https://medicaldevicecourses.com/members/kc4310/activity/ Activity feed for kc4310. Sat, 25 Apr 2026 02:21:41 -0400 https://buddypress.org/?v= en-US 30 hourly 2 094106d7a210d47c02a26c09c9f9c6b9 https://medicaldevicecourses.com/activity/p/22711/ Mon, 21 Jun 2021 03:15:52 -0400 I too agree with the comments above.  The probability of occurrence and the severity of the risk drive the risk values.  The occurrence can be frequent, infrequent or occasional, and the severity can be severe, significant or minor.  These factors…   Read more»

]]> 4d17e3b410c9f8a5d3b6c163dbe7470f https://medicaldevicecourses.com/activity/p/22706/ Mon, 21 Jun 2021 03:04:17 -0400 Changing design may be cost prohibitive , but sometimes it has to be done, even if it cause financial stress for a company.  The alternative is negligence, which can lead to criminal investigations or product liability. Product liability is the failure…   Read more»

]]> 3a3b4ccb908ee8418c49212b7348eff9 https://medicaldevicecourses.com/activity/p/22703/ Mon, 21 Jun 2021 02:20:20 -0400 My time tested risk management tool has been brainstorming with a SWOT analysis mind-set.  The ability to approach brainstorming honestly and to empathize with the perspective of a customer will allow non-obvious ideas and conflicts to surface and to be…   Read more»

]]> 9ca26832f6a1c8eda77c19e53bed1f28 https://medicaldevicecourses.com/activity/p/22702/ Mon, 21 Jun 2021 02:19:37 -0400 My time tested risk management tool has been brainstorming with a SWOT analysis mind-set.  The ability to approach brainstorming honestly and to empathize with the perspective of a customer will allow non-obvious ideas and conflicts to surface and to be…   Read more»

]]> 2139ec61c28bab1e1e046bdbf6229f75 https://medicaldevicecourses.com/activity/p/22617/ Mon, 07 Jun 2021 03:12:10 -0400 Your question has a lot of depth.  As accepting clinical trials “as is” is easy because they have always been done a certain way.  It is easy to also conclude that it must be okay because patients provide consent.   The…   Read more»

]]> 5b3e116684b33d5c7e33c0b5bbce72d0 https://medicaldevicecourses.com/activity/p/22614/ Mon, 07 Jun 2021 02:59:59 -0400 @alexandrabuga Great topic, a nice contrast to typical posts.  I do believe that Henretta lics heirs were ultimately compensated – largely due the pubic cries of “foul”, which I believe appropriate.  You made some interesting points; I am ignorant to…   Read more»

]]> 3934de0edbef7bcb67c6251fa612157f https://medicaldevicecourses.com/activity/p/22605/ Mon, 07 Jun 2021 00:06:24 -0400 @amd29, I think you’re suggesting the multi-billion dollar pharmaceutical industry has little value?  Which I would like to agree, but there is strong evidence to suggest otherwise.  Pharmaceuticals provide a host of benefits for disastrous conditions of human health -…   Read more»

]]> 63105399e23918af341e449a5a3c2dcc https://medicaldevicecourses.com/activity/p/22577/ Mon, 31 May 2021 03:36:52 -0400 Yes, I will consider having a partner.  Having a partner can be a great thing.  Therefore, you must consider what you’re will to trade off.  It is very important to have it all.  Having a partner also spreads the risk. …   Read more»

]]> b7c9b987f75d5b9e6799af95cf0aed2e https://medicaldevicecourses.com/activity/p/22576/ Mon, 31 May 2021 03:30:00 -0400 Medtronic and Boston Scientific are c-corps because they are publicly traded companies with thousands of shareholders.  S-corps are really tough to give an example because they are not created with the same goals of C-corps.  C-corps experience a double tax…   Read more»

]]> bfa785e4be6d2e122022d9e3f295785c https://medicaldevicecourses.com/activity/p/22533/ Mon, 24 May 2021 03:59:00 -0400 The merit is very limited, and you actually make a really good point.  At a minimum, there should be a “time-out” period where comparison to products over a certain age are disallowed.  Medical innovation is happening so fast.  From the…   Read more»

]]> 31c857cdd82a238a5f9e7c0c779f61cf https://medicaldevicecourses.com/activity/p/22532/ Mon, 24 May 2021 03:54:25 -0400 I think the quality department can become to preoccupied with finding problems, which is not hard to do for any product.  Therefore, a collaborative environment must exist so that if problems are located, proper guidance is offered to product managers. …   Read more»

]]> 434a8f228a2b23e2f80056f620dfed38 https://medicaldevicecourses.com/activity/p/22530/ Mon, 24 May 2021 03:47:06 -0400 On occasion, I passively thought the two roles were the same.  Until I had opportunity to do QC.  There is a clear delineation between the two.  QA sets the policy and framework, while QC ensures its implementation and execution.  Both…   Read more»

]]> 1358cd342790749352ab85c754216572 https://medicaldevicecourses.com/activity/p/22493/ Mon, 17 May 2021 03:59:56 -0400 If you select polymers then you will certainly need implantation, genotoxicity, system toxicity, irritation, sensitization, and cytotoxicity test.  Test like these are provided by many companies, and the delivery time can vary.  Therefore, as the project manager you have to…   Read more»

]]> 084048ab35e28e02bc0ecd61152d0019 https://medicaldevicecourses.com/activity/p/22481/ Mon, 17 May 2021 01:05:50 -0400 Both leave a legacy, but I tend to agree that I rather see the impact now.  Still, who’s to say that my research activity will not foster future research, as most science builds upon the work of previous others.  Consider…   Read more»

]]> bbe73fe80ed94ca175a4892032d8a7a2 https://medicaldevicecourses.com/activity/p/22480/ Mon, 17 May 2021 00:55:43 -0400 @merzkrashed great feedback.  Are you a product manager?  Some years ago I had the unfortunate experience of being apart of a product launch that was missing the product manager… I’m still not sure how that was supposed to work.  Needless…   Read more»

]]> 97fb096292bfcc89fd1d157c7ad6cc78 https://medicaldevicecourses.com/activity/p/22479/ Sun, 16 May 2021 22:06:15 -0400 @merzkrashed great feedback.  Are you a product manager?  Some years ago I had the unfortunate experience of being apart of a product launch that was missing the product manager… I’m still not sure how that was supposed to work.  Needless…   Read more»

]]> 56f6923ff6189165a34ac2362d961ab1 https://medicaldevicecourses.com/activity/p/22181/ Mon, 19 Apr 2021 03:07:39 -0400 The planning phase has enormous value to the success of a project. It determine its trajectory.  However, often times the surprises don’t happen until you execute.  Therefore, execution is the more important phase.  It is when all the work happens. …   Read more»

]]> d46a5077188466425f9fc1d355d9336c https://medicaldevicecourses.com/activity/p/22178/ Mon, 19 Apr 2021 02:58:18 -0400 I agree!  Specifically, the selection of vendors is critical.  This is especially true if the vendor is spread too thin, or they do not have capacity.   A recent article I read that assessed the success and failure of information technology…   Read more»

]]> fa4bcf4c3f2143c1c06df3b98d00e1fe https://medicaldevicecourses.com/activity/p/22172/ Mon, 19 Apr 2021 01:57:34 -0400 The change request log has definite importance, but the change request meeting is probably more significant.  Often it is very difficult to articulate a change request in text form – unless it is something simple – but anything requiring a…   Read more»

]]> df8760f9f847065fcf2a99869858482a https://medicaldevicecourses.com/activity/p/21980/ Mon, 05 Apr 2021 02:16:48 -0400 My favorite project is when I hired a software programmer to build a software app and he was on budget.  My worst was the programmer I hired before the successful programmer.  He was a habitual liar, and essentially, the lies…   Read more»

]]> a8ba6037f84c8d7cc49bda26cfbb1fdb https://medicaldevicecourses.com/activity/p/21978/ Mon, 05 Apr 2021 01:53:46 -0400 The communication challenges described in this question’s scenario are reflective of challenges within the culture of the company, or lack thereof.  A good HR business partner will be a solid remedy to provide influence external to the project.  Therefore, the…   Read more»

]]> 8fa5d604b99cb7733b1f71893a9ee15f https://medicaldevicecourses.com/activity/p/21967/ Sun, 04 Apr 2021 20:25:53 -0400 For all the clichés regarding how important it is to plan, perhaps the most famous being: “Measure twice and cut once”, I cannot recall the cliché that says be ready for the surprise.  Actually, it may be Murphy’s Law.  Hence…   Read more»

]]> 7884f41eccf5646aee127a85b317c7e9 https://medicaldevicecourses.com/activity/p/21827/ Sun, 21 Mar 2021 23:41:41 -0400 Upon graduating from college, my first professional job was working in a project-based organization.  I had one main boss, and a second leader who wanted to be both my boss and everyone else’s.  In hindsight, the two of them served…   Read more»

]]> 951d11fc401fa0a688ccff164ae25a0e https://medicaldevicecourses.com/activity/p/21826/ Sun, 21 Mar 2021 22:51:44 -0400 Competency is completely different from personality.  Competency can be taught.  Personality is innate.  In fact, approximately 15 years ago I sold personality assessment tools as a part of a larger solution.  Hence I’m not surprised to hear many organizations still…   Read more»

]]> 4bf5176275c2ae2a4638e6e99e51b692 https://medicaldevicecourses.com/activity/p/21808/ Sat, 20 Mar 2021 01:23:45 -0400 Typically, the overlap between the product and project lifecycle is the development phase of the product.  Within the development phase of the product, which is generally followed by the introduction, growth, maturity, and decline phases, you can have the full…   Read more»

]]> 3e23145714628e80eaa86e1d7ada601b https://medicaldevicecourses.com/activity/p/21759/ Mon, 15 Mar 2021 02:07:01 -0400 Thanks wms7 for this explanation.  I’m new to the project management of a medical device.  The office of combination products seems makes so much sense.  As proper assignment seems to be hardest question to answer for a combination device.  I’m…   Read more»

]]> 2e7214b43a73b1589b04929bd55b3f97 https://medicaldevicecourses.com/activity/p/21755/ Mon, 15 Mar 2021 01:46:31 -0400 For a new PM, my advice is to plan around other stakeholder’s ideas when feasible – especially when they are the customer.  Specifically, go beyond a conversation and request stakeholders to write-up their expectations.  PM’s should include stakeholders ideas in…   Read more»

]]> 31b37c07a155b3b305984116a592c74f https://medicaldevicecourses.com/activity/p/21648/ Sat, 13 Mar 2021 15:00:05 -0500 The impact of an organization type on efficiency of a project is highly dictated by organization culture and size.  We are all familiar with the phrase: “we’ll it’s always been that way,” and generally this is the case because of…   Read more»

]]> c63c4785d9f19c3a6666ad45b0210501 https://medicaldevicecourses.com/activity/p/21555/ Mon, 08 Mar 2021 00:04:38 -0500 I believe that consistency is the most important soft skill that a project manager needs.  Consistency is so important because it stretches a variety of domains.  From the day-to-day work product employees must deliver to the necessity of management to…   Read more»

]]> d81d07b937e301d4ad3f33581e20ca9f https://medicaldevicecourses.com/activity/p/21553/ Sun, 07 Mar 2021 23:20:14 -0500 I am a 6’4” Athletically built African American man, and as such, I must constantly evaluate my emotional intelligence during project management engagements.  Job #1 is often ensuring “others” are comfortable by my presence – for all those reasons citizens…   Read more»

]]> 97e2d4089805c7a7b248460ac9851bdd https://medicaldevicecourses.com/activity/p/21544/ Sun, 07 Mar 2021 22:23:21 -0500 Let us be clear, management at your company is not hiring more employees because it 1.) will increase cost, and 2.) negatively impact their bonuses.  Management bonuses are the reason that your team is being over-worked.  It is the reason…   Read more»

]]> 400af86a813ba9dbc57d4ec80eb87b01 https://medicaldevicecourses.com/activity/p/21527/ Fri, 05 Mar 2021 20:49:32 -0500 0