https://medicaldevicecourses.com/members/cem34/activity/ Activity feed for cem34. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 6e8eba335ea858819906f6388834e36c https://medicaldevicecourses.com/activity/p/24075/ Fri, 26 Nov 2021 01:28:41 -0500 Posted by: @fo3 As learned this week, it is important to protect our ideas and inventions and to do so in the appropriate legal manner. Part of the lesson discussed Non-disclosure agreements, or contracts, and how they can help protect…   Read more»

]]> d1dc90bc80375b66f6bd2cdbd75653f7 https://medicaldevicecourses.com/activity/p/24074/ Thu, 25 Nov 2021 21:28:04 -0500 Posted by: @mmd55 I recently received a job offer and while reviewing my offer I noticed I would have to sign a non-compete agreement, which is an industry standard. I asked the recruiter if I would be able to read…   Read more»

]]> 0ff5869adac52aad0d4f21908f75cd50 https://medicaldevicecourses.com/activity/p/24073/ Thu, 25 Nov 2021 20:55:49 -0500 Posted by: @cef3 Well, Dr. Simon, when I first signed enrolled in this class, I was expecting it to be really more about medical devices and theory that goes into that. I was kind of caught of guard with how…   Read more»

]]> 2459e1920c060fcdcde6d1f2c27a9fb1 https://medicaldevicecourses.com/activity/p/24035/ Sat, 20 Nov 2021 20:01:01 -0500 Posted by: @hg93 As Dr.Simon have mentioned there are different types of organizational structures. Any project is affected by project management system, culture, style, organizational structure and also project management office can influence the project.According to me, organizational structure is…   Read more»

]]> 15b687a7a543af6333b6b1458bbe2889 https://medicaldevicecourses.com/activity/p/24034/ Sat, 20 Nov 2021 19:00:47 -0500 Personally I seem to like the idea of a Project Based Organization structure. To answer your question on which type of medical device company would benefit the most from this, I would imagine one which mainly focuses on R&D would…   Read more»

]]> 8ba03c90db6d1b13278750879b7f41b8 https://medicaldevicecourses.com/activity/p/24033/ Sat, 20 Nov 2021 18:42:07 -0500 Posted by: @fo3 As we know, forming a project team is partly making sure every member is working toward the same goal(s). Each member should be able to contribute something valuable to the project according to their expertise/role. How would…   Read more»

]]> 844efb10874d96707ec175fd3fd67fc6 https://medicaldevicecourses.com/activity/p/23984/ Fri, 12 Nov 2021 18:33:11 -0500 This brings up a fair point. There is only so much a company can do to reduce the risk to their consumers. At the end of the day, there is not going to be a representative of every company in…   Read more»

]]> 23e7e08f888c64b2d46f11e6f110c162 https://medicaldevicecourses.com/activity/p/23982/ Fri, 12 Nov 2021 18:21:32 -0500 Posted by: @fgk4 The ISO 14971:2012 “Risk management for medical devices” requires manufacturers to reduce risk As Far As Possible without any economical consideration. I consider this a huge Conundrum for all medical device manufacturers. It is a gray area…   Read more»

]]> 48c66975e3db9b33c5bf24c49f215236 https://medicaldevicecourses.com/activity/p/23981/ Fri, 12 Nov 2021 18:13:22 -0500 Posted by: @rajamharrison Do you believe risk management is an important part of the planning phase?  Is it necessary or it is just a waste of money and time? Why? Risk management is an important preventative action that one can…   Read more»

]]> 572de89ebfe796ae150a914bdebfdc75 https://medicaldevicecourses.com/activity/p/23936/ Sat, 06 Nov 2021 01:23:51 -0400 As Ridmehta, mentioned most major projects will come with some surprises. It may be impossible to map out perfectly when each segment a project will be completed down to the minute. However, the Gantt charts serves as a guide and…   Read more»

]]> b5014d9e25f8b1c8fb5c533dcfd15b06 https://medicaldevicecourses.com/activity/p/23935/ Sat, 06 Nov 2021 00:25:25 -0400 Hi Hodafattel, I do not work in the industry, however, I can elaborate on each of the two terms which you have mentioned. Validation is quite important in a product, but it may not need to always be performed. Validation…   Read more»

]]> ef1da489343608c1fccddd0278d19823 https://medicaldevicecourses.com/activity/p/23934/ Fri, 05 Nov 2021 22:44:21 -0400 Posted by: @tulikadasp Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and documented. Design control involves establishing procedures to identify,…   Read more»

]]> a465503592e3e47394ae152891d95108 https://medicaldevicecourses.com/activity/p/23874/ Sat, 30 Oct 2021 23:04:31 -0400 An instance were I had to create a Gantt chart for the project which I was working on was actually my first time doing so. I think the key when creating one is to have in mind that the Gantt…   Read more»

]]> 2049067bbe50c977e5a46a31d97aad7d https://medicaldevicecourses.com/activity/p/23873/ Sat, 30 Oct 2021 22:58:39 -0400 During the slides on design verification, it was mentioned that for verification it is advantageous to catch the issue in the design before the verification protocol and report have been initiated. Catching a problem during the verification phase would require…   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»

]]> 14103768067f0136b6a8851d8c3af027 https://medicaldevicecourses.com/activity/p/23808/ Fri, 22 Oct 2021 17:11:12 -0400 I believe that their are great positives that come with this Act, but also some negatives. Two factors which should largely be considered at play in this case is the risk severity associated with the treatment, and how severe the…   Read more»

]]> 46bd65ecfa881b70ee16b2ed77d06569 https://medicaldevicecourses.com/activity/p/23807/ Fri, 22 Oct 2021 17:04:16 -0400 Like Anthony said, need may also be a driving factor for individuals to enroll in clinical trials. One other form of compensation may be trials which are low risk but the method at which they are performed is providing the…   Read more»

]]> 4803f1f8af98c8ebb98f0832c63ffe8b https://medicaldevicecourses.com/activity/p/23806/ Fri, 22 Oct 2021 16:49:34 -0400 For me personally, I would elect to be a Clinical Quality Auditor (CQA). This is the individual which is responsible for verifying that all records are in compliance with the set standards and guidelines. Since their main function is to…   Read more»

]]> 2850ff81f3ca17251b7f512f448e51a1 https://medicaldevicecourses.com/activity/p/23730/ Fri, 15 Oct 2021 07:23:54 -0400 Generating interest for a product before it is released is difficult to do if you are a medical device company, with respect to the consumer side. Attracting the attention of investors, and perhaps B2B sales is some that may generate…   Read more»

]]> 301f78cefd92e927a551c0719b20b8c4 https://medicaldevicecourses.com/activity/p/23729/ Fri, 15 Oct 2021 07:15:07 -0400 Personally, for me I am just starting out and would prefer to gain more time as an engineer before switching positions later in my career path. I believe that someone who has had a few years as an engineer developing…   Read more»

]]> 67ca6baf877435e625957421784a3b53 https://medicaldevicecourses.com/activity/p/23728/ Fri, 15 Oct 2021 05:56:35 -0400 In this hypothetical company, for the sake of clarity we will name it BioStents. BioStents is a privately owned company based in the US, and is primarily focused in R&D, in which they are developing new materials and innovative structures…   Read more»

]]> 00262db62b10520dfd467d8bef992f2c https://medicaldevicecourses.com/activity/p/23639/ Sat, 09 Oct 2021 03:16:49 -0400 Two well-known medical device companies are Medtronic and Stryker. Medtronic’s market cap is $168.59 billion and Stryker’s is $99.43 billion. Therefore, both are massive companies in the space and each dominate their niche, respectively. In the case of Medtronic, they…   Read more»

]]> 78f2a004e4cfdd21446895d10906a3ab https://medicaldevicecourses.com/activity/p/23638/ Sat, 09 Oct 2021 03:00:50 -0400 Hi Hodafattel, I believe you have a point here in that life saving technology are being milked for their maximum value. From a business perspective, the company is doing exactly what they are supposed to and to that extent, they…   Read more»

]]> c4d7f6cad27a2774336eb5a0ed1b0c54 https://medicaldevicecourses.com/activity/p/23637/ Sat, 09 Oct 2021 02:49:33 -0400 Due to the advantages and disadvantages of s-corporations and c-corporations there are suitable for different types companies depending upon their case. For instance, should someone create a corporation which is relatively small and simply does not have the capital to…   Read more»

]]> 7793f930829da67c0e2fc6de67f9ae1f https://medicaldevicecourses.com/activity/p/23508/ Mon, 27 Sep 2021 20:18:28 -0400 Pulling up the results of many job descriptions when applying you’ll find many postings look for a candidate which has experience and understanding in root cause analysis (RCA). In essence this is a analytical approach towards solving a problem which…   Read more»

]]> 707b34e574b5b8cb3370da3584660094 https://medicaldevicecourses.com/activity/p/23506/ Mon, 27 Sep 2021 19:11:31 -0400 Many have mentioned above the implementation of new technologies such as AI will help measure dimensions and automate processes. This in turn will help and rapidly increase production, since a computer can process data much faster than a human. Another…   Read more»

]]> 91e4e3cb2910175bea75f137de3c14ae https://medicaldevicecourses.com/activity/p/23505/ Mon, 27 Sep 2021 17:27:08 -0400 Quality assurance and quality control are two sides of the same coin. The focus revolves around quality of the product, and for medical devices, this can be vital. Having a defect occur in a product can be costly, and may…   Read more»

]]> eb83c39c124777e43b58e1bf8f8a9e58 https://medicaldevicecourses.com/activity/p/23457/ Sat, 25 Sep 2021 03:29:42 -0400 dcbf3083df543b6f1eb527ea70f36585 https://medicaldevicecourses.com/activity/p/23456/ Sat, 25 Sep 2021 03:26:53 -0400 @jwashin3  Your post here is very insightful as I did not know there was a MASSIVE change regarding what is a 510(k) in recent years. For others who want read the exact details on the amendment, the new process is…   Read more»

]]> b6b2488b76d1f15c4976974cc677587c https://medicaldevicecourses.com/activity/p/23438/ Fri, 24 Sep 2021 05:33:59 -0400 I think one interesting point that this thread has not mentioned is how the pandemic has worsened the backlog of device awaiting approval due to the delays in inspection. According to medtechdive, the FDA still has 3,229 device inspections which…   Read more»

]]> 540e03c1c8c92c73c2f9663c9f35bcee https://medicaldevicecourses.com/activity/p/23437/ Thu, 23 Sep 2021 20:15:46 -0400 ISO 9001:2000 and the FDA’s 21 CFR Part 820 draw many parallels. Both of these two regulations deal with the quality of product’s and how they are produced. The FDA;s regulation is part of CGMP (Current Good Manufacturing Process), this…   Read more»

]]> bf374b1f210ccc5e87b86559753491d8 https://medicaldevicecourses.com/activity/p/23346/ Thu, 16 Sep 2021 17:35:31 -0400 Posted by: @yroberts Preclinical research trials are know to be performed on a single lab creature such as rodent, pig, fruit fly, or monkey. Most recent research appears that having an animal model and conditional differences in the studies can…   Read more»

]]> 7f1bfcd7c92ee95fe703787af10ba316 https://medicaldevicecourses.com/activity/p/23342/ Thu, 16 Sep 2021 07:35:39 -0400 This is a topic which crosses the boundaries between what is ethical and what is not. Several individuals will usually have a different take on the topic and the line drawn for testing varies between person to person. I believe…   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»

]]> 3801831ddaa887fd315333b9f481504f https://medicaldevicecourses.com/activity/p/23227/ Wed, 08 Sep 2021 20:17:40 -0400 Personally, I believe the best manager is someone who had previously done the work, or job, of the people which they is managing. Having that experience makes him/her not only knowledgeable on the subject matter, but it also makes that…   Read more»

]]> ae4fe54626b06ccf1f9d4111bcc18d71 https://medicaldevicecourses.com/activity/p/23226/ Wed, 08 Sep 2021 19:57:34 -0400 Gantt charts provide a good way of scoping out a project and providing leaders and team members with a timeline to follow in order to get things done with what to expect by certain dates. There are times however when…   Read more»

]]> 32a8136fdb1fb10295769249c94282c6 https://medicaldevicecourses.com/activity/p/23225/ Wed, 08 Sep 2021 19:14:47 -0400 One interesting way to view a portfolio is in the same manner as a venture capitalist, this may be, a collection of stocks of companies which you own within certain industries. Therefore when someone describes another portfolio as being quite…   Read more»

]]> 34712d4a770e0b7c54b8780026aff5e2 https://medicaldevicecourses.com/activity/p/23149/ Sat, 04 Sep 2021 02:07:09 -0400 @kmbell Although this question is not directed at me, I will answer. From what I understand, it appears as though you are asking if a sales associate from one company would be “short-ending” himself by moving to a sales position…   Read more»

]]> 8044ea458ccd5cd742a37b21a745d249 https://medicaldevicecourses.com/activity/p/23147/ Sat, 04 Sep 2021 01:47:00 -0400 As I begin my second year into my MS degree, I am also taking my last elective which will satisfy my degree requirements. This accounts for 30% of courses which I have taken in the mechanical engineering program. I think…   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»

]]> 9dba35cd6c925125b61e3952763ccd75 https://medicaldevicecourses.com/activity/p/23137/ Sat, 04 Sep 2021 00:10:34 -0400 0