https://medicaldevicecourses.com/members/james-olson/activity/ Activity feed for James Olson. Sun, 15 Nov 2026 11:42:43 -0500 https://buddypress.org/?v= en-US 30 hourly 2 63e3e607945da81f11a6daf1ca99173d https://medicaldevicecourses.com/activity/p/60134/ Thu, 05 Nov 2026 00:12:53 -0500 I was also very interested in the difference between validation and verification! I never really put too much thought into it, as before last week’s lecture I was unaware of the difference between design input and design specifications. As for…   Read more»

]]> c2680d8c7b871e3d0fc84bfdbd2ad3e2 https://medicaldevicecourses.com/activity/p/60133/ Wed, 04 Nov 2026 23:28:10 -0500 @31623940 I agree that the intended setting and user for the product greatly affects how the design should accommodate the user. I would like to bring up that decisions are often made to prioritize making the device as accessible as…   Read more»

]]> 5f60e2c97ff424cdb7c47b4df26734c4 https://medicaldevicecourses.com/activity/p/60132/ Wed, 04 Nov 2026 22:31:06 -0500 The fundamental difference between the definitions of design inputs and design specifications leave plenty of opportunity for an instance where verification is passed but validation is failed. An example that comes to my mind would be a heart rate monitor…   Read more»

]]> 4d1dfe13bf21c516b92fb18130bfdc77 https://medicaldevicecourses.com/activity/p/59918/ Thu, 29 Oct 2026 23:47:18 -0400 @bryan-xavier I would say the most important threshold to meet for a design review is the consensus around whether or not the device addresses its user need. Though this is very broad, the function of the device should be the…   Read more»

]]> fc4555d1a4a30c1b763b31570fc36f80 https://medicaldevicecourses.com/activity/p/59916/ Thu, 29 Oct 2026 23:25:59 -0400 @shreya I would say that requiring diversity-based simulations would increase safety to some degree. However, I don’t believe the lack of simulations solely caused the DePuy incident to occur. Restating what @bryan-xavier said, I think it’s very likely the incident…   Read more»

]]> 169b2fd81d8a5ee4b8e723f7f3e1ec29 https://medicaldevicecourses.com/activity/p/59914/ Thu, 29 Oct 2026 22:53:52 -0400 One limitation/complication that may not come to mind at first would be the presence of national regulations in the case that the contract manufacturing company is international. In the medical device industry, the OEM is responsible for adhering to regulatory…   Read more»

]]> 1101a62af6eda141ed52c872fdf029e6 https://medicaldevicecourses.com/activity/p/59705/ Mon, 26 Oct 2026 02:04:03 -0400 When I searched up Good Clinical Practices, one of the first jobs listed is a Clinical Quality Assurance Program Lead. The role consists of providing quality oversight of the company’s various clinical trials, ensuring FDA guidelines are met. In regards…   Read more»

]]> a54c8127b1e5e6ef0a1a8645f0af2c79 https://medicaldevicecourses.com/activity/p/59699/ Mon, 26 Oct 2026 01:21:38 -0400 Researchers should always prioritize the safety of the patient first and foremost. Specific parameters for initial trials should be based on sound results from animal testing. Before a project moves on to clinical trials, rigorous animal trials are completed to…   Read more»

]]> 4fe758c63e4e745329256afd0e54a276 https://medicaldevicecourses.com/activity/p/59671/ Sun, 25 Oct 2026 22:08:54 -0400 @aysegultinas I agree that being upfront about the informed consent can greatly help build trust between the investigators and the subjects in the case of a blind study. I would like to further emphasize how useful everything disclosed in the…   Read more»

]]> f586c7a85e12d70c103194cecc9b4765 https://medicaldevicecourses.com/activity/p/59110/ Sun, 18 Oct 2026 19:46:32 -0400 @andrewg I disagree, and feel that physicians should not be compensated for recommending products due to ethical concerns and the potential for financial conflicts of interest. I think physicians should be compensated for providing feedback and evaluation of new products…   Read more»

]]> 934c90cbeec843fb4a4a36843bea8859 https://medicaldevicecourses.com/activity/p/59108/ Sun, 18 Oct 2026 19:27:14 -0400 I agree with the general consensus, that product is the most important factor in whether a hospital adopts a new device, as well as long term sales of the device. However, I would like to add to the discussion the…   Read more»

]]> c5c71da66a9e5c031fc5e015390373e2 https://medicaldevicecourses.com/activity/p/59105/ Sun, 18 Oct 2026 18:30:07 -0400 I believe that one of the most important things a medical device company can do when developing a new product is to get significant input from the sales team. As we learned about through this week’s lectures, the sales team…   Read more»

]]> 920456f3482deb6281ae6539d105d898 https://medicaldevicecourses.com/activity/p/58940/ Sun, 11 Oct 2026 21:50:55 -0400 Upon further researching this topic, I discovered it is legally possible for one type of corporation to convert to a different type of corporation outside of the C-Corp S-Corp conversion we learned about during this week’s lecture (ex: a sole…   Read more»

]]> 398effb362874b02ba9d541765650499 https://medicaldevicecourses.com/activity/p/58936/ Sun, 11 Oct 2026 19:13:18 -0400 @imarah-ar    Physicians must make a risk vs reward decision when deciding when to pursue innovation. When a new technology or treatment is authorized for medical use, choosing to adopt it immediately may result in greater financial success, as patients…   Read more»

]]> fd63680c55bccb19e8e723f5963e571f https://medicaldevicecourses.com/activity/p/58933/ Sun, 11 Oct 2026 18:49:04 -0400 @andrewg I believe those first two tradeoffs you mentioned can be remediated by hiring supervisors to ensure your company standards are being met by the company you are outsourcing to. While this doesn’t address the potential problem of working around…   Read more»

]]> 6835ed7aa39320439ef681407221a27f https://medicaldevicecourses.com/activity/p/58857/ Sun, 04 Oct 2026 04:23:57 -0400 A possible method to improve communication between QA and QC is to have them in the same department, which is done relatively often in smaller companies. Even if there are still two separate divisions, having them in close proximity should…   Read more»

]]> 317aede4920b796bb55e8dd76ed1b589 https://medicaldevicecourses.com/activity/p/58856/ Sun, 04 Oct 2026 03:57:22 -0400 I believe quality assurance is a much more difficult task compared to quality control. Spotting a defect takes a lot less effort than reverse engineering the process and determining what caused that defect to occur. The conceptual nature of QA…   Read more»

]]> bb1eb2938fc93ecec7e81b39bf1a290b https://medicaldevicecourses.com/activity/p/58853/ Sun, 04 Oct 2026 02:21:47 -0400 @jfm23 I agree that QC/QA should be an independent body, specifically to ensure a QC/QA professional is always in the building. However, as @31623940 touched on, the responsibilities of QC/QA should not only fall on that body. I would consider…   Read more»

]]> c972f280924bcb8a239821424103be87 https://medicaldevicecourses.com/activity/p/58717/ Sun, 27 Sep 2026 04:41:38 -0400 @raina I was under a very different impression about Regulatory Affairs! Before this week’s lecture, I thought that Regulatory Affairs was basically synonymous with Quality Assurance in a company. After looking into it more, I realized they do have similar…   Read more»

]]> d4d06ca9c7017a21886841dec71d11be https://medicaldevicecourses.com/activity/p/58716/ Sun, 27 Sep 2026 03:35:10 -0400 I don’t necessarily think the 501(k) process discourages innovation, but it does definitely make the approval process easier if a medical device is close enough to an existing product. Saving some time and effort getting the product approved is beneficial,…   Read more»

]]> 59db1ae60d279a180566d7107b84e76a https://medicaldevicecourses.com/activity/p/58697/ Sat, 26 Sep 2026 23:26:28 -0400 @ma3295 I would agree that reapproval is needed in many cases of updating the AI in a medical device, but not all cases. I view the AI as a part of the device that contributes to the success of the…   Read more»

]]> b6c8a9cc072f398682366e75d1c3bf1e https://medicaldevicecourses.com/activity/p/57999/ Mon, 21 Sep 2026 02:26:58 -0400 @pz98 I would say that in industry, long term goals are just as important as short term goals. While they provide results faster when compared to when the goal is formed, they often cannot allow the company to succeed alone….   Read more»

]]> c53c6deb2e3c8c86ad74189476db70d8 https://medicaldevicecourses.com/activity/p/57969/ Sun, 20 Sep 2026 23:06:41 -0400 @ahmed-elmonier I would definitely say the level of evidence needed before moving on should depend on the details of the condition. For example, if a new technology is being developed to potentially reduce the deterioration of a degenerative muscular disease,…   Read more»

]]> cfcbacdd4bc737f0c627ed6ffd6d3557 https://medicaldevicecourses.com/activity/p/57963/ Sun, 20 Sep 2026 22:29:10 -0400 @ahmed-elmonier I wouldn’t use an outside lab for industry for the reason you mentioned, the reduced control and monitoring over the lab. For projects to maintain consistent deadlines, adding a non-affiliated entity to the project has increased potential for miscommunication…   Read more»

]]> e0e79f10e31537f52ec2ea0ba40c761b https://medicaldevicecourses.com/activity/p/57228/ Sat, 12 Sep 2026 21:50:25 -0400 I would agree that people not doing their share of the work is a major problem in teamwork in general, but I would argue that in the workplace, disagreement over ideas would be a larger problem. In the competitive engineering…   Read more»

]]> 5d53328676e3364e5f808f2af7f8bca9 https://medicaldevicecourses.com/activity/p/57227/ Sat, 12 Sep 2026 21:17:45 -0400 During my internship at a medical device company, I made use of Microsoft Excel and PowerPoint to document my progress. Excel has multiple built-in templates to help with work breakdown structure, including multiple types of Gantt Charts, a project date…   Read more»

]]> 05eef2f756149907385b6cfac4cbe4e1 https://medicaldevicecourses.com/activity/p/57223/ Sat, 12 Sep 2026 19:31:15 -0400 @andrewg I would agree that working on the initiating phase for an extended period of time stagnates the project and can lead to deadline issues later on. However, I wouldn’t say that less emphasis should be placed on the initiating…   Read more»

]]> a273ceaf0ed3b929b563ea54aaf0150e https://medicaldevicecourses.com/activity/p/56961/ Fri, 04 Sep 2026 00:26:09 -0400 If I could redesign any medical device, I would attempt to change the current design of an artificial larynx. The original device is incredibly useful for its ability to allow those with damaged vocal cords to communicate with a voice…   Read more»

]]> f4eaaa3bf79f38592d9e76b2e2dce25f https://medicaldevicecourses.com/activity/p/56958/ Thu, 03 Sep 2026 23:32:56 -0400 While I agree that it is definitely unreasonable for students to balance full time work and a full courseload, I would say that it is worth doing if the opportunity is presented to you. Last semester I worked a 20…   Read more»

]]> 5e1be96388a34fa868527d4e78dd5f24 https://medicaldevicecourses.com/activity/p/56956/ Thu, 03 Sep 2026 22:58:02 -0400 I agree that both industry and academia both have great impact and promise, but I’d like to add that how fulfilling each is highly dependent on your unique needs, personality and abilities as a person. For example I feel like…   Read more»

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