I agree with this that the thought process in technical writing in industry is always “if a random person picked up this document, could they understand how it works.” However, undergraduate doesn’t teach much technical industry writing because I believe, most technical writing is learned on the job. Therefore, I don’t believe it is necessary to…[Read more]

From a business standpoint, you would want to open less CAPAs. In manufacturing of medical devices most CAPAs tend to be reactive since they are usually opened after an Event, Non Conformance, SCAR (Supplier Issue), or Customer Compliant. CAPAs, to some extent, demonstrate that your company is attempting to make necessary changes to comply with…[Read more]

Ideally in manufacturing it is best practice to have spare equipment in the instance that a machine fails. Therefore, it is a simple task to bring it in and replace it. If the machine is the same make and model, no validation is required if a previous validation of the machine exist. In general, a “like for like” equipment doesn’t require a…[Read more]

I would like to point out that post market surveillance can also be conducted on clinical studies. The importance of Post Market Clinical Follow Up (PMCF) studies is to try to identify and investigate any enduring risks that are associated with medical devices on the market. This may be needed because of certain risk factors, procedures,…[Read more]

Yes, SOPs should be used in research phase. If you are looking to produce a new product to market or making changes to current products in your product line, SOPs should be strictly followed. During the research phase, chances are the creation of the product or any ideas will need to follow certain processes that are already established within…[Read more]

The company I currently work for generates ECOs to make specific changes to products or manufacturing processes. Our ECOs are generated in a Product Management System, we currently use Agile but there are others such as OTIS or ADAPTIV. Basically, our ECOs are generated and highlight essentially the description of the change, the justification…[Read more]

In agreement that acceptance criteria needs to be re-evaluated. Before that, a deviation should be opened to address the failure of a validation and why the deviation occurred and how it will be addressed. I would re-evaluate what additional testing or changes need to be done, whether its a regression test or opening up tolerance and…[Read more]

It depends what you are looking for.
The DHF would be more useful all around for people in Quality, Regulatory, Supply Chain, and even Product Development. This is because this will provide more then enough information for all the departments to satisfy whatever needs they may have at the moment. I believe it mainly comes down to what the project…[Read more]

The DHF is a living document.
Logically to me it doesn’t even make sense why it wouldn’t be. What is the point of documenting just the original process if you are going to open a 2nd DHF if the product changes due to indications of use or design changes? The DHF should be the original changes plus the ongoing continuous changes of that product.…[Read more]

In the US, nonabsorbable sutures can be classified as Class II with moderate risk of injury. In addition, absorbable sutures can be classified as Class II. In EU it is considered Class IIb medium to high risk if it is nonabsorable. However, if it is absorbable it is considered Class III. Essentially, the sutures classification is based on the…[Read more]

Absolutely. The revisions that have taken place under the Medical Device Directives are meant to be on par or if not more stringent then the US FDA. Notified bodies showing up unannounced and greater scrutiny, which wasn’t existent at this level before, is forcing companies to take higher consideration into introducing their products to market…[Read more]

I don’t believe there should be a defined limit of center or subjects because that should depend fully on what the study is. However, when choosing multi centers or shouldn’t be random centers that chosen just because they are close to proximity. You want to choose centers who have investigators familiar with the work you are doing for the cli…[Read more]

At the medical device company I work at, our marketing team focuses on actively following the customers who continue to buy our products. They stay on top of any issues the customer has in terms of malfunctioning devices, questions, or feedback. Working hand in hand with the surgeons who continue to use our products is key because these are the…[Read more]

As an engineer that currently uses 3D printing, most 3D printing applications have been used toward manufacturing equipment and fixing parts as opposed to 3D printing actual devices. Most items I am 3D printing are used to help fix a faulty part on the manufacturing line and this in turn helps prevent the company from having to order a new part.…[Read more]

I believe when you move from one medical device company to another, as part of the application or on-boarding process they ask “Have you worked for a company in which you are legally non-competing or restricting you from applying”. It is usually something along those lines. I believe most people usually just say No. For those that say YES, I’m…[Read more]

This course was excellent in giving a high overview of how the medical device industry functions. The lectures were really informative and gave me a better understanding about departments that I work with directly. It also helped me weed out some departments I wouldn’t be interested in pursuing. I think NJIT should actually offer this as an…[Read more]

Agree with this. Competition is always good to keep people motivated to bring their best each and everyday. However, if its taken to the point where one is stepping on someone else to move up or get a promotion, then that type of action can kill the company culture.

Having a good communication between departments is key. Passing knowledge…[Read more]