@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 I or II is inefficient. Having the deNovo process is both time and money saving for both the…[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 premarket submission made to FDA to demonstrate that the device to be…[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 product.

As per 21 CFR Parts 201, 801, and 1100
Tobacco product…[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 research, and that’s no always the cases. At Sloan Kettering our top investigators are moving at…[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 and rewarding to see a product out on the market that you helped develop/commercialize. I work on the business side of…[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 for the money, but in certain cases (as the contracts will determine) the ability to publish on the research. A PI…[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. A urinary catheter is an example of a…[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 be doing, budget, payment terms, IP terms, etc. This process is handled by our contracts/legal department and…[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 a portfolio for industry to license. The portfolio can be broken down into segments/programs for…[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 when it comes to devices and FDA regulations, but if there is a similar existing medical device on…[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 if they miss their milestones or are delayed, so is their payment. We expect that the company to a to set…[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 miss their milestones or are delayed, so is their payment. We expect that the company to a to set realistic…[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 had to pick two, I would agree with Scott that Planning and Executing are the crucial aspects for a successful project. For our projects at Sloan…[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. The main challenge we faced was in the Testing phase. We believed the series of questions that…[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 mentions it can also be valuable to have multiple managers provide a certain expertise that…[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 appropriate.
On the non-profit side, there is a more flexible culture where creativity and change are a little more accepting. I found myself…[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 job.
• Go to conferences. Meet people and connect with them and start building your network of contacts.
• Star…[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 ec53 mentioned. I think 70/30 is a reasonable ratio for undergrads since they are still creating an…[Read more]