https://medicaldevicecourses.com/members/ka234/activity/ Activity feed for ka234. Fri, 24 Apr 2026 16:55:57 -0400 https://buddypress.org/?v= en-US 30 hourly 2 c863ccd8fee2863f1b47da6bf8226eac https://medicaldevicecourses.com/activity/p/20019/ Sun, 03 May 2020 17:21:40 -0400 It has to be fear, insecurity, and/or peer pressure. Companies should not expect their employees to work over 40 hours a week if they are salaried employees. If they can earn overtime, that’s a different story. Sure, a few weeks…   Read more»

]]> 233148e214dc3fcab8c5f8e6179c0c6e https://medicaldevicecourses.com/activity/p/20018/ Sun, 03 May 2020 17:10:46 -0400 People will leave when they don’t feel valued. Being “valued” has many different definitions to different people. Some people determine their value based on their income, amount of recognition, type of projects they are given, how well their ideas are…   Read more»

]]> c1e718c67901f5d3b9cbfed721ff5978 https://medicaldevicecourses.com/activity/p/20017/ Sun, 03 May 2020 17:05:26 -0400 Something I learned in this class is that a PM is ultimately responsible for everything related to the project. While they may not have to do everything, i.e they can delegate to Subject Matter Experts, they are still the face…   Read more»

]]> 22741d7804968d170f72e79dfdb2129e https://medicaldevicecourses.com/activity/p/19873/ Thu, 16 Apr 2020 00:33:42 -0400 Posted by: @manolo Dr. Simon touched upon Design Review Meetings. He gave a strategy of sending documents to the expected attendees ahead of time in order to get a faster approval. Is there any other way that you can think…   Read more»

]]> 06cfb872cdc4d8d4a0b6cbbc08947621 https://medicaldevicecourses.com/activity/p/19872/ Thu, 16 Apr 2020 00:23:48 -0400 A big portion of being a PM is following up with people to regarding the status of action items. While this can be done via phone or email, the most effective way to get an answer (and quickly) is to…   Read more»

]]> c19ae4a5f9551292bd0444bcef6c0c40 https://medicaldevicecourses.com/activity/p/19871/ Thu, 16 Apr 2020 00:16:20 -0400 Posted by: @djr32 For my capstone, we had one main project of developing a mobile application. However, within this one project, we had different mini projects which were put together at the end to become one mobile application. One project…   Read more»

]]> 241afeb93e80646f89cbf7b828674191 https://medicaldevicecourses.com/activity/p/19869/ Thu, 16 Apr 2020 00:08:38 -0400 Posted by: @amin-sadig As many of us know, there is a lot of paperwork involved in most processes within projects whether it is for monitoring or documentation purposes and individual companies have different Quality Management Systems. While it is easy…   Read more»

]]> 09471b31b2684862c68bec940af37935 https://medicaldevicecourses.com/activity/p/19867/ Thu, 16 Apr 2020 00:02:51 -0400 @srg36 is correct. Single source is a little risky, but it is a necessary evil while launching a new product to market. The project team does not have enough time to on board a secondary source in most projects. To…   Read more»

]]> 02823aab7c6e0d39be4e1828228adffd https://medicaldevicecourses.com/activity/p/19766/ Sun, 29 Mar 2020 16:27:48 -0400 Personally, the biggest challenge that a PM faces is baby sitting people. People have different priorities, this is the exact reason that a PM is needed. If the project team members understood the priorities of a project, everything would flow…   Read more»

]]> d66a4ad06b3cf5ebeb2e44265f6cb70d https://medicaldevicecourses.com/activity/p/19765/ Sun, 29 Mar 2020 16:22:35 -0400 @jp582 All your points are valid. However, I’ve been in many situations where we are presenting the overall project ghant chart to the customer/management, and almost immediately the first question is “How can we reduce the project timeline?”. The time…   Read more»

]]> 72fbfc1b5780aa89309d1cda17b952ff https://medicaldevicecourses.com/activity/p/19764/ Sun, 29 Mar 2020 16:14:50 -0400 @ajm73 I definitely agree with you that the project team should just focus on the initial project at hand. Unfortunately, that is hard to do, especially for projects that are driven by the customer. I work in a 3rd party…   Read more»

]]> c4e527b46dd2f8b88164609eb1e60499 https://medicaldevicecourses.com/activity/p/19571/ Mon, 24 Feb 2020 00:43:18 -0500 After looking through the FDA’s guidance on Software as a Medical Device (SaMD), which is detailed more simply on this FDA page https://www.fda.gov/medical-devices/digital-health/device-software-functions-including-mobile-medical-applications#e, its clear the FDA is being very tentative about its approval process. From the sheer size of…   Read…[Read more]

]]> 17bd0b9e3910f6df21bc9260bca84f41 https://medicaldevicecourses.com/activity/p/19569/ Sun, 23 Feb 2020 23:59:02 -0500 Initiating projects is getting buy-in from others by balancing research and taking a strong lead in my experience. In contrast to what others have said in this thread, initiating a project isn’t necessarily the very beginning of one. Many times,…   Read more»

]]> f6f2ff7b9eef761a11abc34163d14c5c https://medicaldevicecourses.com/activity/p/19568/ Sun, 23 Feb 2020 23:35:24 -0500 When I saw the first post in the thread, the device that popped into my head was the LifeAlert device that are typically used by seniors to get immediate medical assistance in the instance of an emergency when living independently. …   Read more»

]]> d67b2498b631016db6f2568c36f0b3f4 https://medicaldevicecourses.com/activity/p/19567/ Sun, 23 Feb 2020 22:36:20 -0500 Posted by: @rjs84 According to Daniel Goleman, success can be broken down to be 70% interpersonal skills and 30% technical knowledge. The idea of this balance being in favor of interpersonal skills is not what I am questioning. A Forbes…   Read more»

]]> bb9d5ab53fa39b6d0731ae29d7382e5d https://medicaldevicecourses.com/activity/p/19566/ Sun, 23 Feb 2020 22:34:47 -0500 Posted by: @rjs84 According to Daniel Goleman, success can be broken down to be 70% interpersonal skills and 30% technical knowledge. The idea of this balance being in favor of interpersonal skills is not what I am questioning. A Forbes…   Read more»

]]> 9623c2d6f5461a3da1a7cb0e7c85c34f https://medicaldevicecourses.com/activity/p/19564/ Sun, 23 Feb 2020 21:52:04 -0500 In my experience, a great way to avoid repeated mistakes on company projects as a whole is strategic team building. When managers staff the different phases in projects, it’s important that they pull a diverse group of people from various…   Read more»

]]> 96ca0ceef9dd8609f1356d053902a845 https://medicaldevicecourses.com/activity/p/19426/ Sun, 09 Feb 2020 00:34:29 -0500 Communication is the key to being successful in the medical device industry. Of course, you also need to be technically competent, but interpersonal/communication/management skills with a technical basis is arguably more powerful. If you have a high technical competency and…   Read more»

]]> bbbbbde0a19d25f7d8da9f94cdb944f3 https://medicaldevicecourses.com/activity/p/19425/ Sun, 09 Feb 2020 00:13:34 -0500 Interpersonal skills are a necessary for a project manager to be effective and for them to move their career forward. Being extroverted or introverted doesn’t matter as much as able to communicate and connect with people in order to get…   Read more»

]]> b99b7613f47972a8cdaab5b00dbb49b0 https://medicaldevicecourses.com/activity/p/19424/ Sat, 08 Feb 2020 23:20:07 -0500 International/multicultural project teams can be difficult for a lot of reasons. In my experience, the hardest part is accountability. Various things already spoken go into this, like time zones, cultural differences, communication barriers and etc. I’ve managed projects where we’ve…   Read more»

]]> 4ffeaecc33bca354b8cb555038a9bbd4 https://medicaldevicecourses.com/activity/p/19389/ Tue, 04 Feb 2020 23:50:17 -0500 As someone that currently works in a Medical Device company, I think Global Regulation of Med Devices is something that will happen in this lifetime. The reason I say that is because of money!  If China is able to manufacture…   Read more»

]]> 3044fa63d4d51e4f543a191ea065137b https://medicaldevicecourses.com/activity/p/19388/ Tue, 04 Feb 2020 22:47:55 -0500 I think the most important step in resolving experimental failure is to make sure that the team doesn’t feel like they will get blamed. Human nature is to protect yourself! Once the team understands that a failed experiment doesn’t mean…   Read more»

]]> 271228174860844061c04524d511502c https://medicaldevicecourses.com/activity/p/19387/ Tue, 04 Feb 2020 22:26:44 -0500 As someone who was just a project manager (and hated it), my advise would be “Don’t feel like you are bugging people when you are following up.” People have different priorities, and in my opinion it is the PM’s job…   Read more»

]]> a3bd090038b6d3d6d04fe0392d6b9a30 https://medicaldevicecourses.com/activity/p/19386/ Tue, 04 Feb 2020 22:13:29 -0500 While general wellness products claims are not always reviewed by the FDA (and can be risky), I still think the benefit outweighs the risk. The companies that advertise these products understand the liability of the products they advertise. They undoubtedly…   Read more»

]]> abf2faac95cce04120bc39abcc745d7e https://medicaldevicecourses.com/activity/p/19349/ Sat, 01 Feb 2020 19:36:35 -0500 I currently work at Micro Stamping Corp in Somerset, NJ. We are primarily a project based organization. All project are run through the Steering Committee. One a week, all project managers/leaders report the project status, critical path, and risks to…   Read more»

]]> 9a8645175d899fdbc9319e9a5be254f2 https://medicaldevicecourses.com/activity/p/19348/ Sat, 01 Feb 2020 19:33:23 -0500 To me, an ideal project team is dependent on the project. Some projects, i.e those strictly technical in nature, can be successfully accomplished with 4 PHD members who are super genesis and 1 project manager who can communicate the essential…   Read more»

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