https://medicaldevicecourses.com/members/orleron/activity/mentions/ Activity feed mentioning Josh. Sat, 16 May 2026 03:45:18 -0400 https://buddypress.org/?v= en-US 30 hourly 2 9e61a3fd81742068893cc6ab3d0b990a https://medicaldevicecourses.com/activity/p/26037/ Fri, 01 Jul 2022 03:21:40 -0400 Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

]]> 08d81fe218e66a70da86a1d63a8510e4 https://medicaldevicecourses.com/activity/p/25818/ Sun, 24 Apr 2022 04:27:14 -0400 Posted by: @orleron In this module we learned about organization types and how those can affect medical device projects. What type of organization do you work in or what kind would you like to work in and why? I would…   Read more»

]]> bc45d09f0827140fb20d307c1768cf65 https://medicaldevicecourses.com/activity/p/25203/ Sun, 27 Mar 2022 02:02:00 -0400 Posted by: @orleron Remember “The Four Ps of Marketing”: product, price, promotion, and placement. Product:What are you selling & why?Price:How much does the product cost? When does the price change?Promotion:How will you promote the product? Viral marketing? Internet Advertising?Placement:Who sells…   Read more»

]]> bae5f4c6f06e36f9bac4ab911337b491 https://medicaldevicecourses.com/activity/p/25093/ Sun, 20 Mar 2022 03:08:05 -0400 Posted by: @orleron Perhaps in your career you will meet (or be) a physician who works in a hospital or private practice and wishes to create his or her own medical device.  Though this is a noble goal, what challenges…   Read more»

]]> 98f0bfa94d0e02803fe49a9c85af4437 https://medicaldevicecourses.com/activity/p/25090/ Sun, 20 Mar 2022 01:54:13 -0400 Posted by: @orleron This is a phrase you will encounter sometimes. “The Cost of Quality” is a concept. Let’s say you have a product, and you do no QA/QC on it. For a while, you might do fine. The product…   Read more»

]]> f6de411120e37afcd60c910ba00fc44a https://medicaldevicecourses.com/activity/p/25040/ Wed, 16 Mar 2022 03:49:13 -0400 Posted by: @orleron Up until now we have talked about two big topics:  project management and pre-clinical research.  There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk…   Read more»

]]> 80d6ed48611bddab9c197250c2c6a9f2 https://medicaldevicecourses.com/activity/p/24806/ Sun, 06 Mar 2022 03:53:54 -0500 Posted by: @orleron What do you think the challenges are in doing project management for medical devices, as opposed to, let’s say, being a project manager for building a school or skyscraper? Project management for medical devices would require a…   Read more»

]]> f727dc4792d04e464f44eafe866e06f1 https://medicaldevicecourses.com/activity/p/23872/ Sat, 30 Oct 2021 22:28:59 -0400 Posted by: @orleron The DMR is largely used for US products. It is required by the FDA. The equivalent to the DMR for European products is called the Technical File (for European class I, IIa, and IIb devices) or the…   Read more»

]]> 3cd574a70738da7b5f85ec6d07ea1ce6 https://medicaldevicecourses.com/activity/p/23686/ Mon, 11 Oct 2021 01:45:57 -0400 Posted by: @orleron Well, you did it! You made it to the end of Medical Device Development. The original intent of this course was to teach you what professionals in the medical device field do in the real world if…   Read more»

]]> 844d8cc5d16343311c5678d0a885ba14 https://medicaldevicecourses.com/activity/p/23341/ Thu, 16 Sep 2021 06:37:11 -0400 Posted by: @orleron Up until now we have talked about two big topics:  project management and pre-clinical research.  There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk…   Read more»

]]> 5eb0db3b2bcec5bbe6359708b1e666d5 https://medicaldevicecourses.com/activity/p/23284/ Sun, 12 Sep 2021 03:32:23 -0400 Posted by: @orleron 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…   Read more»

]]> d851e89382722359e5baae9fa282db7e https://medicaldevicecourses.com/activity/p/23247/ Sat, 11 Sep 2021 01:19:53 -0400 Posted by: @orleron This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework. Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA…   Read more»

]]> 8c7e2e405d3088fd40c36b61e2ba2656 https://medicaldevicecourses.com/activity/p/23145/ Sat, 04 Sep 2021 01:20:43 -0400 Posted by: @orleron 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…   Read more»

]]> e34a0eaada8eeec39c4d29ffd2363f99 https://medicaldevicecourses.com/activity/p/23081/ Sat, 28 Aug 2021 19:11:52 -0400 Posted by: @orleron As I said in the lecture for this module, this course is different. Whereas most courses seek to fill you with academic information in order to create a knowledge base for yourself, this course seeks to lay…   Read more»

]]> eae92feb69173ec316d493c786546575 https://medicaldevicecourses.com/activity/p/23079/ Fri, 27 Aug 2021 22:04:24 -0400 Posted by: @orleron As I said in the lecture for this module, this course is different. Whereas most courses seek to fill you with academic information in order to create a knowledge base for yourself, this course seeks to lay…   Read more»

]]> fc5943f19713b4ccdc095276ea343f08 https://medicaldevicecourses.com/activity/p/23076/ Thu, 26 Aug 2021 02:40:39 -0400 Posted by: @orleron 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…   Read more»

]]> 256a31f71b15dd3cd7be8bd8ce8f0151 https://medicaldevicecourses.com/activity/p/22726/ Wed, 23 Jun 2021 03:24:35 -0400 Posted by: @orleron Well, you did it! You made it to the end of Medical Device Development. The original intent of this course was to teach you what professionals in the medical device field do in the real world if…   Read more»

]]> 212d8905072805bb29c328bea2211502 https://medicaldevicecourses.com/activity/p/22715/ Tue, 22 Jun 2021 19:43:14 -0400 Posted by: @orleron In this module we learned about organization types and how those can affect medical device projects. What type of organization do you work in or what kind would you like to work in and why? The laboratory…   Read more»

]]> 65c3491618e45ad832df433c3dfd1eba https://medicaldevicecourses.com/activity/p/22613/ Mon, 07 Jun 2021 02:58:38 -0400 Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a “clinical background”. This means people who have been or are nurses, doctors, or other kinds of technical workers who interact…   Read more»

]]> b0566a690209a89f40f47d44193124d3 https://medicaldevicecourses.com/activity/p/22612/ Mon, 07 Jun 2021 00:55:17 -0400 Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a “clinical background”. This means people who have been or are nurses, doctors, or other kinds of technical workers who interact…   Read more»

]]> a31870eeaf09b3b6e9619d26c00489ac https://medicaldevicecourses.com/activity/p/22589/ Wed, 02 Jun 2021 03:14:35 -0400 Posted by: @orleron As you interact with the CRA profession, you will notice a heavy preference for people with a “clinical background”. This means people who have been or are nurses, doctors, or other kinds of technical workers who interact…   Read more»

]]> d4270d7e8a78f6cc31c63fed1c219707 https://medicaldevicecourses.com/activity/p/22573/ Mon, 31 May 2021 02:32:06 -0400 Posted by: @orleron Remember “The Four Ps of Marketing”: product, price, promotion, and placement. Product:What are you selling & why?Price:How much does the product cost? When does the price change?Promotion:How will you promote the product? Viral marketing? Internet Advertising?Placement:Who sells…   Read more»

]]> fb4d56825123835b613653f3039a48ef https://medicaldevicecourses.com/activity/p/22529/ Mon, 24 May 2021 02:41:18 -0400 Posted by: @orleron This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework. Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA…   Read more»

]]> c2bc2be2ae3a93bde97ab1609f1a3fc1 https://medicaldevicecourses.com/activity/p/22513/ Sat, 22 May 2021 21:42:13 -0400 Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career.  For example: What types of training are relevant to each and how could they differ? What types…   Read more»

]]> f5cfb4abafb1bf1d480be01cedfcba7e https://medicaldevicecourses.com/activity/p/22411/ Thu, 06 May 2021 00:01:19 -0400 Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

]]> 28cca5c57847b4b40717e2cbe18b4753 https://medicaldevicecourses.com/activity/p/22404/ Wed, 05 May 2021 02:52:31 -0400 Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

]]> ae4cd34aaeb7ba857ad26007874a2ffc https://medicaldevicecourses.com/activity/p/22401/ Tue, 04 May 2021 23:46:09 -0400 Posted by: @orleron 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…   Read more»

]]> a17cfbfb4191c08232f3504edbfbc326 https://medicaldevicecourses.com/activity/p/21407/ Mon, 22 Feb 2021 03:32:56 -0500 Posted by: @orleron 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…   Read more»

]]> 0c3d3b7420963729e2e3711f95a6dba5 https://medicaldevicecourses.com/activity/p/21323/ Tue, 09 Feb 2021 09:31:31 -0500 Posted by: @orleron 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…   Read more»

]]> e8b6dc33e71f8a24486b8c06be4a3f51 https://medicaldevicecourses.com/activity/p/21235/ Mon, 01 Feb 2021 01:27:00 -0500 Posted by: @orleron 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…   Read more»

]]> 937ec7d9f8a7fca4dd9438b187f627fd https://medicaldevicecourses.com/activity/p/21192/ Tue, 26 Jan 2021 04:03:21 -0500 Posted by: @orleron How do you think Project Management differs in different industries or different types of Project? If you are a great PM for doing Medical Device Projects, does that mean I can throw you into a software company…   Read more»

]]> 9a33f6dae45fa612bb3557b3bbcf4d20 https://medicaldevicecourses.com/activity/p/20736/ Wed, 28 Oct 2020 14:55:29 -0400 Posted by: @orleron We have begun learning about the Design History File (DHF) this module. We are more than halfway through the course, so congrats for making it this far! This module deals with the DHF contents and how to…   Read more»

]]> 5b0c43252f6d77018364b241aa8f9d08 https://medicaldevicecourses.com/activity/p/20566/ Wed, 07 Oct 2020 17:56:12 -0400 Posted by: @orleron Being able to look at the financial statements of a company and determine some guesses on its health is a good skill to have. All public companies in the US must publish their financial statements quarterly and…   Read more»

]]> 566cfa7358bb255fbb1716753505a638 https://medicaldevicecourses.com/activity/p/20525/ Sun, 04 Oct 2020 03:03:25 -0400 Posted by: @orleron 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…   Read more»

]]> a4d7c5a1a8bc7aac6bc8efaf88bbfe11 https://medicaldevicecourses.com/activity/p/20509/ Fri, 02 Oct 2020 12:58:14 -0400 Posted by: @orleron This is a phrase you will encounter sometimes. “The Cost of Quality” is a concept. Let’s say you have a product, and you do no QA/QC on it. For a while, you might do fine. The product…   Read more»

]]> 5f887dad8a6945613ff9c5b384706125 https://medicaldevicecourses.com/activity/p/20481/ Mon, 28 Sep 2020 03:36:17 -0400 Posted by: @orleron This is always a fun module for discussion topics because there’s always some modern technology out there that challenges the current regulatory framework. Today… e-cigarettes. If you don’t know what one is, google it. Does the FDA…   Read more»

]]> 068429b2242a9e79cd853abff476c0fb https://medicaldevicecourses.com/activity/p/20475/ Mon, 28 Sep 2020 03:06:27 -0400 Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career.  For example: What types of training are relevant to each and how could they differ? What types…   Read more»

]]> 2dc2e3b8c85b711e0bc2af89e50d5769 https://medicaldevicecourses.com/activity/p/20430/ Fri, 25 Sep 2020 19:08:50 -0400 Posted by: @orleron Up until now we have talked about two big topics:  project management and pre-clinical research.  There are some other discussions in this forum about biomaterial selection for scientific and safety purposes, but I want now to talk…   Read more»

]]> 758755ba6c85842d040ed8a38f7885aa https://medicaldevicecourses.com/activity/p/20216/ Sun, 06 Sep 2020 01:53:34 -0400 Posted by: @orleron This week is an overall introduction to the field of medical device development. We take some time to pay attention to the differences between Academia and Industry (Commercial) because students in this course may come from one…   Read more»

]]> 5593eec7f75b6f703fd6d00aeda69acd https://medicaldevicecourses.com/activity/p/18719/ Sat, 05 Oct 2019 15:35:58 -0400 Posted by: @orleron Explain the difference between QA and QC, and think about the differences that each of these have as a career.  For example:What types of training are relevant to each and how could they differ?What types of jobs…   Read more»

]]> aa4566ac0e59518c30f0dad08572ccab https://medicaldevicecourses.com/activity/p/18582/ Thu, 19 Sep 2019 00:54:45 -0400 Posted by: @orleron Take the scenario where an animal study has been designed and as near as you can tell, the design is not flawed. That is to say, you think the design will give you no problems.Your company outsources…   Read more»

]]>