https://medicaldevicecourses.com/members/srg36/activity/ Activity feed for srg36. Fri, 24 Apr 2026 17:20:38 -0400 https://buddypress.org/?v= en-US 30 hourly 2 2762eea86227fff119ba28ba2698726e https://medicaldevicecourses.com/activity/p/15967/ Wed, 15 May 2019 19:15:42 -0400 I have been working as an engineer for 3 years and enjoy what I am doing. I still am not sure if I want to take a technical or managerial career path. I think I would like to gain some…   Read more»

]]> c29b9cf14af77709550b4adfa3662de4 https://medicaldevicecourses.com/activity/p/15966/ Wed, 15 May 2019 19:15:41 -0400 I think there is another very important aspect to this topic that I would like to bring up. I think it is important that managers recognize what type of work motivates their employees, and give them more opportunities to do…   Read more»

]]> 4eba6980c8257ab3de7c41a81946ebcd https://medicaldevicecourses.com/activity/p/15959/ Wed, 15 May 2019 19:15:37 -0400 The division of the company that I work for only submits 510k applications, and the FDA cost associated with submitting a 510k is $10,566. In 2016, the average time to get 510k clearance was 177 days. Just recently, my company…   Read more»

]]> 4942950c98b1f9a1fd65099259789d3d https://medicaldevicecourses.com/activity/p/15956/ Wed, 15 May 2019 19:15:36 -0400 Several of the posts above mentioned how that retention is important because new hires need time to get trained in their job, and I want to emphasize that this can have a huge impact on a project. New employees will…   Read more»

]]> 1190bd94351a276eb17ab01b04bcf9e7 https://medicaldevicecourses.com/activity/p/15830/ Wed, 15 May 2019 19:14:22 -0400 I agree with everyone above that I found these classes very beneficial to me, and especially the topics covered in AMDD helped me gain a better understanding of process validation. The simulations were very realistic, and overall, both MDD and…   Read more»

]]> 11d9803219e164bc78899520ca6b0b48 https://medicaldevicecourses.com/activity/p/15829/ Wed, 15 May 2019 19:14:22 -0400 My company recently underwent a restructuring and recently formed a new clinical department. Before this we really did not focus our efforts on clinical studies, as we were releasing products via 510ks that were similar to other products in the…   Read more»

]]> d81e7d889a141c5d38f461fa1070580d https://medicaldevicecourses.com/activity/p/15825/ Wed, 15 May 2019 19:14:14 -0400 Comparing the simulations with my experience in industry, I can say that they are very representative of what happens in industry. Often after submitting a proposed solution Dr. Simon would come back with something that we hadn’t thought about, and…   Read more»

]]> 9de1f3ee257cded6c93ebc2730854664 https://medicaldevicecourses.com/activity/p/15824/ Wed, 15 May 2019 19:14:14 -0400 I think there should be different levels of rewarding motivation, so team motivation should be rewarded separately from individual motivation. For example, teamwork is encouraged, but it makes sense that each individual would get rewarded differently because each person contributed…   Read more»

]]> 9f8748fd740b82880a66dbafd74226fa https://medicaldevicecourses.com/activity/p/15823/ Wed, 15 May 2019 19:14:13 -0400 In my career thus far I have definitely found that challenging and interesting work created the most motivation for me, similar to the results of the poll that Dr. Simon showed in his lecture. When I first started my job,…   Read more»

]]> 7719a5a2040220ad3996ccbcf289de60 https://medicaldevicecourses.com/activity/p/15740/ Wed, 15 May 2019 19:13:27 -0400 A CAPA really just provides a systematic way for companies to address nonconformances, fix them, and prevent them from happening again. One benefit of using a CAPA to do this rather than just doing it in a haphazard manner is…   Read more»

]]> 2da1ee9ac0f4052704b976fe26917815 https://medicaldevicecourses.com/activity/p/15738/ Wed, 15 May 2019 19:13:26 -0400 Based on my experience in industry, internal audits are conducted on a regular basis (usually once a year) by someone who works for the company. This is just a requirement that most companies have in their procedures and makes sure…   Read more»

]]> 3ef7f063f9a9dacdc654c3d872aa1a20 https://medicaldevicecourses.com/activity/p/15736/ Wed, 15 May 2019 19:13:24 -0400 I think kak33 gave a very good explanation of an effective way to bring up this topic with management. An employee needs to take the initiative to write out exactly why they think that additional headcount is needed. Like kak33…   Read more»

]]> 498145c7dc412bc11456762231a8697d https://medicaldevicecourses.com/activity/p/15734/ Wed, 15 May 2019 19:13:24 -0400 I think one of the pitfalls of the WBS could be not breaking it down far enough. We learned that it is important to break down each task into subtasks and so on so that when you are completed, you…   Read more»

]]> dc2a0f9a0e740950bbd74acad7f7f031 https://medicaldevicecourses.com/activity/p/15733/ Wed, 15 May 2019 19:13:23 -0400 I think krp67 brings up a very interesting and important topic in regards to communication techniques and style for medical device projects, and I think many projects struggle simply because of poor communication. I think the 2 major forms of…   Read more»

]]> ecc569f97f44b3af96283fa5230ae455 https://medicaldevicecourses.com/activity/p/15704/ Wed, 15 May 2019 19:13:02 -0400 I think that a good strategy could be to select a different coating from the same supplier as a short term solution to reduce sourcing risk while keeping the project on track and not causing any delays to the project…   Read more»

]]> d1e3bcebbb57186667d4046678516b69 https://medicaldevicecourses.com/activity/p/15669/ Wed, 15 May 2019 19:12:43 -0400 At my company, we recently updated our design control procedures, and in the updated procedure there was a clause that said that this procedure update applied to newly chartered projects or projects where the team decided to migrate to the…   Read more»

]]> 95431dec26c2c5c12e16db1951a79cfd https://medicaldevicecourses.com/activity/p/15668/ Wed, 15 May 2019 19:12:43 -0400 As tn58 mentioned that there are three types of nonconformances: minor, major, and critical, I would also say that another huge factor that determines the type of nonconformance is when the nonconformance was found. If it was caught prior to…   Read more»

]]> 213e22478e4779258432f1fb056473f2 https://medicaldevicecourses.com/activity/p/15667/ Wed, 15 May 2019 19:12:42 -0400 I agree that small companies would most likely hire an outside contractor to perform an audit if they do not have the resources to do their own internal audit. However, sometimes even larger companies hire independent contractors to perform audits,…   Read more»

]]> 0f5ce724855131403be7f757f0123e7d https://medicaldevicecourses.com/activity/p/15597/ Wed, 15 May 2019 19:08:04 -0400 Similar to aij5, I have had quite a bit of experience working on ECO’s (my company calls them CCFs (Change Control Form)) for a product that my company acquired and it was already on the market. Unfortunately, it was a…   Read more»

]]> ea68e9d98656e24632204821570a05ae https://medicaldevicecourses.com/activity/p/15596/ Wed, 15 May 2019 19:08:04 -0400 I have worked on another project where it failed because of issues that it was having in the field. Our company acquired the product from another small start up company, and since the product was already 510k cleared and released…   Read more»

]]> 06003f79dd07b323d15621731d8d2694 https://medicaldevicecourses.com/activity/p/15585/ Wed, 15 May 2019 19:07:57 -0400 I agree with all the posts above explaining the value of metrics, but I do think there can reach a point where a company can over-track metrics to a point that it becomes burdensome on the project. If having good…   Read more»

]]> 88ad6a838b597ddb568e607b256ed7fe https://medicaldevicecourses.com/activity/p/15579/ Wed, 15 May 2019 19:07:53 -0400 Many of the posts above mentioned that often rather than killing a project, it is just placed on hold until circumstances permit it to continue, and I think this is very true, but I also liked how that hm243 and…   Read more»

]]> 92c6a113bed96f05753210dc5cf0dabd https://medicaldevicecourses.com/activity/p/15465/ Wed, 15 May 2019 19:06:39 -0400 From my experience in industry I have seen several product failures, and one of them was particularly interesting. The product was a spinal implant with unique fixation features. During development of the product, there was a lot of excitement because…   Read more»

]]> e96e9267f56df44d437ca7418b33d0cd https://medicaldevicecourses.com/activity/p/15464/ Wed, 15 May 2019 19:06:38 -0400 One of the biggest hurdles my company has overcome in order to drive more innovation was similar to the point Dr. Simon mentioned in his lecture, about how companies often try to drive their innovation projects with their current operations….   Read more»

]]> 433b12be0d8448d2de8628298ea9c37e https://medicaldevicecourses.com/activity/p/15448/ Wed, 15 May 2019 19:06:29 -0400 I wouldn’t necessarily say they are the most important parts of the entire project, but I would agree that these are very important aspects of the executing phase of a project. Having poor communication, selecting the wrong suppliers, or not…   Read more»

]]> 3ac6a0d3c0d457899d73d88f201518f9 https://medicaldevicecourses.com/activity/p/15447/ Wed, 15 May 2019 19:06:28 -0400 I think those were very good points mentioned by cs22 and msc52njit-edu. Although I do agree that it can be more beneficial in the long run to delay the project in order to fully resolve an issue, I do think…   Read more»

]]> 71059fd5e67013998ab9a99b64eb8b4a https://medicaldevicecourses.com/activity/p/15446/ Wed, 15 May 2019 19:06:28 -0400 In addition to the factors mentioned by msc52njit-edu that can negatively impact the SV of a project, from my experience working on medical device projects one of the factors which often had a negative impact on SV was supplier delays….   Read more»

]]> 679acb778da00cd7f86cdbc482750da1 https://medicaldevicecourses.com/activity/p/15379/ Wed, 15 May 2019 19:05:44 -0400 In my company, there are 2 main categories for our testing deviations: deviating from a standard, or deviating from the protocol. For testing our implants we follow ASTM standards for our testing procedures, but there are certain tests where we…   Read more»

]]> 446cf0155e0a7b1e00fb9be6a95dafd3 https://medicaldevicecourses.com/activity/p/15377/ Wed, 15 May 2019 19:05:43 -0400 I think the best strategy is to get the disagreeing parties together in a room and have a face to face meeting so that everyone can understand the full picture and determine a strategy for moving forward. A very important…   Read more»

]]> 052065d3a15b44c456c54daf63baabd0 https://medicaldevicecourses.com/activity/p/15376/ Wed, 15 May 2019 19:05:43 -0400 A good way to prevent scope creep is to gather inputs from the customer early on in the project and lock down the scope as early as possible. I agree with cdj24 that in some cases scope creep can be…   Read more»

]]> d9f33d955df83f1f4aea9a9457a68a6f https://medicaldevicecourses.com/activity/p/15286/ Wed, 15 May 2019 19:04:51 -0400 In my company, the first step in performing a change is to submit a change request via our Windchill software. This request goes to the change administrator who either approves or reworks the change request. Once approved, a request goes…   Read more»

]]> 6d27d4118a86a9606490dac3b35918d0 https://medicaldevicecourses.com/activity/p/15260/ Wed, 15 May 2019 19:04:31 -0400 I agree with the posts above that state that it is important that medical device companies have both a proactive and reactive risk management system in place. Although I agree that being proactive and trying to prevent failures from happening…   Read more»

]]> 3b75a995d7b65123a1f9bc74263a6399 https://medicaldevicecourses.com/activity/p/15259/ Wed, 15 May 2019 19:04:31 -0400 I agree with the 6 steps outlined by moniquet07. I would just like to elaborate on the importance of the PM developing the the task scheduling with input and feedback from the resources who will be executing the tasks. The…   Read more»

]]> 0202634f3b132545a0e5ce876a6dcf76 https://medicaldevicecourses.com/activity/p/15258/ Wed, 15 May 2019 19:04:30 -0400 I have experienced this situation several times in projects, and I believe that often it is due to a lack of understanding of these seemingly simple parts of the project that may take much more time than is budgeted for….   Read more»

]]> e657f68c151c6dd32d33e513f7711e08 https://medicaldevicecourses.com/activity/p/15165/ Wed, 15 May 2019 19:03:37 -0400 Similar to Viraj D, I’m familiar with FDA regulations from my experience in industry, but I really didn’t understand EU regulations until I took this class, so I found it very interesting to learn about the differences and similarities between…   Read more»

]]> 1c613578003ecf7c6e09d198a2bc91b6 https://medicaldevicecourses.com/activity/p/15161/ Wed, 15 May 2019 19:03:35 -0400 In my company our process validations include machining validations, welding validations, validation of assembly fixtures, and finishing validations, such as electropolish validations. One of the validations that we always struggle with is welding validation, and this is mainly due to…   Read more»

]]> 10e5a30ec8d8538d94a716f370221127 https://medicaldevicecourses.com/activity/p/15155/ Wed, 15 May 2019 19:03:31 -0400 Although proper use of project management tools can definitely mitigate the risk of pitfalls, as wms7 mentioned, even in relatively simple projects, the unexpected will almost always happen. However, when you use these tools effectively, they can be very useful…   Read more»

]]> 116b78532a2fade00a4f1f4109b65f35 https://medicaldevicecourses.com/activity/p/15142/ Wed, 15 May 2019 19:03:24 -0400 From my experience with working on projects in industry, I would agree with the above posts that often during a project, it is necessary to go back to the planning phase to re-evaluate the project based on the current situation….   Read more»

]]> a9113ef8e21ef444559a4c0ff1edd46a https://medicaldevicecourses.com/activity/p/15139/ Wed, 15 May 2019 19:03:23 -0400 I did my undergraduate degree at NJIT in ME, and I thought that I got a decent amount of exposure to technical writing, especially in the form of lab reports. Although it may not be the same as design control…   Read more»

]]> 21ca25adc7332876c153c596227ce3f2 https://medicaldevicecourses.com/activity/p/15131/ Wed, 15 May 2019 19:03:18 -0400 I agree with the posts above that the inputs for the DID should be gotten directly from the end user or customer. In my company the marketing department is responsible for gathering VOC (voice of customer) inputs and using this…   Read more»

]]> 48508aaa39b7dca8ff5c5d431dbf70b4 https://medicaldevicecourses.com/activity/p/15038/ Wed, 15 May 2019 19:02:30 -0400 I agree with those who said that SOPs are not needed for the research phase of a project. It is important to remember that SOPs are very specific, detailed instructions that tell how you how to perform a routine procedure,…   Read more»

]]> d8caaabc94c9a11281140b25796ab6c6 https://medicaldevicecourses.com/activity/p/15027/ Wed, 15 May 2019 19:02:24 -0400 Most of the posts above state that the SOP should be a very detailed document, and I agree with that as well, but I also like the comments made about being concise. There is a difference between being detailed and…   Read more»

]]> d5a2835725d586ba21ae9a7e9b766366 https://medicaldevicecourses.com/activity/p/15022/ Wed, 15 May 2019 19:02:16 -0400 I have sat in on and been an active participant in many design review meetings in my company, and I would like to comment to djr32 that although it may seem outdated to have a scribe for a design review…   Read more»

]]> 22fa979f5b0f994fbef3de601adf1e2a https://medicaldevicecourses.com/activity/p/15021/ Wed, 15 May 2019 19:02:15 -0400 From my experience there is not necessarily a risk/benefit ratio, but rather the company performs an analysis where they weigh all the risks and compare them to the benefits and make a decision whether or not to proceed with the…   Read more»

]]> eca313be1222e272193a65618f1a7f59 https://medicaldevicecourses.com/activity/p/15020/ Wed, 15 May 2019 19:02:14 -0400 If I were a PM running a risk management meeting, I would first create a timeline of events with my team from the time the device is shipped out of the manufacturing facility till the time it is implanted in…   Read more»

]]> 59cd74f1048426b913cd7b08d18590ec https://medicaldevicecourses.com/activity/p/14911/ Wed, 15 May 2019 19:01:18 -0400 In medical device projects that I have worked on and am working on, one of our most important external stakeholders are our suppliers. We do not do any in house manufacturing, so we rely on vendors to manufacture all of…   Read more»

]]> 333ab2ea52c9cc31686bdabbee07fa11 https://medicaldevicecourses.com/activity/p/14903/ Wed, 15 May 2019 19:01:14 -0400 The purpose of an ECO is to provide a framework for making a change to a product once it is already released to the market. Going through the ECO process makes sure that you check everything that was checked during…   Read more»

]]> 691ba79b12cd77109431dc85c5fd2aaa https://medicaldevicecourses.com/activity/p/14902/ Wed, 15 May 2019 19:01:13 -0400 I agree with the above posts regarding the strategies used in post market surveillance (PMS) as well as the benefits obtained from doing PMS. I would like to add to the conversation by describing another beneficial aspect of doing thorough…   Read more»

]]> 8cc2496ed93d8dbcbde176ac8ef3e24c https://medicaldevicecourses.com/activity/p/14898/ Wed, 15 May 2019 19:01:10 -0400 Packaging development is a very important part of a medical device project, and in my company, we have engineers who are dedicated to package development. For packaging, and especially sterile packaging, the tests that are performed are usually very standardized,…   Read more»

]]> f16014f5c938ff6ab65797eb5e1443f2 https://medicaldevicecourses.com/activity/p/14896/ Wed, 15 May 2019 19:01:09 -0400 I agree that choosing the right project team is a very important part of the project initiation phase. However, in almost any team, there will probably be a few team members who do not get along very well. From my…   Read more»

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