Medical Device Courses | Josh | Activity https://medicaldevicecourses.com/members/orleron/activity/ Activity feed for Josh. Sat, 16 May 2026 03:08:14 -0400 https://buddypress.org/?v= en-US 30 hourly 2 ba08cc208f90666704f0b64402c37918 Josh posted a new topic "Making connections between people and schools" - https://medicaldevicecourses.com/activity/p/25038/ Tue, 15 Mar 2022 16:16:23 -0400 Not sure many are aware of this, but there are currently two schools taking Project Management right now in these forums: New Jersey Institute of Technology (NJIT) and Morehouse School of Medicine (MSM).  Many of the people you are interacting…   Read more»

]]> 1eaf1452a986971c94d232961e57c43a Josh replied to the topic "Discussion Topic: Share your project management experience" - https://medicaldevicecourses.com/activity/p/21117/ Fri, 22 Jan 2021 00:39:08 -0500 Refreshing this topic for the new class coming in.  See the first post in the thread here.

]]> b53e132221b1137673a1251733d9c964 Josh replied to the topic "Discussion Topic: Covid19 and medical devices" - https://medicaldevicecourses.com/activity/p/20179/ Thu, 03 Sep 2020 13:23:32 -0400 What other changes are we seeing in the medical devices industry due to covid19?

]]> 1d7ed98c3cd2eb4d5ac9bc172638bfdf Josh replied to the topic "Thoughts on BS, MS, and PhD in BME" - https://medicaldevicecourses.com/activity/p/20178/ Thu, 03 Sep 2020 13:21:59 -0400 A thought here to stimulate more discussion:  Different strokes for different folks.   There are people who like to go to work every day and do the same thing.  Maybe, as someone who is not like that, this is a weird…   Read more»

]]> 5fad1ab733c411543f96df86e76b6ead Josh replied to the topic "Discussion Topic: Practical vs. Informational courses" - https://medicaldevicecourses.com/activity/p/20177/ Thu, 03 Sep 2020 13:17:56 -0400 Posted by: @dh239 Practical courses do fall short to informational courses when research or academia is the goal of the student. For professionals and those looking to go into industry, practical courses are perhaps the most important. For that reason,…   Read more»

]]> 38493ae9ab8e79039b5042ced46e2c37 Josh replied to the topic "Discussion Topic: Brand new biomaterial" - https://medicaldevicecourses.com/activity/p/20087/ Sun, 12 Jul 2020 03:56:06 -0400 @quanzi What specifically do you mean when you say that a “metal for a stent would be incompatible for use with a breast plant”?

]]> 166450e03c0fff9169d48e4a36536a59 Josh replied to the topic "Discussion Topic: Project Management in a medical device setting" - https://medicaldevicecourses.com/activity/p/20086/ Sun, 12 Jul 2020 03:54:04 -0400 @quanzi Yes, and “difficulty” of a medical device project has a number of facets to it.  There’s financial difficulty, technological difficulty, clinical difficulty, and others.

]]> 62ed7c161c4e6428243d74cce31aaa95 Josh replied to the topic "Discussion Topic: Project Management in a medical device setting" - https://medicaldevicecourses.com/activity/p/20085/ Sun, 12 Jul 2020 03:54:01 -0400 @quanzi Yes, and “difficulty” of a medical device project has a number of facets to it.  There’s financial difficulty, technological difficulty, clinical difficulty, and others.

]]> 7a6caf7a2ba0f02b70ef012e92afbec3 Josh posted a new topic "Discussion Topic: Covid19 and medical devices" - https://medicaldevicecourses.com/activity/p/20078/ Sat, 04 Jul 2020 16:06:35 -0400 We are meeting in an interesting time, to say the least.  As a disease, covid19 has many elements to its treatment and many of those elements use medical devices.  There are ventilators and syringes, which we all think about constantly,…   Read more»

]]> 0ad78f5fb795fa17e8b0f0aa7b2647ad Josh replied to the topic "Feasibility Study" - https://medicaldevicecourses.com/activity/p/19468/ Wed, 12 Feb 2020 15:15:43 -0500 You definitely do not want to start a project before you know the idea is feasible, but let me ask this: in strict terms, couldn’t the feasibility practices be a project themselves?  Wouldn’t you want to manage feasibility like a…   Read more»

]]> b9e7c9702a939326c706f42dd18284c3 Josh replied to the topic "Simulations" - https://medicaldevicecourses.com/activity/p/19462/ Tue, 11 Feb 2020 20:20:04 -0500 Face to face interactions can become too much at times, keep in mind.  Ever hear of a company, or work in one, that does nothing but have meetings which leaves nobody with enough time left over to actually do the…   Read more»

]]> f4563db1f48b86009877f7f234287296 Josh posted a new topic "Take a look at the EU" - https://medicaldevicecourses.com/activity/p/19295/ Sat, 25 Jan 2020 17:20:28 -0500 I know we have not gotten into any regulatory stuff for Europe yet, and we generally do not cover that in this class.  (It is covered in Advanced Medical Device Development at NJIT.)  However, take a quick Google search for…   Read more»

]]> 05b27274ff10c6470e8eec399da260c2 Josh replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/17427/ Wed, 15 May 2019 21:39:25 -0400 Class, Thanks for the great 2018 comments. I do take all your words into consideration. This is an interesting time in medical devices, as you will soon find out in your jobs or in my future courses. A lot of…   Read more»

]]> e1ea0dac3fc72d7676f9cd99f6945c3b Josh replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/17047/ Wed, 15 May 2019 21:36:13 -0400 Interestingly, as a brand new development which I have not had time to update for the course, Design Controls are now in fact required virtually everywhere in the world. The new EU Medical Device Regulation (MDR) specifically looks for a…   Read more»

]]> ea058a57fb295f7d76dda4ad6928dc5d Josh replied to the topic "Thoughts and Questions Related to Untested Medicine" - https://medicaldevicecourses.com/activity/p/16441/ Wed, 15 May 2019 19:39:20 -0400 test Spiral Medical Development test post

]]> d017091857fb12ccd4525ea90e2e15b6 Josh replied to the topic "Discussion Topic: Practical vs. Informational courses" - https://medicaldevicecourses.com/activity/p/16081/ Wed, 15 May 2019 19:16:51 -0400 Is a student 100% equipped to know what he or she should focus on during the course of study?

]]> 0790d0a8d3ac7efbaac700837157ff0a Josh replied to the topic "Discussion Topic: Academia vs. Industry" - https://medicaldevicecourses.com/activity/p/16080/ Wed, 15 May 2019 19:16:50 -0400 Regarding budget cuts, keep in mind that although we do not get our funding almost exclusively from grants when we work in industry, we do have budgets and funding to worry about. When a company funds a project, there are…   Read more»

]]> c893f734ddebd3ca9a537e8bd9935a4f Josh replied to the topic "CE TECH File Vs 510(k) submission differences" - https://medicaldevicecourses.com/activity/p/14645/ Wed, 15 May 2019 18:58:49 -0400 Remember as we discussed in Medical Device Development, even if something goes through the 510K process in the US, it still undergoes design controls and has its own DHF. Wanted to clear that up before anyone got confused.

]]> a5c5112b839e02c865d36fb4dfb9af13 Josh replied to the topic "Classification in FDA Vs EU" - https://medicaldevicecourses.com/activity/p/14644/ Wed, 15 May 2019 18:58:49 -0400 Yes, good catch on the joint implants. They are a higher class in the EU than the US. The impression in general is that EU classifications are somehow less strict or easier or lower, and that’s not actually true in…   Read more»

]]> 953a866ea9d28d383f8cee5163573026 Josh replied to the topic "Design Controls in the other countries" - https://medicaldevicecourses.com/activity/p/13799/ Wed, 15 May 2019 17:08:19 -0400 The idea, in general, is that there are two basic kinds of regulatory systems: A) Systems that document the current snapshot of the device’s design/manufacture/risk profile, etc. B) Systems that document the whole history of the device’s design/manufacture/risk profile from…   Read more»

]]> caae13ce91194c072faad357bf5b40d9 Josh replied to the topic "CRO or Big Pharma" - https://medicaldevicecourses.com/activity/p/13682/ Wed, 15 May 2019 17:07:13 -0400 Keep in mind that pharma trials are very different from device trials, i.e. Phase I, II, II vs. no phases. The larger CRO’s can do both types, but there are smaller ones that specialize in one or the other.

]]> 2dc0851979f826325d9e5ee4a38cb79d Josh replied to the topic "Discussion Topic: The Fifth "P" of Marketing" - https://medicaldevicecourses.com/activity/p/13640/ Wed, 15 May 2019 17:06:48 -0400 Keep in mind here that Participation always involves a two-way communication, over whatever media. Product placement, exclusive content, etc. and ads are all “push media” because they are one-way.

]]> 34267359c0312efef8053e01205ca4ad Josh replied to the topic "Marketing Strategy" - https://medicaldevicecourses.com/activity/p/13519/ Wed, 15 May 2019 17:05:36 -0400 One trend to be aware of on these forums is the asking of questions to the class and not giving your own answer or opinion on the matter. That is not something that takes thought or substantive construction of ideas….   Read more»

]]> 370b4911409e02bf39b7246d2962b375 Josh replied to the topic "Medical Device SWOT Analysis" - https://medicaldevicecourses.com/activity/p/13518/ Wed, 15 May 2019 17:05:36 -0400 What company would you choose to analyze, alexandrabuga?

]]> 73b2832773619a3a87ded7338dba7485 Josh replied to the topic "Discussion Topic: Antibiotic-Releasing Hip Stem" - https://medicaldevicecourses.com/activity/p/13167/ Wed, 15 May 2019 17:02:33 -0400 We will learn later than an IDE is required for any clinical trial that poses significant risk, and usually this means that if you change the standard of care for a patient in the clinical trial, it is significant risk…   Read more»

]]> e8e538b5532faa601dfc12811f7f02b6 Josh replied to the topic "Discussion Topic: e-cigarettes" - https://medicaldevicecourses.com/activity/p/13166/ Wed, 15 May 2019 17:02:33 -0400 So given the content for this week, let’s think about this. Some of you are saying, and pointing out, that e-cigs are drug delivery devices rightfully regulated by the FDA. If this is a Class III device, it would mean…   Read more»

]]> 431e331a6209c6cfc219637d1c4ee3d1 Josh replied to the topic "Discussion Topic: Beyond experimental design issues" - https://medicaldevicecourses.com/activity/p/12927/ Wed, 15 May 2019 17:00:21 -0400 Right, so the underlying message there is that CRO’s are businesses that want to maximize their turnover. The more studies they do, the more money they make. How is the situation different in a university? Obviously they also want to…   Read more»

]]> c2722578e51e86e7e2f8dd2525c6c83d Josh replied to the topic "Discussion Topic: Beyond experimental design issues" - https://medicaldevicecourses.com/activity/p/12921/ Wed, 15 May 2019 17:00:17 -0400 Some great points made above, yes. You see some of the pitfalls that have happened with favoring close connections over sound business decisions, but as some of you correctly point out, the sound business decisions are not clear-cut either. *…   Read more»

]]> 6a4d465184934767f6591dd1837c896d Josh replied to the topic "Discussion Topic: Project Management in a medical device setting" - https://medicaldevicecourses.com/activity/p/12751/ Wed, 15 May 2019 16:58:51 -0400 That is an excellent point. What happens many times is the project is broken up into sections. There’s a general product development project, and then several separate regulatory projects hooked onto it, one for each country or region. You will…   Read more»

]]> 73afd84f9f2a1b892d2cdb93ce45b77c Josh replied to the topic "Simulations" - https://medicaldevicecourses.com/activity/p/11796/ Wed, 15 May 2019 16:49:49 -0400 Definitely a good question, especially since either scenario could occur in real life: you could be working on a remote team, or working in an office every day. In either case, you would need to be able to do this…   Read more»

]]> db4474ad574044601db5ab16d2a0a103 Josh replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11444/ Wed, 15 May 2019 16:45:01 -0400 I would like to thank everyone for the great feedback. It confirms for me that the reason why I made this course and the way in which I designed it are benefiting people. You were a good group. One point…   Read more»

]]> d787e7e19f73b63810e25a19b458bbd1 Josh replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/11334/ Wed, 15 May 2019 16:44:00 -0400 That’s an interesting comment which got my attention because it is different from some of the others. What other names or verbiage in the description would make it more accurate? Tell me more.

]]> 02fcfa8da43f7ee1dfad6f6533fba9ca Josh replied to the topic "Risk management and Labels" - https://medicaldevicecourses.com/activity/p/11073/ Wed, 15 May 2019 16:39:39 -0400 Think about a medical device being used during a surgery. The surgeon is scrubbed in and working on the patient. The techs in the OR are following the surgeon’s instructions to hand things over, rinse things off, etc. At what…   Read more»

]]> 385642ae74afb9803790ed3d0c38adb3 Josh replied to the topic "Risk analysis in real company" - https://medicaldevicecourses.com/activity/p/11072/ Wed, 15 May 2019 16:39:38 -0400 Would you be able to share with us some of the differences you see between Medical Device and Pharma risk management structure and technique?

]]> bf61fb73f225f899e756112fb675816b Josh replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/10818/ Wed, 15 May 2019 16:36:52 -0400 The last post here is the most accurate. Design Controls are not “needed” in the EU in the sense that they are not mandated by a regulatory body like they are in the US. Granted, it is still a good…   Read more»

]]> 5ab64db58912c1d196b2e572ad7d258f Josh replied to the topic "Important Part of DDP" - https://medicaldevicecourses.com/activity/p/10817/ Wed, 15 May 2019 16:36:51 -0400 As I may have mentioned in the lecture, the DDP for most companies is just a boiler plate document that gets filled in, and pretty much remains the same throughout the project. What I am trying to teach here and…   Read more»

]]> 258d6609cede46b1a10879a683af7269 Josh posted a new topic "Discussion Topic: Outsource vs. Insource the clinical trial" - https://medicaldevicecourses.com/activity/p/10380/ Wed, 15 May 2019 16:33:02 -0400 Every single task from the moment a clinical trial is conceived to the moment it is submitted to the FDA with complete data as part of a larger submission may be handled by a company or a consultant. There are…   Read more»

]]> 45e57ffa4368e1ff74047631d9488b76 Josh posted a new topic "Discussion Topic: Scope creep....when your project changes" - https://medicaldevicecourses.com/activity/p/10379/ Wed, 15 May 2019 16:33:02 -0400 ….and not always for the better. Using what you have learned in the Scope Management lecture, what situations have you encountered where a project suffered from scope creep? What did you do in that situation? What did you do right?…   Read more»

]]> 562b5d1b19fa927dbe7e4a10e49d59b3 Josh posted a new topic "Discussion Topic: Costs and managing your investment" - https://medicaldevicecourses.com/activity/p/10378/ Wed, 15 May 2019 16:33:01 -0400 Net present value is the calculation that compares the amount invested today to the present value of the future cash receipts from the investment. In other words, the amount invested is compared to the future cash amounts after they are…   Read more»

]]> 259601ca7b21a727c2f33360c422abdf Josh posted a new topic "Discussion Topic: Risk Analysis methods" - https://medicaldevicecourses.com/activity/p/10377/ Wed, 15 May 2019 16:33:01 -0400 Depending on the project, a number of different risk analysis methods are available, but like anything, none of them are perfect. If one of them was, the product that used that method would never have issues but reading the headlines…   Read more»

]]> 740437c2cfda6ea015c129c57c1b7c17 Josh posted a new topic "Discussion Topic: Realities of Planned Value" - https://medicaldevicecourses.com/activity/p/10376/ Wed, 15 May 2019 16:33:00 -0400 Keep in mind that in this course we are teaching the ideals of project management in a medical field. This is the best it could ever be, and more than that, this type of project management we are learning here…   Read more»

]]> 9c1a170b6bd04fda899fc50a784fb277 Josh posted a new topic "Discussion Topic: Design and Process Verification" - https://medicaldevicecourses.com/activity/p/10375/ Wed, 15 May 2019 16:33:00 -0400 When comparing Project Management Processes to Design Controls, I laid out a diagram that synced them up roughly. On that diagram it shows that Verification takes place during the Execution phase of the project. Do you think this is a…   Read more»

]]> f276c3a30123a1faebc16e223621bb99 Josh posted a new topic "Discussion Topic: The critical path" - https://medicaldevicecourses.com/activity/p/10374/ Wed, 15 May 2019 16:32:59 -0400 Everyone who has worked on a project has a story where a critical path was somehow delayed for varying reasons. As someone working in the hydrophilic coatings industry for a while, I had a lot of customers think of my…   Read more»

]]> 6fba1e294534c403b907a68defe11246 Josh posted a new topic "Discussion Topic: Integrating Six Sigma into Project Planning" - https://medicaldevicecourses.com/activity/p/10373/ Wed, 15 May 2019 16:32:59 -0400 In this course we have not discussed other tools such as Six Sigma, but they can nonetheless be important components for project planning.

Explain your thoughts on how a Six Sigma process would integrate with the Project Planning Process.

]]> 9a39f39eec3685251173862bea908b40 Josh posted a new topic "Discussion Topic: What are the PM elements in your company?" - https://medicaldevicecourses.com/activity/p/10372/ Wed, 15 May 2019 16:32:59 -0400 Project Initiation requires several things, as per the lecture, and two of them are enterprise environmental factors and organizational process assets. Give some examples of each as they appear in your organization where you work. How would you mobilize these…   Read more»

]]> b32b13f88f1cc605d9130868fabf5df8 Josh posted a new topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/10371/ Wed, 15 May 2019 16:32:58 -0400 If you currently work in Industry, tell us what kind of organization you work with, i.e. whether it is a functional, matrix, or project-based one. If you do not work in Industry yet, tell us what kind you feel you…   Read more»

]]> 0ca7dfc0e36a0f26e6a22d0c76f07ccd Josh posted a new topic "Discussion Topic: To trial or not to trial" - https://medicaldevicecourses.com/activity/p/10370/ Wed, 15 May 2019 16:32:58 -0400 Take a look at the lecture where it talks about Design Validation. In your words, what is Design Validation? In the following examples, do you think that the device would need a clinical trial as part of Design Validation or…   Read more»

]]> 65c2dcc246fb821f0c65c7f7280eab52 Josh posted a new topic "Discussion Topic: The proper time for Project Initiation" - https://medicaldevicecourses.com/activity/p/10369/ Wed, 15 May 2019 16:32:57 -0400 One of the unsettled discussions in smaller companies especially is when to move on from abstract talk to actual planning and laying out a proposal. Consider a technology like a new biomaterial which may be in development for some time,…   Read more»

]]> 10f649f9fd81910d26ca41fb42b0c0d6 Josh posted a new topic "Discussion Topic: GMP's" - https://medicaldevicecourses.com/activity/p/10368/ Wed, 15 May 2019 16:32:57 -0400 Another important aspect which often overlaps with Regulatory: Good Manufacturing Practices (GMP’s) What are GMP’s? Many of you can google things and bring back links, I’m sure, but in practical terms, in real life, they mean several things. 1) Traceability…   Read more»

]]> a3b8e57d8cdf500efbf261f5891e0bfa Josh posted a new topic "Discussion Topic: The 510k Process" - https://medicaldevicecourses.com/activity/p/10367/ Wed, 15 May 2019 16:32:56 -0400 One “fun” thing to talk about during the Regulatory lectures is the ongoing soap opera of what is happening to the 510(k) process. One of the key events in the saga was a controversial report issued by the Institute of…   Read more»

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