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PJL27 replied to the topic "Verification Failures and Adjusting Test Conditions" – 2 months ago
You bring up a really good point that I think is highly debated in this high stakes industry. Medical device developers will try to increase the scope and range the devices are usable to maximize usability and profitability. For example,… Read more»
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PJL27 replied to the topic "Design Verification Failures" – 2 months, 1 week ago
From my experience in the med tech field, I’ve learned that companies take measures so that devices don’t have to be redesigned. The device is made taking everything in consideration. It is very rare that the entire device needs to… Read more»
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PJL27 replied to the topic "Managing Design Change Requests Effectively Without Disrupting Development" – 2 months, 1 week ago
Design changes can occur due to wanteding to improve the medical device or wanting to fix any issues it may have. In wach case, it is good to have a list of risks to be proactive on as mentioned in… Read more»
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PJL27 replied to the topic "How Frequent Design Reviews Can Improve Medical Device Quality and Reduce Failures" – 2 months, 1 week ago
Having design reviews regularly shows the progression of the project and ensures that it is on the right track. Something that I think would be beneficial in a design review is to meet and review it with all the stakeholders… Read more»
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PJL27 replied to the topic "Caution with Medical Devices that Require a PMA" – 2 months, 2 weeks ago
While the long and challenging process for a PMA make it so that companies are discouraged at innovating new medical devices, it is necessary for a PMA to be rigourous so that the effectiveness is determined to comply with pateint… Read more»
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PJL27 posted a new topic "Humanitarian Device Exemption" – 2 months, 2 weeks ago
The FDA created the Human Device Exemption (HDE) in 1990 to help streamline medical device approval for devices intended to help treat or diagnose rare diseases. There are more than 7,000 rare diseases, but only a few have treatments. A… Read more»
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PJL27 replied to the topic "Misclassification of a Device?" – 2 months, 2 weeks ago
I agree that sometimes it is difficult to classify a medical device, especially if it is a combination product. Having a combination product brings in the additional challenge of determining the primary mode of action to see if the CDRH,… Read more»
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PJL27 replied to the topic "Balancing Stakeholder and Customer Values" – 2 months, 3 weeks ago
A project’s scope is based on customer needs and stakeholder values. Stakeholders are most invested in the financial situation with the project, while customer values focus on what is needed by the customers (surgeons, patients, researchers, etc). Often, project members… Read more»
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PJL27 replied to the topic "Handling Conflicts Among Team Members Effectively" – 2 months, 3 weeks ago
Something that is told very frequently at medical device (or anything healthcare or biotech related) companies is to focus on the “why”. Before jumping onto a project, it is important to understand what the aim of project is and exactly… Read more»
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PJL27 replied to the topic "How to communicate effectively between team mates in project team ?" – 2 months, 3 weeks ago
I think the previous posts bring up great points in having transparency to maintain a clear line of communication. I agree that messages may become unclear through email chains so having a 1:1 talk can clear up any miscommunication. I… Read more»
