My goal is helping others. Helping others makes me feel good, and I work at Sloan Kettering Cancer Center. When you go to the main hospital and see the patients’ faces, you get motivated that you are apart of a…   Read more»

In my experience at Sloan Kettering we have encountered as many have mentioned advantages and disadvantages to using CROs. At Sloan we have an efficient and accomplished clinical department which includes management of clinical trials, contracts, etc and we have…   Read more»

I agree with many have already stated-that you want to make sure you maintain the quality and integrity of the study and not focus just on the cost. However working at a hospital, I know that budget is a big…   Read more»

Central Venous Catheter (CVC) manufactured in the United States and sold only in Europe Class IIb/Class III Medical Device Directive 93/42/EEC, ISO 13485, ISO14971, ISO10993, and GMPs 21 CFR 820 since its manufactured in the US. CE mark to be…   Read more»

To add to this, clear definitions, and attachments with supporting material for timeline, deliverables, pricing, and business and legal contact information. Thinking about the important articles to include in a supplier contract, I also thought about how to pick a…   Read more»

Communication is key- I believe the PM is responsible for clear communications between the project team members, departments, and key stakeholders. The PM also needs to have business acumen to determine when and how to communicate with the different groups….   Read more»

I agree with @merzbrashed that GMPs ensure that production of a good quality product and create credibility for a company. At first glance, it might seem burdensome and costly for manufacturers to follow GMP practices, but I think it does…   Read more»

To add to this discussion, I think its important to note that an internal audit does not mean that it has to be performed by the company employees. For example where I work we do our own internal quality audits…   Read more»

I think management should already have a good understanding of the resources needed to uphold their QSR. As we learned this week in lecture Management oversees the subsystems: i. Design Controls, ii. Corrective and Preventative Actions, iii. Production and Process…   Read more»

I agree with @tme3 that the ambiguity of GMP’s could actually be beneficial to a startup because it allows for a little more flexibility to create their own quality system and since each company is different with different products there…   Read more»

You could monitor progress by looking at EV and SV. Earned Value-the value of the work you have completed so far. Earned Value=Percent complete*original budged cost of task Schedule Variance (SV)= EV- Planned Value (PV) If you have a positive…   Read more»

I would add to this, contingency plans. At the beginning of each project we usually have clearly defined plans with assigned responsibilities and then the inevitable happens when something unforeseen happens that falls out of the detailed plan and its…   Read more»

My office is a little unique in which we have a lot of products that we ultimately out-license to larger device companies. We develop the products and file patents on them and in some situations the market just isn’t there….   Read more»

We usually use passive marketing techniques where people come to us for a license and we usually have consistent sales. However in the last year in order to increase sales, we have created a catalog of all of products available…   Read more»

I agree with the posts above that its important to have both business and interpersonal skills, but I believe its essential to have interpersonal skills to get deals done. Sales is all about not just getting a deal done, but…   Read more»

Over a year ago I was assigned to manage the development of a robotic device. We had a prototype and since it is now first to file, we filed a patent so we could further the development while also pitching…   Read more»

I personally think the planning phase is the most important phase during a project. It sets the tone for the project and as Dr. Simon mentions if you fail to plan, you plan to fail. For instance if you have…   Read more»

As @cdj24 mentioned SV=EV-PV. Where EV is the percent complete* original budgeted cost of task and PV is the vale of the work you are supposed to have on a certain date. I agree as others have mentioned that in…   Read more»

Just to provide another perspective, at MSK we file patents on technologies like medical devices in order to protect IP and to ultimately outlicense. Before we file a patent, we evaluate the technology and the market. Once we move forward…   Read more»

As most have mentioned like @asmibana and @sanam funding in a major role. I work at MSK in the Office of Technology Development so we constantly have new invention disclosures, but unless the PI has resources/funding available-it is hard to…   Read more»