If I were a PM running a Risk Management meeting, I would ask the attendees of the meeting to have them familiarize themselves with with the ISO 14971 standard as @aij5 mentioned, and for them (i) come up with a…   Read more»

At Sloan we outsource the development so when we set up a Project plan we include a scope that clearly defines the deliverables, goals, and deadlines. Since it can be very expensive to develop a medical device we usually break…   Read more»

I agree with @hm243 that SOPs should be very detailed and descriptive laying out the instructions on how to create a specific product. As Dr. Simon mentions in lecture it should be written at a HS level so that anyone…   Read more»

As @julienneviuya described Design History File (DHF) is created during the Design Phase during the product development stage of the device and is written before the production. Whereas the Design History Record (DHR)is produced during the Production Phase and is…   Read more»

In thinking about PMS and detection of problems, I thought about the process of notifying FDA and I cam across a NYT article. In the article, the director of healthy policy for the National Center for Health Research in Washington…   Read more»

I agree with @iala4 that important sections to include are 1. Background 2. Objective 3. Scope 4. Time frame 5. Project budget 6.Key stakeholder. I also agree with @f-dot that a realistic budget and timeline are key. With the projects…   Read more»

In contrast to industry stakeholders, I work at a non-profit Sloan Kettering and when a clinician or nurse comes up with an invention-a new car-T cell therapy, or robotic surgical instrument they disclose their invention to our office (Office of…   Read more»

I agree with @bnb6 that I wouldn’t consider there to be risks with the V&V process itself, but rather the risks if there was a problem during the verification stage or even the verification was completed successfully that the device…   Read more»

I agree with @julienneniuya and @asimbana that Verification is to confirm that design outputs equals the inputs. That the design numbers/specs set out are accomplished whereas with validation is the confirmation on the end user that the device meets the…   Read more»

We work with outside companies that design/develop our commercial medical devices. So I indirectly come into contact with DHFs, but don’t have an influence on the practices of the company we contract to develop the device. I personally however think…   Read more»

Tech File is required regardless of the class of device in the EU, whereas in the US the FDA requires a 510(k)for Class II and higher. Another difference is the Tech File as Dr. Simon mentioned in lecture, it has…   Read more»

Another difference between 510k submission and a technical file is that the 510K is for Class II and above in the US. Whereas the technical file is required regardless of the class of device in the EU. The path to…   Read more»

I agree with the posts mentioned above. Device companies have been seeking early approval in Europe for years because it is easier. I think the two main differences that make it easier to get approval in Europe are: 1. In…   Read more»

Like @srg36, I found the 2005/50/EC directive about the reclassification of hip, shoulder and knee devices from Class IIb to Class III. I also found that in EU All implantable devices and long-term surgically invasive devices are in Class IIb…   Read more»

I think the First Digital Pill in US, Abilify MyCite opens up concerns about patient privacy, but also paves the way for other digital pills. For example, etect Rx is a Florida company that makes another ingestible sensor, the ID-Cap,…   Read more»

I agree with @wms7 that the Office of Combination Products (OCP) would review the primary mode of action (PMOA) to determine the agency assigned; CDRH, CDER, and CBER. When looking at the additional OCP link @wms7 provided, I found that…   Read more»

I think if the company wants to be successful, they need to take the regulatory submission process seriously and not embellish how similar a device is to a predicate device. Substantial equivalence means that the new device is at least…   Read more»

Participation, the fifth P of marketing, is crucial when marketing a product. You need to engage your potential client(s). At Sloan we actively market are medical devices and we will meet with companies and have the surgeon explain the unmet…   Read more»

I work in the office of technology development at Sloan Kettering and oversee the medical device portfolio. The trends I see that Investors/companies are looking for: 1. DATA and 2. AI 1. The number one trend I’m seeing is interest…   Read more»

Yes, I used to work in the contracts unit at Sloan Kettering. I worked on Material Transfer Agreements (MTAs), Confidentiality Agreements (CDAs), Data Transfer Agreements (DTAs) Collaboration Agreements with Industry, Sponsored Research Agreements (SRAs), and Service Agreements. I currently work…   Read more»