I echo the sentiments of others like @asimbana and @bb254 that QA/QC is necessary and is crucial to the success of products. Spending extra time and money and going through QA/QC processes/methods isn’t ideal, but it is necessary to lower…   Read more»

Yes, if this goes through Congress the increase in medical device user fees would affect small/midsize companies. However as the FierceHealthcare article mentions, it is unlikely that it will go through. This article states “The fees are part of an…   Read more»

@Srg36 did a great job of summarizing the de Novo classification process and ruling. I agree that this deNovo classification process is beneficial because previously having an automatic Class III determination and to submit to have down classed to Class…   Read more»

For an antibiotic-releasing hip-stem Device Type: combination device The primary mode of action: Hip-stem, structural replacing a bone- holding up a hip. Agency has governance over it: CDRH Class: Class II Regulatory Pathway: CDRH->Class II-> 510(k) 510(k) defined “is a…   Read more»

As @thuytienlaco and @amandaally1029 stated, e-cigarettes are regulated by the FDA. In Aug 2016 the FDA finalized the rule extending CTP’s regulatory authority to cover all tobacco products, including electronic nicotine delivery systems (ENDS) that meet the definition of a tobacco…   Read more»

I agree with many like @gaberuiz13 and @su65 that academic research is for the passion and thrill of discovery and answering questions for unknowns in their field. However I think there is a generalization that non-profits have slow moving pre-clinical…   Read more»

I agree @hm243 that both types of research are indeed important and necessary. I, like you, am more interested in working on projects that will have a product on the market in my lifetime. I think there’s something very exciting…   Read more»

The University is interested in making connections with Industry-some investigators are in hopes to build a relationship in which the company will fund more research and be a source of funding for the lab. Others are doing it not only…   Read more»

As many have mentioned like @bb254 and @dag56 before testing in clinical trials many tests need to be preformed. The biocompatibility testing needs to be performed in accordance with ISO 10993 including Cytotoxicity, Genotoxicity, Irritation, Systemic Tox, Hemocompatibility, Implantation, Toxikokinetics….   Read more»

I work at a non-profit. If a company outsources a study to a university there would need to be a formal contract in place (collaboration agreement, sponsored research, or service agreement) to cover the scope of the what university will…   Read more»

A portfolio is comprised of multiple programs or multiple projects. For example, I oversee a medical device portfolio at MSK. There are multiple related and non-related devices that make up the portfolio. Our strategy is to market the devices as…   Read more»

Like many have mentioned- I believe the main difference of being a project manager for a medical device company is that it is a highly regulated field and different countries have different regulations. Some have mentioned the novelty and uncertainty…   Read more»

Missing milestones, means failure. At Sloan Kettering we contract out the development of devices. So if milestones aren’t being met by the CMO, then they aren’t getting paid. We have major milestones and phases of projects tied to payment. So…   Read more»

Missing milestones, means failure. At Sloan Kettering we contract the development out. So if milestones aren’t being met by the CMO, then they aren’t getting paid. We have major milestones and phases of projects tied to payment. So if they…   Read more»

I agree with hM23 that the planning phase of the Project is crucial. If you have a great plan, someone else can always execute it. If you have a bad plan, but people to execute, is that helpful? If I…   Read more»

When I first started at Sloan, I created a system with an outside group called eMTA. eMTA is an electronic document management system for our Material Transfer Agreements (eMTAs). Like akshayakirithy’s project, eMTA consumed a lot of time and money….   Read more»

I’ve worked with multiple Project managers. I agree with Puneet that there are both positives and negatives to having multiple project managers. It can get confusing with where to draw the line on different responsibilities and deliverables but as Sahitya…   Read more»

I had an internship in Industry and there were a lot of perks, good pay, and ability for growth to move up. However on a day-to-day basis you were really only expected to follow the SOPs and record keep as…   Read more»

I don’t have a traditional engineering background but my advice would be: • Do an internship. When you’re looking for a job, they want you to have some experience. You also might be able turn your internship into a full-time…   Read more»

I agree with Puneet, hc55, akashranpura, and dag 56 that NJIT should provide and require practical courses for graduate students. It is important to have a strong academic foundation and skillset for students to apply these concepts in industry as…   Read more»