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jdc46 replied to the topic "510(k) clearance vs. Postmarket Approval" – 5 years, 10 months ago
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»
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jdc46 replied to the topic "Challenges to Overcome" – 5 years, 10 months ago
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»
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jdc46 replied to the topic "Discussion Topic: State of your Organization" – 5 years, 10 months ago
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»
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jdc46 replied to the topic "Funding in Medical Devices Industry" – 5 years, 10 months ago
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»
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jdc46 replied to the topic "Should Interpersonal skills be more valuable than technical skills?" – 5 years, 10 months ago
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»
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jdc46 posted a new topic "Lessons Learned" – 5 years, 10 months ago
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»
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jdc46 replied to the topic Avoiding Tunnel Vision in the forum Project Management Application: Clinical Trial 5 years, 11 months ago
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]
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jdc46 replied to the topic How was this class helpful in the forum Project Management Application: Clinical Trial 5 years, 11 months ago
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]
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jdc46 replied to the topic Sponsorship for companies in the forum Project Management Application: Clinical Trial 5 years, 11 months ago
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]
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jdc46 replied to the topic Qualities of a Manager in the forum Project Management Application: Clinical Trial 5 years, 11 months ago
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]
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jdc46 replied to the topic Changining staff in the forum Project Management Knowledge Areas 5 years, 11 months ago
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]
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jdc46 replied to the topic Team Development in the forum Project Management Process and Medical Device Development 5 years, 11 months ago
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]
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jdc46 replied to the topic Design Transfer in the forum Project Management Process and Medical Device Development 6 years ago
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]
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jdc46 started the topic Lessons Learned in the forum Project Management Process and Medical Device Development 6 years ago
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]
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jdc46 replied to the topic Project budget and variance in the forum Project Management Process and Medical Device Development 6 years ago
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]
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jdc46 replied to the topic Challenges PM face in the forum Project Management Process and Medical Device Development 6 years ago
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]
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jdc46 replied to the topic Problem with the Vendors in the forum Project Management Process and Medical Device Development 6 years ago
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]
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jdc46 replied to the topic Factors to look for while evaluating change request in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
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]
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jdc46 replied to the topic Communication and Responsiveness in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
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]
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jdc46 replied to the topic Estimating Project Timeline in the forum Project Management Process and Medical Device Development 6 years, 1 month ago
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]
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