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 that I deal with if we contract out the development we look for the company to provide an extensive timeline with…[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 Technology Development) and we work to protect the intellectual property (IP) and develop the…[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 could be properly validated. For example maybe all the specs are correct and the design outputs are equal to the…[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 user needs. When researching industry validation processes, I came across a New York Times…[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 the school of thought that says the DHF is a living document is most appealing to me, because I…[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 a set format. This format is referred to as the Summary Technical Documentation (STED). The STED format was created by the Global…[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 get a device to market in EU is dependent on class, so its crucial to be able to classify your device early on. In the EU, if your…[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 Europe, a device needs to be determined safe, while in the US, it also has to show that its effective in treating a disease…[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 unless they are intended: to be placed in the teeth, in which case they are in Class IIa, – to be used…[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, which has been or is being tested with opioids, H.I.V. medication and other drugs. The company seeks to FDA…[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 if OCP doesn’t have enough information to determine the PMOA of a product directly or cannot determine the…[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 as safe and effective as the predicate, a legally U.S. marketed device. As per the FDA website to be considered…[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 need that the medical device solves present a pitch deck and, show the company how the medical device…[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 on DATA, BIG DATA. I work at an oncology hospital that has tons of medical records and patient data going very far…[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 in the licensing group where we evaluate invention…[Read more]

I agree with the posts thus far that interpersonal skills are crucial to succeeding. As Ken Blanchard states” None of us is as smart as all of us”. When working at a company you are going to interact with other people, offices, and in order to be successful you have work with them in order to have the project/program/portfolio be successful. When…[Read more]

I work for Sloan Kettering, and the organization is matrixed. I work in the office of technology development in the licensing group, which would seem that it would be a functional organization. However, my role includes licensing a portfolio of medical devices and tangible research materials to my supervisor in the licensing group. I also manage…[Read more]

I agree with @srg36 and @cdj24 that the four categories are in order. Upper management is responsible for developing the strategic plan and how it can be executed. I agree that it can be frustrating for upper management to make these decisions without having input from the Project/Portfolio managers who will end up doing the work, but the reality…[Read more]

Dr. Simon,

I really enjoyed this course. I found the Regulatory and Quality lectures to be very informative and useful. I work more on the business side as Licensing Associate and getting a better understanding of the other roles/departments involved in device development through the lectures, midterm, and final project have been very helpful.…[Read more]

When I first started at Sloan Kettering, I worked in the contracts unit which handled agreements including NDAs. Usually contracts units use in-house counsel to develop templates. Honestly most NDAs include are very similar 1-2 page documents with standard sections/terms. I don’t think its really a consultants role to execute NDAs or provide NDA…[Read more]