I agree with @zw2 that FDA regulations aren’t perfect, but I think the regulations and guideline documents really set the bar to ensure to the best of the its abilities the safety and effectiveness of devices. Sometimes companies follow all the regulations and still something unexpected happens and the product needs to recalled. As we have…[Read more]

To add to the conversation, it is first to file in the U.S.-this means that if this really is a good idea for a commercially viable product, you should file before a potential competitor does. It used to be that if you kept documentation, lab notebooks, records etc you could be determined as claiming patent rights. However now it really is first…[Read more]

To add to the conversation, I think its important to select a good vendor. In selecting a vendor, you should meet with them and see if they have a client that would be willing to speak with you to discuss their experience with that vendor. In some situations you can start by asking other what vendors they have already worked with that was…[Read more]

Yes, I believe most projects have multiple priorities. At Sloan when we have medical device project in our group we usually break it down into I. Development-Scientific II. Development-Business III. Intellectual Property (IP) Protection and Prosecution. Development and IP are both done in parallel and are broken down into different priorities…[Read more]

I agree that it does require social skills and this classes forces you to experience real life situations. For example with the simulations you are assigned a group, you don’t get to select the people you work with that maybe you know or would like to work with personality wise. It really mimics a real life scenario where you are assigned a task…[Read more]

Just to add to the conversation of determining Significant vs Non significant risk medical device studies, the FDA has a guidance document.
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf

The guidance document is intended to provide information and advice to sponsors, clinical investigators, and IRBs on how to…[Read more]

I agree that MDD and AMDD have been integral in providing me the necessary platform not only for my other classes, but for my career. I currently work on the business end, but I am new to the medical device development process from Design to Manufacturing. I think these courses have provided me very valuable information regarding QC and Regulatory…[Read more]

I agree these simulations really allowed for us to think creatively on how to solve problems using methods we learned in lecture. I really enjoyed learning about planning and how important it is that all of the details are addressed upfront because changing them once they have been transferred to manufacturing can be very costly and…[Read more]

I think I would like to a Clinical Project Manager as @Devarshi mentions as a project manager you are able to interact with all departments through the different phases from initiation to closure. It would be exciting to oversee a clinical project from start to finish. I think that would be a very rewarding experience. I also think it would be…[Read more]

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 larger community that is focused on helping others and making a difference. The biggest motivator for me is making a difference for…[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 established relationships with CROs. However sometimes a sponsor wants to select the…[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 part of determining if/where a clinical trial will be done. At Sloan we are located in Manhattan so as you can imagine our IDC (indirect…[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 sold in EU

Embolic coil device manufactured in the EU and sold only in the EU
Implantable but not active,…[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 supplier. I came across an article from Med Device Online “9 Things to Consider…[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. For example the higher level executives don’t want to be receiving a lot of e-mails and…[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 provide a way to produce a quality product. As @mjf34 mentions, GMP is something a customer looks for as a…[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 where we hire an external third party to perform the audit and that is basically us auditing ourself where we can find the problem or…[Read more]