Medical Device Courses | jz365 | Activity https://medicaldevicecourses.com/members/jonathan/activity/ Activity feed for jz365. Fri, 24 Apr 2026 20:59:24 -0400 https://buddypress.org/?v= en-US 30 hourly 2 48308bb4c61b02ab30863a0fd324e65f jz365 replied to the topic "Discussion Topic: Course conclusion and impressions" - https://medicaldevicecourses.com/activity/p/17322/ Wed, 15 May 2019 21:38:32 -0400 Dr Simon, I enjoyed this course pretty thoroughly. It is refreshingly different from most courses at NJIT in the sense that it gives information about how the world actually works, not how a concept works in an ideal situation. It…   Read more»

]]> 40c3407eb1d6fcf7976a57e1f6c68d6d jz365 replied to the topic "Factors to consider when executing the NDA" - https://medicaldevicecourses.com/activity/p/17321/ Wed, 15 May 2019 21:38:31 -0400 An NDA is a way of allowing you to tell some things, but not the whole story. It is analogous to if you told someone a family recipe for cookies. “A little flour, sugar, vanilla extract, a special blend, and…   Read more»

]]> 9f07653888782490f0445086bb5ab66a jz365 replied to the topic "Written Agreement v/s Verbal Agreement" - https://medicaldevicecourses.com/activity/p/17320/ Wed, 15 May 2019 21:38:31 -0400 Verbal contracts are hard to defend in court and are thus not quite as actionable. Generally, if it is important and there are risks associated with one party backing out, it goes in a written contract. If breaking the contract…   Read more»

]]> 48adaea4a132c0386942a1ed77d65961 jz365 replied to the topic "Upper vs Middle Management." - https://medicaldevicecourses.com/activity/p/17276/ Wed, 15 May 2019 21:38:09 -0400 In upper management you have real control over the company but most of your work is confined to maintaining the company and dealing with finances legislature. You are in the position of maintaining the logistics of the company. In middle…   Read more»

]]> 3bd1cedd202487148c983533cbe8a034 jz365 replied to the topic "Organizational Behavior Management" - https://medicaldevicecourses.com/activity/p/17275/ Wed, 15 May 2019 21:38:09 -0400 From my experience the best impact of worker performance is leadership. This works both ways, poor leadership means very poor outcomes. A leader needs to firstly have a clearly defined vision. Without a vision the workers cannot see an end…   Read more»

]]> 93af669e61e1986492348b79fc556429 jz365 replied to the topic "Medical Device Project" - https://medicaldevicecourses.com/activity/p/17274/ Wed, 15 May 2019 21:38:08 -0400 The first thing our team did was go over the timeline of the project. We set up a simple flowchart of what has to happen and what everyone needs to do. Then, we started giving tasks to the people that…   Read more»

]]> 70c722ad03572eabec88b1fdb7441b00 jz365 replied to the topic "What is Risk-benefit analysis ?" - https://medicaldevicecourses.com/activity/p/17118/ Wed, 15 May 2019 21:36:48 -0400 In the assessment of risks of devices section (4.2) the standard lists duration of the risk as a parameter. This is an important distinguisher because it dictates how much damage a risk can do under worst case scenario. Oftentimes business…   Read more»

]]> cab3a19bfd767a27fd16aab9ab9d9e3d jz365 replied to the topic "Sample Size Based on Risk Analysis" - https://medicaldevicecourses.com/activity/p/17117/ Wed, 15 May 2019 21:36:47 -0400 The type of risk plays a role in what statistical analysis you need when testing. Most companies here just use a higher sample size when testing high risk hazards but I believe it can go deeper than that. Each risk…   Read more»

]]> 98955d90cbabc3c2bac9031d27680e73 jz365 replied to the topic "How to run a risk management meeting ?" - https://medicaldevicecourses.com/activity/p/17116/ Wed, 15 May 2019 21:36:47 -0400 I believe the best results from a risk analysis meeting come from minimizing bias. The beginning of the meeting is about finding hazards by going through the chronological life cycle of the project. Starting with the machining/manufacturing process and following…   Read more»

]]> fbb2bf0ccea0fe01ba340677418fc9a5 jz365 replied to the topic "Minutes for meetings" - https://medicaldevicecourses.com/activity/p/17015/ Wed, 15 May 2019 21:35:56 -0400 I am president of a new start up club on campus and we have used various methods to keep track of the meeting progress. Having someone take notes throughout the meeting and upload them directly afterwards to a folder accessible…   Read more»

]]> a86ba5f6c67868b6f166e6130be7dd2c jz365 replied to the topic "Factors to Consider While making Gantt Chart" - https://medicaldevicecourses.com/activity/p/17014/ Wed, 15 May 2019 21:35:55 -0400 The Gantt chart is a useful organizational tool, if not for actually keeping track of the project timeline. When creating the Gantt chart, you are forced to think about reasonable time estimates for the project tasks. It helps to break…   Read more»

]]> 08e4ac17c44adb033d1aa3a3f0be8791 jz365 replied to the topic "Discussion Topic: Supplemental on DHF and DMR" - https://medicaldevicecourses.com/activity/p/17012/ Wed, 15 May 2019 21:35:54 -0400 If you were to make a device in the EU, it would be subject not to the regulatory documents required in the US but to those required in the EU. Every country has its regulating body that ensures the safety…   Read more»

]]> 7149e73e13b752a21073ffc731eecc34 jz365 replied to the topic "Statistical Sampling" - https://medicaldevicecourses.com/activity/p/16918/ Wed, 15 May 2019 21:35:05 -0400 Statistical sampling tests I have used for research included the paired t-test and one way ANOVA. Typically, for something to be taken as statistically significant, a power of 95% or better is needed. Whereas in industry you will be checking…   Read more»

]]> 17d2ede066ce79660ab47d82244ecec8 jz365 replied to the topic "Why VERIFICATION is important? and Your ideas to improve Verification process ?" - https://medicaldevicecourses.com/activity/p/16917/ Wed, 15 May 2019 21:35:05 -0400 Verification ensures that the the customer specifications are meant. Without verifying specifications, you are blindly trusting what the manufacturing department took to be what was meant on the DID. In industry, this is a dangerous assumption because the departments rarely…   Read more»

]]> e33f5874794f7fdde0603301307ed5e5 jz365 replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/16818/ Wed, 15 May 2019 19:42:56 -0400 Putting blinds on a study makes its results subject to less bias and outside influence. The more blinds there are the more representative of normal the data will become, and thus the more believable. With each addition of a blind,…   Read more»

]]> 854600a20c410133329c7152de55c5e9 jz365 replied to the topic "Discussion Topic: Having a "clinical background"" - https://medicaldevicecourses.com/activity/p/16817/ Wed, 15 May 2019 19:42:56 -0400 Asking for clinical trial experience is just asking for job experience. If you apply for a systems engineering job, the company would want systems engineering experience. It is the same thing. Companies always want to hire people who are familiar…   Read more»

]]> 8dc97e70e9b0671c0409392321c14049 jz365 replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" - https://medicaldevicecourses.com/activity/p/16816/ Wed, 15 May 2019 19:42:55 -0400 The necessity for informed consent in clinical trials is purely a legal issue. Before the days of informed consent, it was morally enough to ask “can I treat you”? The same morals still apply today. In many informed consent forms,…   Read more»

]]> 6e34d7f663ae7838154810053a926be4 jz365 replied to the topic "Discussion Topic: The Fifth "P" of Marketing" - https://medicaldevicecourses.com/activity/p/16717/ Wed, 15 May 2019 19:41:55 -0400 Some of the most interesting methods of subtle marketing I have seen are used in television. Everyone knows that no one pays attention to advertisements in between shows. However, everyone who is watching the show is going to pay attention…   Read more»

]]> 6d37a03ce7c82579caf954d5ff63b0b4 jz365 replied to the topic "Discussion Topic: Mission and Vision statements" - https://medicaldevicecourses.com/activity/p/16716/ Wed, 15 May 2019 19:41:54 -0400 “Shifting Health Care Models By Putting People First” Optum “Developing Software to Help People Get Well, Help People Stay Well, and Help Future Generations Be Healthier” Epic I think Optum’s mission statement instills greater confidence than Epic’s. The mission statement…   Read more»

]]> b23ccb20e93304ba80fcfd45423e3bef jz365 replied to the topic "Discussion Topic: Emotional Intelligence and its affect on sales" - https://medicaldevicecourses.com/activity/p/16715/ Wed, 15 May 2019 19:41:54 -0400 Emotional intelligence, as previously said, is the measure of someones ability to sense emotions in other people. But, it also measures how well the person knows their own emotions. In marketing, you need to keep a cool head. People react…   Read more»

]]> 90ca32f61c5b10b7ad7caf9def2866ac jz365 replied to the topic "Discussion Topic: Inc. vs. LLC in the US" - https://medicaldevicecourses.com/activity/p/16579/ Wed, 15 May 2019 19:40:32 -0400 If the company is looking to grow, it should be an Inc instead of an LLC. In an Inc, you can hire Officers to compartmentalize your company. This spreads the task of growth out onto more people. In an LLC,…   Read more»

]]> 2a60cb4704b6b6c285df58320300d898 jz365 replied to the topic "Accepting job based on company." - https://medicaldevicecourses.com/activity/p/16578/ Wed, 15 May 2019 19:40:31 -0400 For me, different aspects of the company would sway my decision more based on where I am in my career. Just starting out, I am not going for anything managerial related. I am more concerned with the company’s profit/debt ratios….   Read more»

]]> 06a2d9fa884abc9865a1ba72ffff7cdd jz365 replied to the topic "What are some ways Document Control can improve?" - https://medicaldevicecourses.com/activity/p/16482/ Wed, 15 May 2019 19:39:40 -0400 Documentation control can be catalyzed with the proper use of online systems. Online folders allow you to organize by section almost indefinitely and access it from any computer in the office. If that is combined with fillable pdf’s of standard…   Read more»

]]> 1d7725501cbfea4dcf0f479a872b3f1a jz365 replied to the topic "Quality Control and Quality Assurance + Ethics" - https://medicaldevicecourses.com/activity/p/16481/ Wed, 15 May 2019 19:39:40 -0400 Quality in business always battles with ethics due to the increasing cost associated with ethical devices. Oftentimes, when you hear about an ethical scandal, such as the famous Ford Pinto, it comes down to cost analysis. Many managers already dislike…   Read more»

]]> 51116a1c050889cdee55aadf9ed10f30 jz365 replied to the topic "Discussion Topic: The cost of Quality" - https://medicaldevicecourses.com/activity/p/16480/ Wed, 15 May 2019 19:39:39 -0400 Having a Quality department in your business is like having a plunger in your bathroom. For the longest time it will just sit there and remind you that you spent money to buy it. But if something happens and you…   Read more»

]]> 7630f53c284421a904512d6f4799014e jz365 replied to the topic "Drugs banned in US but not in other countries" - https://medicaldevicecourses.com/activity/p/16392/ Wed, 15 May 2019 19:38:47 -0400 One drug that was huge in the early development of modern FDA medicinal regulations was Thalidomide. This drug was popular in the 1960’s and was marketed for morning sickness in pregnant women. Unbeknownst at the time, the enantiomer of the…   Read more»

]]> 64875335d0989e033eb467392417f3db jz365 replied to the topic "Discussion Topic: Android app for measuring blood glucose" - https://medicaldevicecourses.com/activity/p/16391/ Wed, 15 May 2019 19:38:47 -0400 The blood glucose meter is an existing product and as such is class 2. It is a medical device and falls under CDRH. The interesting component is that is transmits data to an android app. The thing in question here…   Read more»

]]> 8588b4e3fb0bba40cc72bff9e9d04012 jz365 replied to the topic "Discussion Topic: Antibiotic-Releasing Hip Stem" - https://medicaldevicecourses.com/activity/p/16390/ Wed, 15 May 2019 19:38:46 -0400 The path of an antibiotic releasing hip stem would certainly start out with an RFD. Although the primary function of this device is the physical hip stem, the antibiotic releasing portion is the aspect of the device that would make…   Read more»

]]> 563f59335c9ee913758641ad49fe7ff6 jz365 replied to the topic "Research for the Fututre or Now?" - https://medicaldevicecourses.com/activity/p/16290/ Wed, 15 May 2019 19:37:47 -0400 While they are both important, an we all agree that they are, I think, from a logical standpoint, research for the current generation is and should continue to be the bulk of completed research. There are two types of research,…   Read more»

]]> f0431fd636d2da84ff1db197ebc9ecf8 jz365 replied to the topic "Discussion Topic: Beyond experimental design issues" - https://medicaldevicecourses.com/activity/p/16289/ Wed, 15 May 2019 19:37:47 -0400 My biggest concern in that scenario, like many others, would be the quality of the work done at the outsourced lab. While outsourcing always poses a quality issue, the most dubious aspect of this scenario is the reason for outsourcing…   Read more»

]]> f945efa318653785b8d67ed4ad858bc8 jz365 replied to the topic "Ethics of Animal Testing" - https://medicaldevicecourses.com/activity/p/16288/ Wed, 15 May 2019 19:37:46 -0400 As technology progresses, animal studies will be phased out more and more in favor of computer simulations. Currently however, animal studies are needed because there is no alternative. There are steps humans can take to reduce the ethical issues presented…   Read more»

]]> bb6f8f1f522fe426e436830a8b8f5b94 jz365 replied to the topic "Milestones Missed: Failure or Success?" - https://medicaldevicecourses.com/activity/p/16175/ Wed, 15 May 2019 19:17:58 -0400 When a milestone is missed, it means that something pertaining to the project was misplaced. This could be resources, foresight, proper documentation, or failure to plan for setbacks. If the missed milestone points out a deficit in the product that…   Read more»

]]> 92e6f2f7d02b73d716e7fe986d1be0d8 jz365 replied to the topic "Discussion Topic: Project Management in a medical device setting" - https://medicaldevicecourses.com/activity/p/16174/ Wed, 15 May 2019 19:17:57 -0400 I see a lot of posts on here citing the FDA as a huge difference between a medical device project and a construction project. However, this is just one of many huge differences. The FDA makes life hard for BME’s…   Read more»

]]> bf868341d6faae0ab7a04fb8dfb1e0a2 jz365 replied to the topic "Manager Vs Engineering" - https://medicaldevicecourses.com/activity/p/16173/ Wed, 15 May 2019 19:17:56 -0400 To revive this discussion, I believe the roles of managers and engineers in a project fit a Venn Diagram. One circle is strictly managerial/business tasks and the other is purely design and build tasks. In the overlap are the skills…   Read more»

]]> fab2eef4016ca1ff32848d3b28b4c5a9 jz365 replied to the topic "Advice for Biomedical Engineering Students" - https://medicaldevicecourses.com/activity/p/16088/ Wed, 15 May 2019 19:16:55 -0400 Learn connect and learn again. As a student, your job is to learn. Not just your discipline but everything possible. From biomedical engineering to design to cooking to networking. The more you know the better off you’ll be and the…   Read more»

]]> c541c00795c5d2d9f4c07a9c137a06fc jz365 replied to the topic "Discussion Topic: Practical vs. Informational courses" - https://medicaldevicecourses.com/activity/p/16087/ Wed, 15 May 2019 19:16:55 -0400 While the idea of a ratio of professional to theoretical classes is a possible solution for making sure all students have industry read skills, I disagree with the ratio idea completely. When deciding what the content of education should be,…   Read more»

]]> 1c1cfe934f8dbbfb2fd68af1828d7b61 jz365 replied to the topic "Thoughts on BME degree, "a little of everything"" - https://medicaldevicecourses.com/activity/p/16086/ Wed, 15 May 2019 19:16:54 -0400 My advisor used to tell me “biomedical engineering is a third mechanical, a third chemical, a third electrical, and a third biology”. And from what I have seen of the major, it is true. We may not go into very…   Read more»

]]> 3cddb59699cc141c9a5defb983cf1f05 jz365 posted a new topic "Design Documents in Academia" - https://medicaldevicecourses.com/activity/p/10761/ Wed, 15 May 2019 16:36:18 -0400 We learned about many different project design documents that are needed to produce a product in industry. I am curious to know what the equivalent of these documents is if working in academia. For research, you need an experimental protocol….   Read more»

]]> 8caef895fddb042827bf01d8191ce430 jz365 posted a new topic "Company Ratios" - https://medicaldevicecourses.com/activity/p/10752/ Wed, 15 May 2019 16:36:14 -0400 We learned in Dr. Simon’s lecture that there are numerous different ratios that can be calculated to tell different aspects about the company’s health. Would the relative importance of each ratio be swayed by how big the company is? For…   Read more»

]]> a16ca43fcd9a5c3ad367b5e796d6c0e9 jz365 replied to the topic Discussion Topic: Course conclusion and impressions in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/9152/ Mon, 26 Nov 2018 16:01:42 -0500 Dr Simon,

I enjoyed this course pretty thoroughly. It is refreshingly different from most courses at NJIT in the sense that it gives information about how the world actually works, not how a concept works in an ideal situation. It has opened my eyes to the various roles of engineers in a company and definitely has helped identify roles that sound…[Read more]

]]> 0 99dad13b33af161d32e3009a9dfa46a0 jz365 replied to the topic Factors to consider when executing the NDA in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/9151/ Mon, 26 Nov 2018 15:46:07 -0500 An NDA is a way of allowing you to tell some things, but not the whole story. It is analogous to if you told someone a family recipe for cookies. “A little flour, sugar, vanilla extract, a special blend, and baking”. You tell them some things (that are public knowledge) and something that says you do something different. However, you do not tell…[Read more]

]]> 0 5f010e94cb7ed2f7147135be787ed77e jz365 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics https://medicaldevicecourses.com/activity/p/9150/ Mon, 26 Nov 2018 15:39:10 -0500 Verbal contracts are hard to defend in court and are thus not quite as actionable. Generally, if it is important and there are risks associated with one party backing out, it goes in a written contract. If breaking the contract is not associated with a lot of risk, then it is fine to only use a verbal contract. For example, if someone backing out…[Read more]

]]> 0 4b5dbd26d64d6582b328ba2aa38df45d jz365 replied to the topic Upper vs Middle Management. in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/9105/ Sun, 25 Nov 2018 22:02:36 -0500 In upper management you have real control over the company but most of your work is confined to maintaining the company and dealing with finances legislature. You are in the position of maintaining the logistics of the company. In middle management, you are working with the project teams and concerned with the logistics of the projects. You see…[Read more]

]]> 0 1957e80c1ce3e96df3981f83ac8c6491 jz365 replied to the topic Organizational Behavior Management in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/9104/ Sun, 25 Nov 2018 21:56:38 -0500 From my experience the best impact of worker performance is leadership. This works both ways, poor leadership means very poor outcomes. A leader needs to firstly have a clearly defined vision. Without a vision the workers cannot see an end goal and then it becomes a slog fest for them. Secondly, a leader needs to be animated. The leader needs to…[Read more]

]]> 0 41b71664eb782350fe644b276b4e2cd1 jz365 replied to the topic Medical Device Project in the forum Organizational Development in Device Companies https://medicaldevicecourses.com/activity/p/9103/ Sun, 25 Nov 2018 21:52:02 -0500 The first thing our team did was go over the timeline of the project. We set up a simple flowchart of what has to happen and what everyone needs to do. Then, we started giving tasks to the people that needed to do their job and give it to other people. We set deadlines for that and at the next meeting we will move onto the next developmental…[Read more]

]]> 0 5f516d62c184e128a0369ce2f9893e83 jz365 replied to the topic What is Risk-benefit analysis ? in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/8932/ Mon, 12 Nov 2018 20:02:25 -0500 In the assessment of risks of devices section (4.2) the standard lists duration of the risk as a parameter. This is an important distinguisher because it dictates how much damage a risk can do under worst case scenario. Oftentimes business decisions are guided by worst case scenario simulations. This metric tells you that, at worst case, a very…[Read more]

]]> 0 2425e654b8109a114aa4125ecc1d1d73 jz365 replied to the topic Sample Size Based on Risk Analysis in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/8931/ Mon, 12 Nov 2018 19:51:54 -0500 The type of risk plays a role in what statistical analysis you need when testing. Most companies here just use a higher sample size when testing high risk hazards but I believe it can go deeper than that. Each risk has an associate frequency and severity. For high frequency risks, increasing the sample size does not seem to make as much logical…[Read more]

]]> 0 a1df9ae1cbdf8a63f960010c5d83a1d4 jz365 replied to the topic How to run a risk management meeting ? in the forum Risk Analysis for Medical Devices https://medicaldevicecourses.com/activity/p/8930/ Mon, 12 Nov 2018 19:19:28 -0500 I believe the best results from a risk analysis meeting come from minimizing bias. The beginning of the meeting is about finding hazards by going through the chronological life cycle of the project. Starting with the machining/manufacturing process and following through till contact with end user. Once all the possible hazards are known, then…[Read more]

]]> 0 c1c63e5652800c78757f932b92836381 jz365 replied to the topic Minutes for meetings in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8825/ Mon, 05 Nov 2018 18:30:02 -0500 I am president of a new start up club on campus and we have used various methods to keep track of the meeting progress. Having someone take notes throughout the meeting and upload them directly afterwards to a folder accessible by everyone is crucial. We used to just email the minutes, or try to remember what was said and quickly write it down…[Read more]

]]> 0 12b250d4094e29045b99f9a00aa43a14 jz365 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls https://medicaldevicecourses.com/activity/p/8824/ Mon, 05 Nov 2018 18:19:33 -0500 The Gantt chart is a useful organizational tool, if not for actually keeping track of the project timeline. When creating the Gantt chart, you are forced to think about reasonable time estimates for the project tasks. It helps to break the tasks up as small as reasonably possible to ensure that team members have a clear idea of what they are…[Read more]

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