https://medicaldevicecourses.com/members/manolo/activity/ Activity feed for manolo. Fri, 24 Apr 2026 18:20:46 -0400 https://buddypress.org/?v= en-US 30 hourly 2 6069ef96438be87edc0af08a1c94c57d https://medicaldevicecourses.com/activity/p/18358/ Wed, 15 May 2019 21:47:36 -0400 A project is full of different priorities. I believe that one should prioritize tasks on the critical path in order to not delay the project as a whole. This way you’ll finish the project on time and the client will…   Read more»

]]> c374ed15f03c666aa3f7525ae74e11af https://medicaldevicecourses.com/activity/p/18356/ Wed, 15 May 2019 21:47:35 -0400 I appreciated the practical simulations of this course. While there was also a academic component, the practical component that allowed us to experience what happens in the industry gave great experience. I feel that I will be more of an…   Read more»

]]> 632815ccc266d48d899518eedb704453 https://medicaldevicecourses.com/activity/p/18354/ Wed, 15 May 2019 21:47:34 -0400 A good way to fight tunnel vision is to start with the big picture. Look at what the end goal is and how the particular issue is impeding that. List different ways to tackle this problem, and also bounce ideas…   Read more»

]]> 5f9d23e051510bbfd05f647b6c3bc578 https://medicaldevicecourses.com/activity/p/18273/ Wed, 15 May 2019 21:46:52 -0400 Establishing a good relationship with a vendor starts with communication of expectations. If there are different expectations, there will be unavoidable conflict between you and the vendor. The next step, in my opinion, is paying your invoices on time. At…   Read more»

]]> 3b020aa99157158c1d570782b6f64d52 https://medicaldevicecourses.com/activity/p/18272/ Wed, 15 May 2019 21:46:51 -0400 My biggest motivator is a sense of purpose or “why”. This is found by knowing: (1) what the end product is, (2) how the end product will be impactful, and (3) who will be impacted. Having this overall picture of…   Read more»

]]> a3e06991cf655d85f538c2c36f6501d9 https://medicaldevicecourses.com/activity/p/18271/ Wed, 15 May 2019 21:46:51 -0400 In my opinion, including people in the end goal does wonders for motivation. Showing people what the end product will be, explaining how it will be impactful, and showing them who it will have the impact on is a great…   Read more»

]]> 8c95e10974c8f70d1672d5382f60ee46 https://medicaldevicecourses.com/activity/p/18210/ Wed, 15 May 2019 21:46:18 -0400 In my current line of work I am often responsible for order various parts from vendors. The first thing that I look for when selecting a vendor (assuming we already have an account & are able to order from them…   Read more»

]]> c904c5037c273a32a918ca960ac14c5d https://medicaldevicecourses.com/activity/p/18209/ Wed, 15 May 2019 21:46:18 -0400 Before solidifying the DSD, you would want to make sure the supplier is capable of meeting the requirements. In the case of the minisim, this is what was done. An issue was discovered due to a lack of following company…   Read more»

]]> afeffbc904d210c51e7f315d1aa786e0 https://medicaldevicecourses.com/activity/p/18208/ Wed, 15 May 2019 21:46:17 -0400 I agree with ajm73. In the current mini-sim, the two products are made from 2 separate companies. There could be a point of view that favors having 2 sources from the same company, however. You would already know the work…   Read more»

]]> f3490ddccdba1d0471c31a931ae1bbbf https://medicaldevicecourses.com/activity/p/18116/ Wed, 15 May 2019 21:45:32 -0400 The stakeholders should be involved from the beginning of the planning phase. Each stakeholder will have valuable information in the subject matter that they have expertise in. Involving them too late could result in resistance at different aspects of the…   Read more»

]]> 79763fccfa8cd828cd45d1630cb5aa8f https://medicaldevicecourses.com/activity/p/18115/ Wed, 15 May 2019 21:45:31 -0400 In my opinion, it simple falls down to profit. The project is expected to launch at a certain time and make a certain amount of money. If you spend more than you were initially budgeted for, you’ll cut into the…   Read more»

]]> 28403f326356bd39c3daf5dacfc0206c https://medicaldevicecourses.com/activity/p/18114/ Wed, 15 May 2019 21:45:31 -0400 I would start by contacting the vendor and explaining the situation. They will normally have an explanation on what’s going on with that particular lot of packaging. Being that they are the primary vendor, I’m assuming that their process capability…   Read more»

]]> 60635508f7615aace8b4658830da9070 https://medicaldevicecourses.com/activity/p/18029/ Wed, 15 May 2019 21:44:48 -0400 Planning is important, and with proper planning some pitfalls can be avoided. Revising a plan when new information is discovered is recommended in an attempt to keep everything flowing as smoothly as possible. I’m not sure what would happen that…   Read more»

]]> 5eaab52fe8a719eb60b6906260f37585 https://medicaldevicecourses.com/activity/p/18028/ Wed, 15 May 2019 21:44:47 -0400 My field is regulated by The Joint Commission (TJC) and The Centers for Medicare & Medicaid Services (CMS). Every 3 years an on site audit is performed by either TJC, CMS or both. Not having our logs in order when…   Read more»

]]> 8190bdcdfbac2dadda00273530dc7aaf https://medicaldevicecourses.com/activity/p/18027/ Wed, 15 May 2019 21:44:47 -0400 I agree with ec52. Buffers are set in place to account for unexpected events. As well as with the point that the gantt chart is a living document. I would like to add that communication helps eliminate human error. The…   Read more»

]]> caa5abd7301ae0c20a2812ab3d8a187a https://medicaldevicecourses.com/activity/p/17960/ Wed, 15 May 2019 21:44:11 -0400 The first thing that I would do is identify what issues are currently being faced. In this case, the product was clumping and the CMC was leaking out. With that identified, small fixes would be the next step(changing storage temperatures,…   Read more»

]]> 0fbf5463a2be1e0cbff558301f90fbcd https://medicaldevicecourses.com/activity/p/17959/ Wed, 15 May 2019 21:44:10 -0400 I agree with ec52. When you assume you know everything, you tend to make mistakes. Consulting someone who is an expert in the area of interest can be a tremendous help with scheduling. The Subject Matter Expert will be able…   Read more»

]]> d885aa8e3e3163857f199a9dd740f865 https://medicaldevicecourses.com/activity/p/17958/ Wed, 15 May 2019 21:44:10 -0400 Maybe I worded the original post poorly. Yes, violating the current standards can be dangerous to the end user & costly to the company. As more regulations are developed, making medical devices become more cumbersome. Because of this, medical device…   Read more»

]]> 499b5315c1f419b06b25c549c1e58350 https://medicaldevicecourses.com/activity/p/17900/ Wed, 15 May 2019 21:43:41 -0400 Logging the work that you do is extremely important. An example of this is a recent event at my current workplace. The telemetry system had gone down and I was called in to repair it. This just so happened to…   Read more»

]]> 1a0cb77fa7e9b6f2746d78d682c7ce4b https://medicaldevicecourses.com/activity/p/17899/ Wed, 15 May 2019 21:43:40 -0400 Overcommunication, to me, mirrors micromanaging. Being consistently on top of someone to the point of pestering them.

]]> 9d56a4884ffa0803b9e9c0d411dee0e5 https://medicaldevicecourses.com/activity/p/17898/ Wed, 15 May 2019 21:43:40 -0400 Establish a communication protocol at the first team meeting. Communication is the most important aspect of teamwork, in my opinion. Being fair and appropriate to everyone’s preferred method of communication while having clearly defined consequences is key to effective communication….   Read more»

]]> b697ceb5b370b5ff1c16bedbee700776 https://medicaldevicecourses.com/activity/p/17897/ Wed, 15 May 2019 21:43:39 -0400 This would depend on the timeline as a whole. How much time has been allocated to this segment in the project? Were there any milestones missed prior to this that have already delayed the project? The Project Manager may have…   Read more»

]]> b494c33e2f8933e45e4103354a59207f https://medicaldevicecourses.com/activity/p/17829/ Wed, 15 May 2019 21:43:04 -0400 What I would recommend is falling back on policies and procedures. At my current job, there is a policy surrounding PTO(Paid Time Off). We have to submit a request a minimum 2 weeks prior to the date we are requesting…   Read more»

]]> db0cab1900ea365fbd94119ac9cb97bb https://medicaldevicecourses.com/activity/p/17828/ Wed, 15 May 2019 21:43:04 -0400 The first problem that came to mind is communication. A PM has to communicate effectively to their team, investors and clients (to name a few). They should set up a reliable communication system for each group and update them periodically….   Read more»

]]> 3964ab40a348e6c3625e67618ef4e3ca https://medicaldevicecourses.com/activity/p/17827/ Wed, 15 May 2019 21:43:03 -0400 Missing a Milestone is bad, however, should not be deadly to a project. A well-designed project will have some wiggle room in case of tasks not going as expected. A missed milestone may also set you back budget-wise, but effective…   Read more»

]]> 1f9155c1f308f8bc641b4f7193df22c7 https://medicaldevicecourses.com/activity/p/17763/ Wed, 15 May 2019 21:42:27 -0400 It may seem straightforward to you, however, there are cases where companies are not following regulations. A recent example would be Philips Healthcare. They were forced to cease operations at both their Massachusetts and Washington facilities pending corrective actions due…   Read more»

]]> 19a0d9f2ceddf930bf53f2253ac9b444 https://medicaldevicecourses.com/activity/p/17689/ Wed, 15 May 2019 21:41:48 -0400 The classes defined by the FDA are Class I, II & III. Each company may label them however they want internally. Companies tend to give the projects pseudo/ temporary names while the product is still in development.

]]> 21990d8edf37781c1f30cdaf0d98e505 https://medicaldevicecourses.com/activity/p/17686/ Wed, 15 May 2019 21:41:46 -0400 There are different ways to get funding for a project depending on the size of the company. It also depends on if the company is privately owned or public. Overall, I would more so look at the risk for potential…   Read more»

]]> a7ca2c289bd7474d333da19937a923c2 https://medicaldevicecourses.com/activity/p/17625/ Wed, 15 May 2019 21:41:14 -0400 Design Verification and Validation should, on some level, be implemented throughout the entire life cycle of a medical device. You should verify that you can make each component of the device consistently within tolerance. You should also validate that you…   Read more»

]]> 6e38c08268554d5d1aa590f5a0642382 https://medicaldevicecourses.com/activity/p/17624/ Wed, 15 May 2019 21:41:13 -0400 I don’t see global regulation happening. When filling out the different applications with the FDA, there are application fees. If everything becomes global the application fee will change as well which I do not think will happen. Also, the level…   Read more»

]]> b1e71a4703a55376761315070fcf5609 https://medicaldevicecourses.com/activity/p/17523/ Wed, 15 May 2019 21:40:14 -0400 Anthony, The premise of the device is interesting and can provide needed support with suggested treatment. The reason for the disclaimer, in my opinion, is because electronics can fail. If they state that this can happen 100 % of the…   Read more»

]]> 1238471bf2794773a89b20ea43dbe11a https://medicaldevicecourses.com/activity/p/17522/ Wed, 15 May 2019 21:40:14 -0400 The FDA definition for a medical device captures a broad spectrum of products that one may not initially consider a medical device. An example of this would be a bedpan. Although a band-aid is not used to treat a disease,…   Read more»

]]> 5f836a52cedd5a16859bc1377232d4f5 https://medicaldevicecourses.com/activity/p/17521/ Wed, 15 May 2019 21:40:13 -0400 Picking the proper project team is an essential component of a project. Each project will have multiple moving parts and having a diverse project team will be beneficial. It is important to have a well-rounded team where everyone’s weaknesses and…   Read more»

]]> fadb1d36910ec72bf859696ec5970a00 https://medicaldevicecourses.com/activity/p/17442/ Wed, 15 May 2019 21:39:33 -0400 A project manager needs to be able to make decisions. Communication is an important skill as well, yet without the ability to make a decision a project will fail. Having all of the information in the world won’t matter if…   Read more»

]]> eadb0ff74c075d57651a06bd4d9cd808 https://medicaldevicecourses.com/activity/p/17441/ Wed, 15 May 2019 21:39:33 -0400 I believe education is always a proper investment. In order to succeed at anything, you need to know what is going on. How often do you go to a store or a restaurant and immediately notice when someone who works…   Read more»

]]> 2766379c74bdaff86b21a40e54ba05ed https://medicaldevicecourses.com/activity/p/17440/ Wed, 15 May 2019 21:39:32 -0400 I don’t feel the ratio is as literal as it seems. It’s not that a certain individual is 30% competent technically, it’s that that person’s overall success is relying on their technical knowledge 30% overall. For example, person A is…   Read more»

]]> 873f582c5438d3c0b98699e3cd8ec77d https://medicaldevicecourses.com/activity/p/17325/ Wed, 15 May 2019 21:38:33 -0400 When I think of an NDA, I always think of the Krabby Patty formula. Mr. Krabs kept what he wanted to himself inside a bottle in his safe. Everything else that was common, he didn’t care about. The same goes…   Read more»

]]> 08019e44546813b839816390f13a8394 https://medicaldevicecourses.com/activity/p/17324/ Wed, 15 May 2019 21:38:33 -0400 Dr. Simon, Wow … the semester is already almost over … I really enjoyed this course. I didn’t know about all of the roles that I could have gone into utilizing a BME degree, and I would rather change my…   Read more»

]]> d2a83c9702ea6d84c0b23c4145ad9b5c https://medicaldevicecourses.com/activity/p/17323/ Wed, 15 May 2019 21:38:32 -0400 When entering into a contract, I would dissuade one from relying on a verbal agreement. A contract is similar to meeting minutes if it’s not written in the contract, it did not happen. I’ve seen countless situations where people relied…   Read more»

]]> 12f045bf5e8e6cce711ca0f8adc86342 https://medicaldevicecourses.com/activity/p/17223/ Wed, 15 May 2019 21:37:40 -0400 I work in more of a Project-based Organization. Every hospital is considered a separate account and they run as such. If another account needs help, I can go to that account to lend my expertise for a little before coming…   Read more»

]]> 6df1a36a0d810ff6646b50f3672e9ddb https://medicaldevicecourses.com/activity/p/17222/ Wed, 15 May 2019 21:37:39 -0400 It would be most challenging to work under a matrix organization. This is simply because the resources on your team are split. Situations like that can lead to staff getting burnt out due to the amount of work given by…   Read more»

]]> 5dac17030a9eff0993b2a8fd167dbedc https://medicaldevicecourses.com/activity/p/17221/ Wed, 15 May 2019 21:37:39 -0400 In my opinion, with a new group of people, it is better to have the project group with people who are competent in their expertise vs people who you have a good relationship with. It would be great if everyone…   Read more»

]]> 0195507b8139c7e2069adde436d5a26a https://medicaldevicecourses.com/activity/p/17135/ Wed, 15 May 2019 21:36:57 -0400 “As far as possible” to me would be to the point of common sense. Meaning, depending on the target product audience, there should be a level of intelligence that you expect the user to have. Take a tongue depressor for…   Read more»

]]> 53aa7849198a664c483ce3d7401710ee https://medicaldevicecourses.com/activity/p/17133/ Wed, 15 May 2019 21:36:55 -0400 Labels are an essential part of risk management, but I agree that they are the least useful. This is because (from my experience) people do not normally read the warning labels. Think about things that you use on a daily…   Read more»

]]> 81105cff8c54c428e520d0e8a4cf30f8 https://medicaldevicecourses.com/activity/p/17131/ Wed, 15 May 2019 21:36:54 -0400 Personally, for any business/professional meeting I think it would be most effective to follow Robert’s Rules of Order. (At the end of the post I will link a basic overview of what that is) The first thing you will need…   Read more»

]]> 7a0dcc4eb16706ed2f28c37599119d01 https://medicaldevicecourses.com/activity/p/17046/ Wed, 15 May 2019 21:36:13 -0400 As jz365 has mentioned, the EU has a different regulatory body than the US. For the EU, no design controls are not “needed”. Yet, that will limit your market size because it is needed in the US. I would recommend…   Read more»

]]> fe9a32c53394b351828ccc3aea288115 https://medicaldevicecourses.com/activity/p/17045/ Wed, 15 May 2019 21:36:12 -0400 Each of the documents explains the other’s disadvantage. Not being specific enough can have it’s drawbacks, as well as being too specific. The advantage of the DID is that you can show a customer a broad view of what the…   Read more»

]]> 3e70fe3aa6375d40edb936a30929200c https://medicaldevicecourses.com/activity/p/17044/ Wed, 15 May 2019 21:36:12 -0400 Verification is making sure what you say is going to happen actually happens .. If you say a product is supposed to do something and it does not do it, you’ll end up getting sued and, even worse, could hurt…   Read more»

]]> 7f6b00aee58aada77bf04a3c39efc134 https://medicaldevicecourses.com/activity/p/16952/ Wed, 15 May 2019 21:35:24 -0400 For biological statistics, t & z tests are useful for data analysis. You would want your power to be at lest 80% to be considered a good test, however the higher the power the better. you would use a t…   Read more»

]]> a8c792dcc760535db3b7b3f36602b3e4 https://medicaldevicecourses.com/activity/p/16951/ Wed, 15 May 2019 21:35:24 -0400 I personally would not skip the validation process. 1) you would want to confidently state what parameters your device will conform to without any doubt. 2) If anything happens, it leaves you open to a law suit. Whether it’s required…   Read more»

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