https://medicaldevicecourses.com/members/mattie718/activity/ Activity feed for Mattie718. Fri, 24 Apr 2026 17:22:27 -0400 https://buddypress.org/?v= en-US 30 hourly 2 3fa60ebc9d6678f8881e0cbd47c51418 https://medicaldevicecourses.com/activity/p/18407/ Wed, 15 May 2019 21:48:03 -0400 This is one of the main reasons I left a previous job, there was poor Human Resource Management. Sometimes there would be insane deadlines put on project deliverables and even if the employee worked extremely hard and did a good…   Read more»

]]> d56cafb8e2e0af38acc05205d72ed812 https://medicaldevicecourses.com/activity/p/18406/ Wed, 15 May 2019 21:48:02 -0400 I completely agree with your point that using a supplier as a backup to itself doesn’t make much sense. The point of having a dual source is to ensure complete independence assuming there are any problems with one of them….   Read more»

]]> d2a99e4cabab1c44c03fabfbc913f495 https://medicaldevicecourses.com/activity/p/18405/ Wed, 15 May 2019 21:48:01 -0400 I have had to source vendors several times at my work for different equipment and material needs. Sometimes all it starts with is a good old google search to get it going and find all the different suppliers. Usually you…   Read more»

]]> 6699748ad95b766d031849ae1927533e https://medicaldevicecourses.com/activity/p/18099/ Wed, 15 May 2019 21:45:24 -0400 While project processes and design controls are not directly related, it is pretty standard that verification will be achieved through the executing phase of the large-scale project. Since verification will certainly be done through a series of testing protocols, it…   Read more»

]]> ade4cb1af3bc8a03df1d93c189f05c52 https://medicaldevicecourses.com/activity/p/18098/ Wed, 15 May 2019 21:45:23 -0400 In the medical device industry there are countless things which need to be documented according to the FDA which may seem monotonous but are all the same mandatory. My company was audited by the FDA for several weeks and they…   Read more»

]]> 24c1343cafa3dee5adea91fb72be77de https://medicaldevicecourses.com/activity/p/18097/ Wed, 15 May 2019 21:45:23 -0400 There are many obstacles to consider when attempting to ramp up something from prototype to mass production. Usually a Performance or Process Qualification protocol will need to be completed to prove there is long-term stability and quality built in to…   Read more»

]]> 22ab2091d13ff9c005497610b3749500 https://medicaldevicecourses.com/activity/p/18096/ Wed, 15 May 2019 21:45:22 -0400 Money is one of the main driving factors for any project. Many people including investing stakeholders, upper management, and customers are all concerned with how much money the project is consuming. Planned Value and Earned Value can be compared to…   Read more»

]]> 6a36415c7d633d1f62db4d016c5d4e8e https://medicaldevicecourses.com/activity/p/18092/ Wed, 15 May 2019 21:45:20 -0400 Going with the category of mobile applications, food intake trackers would be considered general wellness products. Apps like MyFitnessPal allow you to log what you are eating and drinking in order to determine how many calories you consume daily. This…   Read more»

]]> d888197e5f8d6a78289c02bf3247c1f6 https://medicaldevicecourses.com/activity/p/18091/ Wed, 15 May 2019 21:45:20 -0400 I think project managers are like a lot of different professions in that you are very specialized in certain types of projects. There are some universal principles such as the initiate, plan, execute, monitor/control, and close phase cycle. These are…   Read more»

]]> 392bf26369b1dd9234630d621c413c02 https://medicaldevicecourses.com/activity/p/18090/ Wed, 15 May 2019 21:45:19 -0400 While some products age different than others, i think this results from how much innovation is possible. Sutures are very simple in that it is basically just nylon wire. There is not much that can be improved on this. In…   Read more»

]]> 2384b17bea41622b50ec66423df01e24 https://medicaldevicecourses.com/activity/p/18089/ Wed, 15 May 2019 21:45:19 -0400 The FDA classification system seems fine for the most part. There have been previous issues with the “predicate device” exemption when companies try to base this off something that was developed more than 15 years ago. Technology has improved so…   Read more»

]]> dc617c24690ab2457c447f520f6f05f9 https://medicaldevicecourses.com/activity/p/18088/ Wed, 15 May 2019 21:45:18 -0400 As someone who has witnessed some design review meetings succeed and fail, there are some things you can do to ensure success. As @vcf3 mentioned, the attendees of the meeting have a high chance of ignoring you completely and showing…   Read more»

]]> e6d07ea1b1afe8196dc1dc04a37f751d https://medicaldevicecourses.com/activity/p/18087/ Wed, 15 May 2019 21:45:17 -0400 Dr.Simon has mentioned multiple times the importance of this in his lectures. It is part of the project manager’s responsibility to create a log of some sorts which details everything that worked and everything that failed during the course of…   Read more»

]]> b90a1be48b291a03d814b3b691084494 https://medicaldevicecourses.com/activity/p/17931/ Wed, 15 May 2019 21:43:57 -0400 I currently work in the manufacturing department of a medical device company. A lot of the principles from this class tie into what goes on in an everyday basis, but perhaps on a smaller scale. Not everybody is responsible for…   Read more»

]]> 358bf9c4041f5649ce62eea3d4973b58 https://medicaldevicecourses.com/activity/p/17930/ Wed, 15 May 2019 21:43:56 -0400 I sort of had a similar experience in Capstone as my group had to keep a detailed log of everything that was working out for us and more important what was not working. Our advisor let us find out for…   Read more»

]]> 035beb840685c74ded06bd19eb10c708 https://medicaldevicecourses.com/activity/p/17791/ Wed, 15 May 2019 21:42:40 -0400 I can see how this could be a common problem in industry, especially when Project Managers get requests from stakeholders not directly involved in planning or executing the project. One day you are on track, have a budget established, and…   Read more»

]]> 0f1dacbe399205a4518fce675bbccdff https://medicaldevicecourses.com/activity/p/17790/ Wed, 15 May 2019 21:42:39 -0400 There are many reasons why a certain product or process will require changes during its life cycle. One example could be cost. To attain certain tight tolerances, material purity, or other favorable physical characteristics, companies may have to pay a…   Read more»

]]> 6eaed00a0a2d996e13f30f95e133cc4e https://medicaldevicecourses.com/activity/p/17787/ Wed, 15 May 2019 21:42:38 -0400 There are plenty sources of input to pool from when developing the Design Input Document (DID). Other than the marketing department you should be collecting information from external such as consumers and doctors. Consumers can be useful by supplying knowledge…   Read more»

]]> 2c2cb1e614088832346d5c700f8a6518 https://medicaldevicecourses.com/activity/p/17694/ Wed, 15 May 2019 21:41:50 -0400 I do not think this is a problem as there have probably been hundreds of medical devices approved using predicate devices and which have probably benefited society due to the faster track of class 2 devices. just because it has…   Read more»

]]> 70e05f5ac371446c8ff3a5fac22a2e0e https://medicaldevicecourses.com/activity/p/17693/ Wed, 15 May 2019 21:41:50 -0400 I currently work as a manufacturing engineering co-op for a medical device company which is most like a functional organization. Each department has their own managers (Manufacturing, Quality, Purchasing, R&D) and they usually conduct work independently on projects concerning the…   Read more»

]]> d2f5e7c4ea18c59cfb2470ae2842fe20 https://medicaldevicecourses.com/activity/p/17690/ Wed, 15 May 2019 21:41:48 -0400 I think there are different situations with the labeling which could result in either immediate corrective action or even a recall. As we have have heard before, labeling is one of the three core components of what constitutes a medical…   Read more»

]]> dab319adf01adb48263ccf9a7d73b98a https://medicaldevicecourses.com/activity/p/17613/ Wed, 15 May 2019 21:41:03 -0400 While this could make it easier to globalize healthcare and allow for easier import/export of drugs and devices, I think it will make it harder to bring new products to the market in the first place. Assuming there is one…   Read more»

]]> 1f17190b7f85ed40b2e08896ee9dbd80 https://medicaldevicecourses.com/activity/p/17612/ Wed, 15 May 2019 21:41:03 -0400 I do think that interpersonal skills are a tremendous asset in the workplace, I do not think that people can just fake their way through without a good basis of technical understanding. Going so far to say they you only…   Read more»

]]> cb54b798a16dda444da55716600a10b2 https://medicaldevicecourses.com/activity/p/17611/ Wed, 15 May 2019 21:41:02 -0400 To me, this is probably one of the hardest part of the design process. There are many problems associated with creating tolerances for various aspects of the product. On the one hand if you make the tolerance too tight, it…   Read more»

]]> cc3e94121db4eb36f8384066891a2978 https://medicaldevicecourses.com/activity/p/17353/ Wed, 15 May 2019 21:38:46 -0400 I do think these restrictions are a bit too harsh. Sure expensive steak and wine dinners are not the most useful allocation of resources but I also do not think someone is swayed into a huge business agreement just because…   Read more»

]]> a25f28b77721d77f8735c9d29c1d0b9a https://medicaldevicecourses.com/activity/p/17351/ Wed, 15 May 2019 21:38:45 -0400 Dr. Simon, As someone who has been working at a medical device company for almost a year, I found this extremely relevant and helpful. It sort of reinforced some of the ideas I already had about the roles of certain…   Read more»

]]> 85889eb8e37449d88f6543b5804ffc15 https://medicaldevicecourses.com/activity/p/17350/ Wed, 15 May 2019 21:38:45 -0400 This is an interesting dilemma you brought up. I think you should divulge as much information as possible under the protection of the Non-Disclosure Agreement since it will be very difficult for the Consultant to help you if you don’t….   Read more»

]]> ff9cbe90d849ceded26d3966f9951b4f https://medicaldevicecourses.com/activity/p/17254/ Wed, 15 May 2019 21:37:59 -0400 I think as a project manager you would want a matrix structure. Project-based structure lacks efficiency in that there can be members of the team who are specialized in certain areas, but that area is not needed for that project.For…   Read more»

]]> fe581b85fe6360d73a028786d1e679a5 https://medicaldevicecourses.com/activity/p/17253/ Wed, 15 May 2019 21:37:58 -0400 While these two are similar, I think education really separates these two levels of management. Being an engineer I am more inclined towards being involved in middle management as those are the people who go and get things done at…   Read more»

]]> 2816dd26fa6ec37d6d46e13bea34f480 https://medicaldevicecourses.com/activity/p/17252/ Wed, 15 May 2019 21:37:58 -0400 I currently work as a manufacturing engineering co-op for a medical device company which is most like a functional organization. Each department has their own managers (Manufacturing, Quality, Purchasing, R&D) and they usually conduct work independently on projects concerning the…   Read more»

]]> e8dd6aae7228b5c99c19eec1ec56783f https://medicaldevicecourses.com/activity/p/17204/ Wed, 15 May 2019 21:37:30 -0400 If the risk has been deemed acceptable enough to reach the end user then I believe the best way to mitigate the risk is to have a scrupulously detailed Instructions For Use (IFU). Sometimes companies will have to determine if…   Read more»

]]> b0136ee64c8a5f046b6548f679483837 https://medicaldevicecourses.com/activity/p/17203/ Wed, 15 May 2019 21:37:30 -0400 You mentioned two of the big factors: Severity (S) of the failure and Occurrence (O) of the failure. These determine how serious the problem is, and how often it happens. A third factor which my company uses is the Detection…   Read more»

]]> 0433b096ac6191792242292ee2587952 https://medicaldevicecourses.com/activity/p/17201/ Wed, 15 May 2019 21:37:29 -0400 I would like to point out that no matter how creative and methodical you are, there will be risks that you will not be aware of until something goes wrong. The Failure Mode and Effects Analysis tool is a live…   Read more»

]]> 2c47b6a7008f235248aa0dde895f18ac https://medicaldevicecourses.com/activity/p/16998/ Wed, 15 May 2019 21:35:47 -0400 The Design Input Document (DID) and Design Specification Document (DSD) are very similar, but I think they belong to distinctly different steps in the product development life cycle. The DID is meant to be just the big picture type of…   Read more»

]]> c4a706925ff348f1ec332c45599af9cc https://medicaldevicecourses.com/activity/p/16993/ Wed, 15 May 2019 21:35:45 -0400 Working in industry, I am aware of design review meetings which happen almost weekly. One of the many engineers will have some sort of change which affects the inputs or outputs of the process or product, and this needs to…   Read more»

]]> eb96b67c072108897fdf347e0df5d913 https://medicaldevicecourses.com/activity/p/16986/ Wed, 15 May 2019 21:35:41 -0400 As mentioned above, verification is one of the most integral parts of the design control process and probably where engineers encounter the most problems. This is the first step where you really get to see if your prototype is on…   Read more»

]]> f3fce1fd5d100f8f17f5b2c12d356b5e https://medicaldevicecourses.com/activity/p/16871/ Wed, 15 May 2019 21:34:42 -0400 I think this law is huge step forward on the clinical world. I can only imagine the difficulty that comes with finding willing participants for certain experiments. Dr. Simon mentioned some college buddies who would try these new drugs in…   Read more»

]]> 0e6a247f28bb03287ef3f43a4efc7e30 https://medicaldevicecourses.com/activity/p/16870/ Wed, 15 May 2019 21:34:42 -0400 Personally, I do not agree with either statement made above. First, I am sure there are medical devices which have failed to improve human well-being or have even backfired and caused unintentional harm during clinical trials. Perhaps the metal being…   Read more»

]]> f97a2293c6bce5091c3fac264a892e66 https://medicaldevicecourses.com/activity/p/16867/ Wed, 15 May 2019 21:34:40 -0400 I think it is very situational as to the qualifications for each position involved in the clinical. The investigator is someone who should probably have a clinical background, but may pass if they have certain other qualities. Since they will…   Read more»

]]> de46d93d710c00a288592505d047f659 https://medicaldevicecourses.com/activity/p/16755/ Wed, 15 May 2019 19:42:16 -0400 This was a very creative form of satire which highlights sometimes the disconnect between management and engineering. Obviously there were some requirements which were laid out in this video and the leader of the company wanted to do everything in…   Read more»

]]> 911b48e9f4bbc155e7a96801ed7ddf84 https://medicaldevicecourses.com/activity/p/16754/ Wed, 15 May 2019 19:42:16 -0400 I do agree to a certain extent that marketing has a manipulative aspect to it, but it depends on the product. Manipulation implies there is deceit behind the veil of the advertisement. If a company is hiding unfavorable side effects…   Read more»

]]> 1ea74a63aff51b8c6f2ac27bee960511 https://medicaldevicecourses.com/activity/p/16738/ Wed, 15 May 2019 19:42:08 -0400 One popular trend in the social media era of today is marketing products through popular influencers on various sites. This is probably most prevalent on Instagram where people can seamlessly integrate certain products into their everyday photo posts. Many times…   Read more»

]]> 8e55a6f4782529d3c3566ffe37ad7443 https://medicaldevicecourses.com/activity/p/16672/ Wed, 15 May 2019 19:41:28 -0400 Partnerships are sometimes a good idea, but you need a strong foundation to build off of. All throughout college you are apart of different class projects in which you must rely on people to make certain decisions and complete certain…   Read more»

]]> 056fc5d20fd2cce8eb32d3f305d55e4d https://medicaldevicecourses.com/activity/p/16671/ Wed, 15 May 2019 19:41:27 -0400 There are several key differences between public and private companies. Public companies can be owned by an almost unlimited amount of shareholders and stocks are traded publicly on the stock market. Owners of this stock may receive dividends for each…   Read more»

]]> 768cabd5956af1b69fc3d5eb2839bdd8 https://medicaldevicecourses.com/activity/p/16669/ Wed, 15 May 2019 19:41:26 -0400 I think it all comes down to the type of person you inherently are: risk-averse tolerant. This is usually applied when talking about investing in money, but can also be applied here when undertaking a business venture. Like you said,…   Read more»

]]> da3b1a3e1c6c045e8cf1e7114b4d425e https://medicaldevicecourses.com/activity/p/16535/ Wed, 15 May 2019 19:40:05 -0400 I think the best way to ensure Document Control requirements are fulfilled is to train the engineers to those high standards as soon as they start working. I know when i first started working I had to thoroughly read a…   Read more»

]]> b8e3bf7d462e81833ec347957156c9ce https://medicaldevicecourses.com/activity/p/16533/ Wed, 15 May 2019 19:40:04 -0400 I work for a company that was audited for several months and it was a very stressful time for not only Quality and Regulatory, but for basically every department. It is a complete effort to comply with the demands of…   Read more»

]]> dfe763abed1ca4681dce0fcb0e4567d7 https://medicaldevicecourses.com/activity/p/16530/ Wed, 15 May 2019 19:40:03 -0400 I currently work for a mid-size medical device company and while I do not think there is technically bad blood between Quality and the other departments, tensions sometimes escalate. I am in the manufacturing department and often times there are…   Read more»

]]> aacb308930e1b48816b6d5b9c2e8a3d8 https://medicaldevicecourses.com/activity/p/16417/ Wed, 15 May 2019 19:39:02 -0400 As stated before there are many reasons for a recall to occur. From personal experience I do not think it is the FDAs fault most of the time. The only reason it would be is a lack of auditing a…   Read more»

]]> d5168698ebb874a198646bd3ecbc9e16 https://medicaldevicecourses.com/activity/p/16416/ Wed, 15 May 2019 19:39:01 -0400 Device: Antibiotic-Releasing Hip Stem Type: Combination of a device (hip stem component) and a drug (antibiotic component) but the primary mode of action is as the hip implant. This product will then need a Request For Designation (RFD) to allocate…   Read more»

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