https://medicaldevicecourses.com/members/as934/activity/ Activity feed for as934. Fri, 24 Apr 2026 17:08:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 e9b482576805eb1f638c9e96acb1756a https://medicaldevicecourses.com/activity/p/19204/ Thu, 28 Nov 2019 01:49:58 -0500 A patent gives the company legal ownership of an idea or design. This allows for the owner of the patent to have exclusive ownership of the idea or design, and gives them the right to sue for patent infringement if…   Read more»

]]> bf43abbbac0f57469b7ddca467e94edb https://medicaldevicecourses.com/activity/p/19203/ Thu, 28 Nov 2019 01:14:40 -0500 While consultants can provide many different areas of expertise, the consultants that I have come across during my career in the medical device industry have mostly been experts in regulatory compliance. Companies may hire compliance consultants to audit their systems…   Read more»

]]> bcd78690d145fc8df8a5b582630da0bb https://medicaldevicecourses.com/activity/p/19202/ Thu, 28 Nov 2019 01:04:28 -0500 I have had two jobs where a non-compete clause in my employment agreement. The first one had clause where I could not work for a competitor within a certain distance from where I was working for six months after leaving…   Read more»

]]> 40fbb6ce913186c8d021dc3ff23256a1 https://medicaldevicecourses.com/activity/p/19174/ Mon, 25 Nov 2019 02:39:40 -0500 When forming a project team, I think it would be best to be able to assemble a team of people who have worked together before and have shown to be able to work well together. However, in many cases the…   Read more»

]]> dfefe1ea43455cc163959172983eb888 https://medicaldevicecourses.com/activity/p/19173/ Mon, 25 Nov 2019 02:29:20 -0500 In my opinion, I think that matrix organizations are the most effective types of organizations. Since employees are still part of a functional department, it can be easier for them to align on certain strategies within their department so that…   Read more»

]]> 6dd3e6facf86e14f7748ad81a14b6d40 https://medicaldevicecourses.com/activity/p/19172/ Mon, 25 Nov 2019 02:17:37 -0500 The organization that I work for would be considered a matrix organization. People are organized by department, and project teams are creating by taking one person from each department. This is useful because there are clear representatives of different functions…   Read more»

]]> 454b3b12868c1d721c092a72d86acc28 https://medicaldevicecourses.com/activity/p/19119/ Mon, 18 Nov 2019 02:50:48 -0500 Post-market surveillance is now required by the FDA. Med device companies must have tracking systems in place, report medical device malfunctions, injuries and deaths, and register where the devices are being built. By conducting post-market surveillance, medical device companies will…   Read more»

]]> 4c73ae72787b7955dfbe517503736791 https://medicaldevicecourses.com/activity/p/19118/ Mon, 18 Nov 2019 02:32:56 -0500 In agreement with some of the replies above, some residual risk is acceptable if it is necessary for the function of the device. In these cases, it is important to consider who will be using the device. For the example…   Read more»

]]> e2ccf753da0e1abb965aaa8db17457ef https://medicaldevicecourses.com/activity/p/19117/ Mon, 18 Nov 2019 02:18:51 -0500 In my experience, FMEA has been the most beneficial tool to use for risk management. Every product in my company has a D(esign)FMEA and a P(rocess)FMEA associated with it to document which failure modes were considered, when their risk index…   Read more»

]]> 9e0e412b07e00ca3ace772f68defb2f6 https://medicaldevicecourses.com/activity/p/19047/ Sun, 10 Nov 2019 23:10:21 -0500 Tests used for design verification must be able to demonstrate that a particular characteristic of the medical device is conforming to the specification. As mentioned in other responses, the FDA does not specifically tell you which tests need to be…   Read more»

]]> b1b8420ea2042f4e43b432276bc08eb6 https://medicaldevicecourses.com/activity/p/19045/ Sun, 10 Nov 2019 22:54:39 -0500 Design Verification testing for any medical device will demonstrate that the product meets all of the specifications listed out in the DSD/Product Specification document. For a balloon catheter, some of this testing may include testing the force required to pull…   Read more»

]]> 246d216a67001ce3471c1f01640d983c https://medicaldevicecourses.com/activity/p/19044/ Sun, 10 Nov 2019 22:37:36 -0500 In my experience there are three parts to process validation: the Installation Qualification (IQ), an Operation Qualification (OQ), and a Process Qualification (PQ). The purpose of the IQ is to ensure that all equipment that it used in a process…   Read more»

]]> ff818c3025d752ed7de280109bce1ada https://medicaldevicecourses.com/activity/p/18972/ Sat, 02 Nov 2019 03:06:37 -0400 In my experience in design review meetings, it is important to be well prepared. Depending on the phase of the design review, the person leading the meeting will send out an agenda with the meeting invitation. He or she usually…   Read more»

]]> 3515504fe44088cef9ef2575327272ea https://medicaldevicecourses.com/activity/p/18970/ Sat, 02 Nov 2019 02:49:21 -0400 As an R&D Engineer, I work with a lot of the types of documents that were described in this weeks lecture. For our Design Input Document (DID) we have a document called a Market Specification, which identifies the market requirements…   Read more»

]]> 566f7d9a40e283e3b0e65028d2ca790f https://medicaldevicecourses.com/activity/p/18968/ Sat, 02 Nov 2019 02:31:25 -0400 When a deviation occurs in a protocol due to a failure, it is often required to investigate the reason why the failure occurred. This investigation is often called a Root Cause Analysis. In a root cause analysis the failure is…   Read more»

]]> 6678c42bdbdfb7450dc06b0d48da0062 https://medicaldevicecourses.com/activity/p/18937/ Mon, 28 Oct 2019 01:25:51 -0400 In a clinical trial, I would perform the monitoring duties. I would choose this because I would be able to travel to all of the locations where the clinical trial is taking place and ensure the integrity of the data…   Read more»

]]> ac880e5b66f1eaf352c781418f7f4409 https://medicaldevicecourses.com/activity/p/18936/ Mon, 28 Oct 2019 01:11:39 -0400 While I have never participated in a clinical trial as an investigator or patient, one idea for being able to track AEs is by having the patient have a wearable device such as an Apple Watch to help monitor patients…   Read more»

]]> 880190e2e5bbe372e717854d97b1a47b https://medicaldevicecourses.com/activity/p/18934/ Mon, 28 Oct 2019 01:03:16 -0400 As mentioned above, responsibility (or blame) may depend on the wording used in the informed consent form and in the ethical practices of the sponsors and investigators running the clinical trial. For example, if the risk of death was mentioned…   Read more»

]]> fdf66f518f114334a42ae6fac7d9165e https://medicaldevicecourses.com/activity/p/18870/ Mon, 21 Oct 2019 00:44:22 -0400 A vision statement is a general and broad statement about what a company wants to accomplish. One example is from Boston Scientific. Their vision statement is, “Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the…   Read more»

]]> 10165f8270156837378aecae0948a5e4 https://medicaldevicecourses.com/activity/p/18865/ Sun, 20 Oct 2019 23:21:18 -0400 One of the advertising campaigns that has stood out has been the Nike poster featuring ex-NFL quarterback Colin Kaepernick. The ad is a close of photo of his face with the words, “Believe in something, even if it means sacrificing…   Read more»

]]> 34cf065f8280e7d2c854652051e6a2c8 https://medicaldevicecourses.com/activity/p/18864/ Sun, 20 Oct 2019 22:49:58 -0400 One of the most common ways that the fifth “P” of marketing is used in today’s environment is by using brand ambassadors on social media. While almost all companies have social media accounts of their own, many count on brand…   Read more»

]]> 59610dea9b88340bc613a7b0f7c63899 https://medicaldevicecourses.com/activity/p/18812/ Mon, 14 Oct 2019 00:43:15 -0400 Choosing a job based on corporate structure is an interesting point to bring up. While I have never formed an opinion of a company solely on whether it was an LLC or a Corporation, I think it is important to…   Read more»

]]> fce987774374a53c2b94e40f4506c028 https://medicaldevicecourses.com/activity/p/18810/ Mon, 14 Oct 2019 00:28:09 -0400 As stated in many of the posts above, the avenue of setting up a business depends on the number of people involved and the type of business being set up. However, one thing that was not mentioned is that it…   Read more»

]]> 4691a30f69f860b01979327b6cf57c8a https://medicaldevicecourses.com/activity/p/18809/ Mon, 14 Oct 2019 00:07:34 -0400 One example for filing for a DBA is for a business which has been bought by a new owner, but continues to operate as the same name. I once worked for a company which operated under a DBA. The situation…   Read more»

]]> 6c19fd0b8ba10dcfc9e00a63a9d7d55a https://medicaldevicecourses.com/activity/p/18735/ Sun, 06 Oct 2019 21:53:29 -0400 One important skill for a QC Engineer to have is investigative skills. The role of QC is not only identifying non-conforming products. Failures sometimes require a root cause analysis. A root cause analysis is a method of identifying the reasons…   Read more»

]]> d753f3a2367c0fe6d0be41442a6c232c https://medicaldevicecourses.com/activity/p/18734/ Sun, 06 Oct 2019 21:37:42 -0400 In my experience, inter-department relationships are best maintained by good communication. The quality signature on a Change Notice can often be the hardest to get, so a strategy that I use is to inform the quality representative of my intended…   Read more»

]]> f8b8fa1ad275498f936dc5690b626a24 https://medicaldevicecourses.com/activity/p/18733/ Sun, 06 Oct 2019 21:14:17 -0400 Using emerging technologies to assist in quality can be a very helpful tool for QA/QC departments. For examples, using AI to perform inspections along the production line can help ensure consistent inspection. This will also help with lean manufacturing because…   Read more»

]]> 15329ad16d34ffb0998b9c4622d4091b https://medicaldevicecourses.com/activity/p/18653/ Sat, 28 Sep 2019 02:33:48 -0400 One of the major recalls in the last few years has been the J&J/DePuy Hip Stem Recall in 2010. The hip replacement was a metal on metal implant which had a high failure rate and was leaving patients unable to…   Read more»

]]> 921bcb87efc3c9038b759f966552be62 https://medicaldevicecourses.com/activity/p/18650/ Sat, 28 Sep 2019 02:11:05 -0400 Working in the medical device industry, it may seem like the FDA rules and regulations are too strict and unnecessary. Compliance and design controls are major things that some companies spend years trying to figure out. However whenever you get…   Read more»

]]> 220c3549328e398345c52352ddfc5ed2 https://medicaldevicecourses.com/activity/p/18649/ Sat, 28 Sep 2019 01:55:47 -0400 For the physician to realize his or her goal of creating a medical device, he or she would need to surround himself with others who are knowledgeable and experienced in product development, process development, quality control, and regulatory affairs. While…   Read more»

]]> 40e142d6901bc65f582f3299e4e65524 https://medicaldevicecourses.com/activity/p/18618/ Mon, 23 Sep 2019 00:43:04 -0400 With several years of product development experience at a medical device company under my belt, I can say that one of the major factors in being able to complete projects is to be able to access more resources when they…   Read more»

]]> 932eeff9fad1c8fb466078a9492977dd https://medicaldevicecourses.com/activity/p/18617/ Mon, 23 Sep 2019 00:22:51 -0400 Animal testing is a crucial part of biomedical research. Before any devices are implanted into humans, we must already have a very good idea of how it will react with the human body. The best way to do this at…   Read more»

]]> 8c3c5b775a712b4260f3c4359cc0a260 https://medicaldevicecourses.com/activity/p/18616/ Sun, 22 Sep 2019 23:13:52 -0400 From the perspective of the project manager, the biomaterial that is chosen for a device can impact the project plan in several ways. First is whether the material is being used for the first time. If the device is made…   Read more»

]]> 4c3115b6f953977e1f6e3dca0cf97024 https://medicaldevicecourses.com/activity/p/18515/ Thu, 12 Sep 2019 03:06:36 -0400 I am in agreement with the other posts above that projects need to meet all three objectives in order to be considered successful. A project can never be successful if it is not achievable, a project that is well understood…   Read more»

]]> 4c1f1d3e71a5d1065acfe5fa9452e1c3 https://medicaldevicecourses.com/activity/p/18514/ Thu, 12 Sep 2019 02:51:22 -0400 One thing that comes to mind when discussing combination devices is the regulatory pathway that it will take. The FDA has three seperate departments for reviewing products. Medical devices fall under the Center for Devices and Radiological Health (CDRH), drugs…   Read more»

]]> 63ef15930a45f192eb74b058b9f19c8d https://medicaldevicecourses.com/activity/p/18508/ Wed, 11 Sep 2019 01:31:42 -0400 The general phases of project management will be the same in different industries, since this is how the process has been developed and has proven to be effective. However, the nature of different projects will determine what tasks are involved…   Read more»

]]> 95209101a5baa434fd8cbb0440f1f93a https://medicaldevicecourses.com/activity/p/18496/ Mon, 09 Sep 2019 13:11:43 -0400 One difference that stands out to me between academia and industry is the source of funding. Researchers in academia often need to seek out funding in the form of grants for the particular research that they are trying to conduct….   Read more»

]]> 81379f6d5c4d4ef215730c9ca8547c4d https://medicaldevicecourses.com/activity/p/18493/ Mon, 09 Sep 2019 01:50:48 -0400 My advice to biomedical engineering student is to network and to go for internship/co-op experience which will expose you to design controls. It is important to develop contacts in the industry in order to hear about opportunities that may not…   Read more»

]]> 6db49856ca0f8d4a9b838bc2bf07a8ea https://medicaldevicecourses.com/activity/p/18492/ Mon, 09 Sep 2019 01:38:55 -0400 As someone working in industry, I think that a student who is fresh out of school and looking to go into industry needs to have at least one of these courses under their belt. The 70/30 ratio would do well…   Read more»

]]> 4e0e8f9256b13cddf1ece2f915e1eaea https://medicaldevicecourses.com/activity/p/18491/ Mon, 09 Sep 2019 01:25:22 -0400 One difference that stands out to me between academia and industry is the source of funding. Researchers in academia often need to seek out funding in the form of grants for the particular research that they are trying to conduct….   Read more»

]]> e1150cf124fa8398bb7d729626d2feea https://medicaldevicecourses.com/activity/p/16010/ Wed, 15 May 2019 19:16:08 -0400 One thing that I would like to expand on from ap962’s post is assigning a dedicated vendor manager. It is good to have a single person designated as the contact person with a vendor in order to avoid sending the…   Read more»

]]> b1d71be7bd618c6193c4c1bd55c5aa9c https://medicaldevicecourses.com/activity/p/16006/ Wed, 15 May 2019 19:16:05 -0400 It is possible for a project to have multiple priorities, but it is important to make sure that these are included in the scope of the project. It is also important to remember that widening the scope of the project…   Read more»

]]> 39bbc2c770cf0d2bbca0256afa0d6547 https://medicaldevicecourses.com/activity/p/16000/ Wed, 15 May 2019 19:16:02 -0400 Once of the most important things that I will take away from this course is the value of good planning. In industry, I have been part of project teams with poor planning and with good planning. On the projects with…   Read more»

]]> 6505fae6956c736e9c2524317aeeaf09 https://medicaldevicecourses.com/activity/p/15872/ Wed, 15 May 2019 19:14:48 -0400 Preparing a schedule for a clinical trial is done using the same tools that were used for others projects: by creating a WBS and a Gant Chart. The WBS should include pre-study tasks, study tasks, and post-study tasks layed out…   Read more»

]]> 63fdf99eae599fd9994a7eefcbe6c526 https://medicaldevicecourses.com/activity/p/15871/ Wed, 15 May 2019 19:14:48 -0400 I think that it is a combination of the culture in America as well as the individual’s inner motives. America’s businesses are valued at how successful they are, and 50-60 hour work weeks stem from the idea that working longer…   Read more»

]]> 3966efc7a057e9471b96662543355ac5 https://medicaldevicecourses.com/activity/p/15870/ Wed, 15 May 2019 19:14:47 -0400 Retaining good talent is important, especially within medical device companies where historical knowledge of the product is very valuable. As stated in the posts above, the key to retaining good employees lies in keeping them motivated. On a scale of…   Read more»

]]> db89c8770e2c71a511fcf21deb49d196 https://medicaldevicecourses.com/activity/p/15752/ Wed, 15 May 2019 19:13:33 -0400 An excellent point that ks629 brought up is that historical knowledge of the products at a medical device company is invaluable to the company. If a company has a culture where engineers are hired only for the duration of a…   Read more»

]]> 735b2a3fdfd0e5733be5f0b06cbdfe7d https://medicaldevicecourses.com/activity/p/15751/ Wed, 15 May 2019 19:13:33 -0400 While it may be beneficial to have a broad communication management plan defined in an SOP, I think that communication management plans tailored to individual projects are more beneficial. This allows for the Project Manager to lay out exactly how…   Read more»

]]> f1b94c94c56ed3a5b4cc6be25e454b91 https://medicaldevicecourses.com/activity/p/15750/ Wed, 15 May 2019 19:13:32 -0400 One of the most important things to have included in a vendor contract is the condition that they need to notify your company about any changes that they have made or are going to make to the components that they…   Read more»

]]> fc61a847e7835ce52c4b49b39319e42e https://medicaldevicecourses.com/activity/p/15634/ Wed, 15 May 2019 19:12:21 -0400 Changes can be made to design control documents, SOPs, DMR, BOM, DID, DDP, DSD, verification/validation protocols, and the risk management plane. Changes will go through a design review process during which documents are reviewed, changes are made if necessary, and…   Read more»

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