Medical Device Courses | Christoph | Activity https://medicaldevicecourses.com/members/christoph/activity/ Activity feed for Christoph. Fri, 24 Apr 2026 12:09:01 -0400 https://buddypress.org/?v= en-US 30 hourly 2 3821ece4a5078be59be2fb1ff0775e2d Christoph replied to the topic "Let's Be Motivated!!!" - https://medicaldevicecourses.com/activity/p/20037/ Mon, 04 May 2020 03:39:05 -0400 Posted by: @djr32 Suppose you are a project manager in a medical industry. What are some ways you would motivate the team members you are managing? Does a project manager’s level of motivation affect the team’s productivity and motivation level?…   Read more»

]]> dfc7be7d278b68190fdd55a812cbd8b9 Christoph replied to the topic "Why do people work?" - https://medicaldevicecourses.com/activity/p/20036/ Mon, 04 May 2020 03:27:51 -0400 Posted by: @talha-chaudhry For the lecture this week, I was fascinated by the results of the study Dr. Simon referenced. The study asked employees why they stayed and worked at the company they are employed at. What motivates them kind…   Read more»

]]> 357639f35d2eea9e25ff8e387f6cb215 Christoph replied to the topic "Sponsorship for companies" - https://medicaldevicecourses.com/activity/p/20032/ Mon, 04 May 2020 03:16:55 -0400 The Sponsors are positioned above the project manager in the company hierarchy.The project manager is accountable to the Sponsor to implement the sponsors vision, to seek approval from for scope, budget and resources. The sponsors would periodical expect reports from…   Read more»

]]> 1ce97d8a863a3263c10b993e19f8df0b Christoph replied to the topic "What’s Your Motivator?" - https://medicaldevicecourses.com/activity/p/19972/ Mon, 27 Apr 2020 02:36:29 -0400 Posted by: @bb254 A lot of people may say that they are motivated to do work because of their family or wanting to help their community. I on the other hand have always been driven to push my own boundaries….   Read more»

]]> afe61845b05a9c5d6abfc73b613f786b Christoph replied to the topic "Engineer vs. Manager" - https://medicaldevicecourses.com/activity/p/19968/ Mon, 27 Apr 2020 02:15:41 -0400 I would like to be in a technical leadership position. I have worked for many year as an engineer.At this point I would like to gain more visibility into product development. So I would like manage production of a product….   Read more»

]]> 4ca902fb7f0b0ce30c3f8bdf75d62b18 Christoph replied to the topic "Clinical Project Team Roles" - https://medicaldevicecourses.com/activity/p/19966/ Mon, 27 Apr 2020 02:05:41 -0400 Posted by: @ak977 As Dr. S listed for us, the roles of a clinical project team are as follows: Clinical Project Manager, Clinical Research Associates (CRA’s), Monitors, Regulatory, Statisticians, Investigators, Site Coordinators, SROs, CROs, Centers, Labs, IRB’s, and Recruitment Organizations….   Read more»

]]> b4bcd89bd0d3bc7f5f38df188fa1f6bc Christoph replied to the topic "Benefits of this course" - https://medicaldevicecourses.com/activity/p/19741/ Mon, 16 Mar 2020 03:34:54 -0400 I agree that the course is of much help. I have worked in medical device industry for a while but had little understanding about medical device product development from business or regulatory perspective.This course has helped me understand the intent…   Read more»

]]> 06a1ae254d60ee2a74722790fedf14ba Christoph replied to the topic "Importance of Metrics" - https://medicaldevicecourses.com/activity/p/19738/ Mon, 16 Mar 2020 03:21:03 -0400 Posted by: @devarshi-joshi After learning about Monitoring and Controlling phase we learnt about metrics. My question is how is this metrics important in project? Metrics is important to a project because it provides feedback on questions like what, when, how…   Read more»

]]> 19faca0a84dd7425ba8b9a6be70965be Christoph replied to the topic "Executing Process" - https://medicaldevicecourses.com/activity/p/19737/ Mon, 16 Mar 2020 03:09:41 -0400 Posted by: @rjs84 Part of the executing process involves information distribution, solicitation, source selection, and managing vendor relations. Most of the time and money of the project go into its execution. I would argue that the parts of the executing…   Read more»

]]> 0692d926d716e6fe921463672b134afb Christoph replied to the topic "Planning Phase" - https://medicaldevicecourses.com/activity/p/19635/ Mon, 02 Mar 2020 05:00:16 -0500 Posted by: @devarshi-joshi If we talk about planning phase in a project of medical devices, according to me one of the important aspect is to find out user needs. Sometimes user needs are bit vague and ambigious but that is…   Read more»

]]> b792fcebf5421fea1a32424d7a1cbfac Christoph replied to the topic "Design Change Request" - https://medicaldevicecourses.com/activity/p/19634/ Mon, 02 Mar 2020 04:51:54 -0500 Posted by: @bb254 Companies have different procedures in order to submit a design change request. Share your experience on the steps needed to complete a design change request at your company. At Maquet, the engineers redline the latest version of…   Read more»

]]> a6b72863ff10ca227db9071b1d5377af Christoph replied to the topic "Project Approval" - https://medicaldevicecourses.com/activity/p/19518/ Mon, 17 Feb 2020 04:43:40 -0500 I agree with the point regarding money being the central issue.Additionally, I will borrow from a related question about feasibility.Below I have listed the steps recommended for feasibility.These are the very steps which will provide the data on which Project…   Read more»

]]> 57546a546dd56183eb98ec0697d5eb58 Christoph replied to the topic "Best timing for validation and verification" - https://medicaldevicecourses.com/activity/p/19514/ Mon, 17 Feb 2020 03:46:22 -0500 Posted by: @la82 The process of validation and verification is very important in device development. with that being said, when is the best time to carry out these two important steps during the project’s span ? Design control places Verification…   Read more»

]]> 4b017e8e788219388c431139d2f84612 Christoph replied to the topic "Feasibility Study" - https://medicaldevicecourses.com/activity/p/19513/ Mon, 17 Feb 2020 02:35:11 -0500 The site projectmanager.com recommends the following steps for a feasibility study:1. Conduct a Preliminary Analysis2. Prepare a Projected Income Statement3. Conduct a Market Survey, or Perform Market Research4. Plan Business Organization and Operations5. Prepare an Opening Day Balance Sheet6. Review…   Read more»

]]> 83a2d32cc807f2ef8f23047b7fc8ca38 Christoph replied to the topic "Product Life Cycle" - https://medicaldevicecourses.com/activity/p/19450/ Mon, 10 Feb 2020 04:55:13 -0500 Posted by: @krp76 In the week 3 lecture we are introduced to the concept of Product Life Cycle and the different phases that constitute this cycle: Development, Introduction, Growth, Maturity, Decline. It seems a natural progression of any product within…   Read more»

]]> e30d3c26dd92a7de4f51ec8c4549b644 Christoph replied to the topic "Challenges for a First-time Project Manager" - https://medicaldevicecourses.com/activity/p/19448/ Mon, 10 Feb 2020 04:33:35 -0500 Posted by: @vcf3 What tips can you give for a new Project Manager who has never been in that position before?I saw this article (http://apexgloballearning.com/blog/project-management-professors/) with some useful tips, but I want to hear your real-life tips and experiences especially…   Read more»

]]> b9f85d827af3327554d3295b6f38f245 Christoph replied to the topic "Validation and Verification" - https://medicaldevicecourses.com/activity/p/19446/ Mon, 10 Feb 2020 04:13:05 -0500 Posted by: @devarshi-joshi Validation is the process of surity that you have objective evidence that are needed by the user and the use of-course. Verification is typically making sure that you are having objective evidence that matches mentioned requirements are…   Read more»

]]> 87998d283e28772082ef09ad8b3285dc Christoph replied to the topic "Interpersonal skills vs technical knowledge" - https://medicaldevicecourses.com/activity/p/19274/ Thu, 23 Jan 2020 04:43:03 -0500 Wow. There have been some really great and informative answers to this question.For myself I agree with others on the point that technical education is necessary but not sufficient for success.  However, I think this is a proper investment in…   Read more»

]]> 8bff9427f896ad681ba21b16fbfca4ef Christoph liked forum post "Interpersonal skills vs technical knowledge" - https://medicaldevicecourses.com/activity/p/19273/ Thu, 23 Jan 2020 04:11:11 -0500 8ffc41e9e4096d79e78625a3d257c2af Christoph liked forum post "Interpersonal skills vs technical knowledge" - https://medicaldevicecourses.com/activity/p/19272/ Thu, 23 Jan 2020 04:08:42 -0500 4636b28a7d4e95da7d7bc9a84da49c06 Christoph replied to the topic "Ideal project team" - https://medicaldevicecourses.com/activity/p/19259/ Tue, 21 Jan 2020 02:31:47 -0500 @jvv6What skills would you mainly prefer if you had to build a project team.A team having the set of technical expertise for the project at hand is a must.However, I think a few added skills that would be very useful…   Read more»

]]> 90866e8a03fc75768de602a42165bb18 Christoph replied to the topic "Restrictions for physician's gifts" - https://medicaldevicecourses.com/activity/p/19236/ Mon, 02 Dec 2019 02:27:01 -0500 No there is nothing that should be done about this. General attitude being conveyed is that gifts are not to be used to unduly influence healthcare providers in their decisions. Regarding the lack of inclusion of spouses meals, i think…   Read more»

]]> a0912a01ce4f730d6b36110dfe5bc551 Christoph replied to the topic "Consultants in the Medical Device Industry" - https://medicaldevicecourses.com/activity/p/19235/ Mon, 02 Dec 2019 02:20:40 -0500 When a company is engaged in building a medical device, the company may not have all the areas of expertise hired as employees. Resource of a domain expert may or may not be required on a long term basis. This…   Read more»

]]> c5498977ad142d3a6f71f87a131453ad Christoph replied to the topic "NDA vs Patents" - https://medicaldevicecourses.com/activity/p/19234/ Mon, 02 Dec 2019 02:11:17 -0500 An NDA is definitely not a substitute for a patent.1. The scope of  a NDA’s application is limited to the  two parties explicitly included in the NDA. A patents scope of  protection implicitly includes any party or person within the…   Read more»

]]> c5f0643e6dfebe71535479c636742d40 Christoph replied to the topic "Matrix Organization- Conflict" - https://medicaldevicecourses.com/activity/p/19181/ Mon, 25 Nov 2019 04:34:39 -0500 Wonderful question. I work in a matrix organization. Interestingly, it was originally more of a functional organization. But in an attempt to be more effective in addressing project needs a decision was made to transition more toward a project based…   Read more»

]]> 27a0ac26a43908d69a8c7a96f39b4833 Christoph liked forum post "Matrix Organization- Conflict" - https://medicaldevicecourses.com/activity/p/19178/ Mon, 25 Nov 2019 03:17:24 -0500 2fb86eb7d0c2c9a1a70086a805b62656 Christoph replied to the topic "Medical Device Project" - https://medicaldevicecourses.com/activity/p/19171/ Mon, 25 Nov 2019 02:17:04 -0500 We had our first in person meeting two fridays ago. We spent most of the meeting defining relevant requirement for the DID. It was a fun collaborative experience. I have worked in the industry for some time but it was…   Read more»

]]> 17f23855964187ecdccf3a886da32bf9 Christoph replied to the topic "Organization Type vs. Effectiveness" - https://medicaldevicecourses.com/activity/p/19165/ Sun, 24 Nov 2019 23:56:54 -0500 In my opinion the best organization structure is the matrix.It provides the best balance between maximizing human resources utilization and role specific development via representation at the a the role specific department manager  level.I think it offers also a better…   Read more»

]]> cbccc87abfba29ceb25c38ec0a9eaf1e Christoph replied to the topic "Customer Needs and Design Input" - https://medicaldevicecourses.com/activity/p/19056/ Mon, 11 Nov 2019 03:01:18 -0500 Definitely in agreement with much of what has been said.Two ideas put forward so far best capture the contrast between the DID and DSD.The idea that they are each for different audience, and the idea that the DID represent a…   Read more»

]]> b326f7b34a82e7f815e792540d8104c5 Christoph replied to the topic "What are Design Controls?" - https://medicaldevicecourses.com/activity/p/19017/ Fri, 08 Nov 2019 07:41:29 -0500 There has been much offered so far to answer the question “What are Design Controls”.Working at a medical device company fory  several years i would like to offer what i observed from my experience. Not necessarily a definitive answer but…   Read more»

]]> c509f9cf2510f0d15125497928139a38 Christoph replied to the topic "Clinical Studies" - https://medicaldevicecourses.com/activity/p/18946/ Mon, 28 Oct 2019 03:59:57 -0400 There is no complete correspondence between animal testing and humans.Doing tests on tissue apart from a live person is not always possible.So there is no way to get conclusive results wi

]]> f93a56be77ff4815bd0340ff85d999db Christoph replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" - https://medicaldevicecourses.com/activity/p/18942/ Mon, 28 Oct 2019 03:27:48 -0400 I think consent should by all means be secured from patient prior to using materials or data from patients. It is crucial people and therefore patient have complete control over being. At the core of slavery of African for several…   Read more»

]]> 6ef5df461f7308ffd47ceb0fa6b65384 Christoph replied to the topic "Double Blind Vs Single blind Study" - https://medicaldevicecourses.com/activity/p/18941/ Mon, 28 Oct 2019 03:08:44 -0400 A double blind study help to eliminate bias of doctors participating. It is within the realm possibility to have a doctor whom may be willing to influence a study out come for monetary gain. The doctor could have accessed to…   Read more»

]]> 39be919e61af157d8c92f727e5149ffe Christoph replied to the topic "Medical Device SWOT Analysis" - https://medicaldevicecourses.com/activity/p/18862/ Sun, 20 Oct 2019 20:41:19 -0400 The product I chosen for SWOT analysis is the  LIFEPAK automatic electrical defibrillator product series manufactured by Physio-Control, recently acquired by Stryker. Physio-Control reported $503 million in sales in fiscal 2015,680 million US$ in 2019,STRENGTHPhysio-Control Strength makes several models of automatic…   Read more»

]]> cc12f81839d3b668c5de99ae0c2db51a Christoph replied to the topic "WHAT IS MARKETING TO YOU?" - https://medicaldevicecourses.com/activity/p/18860/ Sun, 20 Oct 2019 19:56:13 -0400 Assessing marketing is a new exercise for me. Prior to taking this course my perspective of marketing was its role was limited to conveying company information to potential customers. But this weeks lecture taught me that marketing includes the role…   Read more»

]]> eeb111b237d18bf6fe3b839bc164165f Christoph replied to the topic "Discussion Topic: Mission and Vision statements" - https://medicaldevicecourses.com/activity/p/18849/ Sun, 20 Oct 2019 03:40:03 -0400 I looked at the vision/mission statements the following medical device companies: Siemens-Healthineers, Medtronic, Abbott, Beckman-Coulter, and Stryker. What they all have in common is a recognition that they are assisting heath care provider to help care for patient health.  The…   Read more»

]]> a16c9d7a5315efb98089230c4c7209f1 Christoph replied to the topic "LLC vs LLP" - https://medicaldevicecourses.com/activity/p/18796/ Sun, 13 Oct 2019 01:36:59 -0400 A comparison of LLC versus LLP related to management, taxation, liability can be used to illustrate their difference as follows.  Regarding management LLC may be management is not limited to members. While for a LLP management is limited to members.Regarding…   Read more»

]]> adf31cf1b53eccf355c7084dfb985f2c Christoph replied to the topic "Emerging technologies and QA" - https://medicaldevicecourses.com/activity/p/18755/ Mon, 07 Oct 2019 03:40:07 -0400 Quality Assurance can be made more efficient and accurate by emerging technologies by facilitating more traceability in the methods used to produce medical devices RFID in the supply chain, Computer aided selection test for validation. After market tracking of device…   Read more»

]]> c95736f7395fa1fb8840659114c9331f Christoph posted a new topic "510K is Nonsense" - https://medicaldevicecourses.com/activity/p/18687/ Mon, 30 Sep 2019 03:47:34 -0400 To a layman, a surperficial assessment of 510K process is that it is nonsensical.WHY are devices being compared to devices created 40 years ago.This makes no sense to me. Why arent the just assessed on their own merits.This seem like…   Read more»

]]> a69e986ba956a5cfe782e73f632ec108 Christoph replied to the topic "Discussion Topic: Make a few, sell a few" - https://medicaldevicecourses.com/activity/p/18679/ Mon, 30 Sep 2019 02:29:56 -0400 This is a great question.From reading the FDA regulatory articles provided the main concern of any medical device is two things1) Is it safe, 2) Is it effective.From business startup prospective I think the challenges is to assess if there…   Read more»

]]> 83d18d2007c5ecc5c379e8cf9e9f51e1 Christoph liked forum post "Make a few, sell a few" - https://medicaldevicecourses.com/activity/p/18676/ Mon, 30 Sep 2019 02:01:51 -0400 bad7158b620f6edc8a000ab7c450d095 Christoph replied to the topic "FDA on Recalled Items" - https://medicaldevicecourses.com/activity/p/18675/ Mon, 30 Sep 2019 01:47:45 -0400 So there is actually a long list of medical device recall that have occured this year alone.What is very interesting is I did not realize there was a public listing available of all such devices accessible from the FDA website.Since…   Read more»

]]> b5885460bc6c76feeb6ed9a9b07b47c7 Christoph replied to the topic "Discussion Topic: Android app for measuring blood glucose" - https://medicaldevicecourses.com/activity/p/18674/ Mon, 30 Sep 2019 01:24:56 -0400 An example of an FDA approved medical device using a mobile app is shown herehttps://www.medicalbag.com/home/more/tech-talk/fda-approves-first-mobile-app-for-use-in-preventing-pregnancy/The article sites efficacy statistics but not safety since there are no safety risks associated with this…[Read more]

]]> 8b75209310cfe2568736bb26d9523c18 Christoph replied to the topic "Ethics of Animal Testing" - https://medicaldevicecourses.com/activity/p/18585/ Thu, 19 Sep 2019 03:33:51 -0400 Is animal testing ethical? are there any alternatives?This question arises in the context of preclinical testing. What then is the purpose of preclinical testing?It is testing that is done in an attempt to be ethical in human testing so as…   Read more»

]]> f35bc8f39e0b7e35ca0587f4d2dffab9 Christoph replied to the topic "Milestones Missed: Failure or Success?" - https://medicaldevicecourses.com/activity/p/18551/ Sun, 15 Sep 2019 22:44:21 -0400 Is missing a milestone a failure or success for the overall project? My first answer to this question is it depends on the consequences resulting from missing the milestone. Multiple factors need to be considered. A project is undertaken for the…   Read more»

]]> a380cf83e4538e05df88d5ba7e61779c Christoph replied to the topic "Project Life Cycle" - https://medicaldevicecourses.com/activity/p/18507/ Tue, 10 Sep 2019 05:27:40 -0400 My opinion is that the planning phase is the most important. The planning phase establishes the “what by when”. It defines what deliverables are expected when. During the planing phase resources are allocated such as  funds and people.  If planning…   Read more»

]]> 52207a5b2eb984881c57d2c0bf389441 Christoph posted a new activity comment https://medicaldevicecourses.com/landing-your-first-medical-device-job-3-things-you-shouldnt-be-doing/#comment-3443 Mon, 09 Sep 2019 11:29:53 -0400 “If you find that you have no way of meeting their needs, you are probably in talking to the wrong person …. and if you get that job, you would not be happy or productive”

I really like this quote from the article. It resonates with me because I think its important to identify what contribution your skill set has prepared you to make. And t…[Read more]

In reply to - Josh wrote a new post In my last article about landing your first medical device job, I talked about three ways in which you can stand out. Having taught nearly a thousand students the art and science of medical […] ]]> d2d63375789fccadcab5989fd87a5cc0 Christoph replied to the topic "Discussion Topic: Practical vs. Informational courses" - https://medicaldevicecourses.com/activity/p/18494/ Mon, 09 Sep 2019 02:54:36 -0400 Academics is academics. Industry is industry.Definitely there is a practical learning curve to be traversed when one leaves academia and enters industry.The 7/10 ratio works well. Coops and internships can also help bridge the difference.However, an academic versus industry perspective…   Read more»

]]> ebd75fe0fa45c7b00c292b07ea249adf Christoph replied to the topic "Advice for Biomedical Engineering Students" - https://medicaldevicecourses.com/activity/p/18480/ Sun, 08 Sep 2019 17:31:21 -0400 My advice is volunteer at a hospital, listen to podcast about medical devices and attend trade showshttps://soundcloud.com/medical-device-podcasthttp://www.nebec.org/I think the most important advice is to take an inventory of your objectives  and your skills.Then decide what contribution you would like to…   Read more»

]]> 48419c63773fbe5a5833558a81d64da1 Christoph liked forum post "Advice for Biomedical Engineering Students" - https://medicaldevicecourses.com/activity/p/18465/ Sun, 08 Sep 2019 03:03:49 -0400