Medical Device Courses | jdc46 | Activity https://medicaldevicecourses.com/members/jdc46/activity/ Activity feed for jdc46. Sat, 25 Apr 2026 00:17:23 -0400 https://buddypress.org/?v= en-US 30 hourly 2 5a4d06c05d3bdbb74e2a2667f2f3298b jdc46 replied to the topic "Avoiding Tunnel Vision" - https://medicaldevicecourses.com/activity/p/18340/ Wed, 15 May 2019 21:47:27 -0400 I continuously aim to live a life not blurred by my own personal ideas and beliefs, but as humans, we all at some point default to the comfort of our own thoughts. To defeat this, we have to recognize the…   Read more»

]]> 7ba5b677a1d57e0f92e6a3537d4118ad jdc46 replied to the topic "How was this class helpful" - https://medicaldevicecourses.com/activity/p/18339/ Wed, 15 May 2019 21:47:26 -0400 As transitioning from academics into industry, this course is incredibly valuable in teaching what to expect. I have a far better understanding of the differences and overlap of the standards followed in Project Management processes and medical device Design Controls….   Read more»

]]> 2f46c363bf5c13894e986e8dcd371765 jdc46 replied to the topic "Sponsorship for companies" - https://medicaldevicecourses.com/activity/p/18323/ Wed, 15 May 2019 21:47:17 -0400 Sponsors are the most valuable source of revenue for a small company. The business sponsor relationship is facilitated through the stakeholder management knowledge area of the project manager. Obtaining sponsorship for any business with minimal resources are almost always entirely…   Read more»

]]> cbfd8694146411f563ad05fa477db1e8 jdc46 replied to the topic "Qualities of a Manager" - https://medicaldevicecourses.com/activity/p/18270/ Wed, 15 May 2019 21:46:50 -0400 The most valuable quality to have as a PM is to know your team members. The performance of a team is most dependent on how engaged each member feels in working on the project. A PM must be able to…   Read more»

]]> d8e654028da39ceba432138dfe3058df jdc46 replied to the topic "Changining staff" - https://medicaldevicecourses.com/activity/p/18204/ Wed, 15 May 2019 21:46:15 -0400 A team is only as good as a team without its most valuable member. Team members get sick. They take vacation time. Emergencies happen. There will be a time when highly valued members aren’t around to help, but if a…   Read more»

]]> c0ee5871ea71a38aab701d7afe3b5f95 jdc46 replied to the topic "Team Development" - https://medicaldevicecourses.com/activity/p/18145/ Wed, 15 May 2019 21:45:46 -0400 As the execution phase transitions into a project’s process, the development of a team foments. Keeping records of all team members and establishing effective communication is tremendously important when developing a team. Each team members should always have the freedom…   Read more»

]]> f727ddeb3d8f34b49a0be32a7aa3ca9f jdc46 replied to the topic "Design Transfer" - https://medicaldevicecourses.com/activity/p/18083/ Wed, 15 May 2019 21:45:15 -0400 It is important to note that manufacturing plays a critical role in the design control process. As development completes a project with design controls, manufacturing is managing design controls in parallel to determine how to implement the designs into production….   Read more»

]]> 7cdd5feb5b5ea7f952a97d04315cdab4 jdc46 replied to the topic "Project budget and variance" - https://medicaldevicecourses.com/activity/p/18051/ Wed, 15 May 2019 21:44:59 -0400 It is important to note that Earned Value (EV) is dependent on the percent completion of the project and not necessarily the specific date that the cost is being evaluated. That is, when looking at Cost Variance (SV), if you…   Read more»

]]> e93e567a13a50ca80e7da5e9abf0980c jdc46 replied to the topic "Challenges PM face" - https://medicaldevicecourses.com/activity/p/17995/ Wed, 15 May 2019 21:44:29 -0400 The PM is critical in moving a project along. It is their responsible to ensure that the whole team is on the same page and stay on schedule. As seen in this week’s mini simulation, sometimes different functional areas collide,…   Read more»

]]> 965623fd6b790b6f8db7c89fe98dfaa0 jdc46 replied to the topic "Problem with the Vendors" - https://medicaldevicecourses.com/activity/p/17986/ Wed, 15 May 2019 21:44:24 -0400 As ih37 described, it is critical to clearly establish your customer needs and expectations in your relationship with the vendor. When the packaging provided by the vendor is arriving with defects, they are not meeting their contractual agreement. Well before…   Read more»

]]> 61e9a465d425aabed521621fb56cbd25 jdc46 replied to the topic "Factors to look for while evaluating change request" - https://medicaldevicecourses.com/activity/p/17880/ Wed, 15 May 2019 21:43:31 -0400 Change to a project can have different effects on the overall project. When considering change, it must remain within the project scope. Changes cannot be made if it changes the project to the extent that it no longer meets the…   Read more»

]]> ede61f13e392d24e75c4cfed19138048 jdc46 replied to the topic "Communication and Responsiveness" - https://medicaldevicecourses.com/activity/p/17866/ Wed, 15 May 2019 21:43:23 -0400 A successful project manager lays out the communication requirements and how information is shared through the team before the start of a project. This means what details of the project must be communicated, when there must be communication, who is…   Read more»

]]> 0ec8cf1e828b08f43928890e76a0999b jdc46 replied to the topic "Estimating Project Timeline" - https://medicaldevicecourses.com/activity/p/17863/ Wed, 15 May 2019 21:43:22 -0400 The initial project timeline is never set. The planning process of a project breaks down the project into actionable tasks (WBS), allowing team to make rough estimates for each task, but the timeline will constantly be revisited. When a team…   Read more»

]]> 9037116b378765a2ebaef267e31b0cb7 jdc46 replied to the topic "Execution phase" - https://medicaldevicecourses.com/activity/p/17789/ Wed, 15 May 2019 21:42:39 -0400 It is important to understand that the input to a phase process group is the output from the previous phase group process. That is, the inputs that are going into the execution process group requires the use of the the…   Read more»

]]> 8b99b1644fd2447f9bd94695208540f9 jdc46 replied to the topic "Risk Management Team" - https://medicaldevicecourses.com/activity/p/17768/ Wed, 15 May 2019 21:42:29 -0400 Evaluating risk may not be as murky as it may first appear. The lectures does not go too deep into risk management, but after assessing the risks, there are methods to better quantify the risks involved. Performance measurement metrics could…   Read more»

]]> c8b39b5046342628f0bca6b38b4a8eab jdc46 replied to the topic "Risk Management Selection" - https://medicaldevicecourses.com/activity/p/17767/ Wed, 15 May 2019 21:42:29 -0400 The team structuring of risk management is dependent on the risk, resources, and time restraints on the project. As mentioned by jb678, the amount of risk involved in a project will determine the need for a separate risk management team….   Read more»

]]> 8e1d9eaeb68e1e3388428adb2933d730 jdc46 replied to the topic "Experiments" - https://medicaldevicecourses.com/activity/p/17692/ Wed, 15 May 2019 21:41:49 -0400 In resolving failure, the first step to take is to define the scope of what can be modified. In our simulation, this is the verification protocol and the product components. The listed specifications could not be modified. Therefore, we are…   Read more»

]]> d1ca6fc09f05dc39fd0095bbf770a8ce jdc46 replied to the topic "Design Control Process" - https://medicaldevicecourses.com/activity/p/17641/ Wed, 15 May 2019 21:41:22 -0400 If I was placed in the Design Control process of a project, I would likely find preference in the putting together the Design Specification Document (DSD). This is where the meat of the engineering is. The DSD is the transitioning…   Read more»

]]> b997804c96448fc418e347e8b081665f jdc46 replied to the topic "Design Review Meeting" - https://medicaldevicecourses.com/activity/p/17640/ Wed, 15 May 2019 21:41:22 -0400 This question becomes tricky because these documents should be carefully reviewed to ensure the safety and effectiveness of the device. We would not want minor miscalculation to snowball into a much larger issues that can become detrimental to the whole…   Read more»

]]> 5b0c2644b950a1712c3c845dd0c3f535 jdc46 replied to the topic "Determining Spec" - https://medicaldevicecourses.com/activity/p/17637/ Wed, 15 May 2019 21:41:20 -0400 From my experience working on projects, deciding on detailed specifications may seem to be the most daunting task, but becomes clear-cut the more you are familiar with the process. The most important factor when specifying ranges of specs is the…   Read more»

]]> 6713d131d5dc37c16f5e6240e7b96dfd jdc46 replied to the topic "510(k) clearance vs. Postmarket Approval" - https://medicaldevicecourses.com/activity/p/17535/ Wed, 15 May 2019 21:40:21 -0400 As Dr. Simon discussed in his lecture videos, the clearance of a Class II device can at times be as costly and timely as a Class III device. Certain Class II devices will require a investigational device exemption (IDE) to…   Read more»

]]> aebae8284d6842bb518cad60a67f8322 jdc46 replied to the topic "Challenges to Overcome" - https://medicaldevicecourses.com/activity/p/17534/ Wed, 15 May 2019 21:40:20 -0400 While the enforcement of regulatory compliance maintains safety and effectiveness of medical devices, it stymies innovation in the medical marketplace. As ec52 discussed, the EU’s transition to implement new regulations on medical devices to heighten scrutiny on clinical trials and…   Read more»

]]> c2725a3f75d28b9c83fd5b0bb2ccc0f3 jdc46 replied to the topic "Discussion Topic: State of your Organization" - https://medicaldevicecourses.com/activity/p/17474/ Wed, 15 May 2019 21:39:50 -0400 I am not currently working in industry, but a variant of matrix organization structure would provide a suitable working environment. Consider an organization that separates their company into different industries to achieve specific corporate objective. Each industry has different divisions,…   Read more»

]]> 79f66ad38c90bee71acc4d1d6c418c1a jdc46 replied to the topic "Funding in Medical Devices Industry" - https://medicaldevicecourses.com/activity/p/17468/ Wed, 15 May 2019 21:39:47 -0400 The funding of a project is dependent on the corporate strategy. If a medical device corporation aims to improves preventative healthcare, the company will take on projects that align with prevent diseases. This can be screening technology or improvement to…   Read more»

]]> 7ad27dbe143b8a1e730ed04b882e2397 jdc46 replied to the topic "Should Interpersonal skills be more valuable than technical skills?" - https://medicaldevicecourses.com/activity/p/17464/ Wed, 15 May 2019 21:39:45 -0400 I believe that the 70/30 for success is completely justified. If anything, 70% interpersonal skills is too low. The most important thing in life is the relationships you foster. Your relationships define your network and the opportunities that are opened…   Read more»

]]> 5762ffbe6eb51f82c5796b51a8f3ceba jdc46 posted a new topic "Lessons Learned" - https://medicaldevicecourses.com/activity/p/10799/ Wed, 15 May 2019 16:36:36 -0400 Controlled documentation is key to any company in keeping everyone on the same page when part of a project. Through this week’s lecture, reporting lessons that a project team learned was discussed as an output for both change control and…   Read more»

]]> b00f452c504e042c45ef432c2ee247be jdc46 replied to the topic Avoiding Tunnel Vision in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10255/ Sun, 05 May 2019 19:42:22 -0400 I continuously aim to live a life not blurred by my own personal ideas and beliefs, but as humans, we all at some point default to the comfort of our own thoughts. To defeat this, we have to recognize the value in other people. Coming together as part of a conversation pools ideas and beliefs that may have never been considered otherwise. Whenever…[Read more]

]]> 0 47ed281cfc0f7549b5a17448e2097f49 jdc46 replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10254/ Sun, 05 May 2019 19:25:34 -0400 As transitioning from academics into industry, this course is incredibly valuable in teaching what to expect. I have a far better understanding of the differences and overlap of the standards followed in Project Management processes and medical device Design Controls. The learning was supplemented by the weekly contribution to conversations. By…[Read more]

]]> 0 85fe006b24c9089add3eef7a89f30042 jdc46 replied to the topic Sponsorship for companies in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10238/ Fri, 03 May 2019 18:00:38 -0400 Sponsors are the most valuable source of revenue for a small company. The business sponsor relationship is facilitated through the stakeholder management knowledge area of the project manager. Obtaining sponsorship for any business with minimal resources are almost always entirely dependent on sponsorships. In obtaining these sponsorships, the…[Read more]

]]> 0 231aed7ed0692b2396a7e89f3e086caa jdc46 replied to the topic Qualities of a Manager in the forum Project Management Application: Clinical Trial https://medicaldevicecourses.com/activity/p/10182/ Sun, 28 Apr 2019 15:33:37 -0400 The most valuable quality to have as a PM is to know your team members. The performance of a team is most dependent on how engaged each member feels in working on the project. A PM must be able to cater to each member’s personality to ensure everyone feels that the time and energy they put into work is valued. The different personality types…[Read more]

]]> 0 6e7fb205fab2b998fb89798deb38cdab jdc46 replied to the topic Changining staff in the forum Project Management Knowledge Areas https://medicaldevicecourses.com/activity/p/10115/ Sun, 21 Apr 2019 21:05:41 -0400 A team is only as good as a team without its most valuable member. Team members get sick. They take vacation time. Emergencies happen. There will be a time when highly valued members aren’t around to help, but if a team is well organized, efficiency shouldn’t be affected. If a great employee leaves the team in the middle of a project, the team…[Read more]

]]> 0 62db42b905a580f87fb4c72c3a79b5f0 jdc46 replied to the topic Team Development in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/10055/ Mon, 15 Apr 2019 01:07:20 -0400 As the execution phase transitions into a project’s process, the development of a team foments. Keeping records of all team members and establishing effective communication is tremendously important when developing a team. Each team members should always have the freedom to take their owed vacation time off. Team members should never feel that…[Read more]

]]> 0 f8517cda274bb69672c15b37ea866f06 jdc46 replied to the topic Design Transfer in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9991/ Mon, 01 Apr 2019 03:16:21 -0400 It is important to note that manufacturing plays a critical role in the design control process. As development completes a project with design controls, manufacturing is managing design controls in parallel to determine how to implement the designs into production. Manufacturing plays an essential roles during this period when transferring designs…[Read more]

]]> 0 4aaf5cdb1ddf79e1197c85845ed2cdd1 jdc46 started the topic Lessons Learned in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9958/ Sun, 31 Mar 2019 01:27:06 -0400 Controlled documentation is key to any company in keeping everyone on the same page when part of a project. Through this week’s lecture, reporting lessons that a project team learned was discussed as an output for both change control and project closing. This is incredibly valuable to understanding important decisions made through the progression…[Read more]

]]> 0 92a57ebebc04d0b1ef2a4786c75a5277 jdc46 replied to the topic Project budget and variance in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9957/ Sun, 31 Mar 2019 00:56:10 -0400 It is important to note that Earned Value (EV) is dependent on the percent completion of the project and not necessarily the specific date that the cost is being evaluated. That is, when looking at Cost Variance (SV), if you are spending heavily early on, it can be that 25 percent of the project is completed in the first week while the rest of the…[Read more]

]]> 0 1a624314f8f6e606cec016abd2a4b0ed jdc46 replied to the topic Challenges PM face in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9897/ Sun, 17 Mar 2019 23:03:04 -0400 The PM is critical in moving a project along. It is their responsible to ensure that the whole team is on the same page and stay on schedule. As seen in this week’s mini simulation, sometimes different functional areas collide, which can cause major disruptions to the project’s schedule. The biggest challenge of a PM is to effectively intervene in…[Read more]

]]> 0 98f5cddbae1f77502eb1a0a833ec661c jdc46 replied to the topic Problem with the Vendors in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9888/ Sun, 17 Mar 2019 16:13:01 -0400 As ih37 described, it is critical to clearly establish your customer needs and expectations in your relationship with the vendor. When the packaging provided by the vendor is arriving with defects, they are not meeting their contractual agreement. Well before considering finding a new vendor, the detected defects must be directly discussed with…[Read more]

]]> 0 44a0a53ac49a85848ef15f49cc28f44f jdc46 replied to the topic Factors to look for while evaluating change request in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9777/ Mon, 04 Mar 2019 03:34:53 -0500 Change to a project can have different effects on the overall project. When considering change, it must remain within the project scope. Changes cannot be made if it changes the project to the extent that it no longer meets the needs of customer, stakeholder, and business. If change requests are within the project scope, changes must be considered…[Read more]

]]> 0 9c737a5050c073208ba3945d8b0ae288 jdc46 replied to the topic Communication and Responsiveness in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9763/ Sun, 03 Mar 2019 22:29:39 -0500 A successful project manager lays out the communication requirements and how information is shared through the team before the start of a project. This means what details of the project must be communicated, when there must be communication, who is responsible for communicating each aspect of a project, and the documentation of the communication.…[Read more]

]]> 0 0e2856ceb9cd6b118da4acbd184fd077 jdc46 replied to the topic Estimating Project Timeline in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9760/ Sun, 03 Mar 2019 22:05:17 -0500 The initial project timeline is never set. The planning process of a project breaks down the project into actionable tasks (WBS), allowing team to make rough estimates for each task, but the timeline will constantly be revisited. When a team is put together and a Team Communication Plan is completed, PM will have several team meetings where the…[Read more]

]]> 0 70835c215105c21e680667463bb17967 jdc46 replied to the topic Execution phase in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9684/ Mon, 25 Feb 2019 01:51:42 -0500 It is important to understand that the input to a phase process group is the output from the previous phase group process. That is, the inputs that are going into the execution process group requires the use of the the documentation from the planning process group. Without a Project Management Plan, Quality Management Plan, Work Breakdown…[Read more]

]]> 0 28a871999b68c024fdf4938b5eef43ca jdc46 replied to the topic Risk Management Team in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9663/ Sun, 24 Feb 2019 17:50:32 -0500 Evaluating risk may not be as murky as it may first appear. The lectures does not go too deep into risk management, but after assessing the risks, there are methods to better quantify the risks involved. Performance measurement metrics could be used directly in evaluating FMECA scores when determining the likelihood of failure. Of course, there is…[Read more]

]]> 0 c25d399b380cd2bbd5194924bec13460 jdc46 replied to the topic Risk Management Selection in the forum Project Management Process and Medical Device Development https://medicaldevicecourses.com/activity/p/9662/ Sun, 24 Feb 2019 17:05:28 -0500 The team structuring of risk management is dependent on the risk, resources, and time restraints on the project.

As mentioned by jb678, the amount of risk involved in a project will determine the need for a separate risk management team. Risk management is a science, and so for a project with high risk, a specialized team in risk management would…[Read more]

]]> 0 d3ecbeac309627f75c9e4ef9c0ed3326 jdc46 replied to the topic Experiments in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/9578/ Sun, 17 Feb 2019 19:35:47 -0500 In resolving failure, the first step to take is to define the scope of what can be modified. In our simulation, this is the verification protocol and the product components. The listed specifications could not be modified. Therefore, we are limited to resolve the failure within the scope of changing the product components used and testing…[Read more]

]]> 0 4702b3947de5ff57e7991959e60ca3ea jdc46 replied to the topic Design Control Process in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/9525/ Mon, 11 Feb 2019 00:05:23 -0500 If I was placed in the Design Control process of a project, I would likely find preference in the putting together the Design Specification Document (DSD). This is where the meat of the engineering is. The DSD is the transitioning stage from planning to execution, and requires detailed consideration in the design of a successful project. Several…[Read more]

]]> 0 73575705554203375429d67e642f4596 jdc46 replied to the topic Design Review Meeting in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/9524/ Sun, 10 Feb 2019 23:35:20 -0500 This question becomes tricky because these documents should be carefully reviewed to ensure the safety and effectiveness of the device. We would not want minor miscalculation to snowball into a much larger issues that can become detrimental to the whole organization. Therefore, care must be taken when approving any Design Control documentation.…[Read more]

]]> 0 b139a909247af83046621c0fdc37aa56 jdc46 replied to the topic Determining Spec in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/9521/ Sun, 10 Feb 2019 22:39:25 -0500 From my experience working on projects, deciding on detailed specifications may seem to be the most daunting task, but becomes clear-cut the more you are familiar with the process. The most important factor when specifying ranges of specs is the limiting conditions involved in the design input. I work on designs for a Solar Car team, and when we…[Read more]

]]> 0 323d07eb37af14719d5724da293962a2 jdc46 replied to the topic 510(k) clearance vs. Postmarket Approval in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/9411/ Sun, 03 Feb 2019 18:39:32 -0500 As Dr. Simon discussed in his lecture videos, the clearance of a Class II device can at times be as costly and timely as a Class III device. Certain Class II devices will require a investigational device exemption (IDE) to support the safety and effectiveness in the 510(k) application. An IDE must be approved by the FDA to perform clinical trials…[Read more]

]]> 0 1da464153a6b28fdcc99c23ab7c76687 jdc46 replied to the topic Challenges to Overcome in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/9410/ Sun, 03 Feb 2019 17:40:34 -0500 While the enforcement of regulatory compliance maintains safety and effectiveness of medical devices, it stymies innovation in the medical marketplace. As ec52 discussed, the EU’s transition to implement new regulations on medical devices to heighten scrutiny on clinical trials and post-market compliance is transforming the medical industry on the…[Read more]

]]> 0 10aaa10b733f841a5407167f732ed320 jdc46 replied to the topic Discussion Topic: State of your Organization in the forum Introduction to Project Management https://medicaldevicecourses.com/activity/p/9338/ Sun, 27 Jan 2019 17:25:55 -0500 I am not currently working in industry, but a variant of matrix organization structure would provide a suitable working environment. Consider an organization that separates their company into different industries to achieve specific corporate objective. Each industry has different divisions, each with the standard departments (R&D, marketing,…[Read more]

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