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jrc99 posted a new topic "Design Input Document (DID) and Design Specification Document (DSD)" – 1 month, 3 weeks ago
The Design Input Document (DID) and Design Specification Document (DSD) are procured during the PDCA cycle of a project. The first document being a more brief overview of the inputs and basic details what they want the product to have…. Read more»
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jrc99 replied to the topic "Managing Design Change Requests Effectively Without Disrupting Development" – 1 month, 4 weeks ago
Design change requests in medical device development are definitely a challenge I agree. An idea on how a company can handle these change requests is finding primary and back up options for the parts/materials they will be using for the… Read more»
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jrc99 replied to the topic "Humanitarian Device Exemption" – 2 months ago
I think the previous post has made some excellent posts and definitely highlights the potential problems with this exemption program from the FDA. However, even with all of these points stated, I feel this is still a program that can… Read more»
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jrc99 replied to the topic "Optimizing the Design Development Plan (DDP) for More Efficient Product Development" – 2 months ago
I agree that companies can utilize techniques to create a DDP that is both structured but flexible such as a Gantt chart. Gantt charts are great at keeping your team informed about the development progress. It also helps identify which… Read more»
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jrc99 replied to the topic "Caution with Medical Devices that Require a PMA" – 2 months ago
@bryan-xavier Your information about the Breakthrough Devices Program definitely changed my own view about this topic I created. When I found out about this certain predicament from Dr. Simons lecture, my thoughts were pretty set on that medical device innovation… Read more»
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jrc99 liked forum post "Caution with Medical Devices that Require a PMA" – 2 months ago
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jrc99 liked forum post "Caution with Medical Devices that Require a PMA" – 2 months ago
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jrc99 liked forum post "Caution with Medical Devices that Require a PMA" – 2 months ago
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jrc99 posted a new topic "Caution with Medical Devices that Require a PMA" – 2 months, 1 week ago
In Dr. Simon’s Week 2 Lecture, there are mentions of caution and avoidance of creating new devices that require a PMA. A PMA (Premarket Approval Application) does not allow a new device to use the substantially equivalent claim and clinical… Read more»
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jrc99 replied to the topic "Avoiding Regulatory Pitfalls in Medical Device Project Management" – 2 months, 1 week ago
I agree with the previous claims of underestimating regulatory requirements from the start. To add to that, picking the wrong classification of your medical creation will certainly create problems. Your potential product will fall under a single or a combination… Read more»
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jrc99 replied to the topic "Balancing time, cost and scope in project management" – 2 months, 1 week ago
I think the biggest challenge out of the triple constraint is scope. Scope has to be almost perfectly planned out before the medical device development, especially before FDA approval. The scope needs to be definitive. If it turns out the… Read more»
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jrc99 replied to the topic "Role of Project Management in Medical Device Development" – 2 months, 1 week ago
I think the biggest challenge in managing medical device projects is regulatory hurdles. Regulatory hurdles can put a heavy impact on your medical device development cycle. For one, it costs a lot of money to submit these regulatory applications. Depending… Read more»
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jrc99 replied to the topic "Role of risk management in medical device projects" – 2 months, 1 week ago
I agree for the most part that regulatory process may be a big risk in the medical device project management. However my opinion is more that the technical, financial, and regulatory risks are more equally present and intertwined with each… Read more»
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jrc99 liked forum post "Balancing time, cost and scope in project management" – 2 months, 1 week ago
