Having conferences is a great way for marketing and per-launch, one great way i experienced was having the showcase for the product using VR which was fun to use and to interact with. On bad side that happened,the laboratory device…   Read more»

Sales and product management play a complementary role, where if there is no sales that mean no business, no business = no cash and the company is out of the game. Sam Walton once said ” there is only one…   Read more»

I am not a fan of all type of advertisement, but the ones that i might like are the ones that had a nice music, real example that happened, while  I am driving I had YouTube play my list of…   Read more»

I choice Apple(Jun-30-2020) Gross Profit margin: 38.19% this number considered low as it is the amount of money the company make after spending a certain money. Net profit margin: 21.33% which is almost the same as (with small difference) from…   Read more»

I would consider doing a partnership. Having someone with the same vision and passion for the dream we want to achieve. It is a great adventure to start the life with, but i don think i will consider it as…   Read more»

Ratio importance depends on the company type (what they do) , it gives indications about the health of the business and how it is growing. for example, doing an inventory turns for barbershop business make no seance. Bad ratio can…   Read more»

I agree, ethics and QA are related and you can see this in any type of environment. One of things a always notice, the drive force for people to follow the rules (QA system) comes from fear “what happen if…   Read more»

QA is derived from FDA and ISO regulation and the company Vision. QA Team should keep an eye around what is happening in the world and what going on inside the company. Communication always help improvement with feedback in the…   Read more»

I also agree that this game – unfortunately – exists in  the world, and as it have been said, it is human nature. I do not think there is any cure for this situation, humans have different personality. You have…   Read more»

Sirolimus Eluting Coronary Stent. This device is indicated for improving coronary luminal in patients.The mode of Action for this device is a drug elutingballoon- expandable stent that is pre-mounted on PTCA catheter delivery system. It falls under CDRH and considered…   Read more»

productivity might get negatively effected with having people from different cultural background. For example having different holidays, which might effect the project timeline. But other thank that from my experience it helped more as people have different experiences and can…   Read more»

let’s make the question as, what does it mean to have an imprecise  and inaccurate medical device? The answer would be, that would not consider a medical device, it can count as a broken device. If the device does not…   Read more»

It is hard to choose one over the other. Seeing the result right away give satisfaction for sure, but doing research that help the next generation might be like predicting the future. In addition, it is hard to state that…   Read more»

Animal testing is needed to reduce the time needed for development, maybe it seems the only possible way but there is different thing that can be done. For me I don’t like it, and i consider it not ethical. Human…   Read more»

All what have been said make a good points, but for me when talking about project management stand point, the most important part is money, time, and same specs. we all agree that Biomaterials must be compatible with the human…   Read more»

The most challenging part for combination device is to know to what FDA Department it will be classified under (CBER, CDER and CDRH). As each one of these department has it is own rules for reviewing the product. Depending on…   Read more»

Project Objectives should also be S.M.A.R.T : Specific, Measurable, Achievable, Relevant and Time-Related. To have objectives to the project but the most important part is to get the Right Objectives. Its good to learn from previous projects experiences to build…   Read more»

I agree with what had been said, Good project manager should have a lot of different soft skills with good experience. In my opinion, if a person have 15 years experience in the industry with no leadership or good soft…   Read more»

My advice, is never stop learning, always keep searching in the field to see what’s going around (don’t leave your self in the dark), even check what skills needed in each Job posted, examin yourself and work on how to…   Read more»