https://medicaldevicecourses.com/members/alexandrabuga/activity/ Activity feed for alexandrabuga. Fri, 24 Apr 2026 18:53:59 -0400 https://buddypress.org/?v= en-US 30 hourly 2 7a9a027240cecc80535db36c5754be7b https://medicaldevicecourses.com/activity/p/16061/ Wed, 15 May 2019 19:16:40 -0400 Yes as @srg mentioned the 501k rates. Just to add ot the conversation as per Medical Device User Fee Amendments to the FDA Reauthorization Act (MDUFA IV) through 2022: 2018 standard rate for 510k is $10,5666 and small business is…   Read more»

]]> ce4f52fe25567e8d40ed1693f17e9566 https://medicaldevicecourses.com/activity/p/16060/ Wed, 15 May 2019 19:16:39 -0400 I agree with others that the Design History File (DHF) is a living document. The FDA states that ” the DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved…   Read more»

]]> ad11e58b2bd62019acf0e8530ef70a53 https://medicaldevicecourses.com/activity/p/16059/ Wed, 15 May 2019 19:16:38 -0400 There’s a new EU Medical Device Regulation (MDR) that will be effective in 2020 This article goes into the “6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation”: 1. Plan Ahead 2. Conduct a…   Read more»

]]> ad29720ad8959738d4ccaa20593df393 https://medicaldevicecourses.com/activity/p/16058/ Wed, 15 May 2019 19:16:38 -0400 This example is out of the scope of what I encounter with my job responsibilities but I agree with how others have stated that if the equipment is going to be taken a part and moved to a new location…   Read more»

]]> 9df5bb4148829ac5996b7652bdaadcb6 https://medicaldevicecourses.com/activity/p/16057/ Wed, 15 May 2019 19:16:37 -0400 Yes, I agree with Ashley that its good to set buffers in your schedule to account for the unexpected. At Sloan, if I’m working on a project-especially the development of a medical device- I always include buffers to my timeline….   Read more»

]]> 0ef67183c0eee94ac1e8abf6982c1730 https://medicaldevicecourses.com/activity/p/16056/ Wed, 15 May 2019 19:16:37 -0400 To add to conversation, I agree with @krp67 that people “fudging” the data is unethical but people are bound to do this in order to promote themselves in some way to advance, look good, etc. I agree that if I…   Read more»

]]> e30930cd7957b1f213a5e9c2dd54858e https://medicaldevicecourses.com/activity/p/16055/ Wed, 15 May 2019 19:16:36 -0400 Reading this discussion about FDA regulation and example of acupuncture made me think of whole body cryotherapy. I myself have actually done a few cryotherapy sessions and reading this was curious to see what the FDA had approved. Interestingly enough…   Read more»

]]> 259ca26b573767d1f1ed9cabf3784d22 https://medicaldevicecourses.com/activity/p/16054/ Wed, 15 May 2019 19:16:36 -0400 As @hc255 mentions the burst test. I actually YouTube’d different burst tests and it is has proven extremely informative and entertaining. It is really interesting to watch the video examples to see how the different testing is done. Some even…   Read more»

]]> 2c39bc88504c1073bd70e10e1d5935bf https://medicaldevicecourses.com/activity/p/16053/ Wed, 15 May 2019 19:16:35 -0400 @f-dot, I agree that the FDA does have to stay on top of modern day devices applications, but don’t think modern day technologies need a different classification system. I think it is still useful to a classification system based on…   Read more»

]]> 295e359357a271bb5db8f971c5e6265f https://medicaldevicecourses.com/activity/p/16052/ Wed, 15 May 2019 19:16:35 -0400 I think this is a portraying an emergency situation which would require a quick Yes or No to use an unapproved medical device. I think as we learned with IRB, that it would also need IRB clearance. I can’t think…   Read more»

]]> cfa3fcd7672481822cbd675648c407ba https://medicaldevicecourses.com/activity/p/16051/ Wed, 15 May 2019 19:16:34 -0400 I agree with @williamzembricki and @rjs84 that label is crucial and if something happens to the labels that just as important as the product. In some cases FDA requires a certain font to make sure the user can read and…   Read more»

]]> 1c6f9d14f70f5dcfa987bb774349251d https://medicaldevicecourses.com/activity/p/16050/ Wed, 15 May 2019 19:16:33 -0400 I agree with @zw2 that FDA regulations aren’t perfect, but I think the regulations and guideline documents really set the bar to ensure to the best of the its abilities the safety and effectiveness of devices. Sometimes companies follow all…   Read more»

]]> 47b930816d243bb34682cde710e400a6 https://medicaldevicecourses.com/activity/p/16049/ Wed, 15 May 2019 19:16:33 -0400 To add to the conversation, it is first to file in the U.S.-this means that if this really is a good idea for a commercially viable product, you should file before a potential competitor does. It used to be that…   Read more»

]]> 585a404db3c4c5044d35c66a65ce987e https://medicaldevicecourses.com/activity/p/16035/ Wed, 15 May 2019 19:16:25 -0400 To add to the conversation, I think its important to select a good vendor. In selecting a vendor, you should meet with them and see if they have a client that would be willing to speak with you to discuss…   Read more»

]]> b5694382f5f5f33095ffde6f27df0e1a https://medicaldevicecourses.com/activity/p/16032/ Wed, 15 May 2019 19:16:24 -0400 Yes, I believe most projects have multiple priorities. At Sloan when we have medical device project in our group we usually break it down into I. Development-Scientific II. Development-Business III. Intellectual Property (IP) Protection and Prosecution. Development and IP are…   Read more»

]]> 2d7d7bca3240d6a1f459b1e9fea711fe https://medicaldevicecourses.com/activity/p/16029/ Wed, 15 May 2019 19:16:23 -0400 I agree that it does require social skills and this classes forces you to experience real life situations. For example with the simulations you are assigned a group, you don’t get to select the people you work with that maybe…   Read more»

]]> 7bff52441dc1c12d5a00df685af9ebe2 https://medicaldevicecourses.com/activity/p/16024/ Wed, 15 May 2019 19:16:15 -0400 Just to add to the conversation of determining Significant vs Non significant risk medical device studies, the FDA has a guidance document. https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf The guidance document is intended to provide information and advice to sponsors, clinical investigators, and IRBs on…   Read…[Read more]

]]> f27dd3d32768b7f6b5708a9f5c2b33ea https://medicaldevicecourses.com/activity/p/16020/ Wed, 15 May 2019 19:16:13 -0400 I agree that MDD and AMDD have been integral in providing me the necessary platform not only for my other classes, but for my career. I currently work on the business end, but I am new to the medical device…   Read more»

]]> b37f625881faa7832d91dc9fc7ce046b https://medicaldevicecourses.com/activity/p/16019/ Wed, 15 May 2019 19:16:12 -0400 I agree these simulations really allowed for us to think creatively on how to solve problems using methods we learned in lecture. I really enjoyed learning about planning and how important it is that all of the details are addressed…   Read more»

]]> 166f3e4d12afbf8f23d6a72576e64374 https://medicaldevicecourses.com/activity/p/15909/ Wed, 15 May 2019 19:15:10 -0400 I think I would like to a Clinical Project Manager as @Devarshi mentions as a project manager you are able to interact with all departments through the different phases from initiation to closure. It would be exciting to oversee a…   Read more»

]]> 465ea9cd1995c424bddf2241c9b0fe0b https://medicaldevicecourses.com/activity/p/15907/ Wed, 15 May 2019 19:15:09 -0400 My goal is helping others. Helping others makes me feel good, and I work at Sloan Kettering Cancer Center. When you go to the main hospital and see the patients’ faces, you get motivated that you are apart of a…   Read more»

]]> 6e80a817b4f5e67223a7fece3330f19e https://medicaldevicecourses.com/activity/p/15887/ Wed, 15 May 2019 19:14:58 -0400 In my experience at Sloan Kettering we have encountered as many have mentioned advantages and disadvantages to using CROs. At Sloan we have an efficient and accomplished clinical department which includes management of clinical trials, contracts, etc and we have…   Read more»

]]> 2c4d5236a081bbdc009b307253a1bd97 https://medicaldevicecourses.com/activity/p/15885/ Wed, 15 May 2019 19:14:57 -0400 I agree with many have already stated-that you want to make sure you maintain the quality and integrity of the study and not focus just on the cost. However working at a hospital, I know that budget is a big…   Read more»

]]> f2982bbe257287cf76ebba8edaea6013 https://medicaldevicecourses.com/activity/p/15883/ Wed, 15 May 2019 19:14:56 -0400 Central Venous Catheter (CVC) manufactured in the United States and sold only in Europe Class IIb/Class III Medical Device Directive 93/42/EEC, ISO 13485, ISO14971, ISO10993, and GMPs 21 CFR 820 since its manufactured in the US. CE mark to be…   Read more»

]]> 7120c77625024cc6ff1a84c3f673da77 https://medicaldevicecourses.com/activity/p/15770/ Wed, 15 May 2019 19:13:43 -0400 To add to this, clear definitions, and attachments with supporting material for timeline, deliverables, pricing, and business and legal contact information. Thinking about the important articles to include in a supplier contract, I also thought about how to pick a…   Read more»

]]> 4813fec9fa792613196c52a928bf9a9b https://medicaldevicecourses.com/activity/p/15768/ Wed, 15 May 2019 19:13:42 -0400 Communication is key- I believe the PM is responsible for clear communications between the project team members, departments, and key stakeholders. The PM also needs to have business acumen to determine when and how to communicate with the different groups….   Read more»

]]> 31f0ec54e8a3add58ae71be48f2f71fe https://medicaldevicecourses.com/activity/p/15765/ Wed, 15 May 2019 19:13:40 -0400 I agree with @merzbrashed that GMPs ensure that production of a good quality product and create credibility for a company. At first glance, it might seem burdensome and costly for manufacturers to follow GMP practices, but I think it does…   Read more»

]]> a477ffa3a2262e841d9bc450f1c1be23 https://medicaldevicecourses.com/activity/p/15763/ Wed, 15 May 2019 19:13:39 -0400 To add to this discussion, I think its important to note that an internal audit does not mean that it has to be performed by the company employees. For example where I work we do our own internal quality audits…   Read more»

]]> 3365776f256f8e33b185a04bc717ff93 https://medicaldevicecourses.com/activity/p/15681/ Wed, 15 May 2019 19:12:50 -0400 I think management should already have a good understanding of the resources needed to uphold their QSR. As we learned this week in lecture Management oversees the subsystems: i. Design Controls, ii. Corrective and Preventative Actions, iii. Production and Process…   Read more»

]]> 33d8fa5554da186fb904ab4bb4cd37da https://medicaldevicecourses.com/activity/p/15679/ Wed, 15 May 2019 19:12:49 -0400 I agree with @tme3 that the ambiguity of GMP’s could actually be beneficial to a startup because it allows for a little more flexibility to create their own quality system and since each company is different with different products there…   Read more»

]]> a54fb41213449de284dece3aff3a2458 https://medicaldevicecourses.com/activity/p/15632/ Wed, 15 May 2019 19:12:19 -0400 You could monitor progress by looking at EV and SV. Earned Value-the value of the work you have completed so far. Earned Value=Percent complete*original budged cost of task Schedule Variance (SV)= EV- Planned Value (PV) If you have a positive…   Read more»

]]> 1c9c6ef07fe3dd3dbd791b72d6e0ce02 https://medicaldevicecourses.com/activity/p/15631/ Wed, 15 May 2019 19:12:19 -0400 I would add to this, contingency plans. At the beginning of each project we usually have clearly defined plans with assigned responsibilities and then the inevitable happens when something unforeseen happens that falls out of the detailed plan and its…   Read more»

]]> 8ac2699ffc6ea379a939acd00a92fd85 https://medicaldevicecourses.com/activity/p/15628/ Wed, 15 May 2019 19:12:17 -0400 My office is a little unique in which we have a lot of products that we ultimately out-license to larger device companies. We develop the products and file patents on them and in some situations the market just isn’t there….   Read more»

]]> c48b4fa432d9ea5d4527fcbb589993a3 https://medicaldevicecourses.com/activity/p/15626/ Wed, 15 May 2019 19:08:22 -0400 We usually use passive marketing techniques where people come to us for a license and we usually have consistent sales. However in the last year in order to increase sales, we have created a catalog of all of products available…   Read more»

]]> 5bb76722aa4d0a3e2f52dd2cd1dd5102 https://medicaldevicecourses.com/activity/p/15624/ Wed, 15 May 2019 19:08:21 -0400 I agree with the posts above that its important to have both business and interpersonal skills, but I believe its essential to have interpersonal skills to get deals done. Sales is all about not just getting a deal done, but…   Read more»

]]> 7d2b48920930b52ccffb6c1d2f53a5e8 https://medicaldevicecourses.com/activity/p/15513/ Wed, 15 May 2019 19:07:10 -0400 Over a year ago I was assigned to manage the development of a robotic device. We had a prototype and since it is now first to file, we filed a patent so we could further the development while also pitching…   Read more»

]]> 1aa48058789d9b30d7a5dc45aa159964 https://medicaldevicecourses.com/activity/p/15508/ Wed, 15 May 2019 19:07:07 -0400 I personally think the planning phase is the most important phase during a project. It sets the tone for the project and as Dr. Simon mentions if you fail to plan, you plan to fail. For instance if you have…   Read more»

]]> e2796ea37b818edd5a74fcc6ff4ca678 https://medicaldevicecourses.com/activity/p/15507/ Wed, 15 May 2019 19:07:06 -0400 As @cdj24 mentioned SV=EV-PV. Where EV is the percent complete* original budgeted cost of task and PV is the vale of the work you are supposed to have on a certain date. I agree as others have mentioned that in…   Read more»

]]> b97feab2bde61ded2f5c22c85c5cb637 https://medicaldevicecourses.com/activity/p/15504/ Wed, 15 May 2019 19:07:04 -0400 Just to provide another perspective, at MSK we file patents on technologies like medical devices in order to protect IP and to ultimately outlicense. Before we file a patent, we evaluate the technology and the market. Once we move forward…   Read more»

]]> 581066444ff6302e8b0a648bce09e059 https://medicaldevicecourses.com/activity/p/15503/ Wed, 15 May 2019 19:07:03 -0400 As most have mentioned like @asmibana and @sanam funding in a major role. I work at MSK in the Office of Technology Development so we constantly have new invention disclosures, but unless the PI has resources/funding available-it is hard to…   Read more»

]]> 7bf1f5fb48b1c3a8a59cc8a2b31f3019 https://medicaldevicecourses.com/activity/p/15480/ Wed, 15 May 2019 19:06:47 -0400 The Discovery and Innovation phase as many have mentioned is the part of the life cycle that identifies customer needs, market, and competitors the “Climbing the Hill” phase where we search for ideas, unmet needs and look at how we…   Read more»

]]> 51aafa04bf56cd8d4cb3d580c0c2a1fa https://medicaldevicecourses.com/activity/p/15403/ Wed, 15 May 2019 19:05:57 -0400 I think @smithshah sums it up well above. Design Verification Inputs=Outputs Design Validation Outputs=user needs and intended use Design Verification is- did you design the device correctly? Does your device meet the design requirements you set out in DID? Whereas…   Read more»

]]> 93e269b11b2b9d026336cba769f924d4 https://medicaldevicecourses.com/activity/p/15402/ Wed, 15 May 2019 19:05:56 -0400 Hopefully if the user needs are not met as @hc255 mentions above, they would go back to the spec and make sure the output meets the user needs and intended use. I really don’t think there is any room for…   Read more»

]]> 7d3b4636564eb4716f3aa34a75dbd6f3 https://medicaldevicecourses.com/activity/p/15396/ Wed, 15 May 2019 19:05:53 -0400 So for this particular example to plan on selling a medical device in US and then decide in executing phase to sell in Japan, this would be a big scope creep in my opinion. I agree with the comments above,…   Read more»

]]> 945c7d6fb51369d528b8de8ff7345d77 https://medicaldevicecourses.com/activity/p/15395/ Wed, 15 May 2019 19:05:52 -0400 If you’re in the Executing Phase it is the Project Manager’s responsibility to make sure that the team is performing their tasks on schedule and to deal with a team member’s vacation, or absence. As @cdj24 mentions, it should be…   Read more»

]]> cb2206cdfcbd8760f98118f5f158b64f https://medicaldevicecourses.com/activity/p/15323/ Wed, 15 May 2019 19:05:13 -0400 The PMBOK guide provides an overview of the Project Integration Management processes. I. Project charter as mentioned above II. Project Management Plan the process of performing the work defined in the project management plan to achieve the project’s objectives. III…   Read more»

]]> 352619e0d7097fe4fcc86a7e7ddaa5e0 https://medicaldevicecourses.com/activity/p/15315/ Wed, 15 May 2019 19:05:09 -0400 I also think its important to identify what the new PM considers the error in the Scope to be. I agree with the above posts, but I think if the key Stakeholders had signed off on the scope of the…   Read more»

]]> cc414dc6bb4877ad7dd7c34561533e56 https://medicaldevicecourses.com/activity/p/15314/ Wed, 15 May 2019 19:05:08 -0400 As a means to save time and money and still hit the product launch, I agree with @cdj24 to get as much research done as possible so that you don’t spend as much time and money on experiments that might…   Read more»

]]> bf828803d637c8e9292d7c8bdae7000c https://medicaldevicecourses.com/activity/p/15313/ Wed, 15 May 2019 19:05:08 -0400 I agree with what most of said that determining the main cause of the equipment failure and to add to the discussion, I would say based on this week’s Simulation, the importance of logging these incidences. In case there is…   Read more»

]]> 2f0d2af60dfb3632c8bdca608a7f2081 https://medicaldevicecourses.com/activity/p/15312/ Wed, 15 May 2019 19:05:07 -0400 As @merzkrashed mentions the FDA “results of a process cannot be FULLY verified by subsequent inspection and test” and ISO “processes for production and service provision where the resulting output cannot be verified by subsequent monitory or measurement”. So if…   Read more»

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