 May 2019 22:44:14 -0400 I found that the best way to avoid this tunnel vision is to have thorough planning. Whenever starting a project, it is vital to examine all routes available. It is also important to explore each option individually and pick the one that is most suited for you while having the others in your back pocket. It is sometimes easy to view all your…[Read more]

]]> 0 855ca618845408f9be6b2ca2def3b463 ab2346 replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10257/ Sun, 05 May 2019 22:36:02 -0400 This class taught me a great deal. From the definition of a project, all the way to finalizing a project. I learned about risk assessment, about the project life cycle, about different departments and their roles. What was most intriguing about this course were the simulations. They allowed us to take all the material we were learning in lecture…[Read more]

]]> 0 d5f459f6d1fe93bb00b6a9113ad3640a ab2346 replied to the topic How to make good relation with vendors in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10204/ Mon, 29 Apr 2019 03:19:29 -0400 Establishing good relationships with vendors is critical to your company’s success. Without a strong relationship, you won’t be able to produce as much revenue as hoped for.

Here are some tips to maintaining a good relationship with vendors:

1. Explain to them your business goals: when a vendor understands how important customer service is to…[Read more]

]]> 0 db6b7e7a95e4ea94a60c082710d45ee8 ab2346 replied to the topic Discussion Topic: Outsource vs. Insource the clinical trial in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10203/ Mon, 29 Apr 2019 03:12:27 -0400 I agree with gingeranderson, a company should look at how much time, effort, and cost its going to take to in-source a clinical trial. They then should call a CRO and get a quote from it and compare the two. I believe that in most cases, unless a company has some type of previous experience with clinical trials, it should hire a CRO. These…[Read more]

]]> 0 4e1de496899f9d193a210a611ae716b8 ab2346 replied to the topic Engineer vs. Manager in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10202/ Mon, 29 Apr 2019 03:04:05 -0400 I would definitely pick an engineering role. This is because, engineering roles are a lot more interactive in terms of hands on projects and technical skills. An engineering role deals with the details and the analysis and everything that actually gets put into a project, while a manager only directs and sees the outcome. The best part about an…[Read more]

]]> 0 d339e217836718c08e682f128d0c3a1d ab2346 replied to the topic Changining staff in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/10129/ Mon, 22 Apr 2019 02:41:42 -0400 Filling a position of an employee that performed critical work for a project can be very challenging. This is especially because he/she is probably an expert in the tasks they perform for the project and know the most about whatever they’re doing. A solution could be trying to find someone on their same team that can take on the work they have b…[Read more]

]]> 0 3315154f6df9b47253e875224731a1f8 ab2346 replied to the topic Deadlines and SOP's in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/10128/ Mon, 22 Apr 2019 02:40:47 -0400 I believe our company tackles this issue wisely. Each employee has a manager that practices reactive management. But each employee is assigned to a team and each team has a lead. That lead practices preventive management. This combination allows for the good in each style of management to be used and the outcome is a smooth and complete work…[Read more]

]]> 0 572f42797d8aa6ae38e2df9f9c986acb ab2346 replied to the topic Single Source/Dual Source in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/10127/ Mon, 22 Apr 2019 02:39:12 -0400 I don’t think that using the same supplier but a different coating would satisfy the dual source requirement. Using a different coating might not be as useful and productive because each coating has a different set of properties. These properties dictate the behavior of the coating over time. They might last a different amount of years, be used f…[Read more]

]]> 0 b450f7aeafc6996b912db80b660c937a ab2346 replied to the topic planned value vs actual costs in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9992/ Mon, 01 Apr 2019 03:23:23 -0400 In the monitoring and controlling phase, it is very important to keep track of unexpected growth. That growth can be in terms of monetary value. The project might go through a scope change that would require a larger sum of money to complete. The monitoring and controlling phase helps keep track of those scope changes and those planned and actual…[Read more]

]]> 0 83dc9b0167db04b578a8280ca052e48c ab2346 replied to the topic Design Change Request in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9988/ Mon, 01 Apr 2019 02:50:48 -0400 A change request at Lockheed Martin works in a very similar manner. First the person submitting the change request must log it on a special program and that program. That program will ask him a series of questions about the change like why is it being made and how important it is and if it’s a flaw or an enhancement. Then that program provides the…[Read more]

]]> 0 e72007324623d738fe47f2c93569875a ab2346 started the topic Scope Growth in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9986/ Mon, 01 Apr 2019 02:43:07 -0400 This week’s lecture slightly touched on scope growth and how it is one thing to watch out for as part of the monitoring and controlling phase. This is usually a very hard thing to monitor in big companies because of how many employees might be involved. For example, at Lockheed Martin, my team of about ten employees usually works on about 2 or 3…[Read more]

]]> 0 922169d5ba8759f1ea4f2509110b5ce5 ab2346 replied to the topic Estimating Project Timeline in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9906/ Mon, 18 Mar 2019 01:57:28 -0400 We have a very efficient way of tackling this dilemma. Every two weeks each team sits in a room and looks through the work needed to be performed for the following two weeks. Based on this, we write tasks for about 45 minutes to an hour. Then, after everyone is done writing their tasks, we discuss them one by one. We give an hour estimate to how…[Read more]

]]> 0 abfc3c91cc9786329a8b8e400a101599 ab2346 replied to the topic Problem with the Vendors in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9905/ Mon, 18 Mar 2019 01:47:41 -0400 The project manager should look at other vendors in a timely manner and contact them for a quote. He should also look at the all their track records and only contact the ones with a clean record. He could also host a meeting with project team members and ask their thoughts. He could host a vote amongst members. One of the most important things is…[Read more]

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