https://medicaldevicecourses.com/members/dbonanno1/activity/ Activity feed for dbonanno1. Fri, 24 Apr 2026 18:53:59 -0400 https://buddypress.org/?v= en-US 30 hourly 2 f95e14253250522f433e6fa2084ae390 https://medicaldevicecourses.com/activity/p/14365/ Wed, 15 May 2019 18:55:29 -0400 I was able to find a kickback allegation that happened very recently, this past September 2017. It involves Galena Biopharma with a prescription opioid scheme. Galena Biopharma had to pay more than $7 million in the settlement. Two of the…   Read more»

]]> 1e87a1f02ec245b6413cbdd60c8798cb https://medicaldevicecourses.com/activity/p/14364/ Wed, 15 May 2019 18:55:29 -0400 As a person who has been working in the medical device field for multiple years, before I started this course I definitely was not sure what to expect as far as the class content / structure. I can honestly say…   Read more»

]]> 9b3310103cde430703b39faa6ffb3b6d https://medicaldevicecourses.com/activity/p/14089/ Wed, 15 May 2019 18:51:48 -0400 As others have said in this thread I think it is very crucial to ensure that everyone attending / participating in the risk management meetings have a thorough understanding of exactly how the product works. From there as a team…   Read more»

]]> 0a2f11c6e93008df963ab7e43eef916f https://medicaldevicecourses.com/activity/p/14088/ Wed, 15 May 2019 18:51:47 -0400 From my experience and in my opinion I do not think the risk associated with a specific product performance (or lack thereof), should have a major impact on the sample size that you use for testing. Sample size is usually…   Read more»

]]> d3d82d24da93560e262ecbe385f62a8d https://medicaldevicecourses.com/activity/p/14087/ Wed, 15 May 2019 18:51:47 -0400 I currently work as an R&D engineer for a medical device company, and have had some experience with working with the QA (quality) department on risk analysis. As our professor has mentioned in this week’s lecture the identification (assessment) of…   Read more»

]]> 818f0a771603b9e457574814a4fc4b7e https://medicaldevicecourses.com/activity/p/13980/ Wed, 15 May 2019 17:10:07 -0400 If any requirement in the Design Verification (DV) Protocol is not met during testing you will be unable to complete DV until this situation is rectified. I have been in this situation before and there are a few common options…   Read more»

]]> 4f22b281aa495e7150559d1fbceebe0c https://medicaldevicecourses.com/activity/p/13979/ Wed, 15 May 2019 17:10:06 -0400 It seems everyone in this thread agrees that the determination for the appropriate sample size for statistical analysis stems from what your desired confidence and reliability levels. At the company I work for we use our confidence and reliability to…   Read more»

]]> 13b6185848ee85058462b252c311afbb https://medicaldevicecourses.com/activity/p/13885/ Wed, 15 May 2019 17:09:06 -0400 I actually have experience working as a test method development engineer for a medical device company (Becton Dickinson), working as this role your main job objectives are to develop and validate test methods that are used for design verification testing….   Read more»

]]> 05f68b2ecd20bc2ee5a625e91ef4eef0 https://medicaldevicecourses.com/activity/p/13884/ Wed, 15 May 2019 17:09:06 -0400 Based on my experiences working within relatively big medical device project teams the two biggest things that I think are very important with regards to creating /managing gantt charts are the “critical path” and amount of “slack”. Whoever the project…   Read more»

]]> d1e1ca1d3eb6da1745cc7c9498f53aa9 https://medicaldevicecourses.com/activity/p/13882/ Wed, 15 May 2019 17:09:05 -0400 I do have experience attending a few design reviews and also leading one. From my experiences design reviews are exactly as everyone has been describing. They are important milestones within the medical device development cycle, and are a part of…   Read more»

]]> a9840c7de7e08aa6c34d6bfde8caabf5 https://medicaldevicecourses.com/activity/p/13705/ Wed, 15 May 2019 17:07:24 -0400 If I was involved in clinical research trials I would like to be a monitor. I would enjoy being able to monitor the clinical trial participants heath throughout the study, and see what the effects are of taking or not…   Read more»

]]> 2fd285df1eaee4dd1eb76038d937ef68 https://medicaldevicecourses.com/activity/p/13704/ Wed, 15 May 2019 17:07:24 -0400 Yes, I do think that Placebo-controlled trials are both ethical and necessary. When performing any scientific study, I think it is very important to have a control to be able to compare the effects of whatever it is you are…   Read more»

]]> 297f85c746a1f89fc0d51b8f5c295c74 https://medicaldevicecourses.com/activity/p/13703/ Wed, 15 May 2019 17:07:23 -0400 I would start out by saying the obvious, which is that since companies are willing to people as a CRA without having any clinical background would mean that it is not a complete necessity. On the other hand I do…   Read more»

]]> 72d57300d259dca19fdcc175bc1c7e70 https://medicaldevicecourses.com/activity/p/13549/ Wed, 15 May 2019 17:05:59 -0400 In the time period we are currently living in, as many others have mentioned, I believe the most effective ways of getting customers to get engagement with marketing information that they are interested in is definitely via all the types…   Read more»

]]> 40d628655ef62ad13fc18fdc43abfbe8 https://medicaldevicecourses.com/activity/p/13548/ Wed, 15 May 2019 17:05:58 -0400 Becton Dickinson (BD) Mission Statement: “To help all people live healthy lives” Vision Statement: “Become the organization most known for eliminating unnecessary suffering and death from disease, and in doing so, the best performing companies in the world.” Quality Policy:…   Read more»

]]> bf1d110d8bc5cc90f7573cd883ef5e5f https://medicaldevicecourses.com/activity/p/13396/ Wed, 15 May 2019 17:04:33 -0400 The major difference between public and private companies, is that public companies have shares that can be publicly traded on the stock market. A private company might become a public company by conducting an initial public offering, which is when…   Read more»

]]> ea6b91b36c91d75a949c9434e7a6f3cb https://medicaldevicecourses.com/activity/p/13395/ Wed, 15 May 2019 17:04:33 -0400 For a mid-sized medical device company like you have described (50 people & approx. 10 million in revenue), there are a few benefits that a company like this could get from becoming an “Inc.” versus an “LLC”. First would be…   Read more»

]]> 331008a1fc8c22600b4d7d689d1dab6d https://medicaldevicecourses.com/activity/p/13237/ Wed, 15 May 2019 17:03:09 -0400 I think there could be many ways to overcome the bad relations that the quality department often has with other departments such as R&D. One way could be to ensure that the quality representative or team that is involved in…   Read more»

]]> 63619468a68b725646ca82e115a90dec https://medicaldevicecourses.com/activity/p/13223/ Wed, 15 May 2019 17:03:02 -0400 Hello Professor, as someone who works as an R&D engineer and has a lot of experience working with the quality department I can relate to the notion of quality as “burden”. After spending so much time working with quality on…   Read more»

]]> 14c8182d772e76c9ea00fcabd4cf0b2c https://medicaldevicecourses.com/activity/p/13139/ Wed, 15 May 2019 17:02:19 -0400 De Novo is a classification process which uses a risk based strategy for new novel devices whose types has not previously been classified. It can be used for devices that would have been classified into Class III to allow them…   Read more»

]]> 4d98599834b99cc9341339ed8d26ce68 https://medicaldevicecourses.com/activity/p/13137/ Wed, 15 May 2019 17:02:19 -0400 A product that was recently recalled was the BD Intelliport Medication and Management System Sensor, which was officially recalled by the FDA on January 09, 2017. This product was recalled on its inability to assure sterility of the product, which…   Read more»

]]> bb3437fc9f9dc15dd9525ea052eb2142 https://medicaldevicecourses.com/activity/p/13135/ Wed, 15 May 2019 17:02:18 -0400 Based on the research I was able to find the FDA does regulate all cigarettes, smokeless (e-cigs), and roll your own tobacco and these regulations have been in effect since 2009. On August 8th, 201 the FDA finalized a rule…   Read more»

]]> ad8867aaed069ba4ff5337a247d8d5fb https://medicaldevicecourses.com/activity/p/12962/ Wed, 15 May 2019 17:00:46 -0400 In my experience in working as an R&D product development engineer in the medical device industry, I would say that projects do generally get pushed to get done quicker due to project deadlines but I do not feel that it…   Read more»

]]> f7b693bece3c1bb9f3626bfa1a0ee1c6 https://medicaldevicecourses.com/activity/p/12955/ Wed, 15 May 2019 17:00:42 -0400 As many have already said in this thread, both types of research are important and I do not necessarily see one as more important than the other. There will always be a need to solve current societal problems, for this…   Read more»

]]> 36cf4d3d86d7b289484153659aea96a5 https://medicaldevicecourses.com/activity/p/12805/ Wed, 15 May 2019 16:59:17 -0400 In my opinion, most of the challenge for project management of medical devices comes from the process (aka Design Controls). Developing medical devices requires a lot of detailed traceable documentation that must been done in a certain way. All of…   Read more»

]]> bbcdb97b00a045526a8fd7ad18a55a14 https://medicaldevicecourses.com/activity/p/12802/ Wed, 15 May 2019 16:59:16 -0400 I have experience working in the industry and my company uses Microsoft Project. Based on my past experiences, and in talking with others who work for my company, Microsoft Project is definitely one of the most popular softwares that is…   Read more»

]]> 1b6929f010e8edccda4f3e62d892d4e8 https://medicaldevicecourses.com/activity/p/12644/ Wed, 15 May 2019 16:57:51 -0400 Another piece of advice I would give to current engineering students would be to potential work in the industry for a few years before going back to get your master’s degree. This is an approach I have taken with my…   Read more»

]]> 74379c07b5fb2920f33000ed3f0c438f https://medicaldevicecourses.com/activity/p/12641/ Wed, 15 May 2019 16:57:50 -0400 My answer would be it depends, and my answer stems from what you want to do with your career as an engineer. I believe that some engineering jobs require more technical (academic) knowledge, and for those types of jobs it…   Read more»

]]> 3a495bf9cb42cb7491da04b9c819bf17 https://medicaldevicecourses.com/activity/p/12640/ Wed, 15 May 2019 16:57:49 -0400 I agree with the other two posts, definitely try to get into as many co-ops / internships as you can while your still in school. I have been working in the industry for about 6 years and I did not…   Read more»

]]> facdb11cb459cbcd4b4bbc9ae417c480 https://medicaldevicecourses.com/activity/p/12639/ Wed, 15 May 2019 16:57:49 -0400 My answer would be it depends, and my answer stems from what you want to do with your career as an engineer. I believe that some engineering jobs require more technical (academic) knowledge, and for those types of jobs it…   Read more»

]]> b0513f3d85266e55fd7938cfcc239fb1 https://medicaldevicecourses.com/activity/p/10604/ Wed, 15 May 2019 16:34:53 -0400 Something that is related to this lecture that was not talked about is a “Non Compete Agreement”. Usually bigger companies will make you sign a non compete agreement before you start working there which would prohibit you from leaving the…   Read more»

]]> 03c6f960cb2ff5ed15597d2e850b7712 https://medicaldevicecourses.com/activity/p/10597/ Wed, 15 May 2019 16:34:50 -0400 For medical devices that are not used inside of humans / animals, and do need include any kind of medication dose accuracy are Clinical & Pre-Clinical Trials needed? or will Design Verification and Validation suffice? Give an example of a…   Read more»

]]> 6f7166cdc462210c6e2328ddc4ffc100 https://medicaldevicecourses.com/activity/p/10577/ Wed, 15 May 2019 16:34:41 -0400 After watching the lectures from this past week, one of the slides that depicts a comic strip of what a customer wanted versus how everyone in the company perceived the customers request was shown. This comic strip immediately made me…   Read more»

]]> 8179aeae252b2dacea19ab287e48a6f6 https://medicaldevicecourses.com/activity/p/10570/ Wed, 15 May 2019 16:34:38 -0400 When i think of a companies that are corporations, I never think of that corporation being specifically an “S-Corp” or a “C-Corp”. I just think of them as a corporation, can you please provide an example of each type of…   Read more»

]]> fa6ab253ad90939b0938ef07fd743d3a https://medicaldevicecourses.com/activity/p/10557/ Wed, 15 May 2019 16:34:32 -0400 I am currently working as an R&D Engineer for a medical device company, and have been for the past 6 years. As an R&D engineer I do have a lot of experience working with the Quality departments (QA, QC, etc.)….   Read more»

]]> e3b4ddf449be21801b2d822d8c64b1f1 https://medicaldevicecourses.com/activity/p/10540/ Wed, 15 May 2019 16:34:24 -0400 I have been working in the industry for the past 6-7 years, and i have worked with a couple of different project managers during that time period. Each project manager i have worked for has had completely different personalities and…   Read more»

]]> ad50ca71a7877b1e901f0685bc831370 https://medicaldevicecourses.com/activity/p/5412/ Wed, 29 Nov 2017 03:04:27 -0500 Something that is related to this lecture that was not talked about is a “Non Compete Agreement”. Usually bigger companies will make you sign a non compete agreement before you start working there which would prohibit you from leaving the company and then directly going to work for a competitor company. There are other fine details that go along…[Read more]

]]> 0 5e2eb8b894f898bf4568cccfca7266f8 https://medicaldevicecourses.com/activity/p/5411/ Wed, 29 Nov 2017 02:55:15 -0500 I was able to find a kickback allegation that happened very recently, this past September 2017. It involves Galena Biopharma with a prescription opioid scheme. Galena Biopharma had to pay more than $7 million in the settlement. Two of the doctors involved actual went to jail for over 20 years. The doctors were prescribing these opioid drugs to…[Read more]

]]> 0 50601803a7e8288709c69f7b92ab5838 https://medicaldevicecourses.com/activity/p/5410/ Wed, 29 Nov 2017 02:29:32 -0500 As a person who has been working in the medical device field for multiple years, before I started this course I definitely was not sure what to expect as far as the class content / structure. I can honestly say that I did learn many different aspects about medical device development that I did not know before taking the class. The vast majority of…[Read more]

]]> 0 e3e06dccd7209afb6efe8d0363eb21bd https://medicaldevicecourses.com/activity/p/5120/ Wed, 15 Nov 2017 13:56:30 -0500 As others have said in this thread I think it is very crucial to ensure that everyone attending / participating in the risk management meetings have a thorough understanding of exactly how the product works. From there as a team you should break down all the different risks associated with these 3 categories: what risks / failures are associated…[Read more]

]]> 0 63f6757b5a18b8aadb7dd8762084e7b3 https://medicaldevicecourses.com/activity/p/5119/ Wed, 15 Nov 2017 13:45:11 -0500 From my experience and in my opinion I do not think the risk associated with a specific product performance (or lack thereof), should have a major impact on the sample size that you use for testing. Sample size is usually driven by the confidence and reliability associated with a specific product requirement in conjunction with the test evaluation…[Read more]

]]> 0 cc963626fab16edcb00fe8ecada65dcf https://medicaldevicecourses.com/activity/p/5118/ Wed, 15 Nov 2017 13:32:34 -0500 I currently work as an R&D engineer for a medical device company, and have had some experience with working with the QA (quality) department on risk analysis. As our professor has mentioned in this week’s lecture the identification (assessment) of risks usually occurs in a brain storming team meeting. Generally the philosophy I have seen taken i…[Read more]

]]> 0 7ad6bd46d60057b90156772791fcc947 https://medicaldevicecourses.com/activity/p/4999/ Sat, 11 Nov 2017 20:41:49 -0500 For medical devices that are not used inside of humans / animals, and do need include any kind of medication dose accuracy are Clinical & Pre-Clinical Trials needed? or will Design Verification and Validation suffice? Give an example of a medical device product where Design Verification and Validation would be sufficient and where no clincal…[Read more]

]]> 0 c5f64a32205f164ceaecd5f4ffa14674 https://medicaldevicecourses.com/activity/p/4997/ Sat, 11 Nov 2017 20:23:28 -0500 If any requirement in the Design Verification (DV) Protocol is not met during testing you will be unable to complete DV until this situation is rectified. I have been in this situation before and there are a few common options you have to choose from depending on specific requirement that was not met. Like it has already been mentioned one…[Read more]

]]> 0 1c29b77131f09514923003bec338aece https://medicaldevicecourses.com/activity/p/4996/ Sat, 11 Nov 2017 20:07:55 -0500 It seems everyone in this thread agrees that the determination for the appropriate sample size for statistical analysis stems from what your desired confidence and reliability levels. At the company I work for we use our confidence and reliability to determine how we evaluate specific product requirements based on whether or not the test we are…[Read more]

]]> 0 b7ab480c229b0a8eb705cb01bfd6757d https://medicaldevicecourses.com/activity/p/4892/ Sun, 05 Nov 2017 22:49:10 -0500 I actually have experience working as a test method development engineer for a medical device company (Becton Dickinson), working as this role your main job objectives are to develop and validate test methods that are used for design verification testing. Another part of this job role also includes identification and validation of the equipment…[Read more]

]]> 0 9164f846d04ec037977823c11b38f236 https://medicaldevicecourses.com/activity/p/4891/ Sun, 05 Nov 2017 22:33:19 -0500 Based on my experiences working within relatively big medical device project teams the two biggest things that I think are very important with regards to creating /managing gantt charts are the “critical path” and amount of “slack”. Whoever the project manager is for a project, aside from making sure that all milestones are being achieved the nex…[Read more]

]]> 0 bfb95b7924af34b7fd487c6bd10886bd https://medicaldevicecourses.com/activity/p/4889/ Sun, 05 Nov 2017 22:14:55 -0500 I do have experience attending a few design reviews and also leading one. From my experiences design reviews are exactly as everyone has been describing. They are important milestones within the medical device development cycle, and are a part of the required design control process. Design Reviews do require a lot of preparation, and the way in…[Read more]

]]> 0 da0ee60aa9eca779c9ecee283298af50 https://medicaldevicecourses.com/activity/p/4556/ Sat, 28 Oct 2017 19:47:27 -0400 If I was involved in clinical research trials I would like to be a monitor. I would enjoy being able to monitor the clinical trial participants heath throughout the study, and see what the effects are of taking or not taking the medication (treatment, etc,). I am very analytical in nature and being able to gather all of the patient’s health data w…[Read more]

]]> 0 66009f8ad7c90eafdb32dd36d3f1d7ef https://medicaldevicecourses.com/activity/p/4555/ Sat, 28 Oct 2017 19:36:39 -0400 Yes, I do think that Placebo-controlled trials are both ethical and necessary. When performing any scientific study, I think it is very important to have a control to be able to compare the effects of whatever it is you are studying (medication, treatments, etc.) to someone that has not received these medications or treatments. Having a control…[Read more]

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