I work at a medical device company and it is interesting to see design controls being used in the real world. I had to read a multitude of SOPs to better understand the importance of design controls when it came…   Read more»

As a project manager for a company that manufactures ReShape Integrated Dual Balloon Systems, the discovery that the balloon pops immediately after placement would require several adjustments to the Gantt chart. The missed milestone would likely impact the project’s timeline,…   Read more»

As a project manager, making quick decisions with little information is a common challenge. To ensure the team is given the most complete and robust solutions, a structured decision-making process should be in place. This process involves defining the problem,…   Read more»

The optimization of supply chains has indeed had a significant impact on every industry, including project management. With the focus on making processes faster and more efficient, project managers are under pressure to deliver projects on time, within budget, and…   Read more»

One challenge that project managers commonly face is managing changes to the project scope or requirements. As the project progresses, stakeholders may request changes, or the team may encounter unforeseen issues that require modifications to the original plan. These changes…   Read more»

I think stakeholders can have a significant amount of power when it comes to the success of a project. They can influence the project’s goals, scope, budget, and timeline, as well as provide critical feedback and guidance throughout the project…   Read more»

The risks with these dates can be minimized so that the task would not be significantly affected by lateness through allowing for slack. Slack allows for extra time to be assigned for tasks to compensate for any potential delays that…   Read more»

The FDA requires design controls to facilitate a structured design and development process for medical devices. There are numerous checkpoints in place to ensure that the device is safe and effective when it is released to the public. Compliance with…   Read more»

Although I have already answered this post I have come back to read some of my peers thoughts and would have to agree with everything that has been said. Reading some of the additional posts, @gdecarvalho proposed a question addressing…   Read more»

I agree with the prior posts, stakeholders are important people and must be considered and communicated with continuously through any change to a project. However, @gdecarvalho brings up a great question, how should a project team/ manager react to a…   Read more»

The optimization of supply chain has certainly impacted project managers in many different ways. As many prior posts have stated, this optimization has resulted in making process faster and more efficient. However, one post has stood out the most by…   Read more»

Devices such as a colostomy bag wouldn’t require a clinical trial and would suffice with validation and verification. This would not require a clinical trial because they do not pose a risk to the patient. This would be considered a…   Read more»

Properly constructed and conducted design controls are integral to mitigating the risk of a product. The purpose of design controls is to ensure that corporations uphold their responsibility of releasing good products, that is produced in an ethical manner and…   Read more»

Design verification and validation are some of the last steps of the design control process. Design verification checks that the inputs outlined in the design input document match the outputs Verification involves creating and conducting tests for each output and…   Read more»

I don’t have any working experience as a manager in the industry. But I used to attend a company cooperation project at my last university. Although it’s short, I learned a lot in that team. I believe both of them…   Read more»

As everyone mentioned above. Insufficient design control will result in a recall and law case. But I think insufficient design control is easily found before marketing the biomedical device. When the problem comes to the project team, the team needs…   Read more»

As a person who sits in many different meetings, meetings for minutes are super important!  Meeting minutes are the ability to have reference to what was done during a meeting at a specific time period time is very important especially…   Read more»

This is an excellent discussion period some of the factors that I think would be considered when designing test methods have to do with relations to the product application. Understanding what the product will be used for in the future…   Read more»

I think that everyone involved in this project should attend the review meeting. It’s hard to always keep the design on trial, and it does not have to be a significant change. Members who participate in these little changes need…   Read more»