Analyzing the task at hand, comparing the current task with the previous tasks that were done by the company and then taking the appropriate decision as to how much time would be required. When the PM is new this is how he/she will assign the time for the task so as to reduce the risk but as the PM would be experienced he will know the task at…[Read more]

Yes I do think assigning the time frame for each task is a tough ask and I think to assign the task the appropriate time the PM has to look into the past to see if such a task was performed before and what was the time required for that task and does it match the current task at hand. The manager has to do his calculations and come up with the…[Read more]

It’s true that marketing team brings most of the inputs for DID as they are the one who handle all the service requests and know what is wrong with the device.
Learn from the mistakes of the earlier generation device.
Apart from that I feel doctors who use the device can give useful inputs for the device.
Also we should consider the competitor’s…[Read more]

I used to work in a opthalmology devices manufacturing company, the product i was working on was fundus camera. During the planning phase we were working with a doctor who used to give us inputs for each phase of the device planning, he used to test the device every time during the device cycle on the subjects and used to give his feedback on it.…[Read more]

i don’t think the group leader/ risk management leader will do that as investor’s invest a lot of money in the project and if the group leader/ risk management leader somehow show that it’s a low risk project and go through with it then this is against professional ethics.This will ruin his/her career and company’s reputation as well if things…[Read more]

I disagree that some products don’t decline, every product has a life cycle as mentioned by Dr. Simon and hence there is a decline in the sale of the product once a good alternative comes in the picture.
In this case, sutures have been used for a long long time, now we have biodegradable sutures in the market that is widely used. Recently a…[Read more]

I really don’t think there is any faster way to get an approval as the document needs to be studied properly before being passed ahead, which will take time so I feel one week ahead before the meeting is enough to study the document point out the necessary changes and then go ahead with the meeting.

I think we have to go through each aspect of the experiment we are going through, and then recheck where we are failing like in this case there was only one thing that was not justified and hence we went back and changed it. Going back to the drawing board and verifying again is the most effective method to find the desired solution.

Initiating an idea is the hardest part of Design control as you need to have the market knowledge and if there exist any device similar to the idea that we have in mind. Market research is important as without that one would not know if the project is needed in the market and if it’s not needed as there are cheaper alternatives to it then it will…[Read more]

I haven’t been a part of the Industry but I want to be involved in the planning phase of the design control process as this is the crucial step for all the other processes to follow. The project should be well thought through the project description, business output, device scope etc as only if you have proper planning, the necessary resources and…[Read more]

I don’t think the medical device community is moving towards globalization of regulatory procedures but in future, an optional global standard must exist.
Each country has its own set of regulatory standards for device manufacturers, I agree with @mattie718 on the point that globalization of regulatory standards will have strict requirements of…[Read more]

I don’t think there is a need for a separate classification for the device as the function of the device is known and such devices already exist in the market so it falls into class II classification of devices. If changes are made to the LAA closure device that in some way change the function of the device, if the function is unique to the device…[Read more]

FDA standards are there to be followed and every manufacturer has to follow the standards. The product should be tested for enough amount of times in suitable working conditions to be sure enough of its working, sustainability, the FDA standards of testing should be taken into consideration for the device testing. There are cases where the devices…[Read more]

I think if there is a problem with the labels stating useful information about the product then the product should be recalled as labels help in assisting the customer about the proper handling of the product as well as if the safety label information of the product is not in place then it needs to be recalled as the operator would not know how to…[Read more]

All projects start off initially with an idea, then the idea if interesting is further discussed upon among group all the important members of the company and if they find it has potential, they move forward with the idea or else the idea gets scrapped of then and there, or sometimes allocated a limited amount of funding. Many of the ideas that…[Read more]

I feel for a project to be completed successfully and on time, the project management team should have proper communication and understanding among each other. It is always a case that one part of the project is dependant on the other and each chunk together makes a project complete, so every part is crucial for the success of the project. The…[Read more]

I used to work as a Sales and Service engineer at intuvision labs which were an Indian company that manufactures low-cost fundas camera. I used to go on breakdown calls at the client’s clinic or hospitals whenever required. I then worked as an Area Manager at Solis HealthTech where I and my team worked together to achieve our overall sales target…[Read more]