https://medicaldevicecourses.com/members/aohara/activity/ Activity feed for aohara. Sat, 25 Apr 2026 01:24:17 -0400 https://buddypress.org/?v= en-US 30 hourly 2 252a40a36f89a47ba81da3b9673cb7bc https://medicaldevicecourses.com/activity/p/21042/ Sat, 28 Nov 2020 02:02:22 -0500 I also found these restrictions to be quite ridiculous, especially not being able to pay for the physicians spouse. However, I do understand why these regulations are in place and what they are preventing. As Professor Simon had mentioned in…   Read more»

]]> 37ed66071455e993bb0f7300a5dcd364 https://medicaldevicecourses.com/activity/p/21041/ Sat, 28 Nov 2020 01:50:17 -0500 Although recognized as a legal contract, I personally do not think verbal agreements, especially on behalf of a company, should be used. As Professor Simon had also mentioned in the video lecture, there are 5 parts every contract must have,…   Read more»

]]> 3f4edc44a388725e5e66f6223976b4f6 https://medicaldevicecourses.com/activity/p/21040/ Sat, 28 Nov 2020 01:37:42 -0500 Being that the only experience in industry I’ve had is the position I currently hold at a medical device manufacturing company, I found this course to be immensely helpful and somewhat like a roadmap. Prior to this semester, I was…   Read more»

]]> eb03322eee78421bf5ff39df6b1487d9 https://medicaldevicecourses.com/activity/p/20992/ Sun, 22 Nov 2020 19:06:40 -0500 I agree that the size of the company and the product being produced plays a large role in deciding which is the best organizational structure. For smaller companies, I can see the benefits of having a functional structure because the…   Read more»

]]> 273f760ad963ff4fafa4cdb56bf7fca9 https://medicaldevicecourses.com/activity/p/20991/ Sun, 22 Nov 2020 18:33:46 -0500 The medical device development company I currently work at has a functional organization type. As Professor Simon had explained in his lectures, this is where the company is structured into departments that are each run by a manager and the…   Read more»

]]> 5ef0fff18dbeb22342a5ca7f239a9d37 https://medicaldevicecourses.com/activity/p/20988/ Sun, 22 Nov 2020 18:13:54 -0500 Although it is rare you are able to directly chose each individual on your entire project team, I believe a diverse group who holds expertise in varying departments is necessary for a projects success. Depending on the organizational structure of…   Read more»

]]> e464c694c768b78291513e14de69afa0 https://medicaldevicecourses.com/activity/p/20937/ Mon, 16 Nov 2020 01:32:42 -0500 When identifying and analyzing risks, there are tools that can be used such as brainstorming, failure mode effects analysis (FMEA), fish bone diagrams etc. to help lay out why the risk is present, how failures can occur, the probability of…   Read more»

]]> 8efc16ee8ea2a435a6138dc575a0fc91 https://medicaldevicecourses.com/activity/p/20933/ Mon, 16 Nov 2020 01:11:10 -0500 Within the risk management process, there are four stages which include analysis, evaluation, management, and measurement. Once we have identified and categorized each risk in the analysis, assigned probability of occurrence and considered severity in the evaluation, we move into…   Read more»

]]> d9e0e101dbd650f0a80cb4cd8f2d9c8a https://medicaldevicecourses.com/activity/p/20931/ Mon, 16 Nov 2020 00:44:39 -0500 There are four ways to manage risk: avoidance, mitigation, acceptance, and transference. Transference is basically transferring the risk elsewhere and not commonly used in medical device development. However, one of the remaining three tactics must be considered in order to…   Read more»

]]> a8171a9487295e22e1d928a916b439d8 https://medicaldevicecourses.com/activity/p/20871/ Mon, 09 Nov 2020 04:33:01 -0500 Dr.Simon’s stress on the importance of meeting minutes is for good reason. To begin, meeting minutes are an all encompassing record of what took place during the meeting. This can include the date and time of the meeting, who attended,…   Read more»

]]> 68bde805a850f0a1a1fc5acffd45ca0c https://medicaldevicecourses.com/activity/p/20861/ Mon, 09 Nov 2020 03:32:03 -0500 I agree that one way to keep the DHF audit ready is to ensure the document is “living” and accurate to the product currently being produced. Although, I would like to bring up some of the risks associated when auditing…   Read more»

]]> a33348dfed4e36040c26843f5375bf1b https://medicaldevicecourses.com/activity/p/20746/ Fri, 30 Oct 2020 23:24:12 -0400 Design controls are an elemental piece of getting a well-thought out idea on a piece of paper to a manufactured reality. Design controls include nine parts: planning, input, output, review, verification, validation, transfer, design changes and the design history file….   Read more»

]]> 5e661035700186d8a4df6af7eea722d9 https://medicaldevicecourses.com/activity/p/20742/ Thu, 29 Oct 2020 02:42:00 -0400 Although I have not had the opportunity to prepare a Gantt Chart for the company I work at in industry, I did have to include this in my senior design capstone proposal and got a brief introduction into what should…   Read more»

]]> c9eeab0e0e9f2127b6d7ed61cd0609e7 https://medicaldevicecourses.com/activity/p/20741/ Thu, 29 Oct 2020 02:12:28 -0400 Outsourcing the design transfer can be beneficial in many ways, such as cost efficiency or a shorter time to market. However, and possibly bias because I am currently a supplier quality intern at a medical device manufacturing company, I believe…   Read more»

]]> e8623f8424aa69bd8db1e5241acb57fb https://medicaldevicecourses.com/activity/p/20716/ Sun, 25 Oct 2020 20:55:28 -0400 I would respectfully disagree that only medical devices have been proven to improve human health, and not pharmaceuticals. In addition, a drug does not need to cure a disease in order to be classified as effective or safe. Reducing side…   Read more»

]]> 281f26321a371bd87d24aaa45308f192 https://medicaldevicecourses.com/activity/p/20705/ Sat, 24 Oct 2020 21:08:04 -0400 I agree with the last statement that clinical studies are necessary for discovery, although I am conflicted with risking human lives for such advancements. It would not be possible to administer a treatment and have an understanding of its effects…   Read more»

]]> 7c1c0296cdeea671a91599d69aa65036 https://medicaldevicecourses.com/activity/p/20704/ Sat, 24 Oct 2020 20:37:58 -0400 I do believe that having a clinical background would be of benefit in certain roles, such as the Principle Investigator or the Study Coordinator. Mostly because these are individuals that would be dealing directly with the patients and reporting any…   Read more»

]]> 54e7092a4e4b52fe57a14f98e07a0da4 https://medicaldevicecourses.com/activity/p/20641/ Sat, 17 Oct 2020 21:12:37 -0400 Rather than being considered separate entities, let us think of sales as a subcategory within product management. Product management is considered over the life cycle of a product. And once past the developmental stages, sales should be ready to commence….   Read more»

]]> 70465bfce2f31c6b0aa1b8e5d8b244fc https://medicaldevicecourses.com/activity/p/20640/ Sat, 17 Oct 2020 20:41:38 -0400 The function of product development is to plan how to develop a new product, actually manufacture it, and sell the product to consumers. There are a few moving parts that go into the development of a product, but most of…   Read more»

]]> eba1ff87c4563e305dee7ee7e32d2b69 https://medicaldevicecourses.com/activity/p/20639/ Sat, 17 Oct 2020 20:19:58 -0400 Advertising is a critical component of marketing, and if not executed effectively, could be the make or break of a product. Within the Four P’s of Marketing, advertising falls under promotion. There are many different ways to promote a product,…   Read more»

]]> 9669159bc0b12ebc78996afd825f128e https://medicaldevicecourses.com/activity/p/20576/ Fri, 09 Oct 2020 04:38:54 -0400 Prior to this lecture, I don’t believe I really put any thought into this topic. To say I’m an engineer, it makes sense that I was unfamiliar with just about all of the corporation types, and what exactly each one…   Read more»

]]> 0450ab647f2a422a0171218e4b56a225 https://medicaldevicecourses.com/activity/p/20575/ Fri, 09 Oct 2020 04:22:12 -0400 In short, there really is not a correct answer to this question. Although of course an influence, the type of corporation chosen will not determine if a business is going to be successful or not. Many more factors, other than…   Read more»

]]> c8d0c220286698cfadce4309c56161d7 https://medicaldevicecourses.com/activity/p/20573/ Fri, 09 Oct 2020 03:55:16 -0400 It is true that the initial cost of investment with a partnership will be split between the partners; however, I would not consider this a lower risk for a few different reasons. First, just as you are splitting the cost…   Read more»

]]> 7ff5b357628709bda127d9bbd867bbb5 https://medicaldevicecourses.com/activity/p/20532/ Sun, 04 Oct 2020 22:53:43 -0400 As I am still new in industry, I have yet to meet someone who believes Quality is a burden; but from the perspective of a Supplier Quality Engineering Intern, if I ever do meet someone who believes this, I would…   Read more»

]]> b8a76a7adf941cff13d5e8a7a59a59ab https://medicaldevicecourses.com/activity/p/20531/ Sun, 04 Oct 2020 22:36:09 -0400 A Form 483 is given by the FDA when a company fails to comply with the practices set in place by their own Quality Management System (QMS) or the FDA’s standard regulations. I believe the analogy of receiving a speeding…   Read more»

]]> 369f958a7c300f1120574104208f7177 https://medicaldevicecourses.com/activity/p/20528/ Sun, 04 Oct 2020 11:08:15 -0400 I do agree there is a game being played between physicians and drug companies- you go to the doctor, tell them what’s wrong, they prescribe you some pills and you hopefully feel better soon. Well, if that weren’t the case,…   Read more»

]]> 74f1d0d91a1bb1156d1625eda6c6e8c0 https://medicaldevicecourses.com/activity/p/20454/ Sun, 27 Sep 2020 17:56:25 -0400 Accuracy is defined as how well a value agrees with the a standard measurement of comparison. In regard to medical devices, accuracy can mean a few things. First, the accuracy that the product proves to be effective in its intended…   Read more»

]]> d96b72212073770f608999c434d2fe2a https://medicaldevicecourses.com/activity/p/20453/ Sun, 27 Sep 2020 17:29:06 -0400 There are many challenges that go into the creation of a medical device, whether that it be novel or a predicate device. During the pre-market lifecycle of the product, the physician must go about defining exactly what kind of medical…   Read more»

]]> bb850b70d44e6c878bcacf8ddf5879f8 https://medicaldevicecourses.com/activity/p/20452/ Sun, 27 Sep 2020 16:54:29 -0400 During this MDD course is the first I was made aware of what the FDA’s mission statement is. I actually giggled out loud at the second portion which claims they are “advancing the public health by helping to speed innovations…   Read more»

]]> 2b12caee901ff95869c35e71e91515d9 https://medicaldevicecourses.com/activity/p/20339/ Thu, 17 Sep 2020 01:59:45 -0400 I would like to respond to this question by respectfully challenging the initial hypothesis of academic research creating results for future generations, and industry for now. In a sense, I believe this to be true. Although there is the perspective…   Read more»

]]> e92102a463a30c23045dc187f61c6d56 https://medicaldevicecourses.com/activity/p/20337/ Thu, 17 Sep 2020 01:09:10 -0400 To answer the first question posed regarding if projects in industry are successful- well, yes. In fact, many times in industry, a company’s success is based off the success of their projects. Projects are obviously focused on the objective at…   Read more»

]]> 82c3e8eba61746d43990d7f4d6b3ac7f https://medicaldevicecourses.com/activity/p/20336/ Thu, 17 Sep 2020 00:38:39 -0400 I unfortunately do not believe there is a current alternative that can produce results as reliable and meaningful than on living animal subjects when testing for safety and efficacy of a product on living human subjects. Recent technological advancements have…   Read more»

]]> 1efc781154529b83d1658e56f16b333e https://medicaldevicecourses.com/activity/p/20262/ Fri, 11 Sep 2020 22:20:56 -0400 I also do not have much experience within the industry and am only speaking from an academia perspective in terms of project management, however, I believe there are a few commonly overlooked attributes in identifying a good project manager. The…   Read more»

]]> 8ac0bc0dcaafc340b158aecdf06b036d https://medicaldevicecourses.com/activity/p/20261/ Fri, 11 Sep 2020 21:38:58 -0400 I have not had the opportunity to work on a project where there were multiple project managers, although depending on the size of the project, I do think this method could be more efficient in some cases. Having multiple project…   Read more»

]]> 421ab8c977f79b91e562104f3a32ab9a https://medicaldevicecourses.com/activity/p/20260/ Fri, 11 Sep 2020 21:25:12 -0400 While working on my Capstone Design Project with a team of six, it was very difficult to find time outside of class for everyone to meet. The focus of our project was to prototype a functional near-infrared spectroscopy (f-NIRS) cap…   Read more»

]]> bfa9353eaf05d72a26d54b209852aad5 https://medicaldevicecourses.com/activity/p/20174/ Thu, 03 Sep 2020 04:35:12 -0400 Good topic- I feel like this is a common struggle, especially coming out of undergrad. I believe a BS is the minimum requirement to obtain any sort of industry or academia job in BME. An MS/ME provides benefits of a…   Read more»

]]> f8347116471d6e9aa7c677d6a34a1cdd https://medicaldevicecourses.com/activity/p/20173/ Thu, 03 Sep 2020 04:07:49 -0400 BME is definitely a broad degree and depending on where the education is from, can be taught in many different ways- such as theory vs practical. One of the main reasons I decided to pursue my Masters in Biomedical Engineering…   Read more»

]]> 48f81bacb261b38919964d8875a5b622 https://medicaldevicecourses.com/activity/p/20172/ Thu, 03 Sep 2020 03:43:04 -0400 I am also new in my career as a Biomedical Engineer and find myself struggling over the decision to pursue a career in academia vs industry. I resonated with the conclusion stated by kak33 to become a Research Engineer because…   Read more»

]]> bf73f76c8b33a85091c0b0dfb3b31ab5 https://medicaldevicecourses.com/activity/p/20168/ Thu, 03 Sep 2020 02:42:29 -0400 0