Medical Device Courses | Anthony | Activity https://medicaldevicecourses.com/members/anthony/activity/ Activity feed for Anthony. Fri, 24 Apr 2026 22:24:51 -0400 https://buddypress.org/?v= en-US 30 hourly 2 b24f631ad936ace328db3eb0154fe121 Anthony replied to the topic "Choosing a CRO" - https://medicaldevicecourses.com/activity/p/18403/ Wed, 15 May 2019 21:48:00 -0400 ec52 and Sk90, thank you for your responses. The answers you’ve provided about CRO selection criteria, questions to ask when inquiring about them, and selecting at least three to evaluate are valuable insights. Sk90, the data exporting point you bring…   Read more»

]]> e25be208308e55c0ca051293e89a1d1c Anthony replied to the topic "Discussion Topic: Outsource vs. Insource the clinical trial" - https://medicaldevicecourses.com/activity/p/18288/ Wed, 15 May 2019 21:46:59 -0400 I think outsourcing a clinical trial is the most efficient option for a medical device company. In my opinion I think that outsourcing will free up human resources for working on additional projects and ensure that the trial is completed…   Read more»

]]> 0127443a7e171e88bf747e8f39cc6d8b Anthony replied to the topic "Avoiding Tunnel Vision" - https://medicaldevicecourses.com/activity/p/18285/ Wed, 15 May 2019 21:46:58 -0400 Tunnel vision can lead to the downfall of a project because you may miss valuable information or indicators while focusing on a single task. I think the best way to avoid tunnel vision is to have an experienced project team…   Read more»

]]> b2cd3738e256d44cda0c4b240697d13e Anthony replied to the topic "How was this class helpful" - https://medicaldevicecourses.com/activity/p/18284/ Wed, 15 May 2019 21:46:57 -0400 I have gotten the most out of the simulations from this course. They teach you to not only think about a scientific or technical solution to a problem that may arise during a project, but to also think about other…   Read more»

]]> 8dbf84709b05a5a4e84ac8531a01a3f0 Anthony replied to the topic "Changining staff" - https://medicaldevicecourses.com/activity/p/18203/ Wed, 15 May 2019 21:46:15 -0400 If you are in a weak matrix organization then the functional heads may have more power than the project managers and may dictate who is allowed to be on your project team and for how long. These employees will still…   Read more»

]]> 367c9d0801657df0809bbd9ce448eea3 Anthony replied to the topic "Specifications: A double edged sword?" - https://medicaldevicecourses.com/activity/p/18174/ Wed, 15 May 2019 21:46:01 -0400 I think that it may be a good idea to put the extra time into thinking about the specifications of a critical component. Yes you want them to be as specific as possible, but if you know during design specification…   Read more»

]]> c86c3ba3e14069cd32367afa9e3c2836 Anthony replied to the topic "Single Source/Dual Source" - https://medicaldevicecourses.com/activity/p/18173/ Wed, 15 May 2019 21:46:00 -0400 This is one of those situations where you would need to find the balance between your quality management plan and your risk management plan. You need to satisfy your quality requirements first and then you need to assess the risk…   Read more»

]]> 392a5ad9971171d17f0318c7bdfccaeb Anthony replied to the topic "Which of the following project would you say is better and why" - https://medicaldevicecourses.com/activity/p/18117/ Wed, 15 May 2019 21:45:32 -0400 In my opinion I think in a general sense it is better to have negative SV paired with a positive CV. My reasoning goes like this, if you are on a project that is behind schedule with a negative SV…   Read more»

]]> 4d534f326ad446925ac30a61bf8d2b87 Anthony replied to the topic "Design Review Meetings" - https://medicaldevicecourses.com/activity/p/18038/ Wed, 15 May 2019 21:44:52 -0400 No first hand experience here, but I’d have to agree with Ryan, the early stages of the project are the foundation for the future stages. Im sure small aspects can overlap or melt between two process groups, but it would…   Read more»

]]> d3b27c3eff8d93f628c90c18a1a972fb Anthony replied to the topic "Monitoring and Controlling Phase" - https://medicaldevicecourses.com/activity/p/18037/ Wed, 15 May 2019 21:44:52 -0400 I don’t have any first hand experience, but I do understand and agree with why a project should be tracked this way. Your planned value will create a target to aim for by a certain date, the earned value will…   Read more»

]]> 45df5e90ccc5b381a72e02b1329f7d5b Anthony replied to the topic "Work Logs and FDA Audits" - https://medicaldevicecourses.com/activity/p/18036/ Wed, 15 May 2019 21:44:51 -0400 I have an example that was thankfully caught by internal QC before any other agency was aware. There was a situation in a diagnostic lab where a new processing technician (non-bench/wet lab position), responsible for accessioning specimen and distributing them…   Read more»

]]> b15d26f3405819e5d4bb0295bc5929df Anthony replied to the topic "Design Validation" - https://medicaldevicecourses.com/activity/p/17979/ Wed, 15 May 2019 21:44:20 -0400 The whole reason why medical devices, or products in general, are created are to fill a users need, and that need will be heavily researched prior to the initiation of the project, think back to the initiation stage. If you…   Read more»

]]> 32bdf7a8affad294389922b0251612fb Anthony replied to the topic "Unexpected Time Delays - miniSim" - https://medicaldevicecourses.com/activity/p/17972/ Wed, 15 May 2019 21:44:17 -0400 I think that there are some cases where shortening the time frame of a study is a good option. Using the bone void filler syringes from the last simulation as an example, we needed to verify a two year shelf…   Read more»

]]> 95ae05400d488c2b067f56abaddf9bc4 Anthony replied to the topic "Problem with the Vendors" - https://medicaldevicecourses.com/activity/p/17971/ Wed, 15 May 2019 21:44:16 -0400 From our most recent lecture we learned that requesting seller responses and selecting vendors is part of directing and managing project execution. During this phase you are obtaining quotes from approved vendors and verifying them with quality systems depending on…   Read more»

]]> cdd0e1ae36559b120152fcc5db96d52f Anthony replied to the topic "Are Missed Milestones really Bad?" - https://medicaldevicecourses.com/activity/p/17840/ Wed, 15 May 2019 21:43:09 -0400 I agree with the above statements, but in addition, missing a milestone is a bad thing no matter how you spin it. Take it as a learning experience for future improvement you may think, but in reality depending on how…   Read more»

]]> be187900b54b5e3feb7fa04a91b4bdf4 Anthony replied to the topic "Estimating Project Timeline" - https://medicaldevicecourses.com/activity/p/17839/ Wed, 15 May 2019 21:43:09 -0400 I think the best way to avoid an inaccurate estimation is to actually have members on the team that have done similar tasks before, you wouldn’t want to take the opinion of an inexperienced person. This goes to show how…   Read more»

]]> a43474a90499262ab3eb67f0be52e6b5 Anthony replied to the topic "Unexpected changes to the Project" - https://medicaldevicecourses.com/activity/p/17834/ Wed, 15 May 2019 21:43:07 -0400 jr377 taking into account how long the built in buffer should be is an important point to bring up. As with all parts of the project this too will be a factor that impacts the budget. The extra time allotted…   Read more»

]]> ef43fc3cca07a9f369d12d6aabf7adfa Anthony replied to the topic "Scope Creep" - https://medicaldevicecourses.com/activity/p/17754/ Wed, 15 May 2019 21:42:21 -0400 In my opinion a good way to avoid scope creep is to have a highly efficient planing stage prior to the submission of a final scope statement. Make the most out of each meeting and get all ideas on the…   Read more»

]]> a88f2bcec2b9cdecae58692c1b73712b Anthony replied to the topic "Risk Management Team" - https://medicaldevicecourses.com/activity/p/17753/ Wed, 15 May 2019 21:42:21 -0400 Honestly I don’t think there is a grey area on when to shut down or continue a project with an assessed risk. I think that when a risk analysis is done and the results are shown to the company/stakeholders/sponsors, they…   Read more»

]]> 27b715b3621fcc91b5dbff15af553c50 Anthony replied to the topic "Unexpected changes to the Project" - https://medicaldevicecourses.com/activity/p/17751/ Wed, 15 May 2019 21:42:20 -0400 I think that the best way to prevent employees from going off on their own and making decisions that will effect the whole project, is to have a clear scope baseline. As a project manager you should have your scope…   Read more»

]]> ed3ee43b516453b348c57e3b482e9e29 Anthony replied to the topic "Medical Device Companies and the Labs That Use Their Devices." - https://medicaldevicecourses.com/activity/p/17677/ Wed, 15 May 2019 21:41:40 -0400 “High Complexity Tests This category includes those tests that are modified by the laboratory, developed by a laboratory, or a test classified as high complexity under CLIA. Laboratories under CLIA and COLA also must comply with Section §493.1201 (general QC):…   Read more»

]]> d25c046ed39d4ce90140921ea2187bfc Anthony replied to the topic "Possibility of Global Regulation of Medical Devices?" - https://medicaldevicecourses.com/activity/p/17670/ Wed, 15 May 2019 21:41:37 -0400 test

]]> 76dfc7195fabe3515cb1e1aae936f79d Anthony replied to the topic "Determining project priority" - https://medicaldevicecourses.com/activity/p/17664/ Wed, 15 May 2019 21:41:34 -0400 In an ideal world a company would fully fund projects large and small, but I think priority will ultimately come down to a risk reward analysis, how much money a company is willing to put into a project versus how…   Read more»

]]> 1b131d3f6440b36c8d3b67fab0800fce Anthony replied to the topic "Design Review Meeting" - https://medicaldevicecourses.com/activity/p/17642/ Wed, 15 May 2019 21:41:23 -0400 In addition to giving ample time for members of the project team to review documents before their approval, I think that it would be beneficial to have frequent short meetings in between official design review document approval meetings. I think…   Read more»

]]> b701d2a9e0552ec6a82fb4d1ad962630 Anthony replied to the topic "Design Control Process" - https://medicaldevicecourses.com/activity/p/17616/ Wed, 15 May 2019 21:41:05 -0400 I haven’t had the opportunity to work in industry yet, but if I could choose one of the nine parts of design controls to focus on I would choose design validation. Having a product that is ready for a clinical…   Read more»

]]> 1ba32b730f775e6ec816706ab7759432 Anthony replied to the topic "Possibility of Global Regulation of Medical Devices?" - https://medicaldevicecourses.com/activity/p/17615/ Wed, 15 May 2019 21:41:05 -0400 I do not think that the medical device community as a whole is moving towards a globalization of regulatory procedures because as we have learned in lecture, the approach to regulation regarding drugs and medical devices has been a reactive…   Read more»

]]> 0c8cb9a43762b52fb68e431d84fdb45e Anthony replied to the topic "Update to Classification System" - https://medicaldevicecourses.com/activity/p/17520/ Wed, 15 May 2019 21:40:13 -0400 Over a medical device’s lifetime the amount of information regarding its safety and effectiveness will increase and can possibly reduce the risk associated with the device. If this happens there is a reclassification process that can be used to update…   Read more»

]]> 0727dd1564d2e862b2fc51dfb3ecc529 Anthony replied to the topic "FDA Approves First Digital Pill in USA" - https://medicaldevicecourses.com/activity/p/17506/ Wed, 15 May 2019 21:40:06 -0400 With the standard pill, not containing the event marker, there were 6 clinical trials done to get the drug approved. With the addition of the marker the new combination product required new clinical trials using the prior 6 trial data…   Read more»

]]> 9fc90065f4a9efe0af92758ab72a558c Anthony replied to the topic "''Quality Plan'' meaning ?" - https://medicaldevicecourses.com/activity/p/17504/ Wed, 15 May 2019 21:40:05 -0400 In my experience working in clinical diagnostic laboratories I have had to adhere to many quality control standards and guidelines. When a new device is being validated for clinical use it must have a clear quality control procedure and tracking…   Read more»

]]> 6abf843eaca22dc25077919f4949afae Anthony replied to the topic "Funding in Medical Devices Industry" - https://medicaldevicecourses.com/activity/p/17477/ Wed, 15 May 2019 21:39:51 -0400 As someone who has never worked in industry, I’m curious to know what happens when a project does get scrapped. I’m sure the repercussions would be determined by the size of the company, but if a project loses funding or…   Read more»

]]> 5cde00f9f59d83b3478b6bbab89836e8 Anthony replied to the topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/17444/ Wed, 15 May 2019 21:39:34 -0400 I am not currently working in the medical device industry, but throughout my career as a Medical Technologist I have experienced what it is like to work in a strictly functional organization. Previously I worked for a company called BioReference…   Read more»

]]> 1bc2e921d14509cd07f12a928e5ed2a0 Anthony replied to the topic "Should Interpersonal skills be more valuable than technical skills?" - https://medicaldevicecourses.com/activity/p/17443/ Wed, 15 May 2019 21:39:34 -0400 In response to vcf3, ih37, and jl959, I feel there has been a misunderstanding of what the 70:30 ratio actually represents. When it is said that an individual’s success relies 70% on interpersonal skill and 30% technical knowledge, I do…   Read more»

]]> 6d54734e3b3e9d98a92e7a5dee19dd5f Anthony posted a new topic "Choosing a CRO" - https://medicaldevicecourses.com/activity/p/10805/ Wed, 15 May 2019 16:36:38 -0400 Does partnering with a CRO reduce project risk? If you do choose to partner with a CRO how do you go about choosing the CRO? My initial thought was that hiring a CRO does indeed reduce risk, but then I…   Read more»

]]> 56b0b59fc4e9eb2e62d689e562180ef7 Anthony posted a new topic "Medical Device Companies and the Labs That Use Their Devices." - https://medicaldevicecourses.com/activity/p/10781/ Wed, 15 May 2019 16:36:28 -0400 The lab I work for purchased a new automated diagnostic machine about a year ago and I had the luxury of validating the device for use. It is called nanoString DX digital analyzer and prep station, the test is called…   Read more»

]]> e2527cfc724634249e172c60f6275ab1 Anthony replied to the topic Choosing a CRO in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10320/ Tue, 07 May 2019 21:52:54 -0400 ec52 and Sk90, thank you for your responses. The answers you’ve provided about CRO selection criteria, questions to ask when inquiring about them, and selecting at least three to evaluate are valuable insights. Sk90, the data exporting point you bring up is becoming more and more important as technology evolves, will the data be stored onsite or…[Read more]

]]> 0 dd391d65f0ca8f0423409a29da29fe84 Anthony started the topic Choosing a CRO in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10215/ Tue, 30 Apr 2019 04:00:41 -0400 Does partnering with a CRO reduce project risk?
If you do choose to partner with a CRO how do you go about choosing the CRO?

My initial thought was that hiring a CRO does indeed reduce risk, but then I got stuck with the questions: How do I pick the right CRO to partner with? and do I pick the cheapest or the most reputable?

In the following…[Read more]

]]> 0 fc58224b87b2b5c41df2f582f805197d Anthony replied to the topic Discussion Topic: Outsource vs. Insource the clinical trial in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10200/ Mon, 29 Apr 2019 02:07:58 -0400 I think outsourcing a clinical trial is the most efficient option for a medical device company. In my opinion I think that outsourcing will free up human resources for working on additional projects and ensure that the trial is completed by professionals as fast as possible while maintaining compliance with all the clinical trial rules and…[Read more]

]]> 0 d728c9bcaf100c2b95b679f0c775f0ca Anthony replied to the topic Avoiding Tunnel Vision in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10197/ Mon, 29 Apr 2019 01:47:18 -0400 Tunnel vision can lead to the downfall of a project because you may miss valuable information or indicators while focusing on a single task. I think the best way to avoid tunnel vision is to have an experienced project team that has open communication and are willing to voice their opinion when they think tunnel vision is occurring or if they feel…[Read more]

]]> 0 977494d0ebf8a597b68352f2abb2a4e7 Anthony replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10196/ Mon, 29 Apr 2019 01:26:37 -0400 I have gotten the most out of the simulations from this course. They teach you to not only think about a scientific or technical solution to a problem that may arise during a project, but to also think about other factors such as interpersonal relations and business strategy. After receiving feedback from the previous simulation and finding out…[Read more]

]]> 0 6bdc41372e5f2bee2f84f60ff025c79d Anthony replied to the topic Changining staff in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/10114/ Sun, 21 Apr 2019 17:55:45 -0400 If you are in a weak matrix organization then the functional heads may have more power than the project managers and may dictate who is allowed to be on your project team and for how long. These employees will still have to answer to their functional heads who may pull them off of a project entirely for whatever reason. If all parties are taking…[Read more]

]]> 0 5f6a87961e5bc9df9e5546ef1f7984aa Anthony replied to the topic Specifications: A double edged sword? in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/10084/ Fri, 19 Apr 2019 05:55:52 -0400 I think that it may be a good idea to put the extra time into thinking about the specifications of a critical component. Yes you want them to be as specific as possible, but if you know during design specification that you will need to dual source a specific component for your product, maybe it would be a good idea to do some research on what…[Read more]

]]> 0 afce5fce9d586ca61723e95c1d2483da Anthony replied to the topic Single Source/Dual Source in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/10083/ Fri, 19 Apr 2019 05:40:27 -0400 This is one of those situations where you would need to find the balance between your quality management plan and your risk management plan. You need to satisfy your quality requirements first and then you need to assess the risk regarding the changes you’ve made. If you really thought about the risk involved in having a critical component and its…[Read more]

]]> 0 4028da8bb1b67ae8bf48f0e386c21067 Anthony replied to the topic Which of the following project would you say is better and why in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/10027/ Sat, 13 Apr 2019 21:44:04 -0400 In my opinion I think in a general sense it is better to have negative SV paired with a positive CV. My reasoning goes like this, if you are on a project that is behind schedule with a negative SV but for the work you’ve completed your CV is positive I think you are in a more favorable position. You can work harder to correct your scheduling…[Read more]

]]> 0 f5e729df7e5151148220871725235a74 Anthony replied to the topic Design Review Meetings in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9942/ Fri, 29 Mar 2019 19:58:15 -0400 No first hand experience here, but I’d have to agree with Ryan, the early stages of the project are the foundation for the future stages. Im sure small aspects can overlap or melt between two process groups, but it would be pretty impossible to move on to the next stage if the proper documents weren’t able to be completed and approved. When your…[Read more]

]]> 0 9eb60eae09112657980eaec86cdb0079 Anthony replied to the topic Monitoring and Controlling Phase in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9941/ Fri, 29 Mar 2019 19:40:02 -0400 I don’t have any first hand experience, but I do understand and agree with why a project should be tracked this way. Your planned value will create a target to aim for by a certain date, the earned value will put a dollar amount on what work has been completed and when you take them both into account you will be able to see monetarily how ahead or…[Read more]

]]> 0 8085fadd0bb4de802b71017c2a43f7e5 Anthony replied to the topic Work Logs and FDA Audits in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9940/ Fri, 29 Mar 2019 19:18:25 -0400 I have an example that was thankfully caught by internal QC before any other agency was aware. There was a situation in a diagnostic lab where a new processing technician (non-bench/wet lab position), responsible for accessioning specimen and distributing them to the proper department, was pouring off peripheral blood and bone marrow from original…[Read more]

]]> 0 9eee212afe4e6413d964df50fa8fc4a0 Anthony replied to the topic Design Validation in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9881/ Sun, 17 Mar 2019 02:34:56 -0400 The whole reason why medical devices, or products in general, are created are to fill a users need, and that need will be heavily researched prior to the initiation of the project, think back to the initiation stage. If you come to the validation stage of product development and your inputs are “abc” and your user needs are “xyz” (very far off)…[Read more]

]]> 0 fb9c7af5e8ffc40de45e70a0585a448c Anthony replied to the topic Unexpected Time Delays - miniSim in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9874/ Sat, 16 Mar 2019 22:37:22 -0400 I think that there are some cases where shortening the time frame of a study is a good option. Using the bone void filler syringes from the last simulation as an example, we needed to verify a two year shelf life for the product without having two years to spend on the study. Yes, running a stability study for two years would give us accurate…[Read more]

]]> 0 e2c48b24fa14faeebd7e45008954e89f Anthony replied to the topic Problem with the Vendors in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9873/ Sat, 16 Mar 2019 21:56:15 -0400 From our most recent lecture we learned that requesting seller responses and selecting vendors is part of directing and managing project execution. During this phase you are obtaining quotes from approved vendors and verifying them with quality systems depending on the components critical impact to your product. The company has done their due…[Read more]

]]> 0 712f9d86fe4dd107e90473a73081bbed Anthony replied to the topic Are Missed Milestones really Bad? in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9737/ Sat, 02 Mar 2019 02:43:23 -0500 I agree with the above statements, but in addition, missing a milestone is a bad thing no matter how you spin it. Take it as a learning experience for future improvement you may think, but in reality depending on how big the company is a missed milestone can be the difference between renewed funding and loss of contracts. Take a public biotech…[Read more]

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