Since the development phase of production is one of the most expensive parts of production, I think a company, depending on their resources and priorities, should consider killing the project. This can vary from company to company, for example a start up with only one project may lean towards maintaining this project even if the market becomes…[Read more]

It is essential to have both accurate business knowledge as well as good interpersonal skills. This comes from any point of sales in any aspect, everything from clothing retail to medical device sales. In order to first develop a bond with the customer, the interpersonal skills must be present. A sales rep cannot be awkward and standoffish when…[Read more]

I find that the development phase can be the more expensive phase as not every investment made during this phase will ultimately have a pay off or even lead down the path that the company wants to go down. This part of the product life cycle phase costs a company a significant amount of money because there are many ideas being pursued and…[Read more]

There is always a push and pull between keeping companies as is, and moving forward towards innovation. In my experience, there has always been individuals that have been in place for so long that they lack the motivation to change. They have become experts in the current standards and processes that they prefer to stay the experts rather than…[Read more]

I have had experience with obsoleting product in my company that had been cumbersome to carry as a product. These were product that had not been making the amount of money that was worth the cost of production. The undertaking was a long process, as the product had many accompanying documentation and there was existing stock in the warehouse and…[Read more]

It would vary with each company, but even if the equipment does not go through the entire validation process again, it does have to keep up with calibration expiration as well as preventive maintenance at scheduled intervals. With these routine fixes, the system would never fall too far out of validated conditions.

It is important to have preventative action in medical devices because once a negative effect happens, it has already been out on the market if it was not prevented and this could cost lives. Reactive action is important but it may have been too late for some patients. While it is not possible to anticipate every action that may be required in the…[Read more]

I have come across this issue with a certain gauge that was applicable to several parts of the production process. The manufacturing department argued that it can just be specified that this gauge has several locations but still performs the same process. However, the production manager said that with each time it moves it should be treated like a…[Read more]

I agree with the posts above, depending on the degree of failure and the complexity of the machine, it may need to undergo IQ OQ PQ again to ensure safety and efficacy. However, if it is just undergoing routine maintenance or is a minor discrepancy, there is no need to undergo these processes. It may just require a few start up runs before being…[Read more]

In my undergraduate experience, I took Capstone which was a two-semester long simulation of what industry is like. This class exposed me to technical writing in order to make clear and concise documentations. My professor would use the term “idiot-proof” for documents such as test plans to ensure that any instructions found in this document would…[Read more]

There is a vast difference between the Design History File (DHF) and the Device History Record (DHR). Once the timeline during which these are created is understood, the difference is apparent. The Design History File is created during the product development stage of the device. This is the main deliverable of the Design Input phase containing…[Read more]

Our company uses ECOs and refers to them as Change Notices, as these can be originated by non-engineering as well. These CNs serve to make revisions to any document in the Quality Management System, including but not limited to SOPs, device and tooling drawings, manufacturing floor plans, equipment registrations, etc. In order for this to be…[Read more]

Regarding verification and validation themselves, the difference lies in what is being confirmed. Verification is the confirmation that the design output meets the design input requirements. Verification is showing that what the project defined as their requirements of the design came out successful. Validation is the assurance that the device…[Read more]

I agree with the above points that this debate would have to be on a case by case basis. If there is a failure in V&V testing, it is primarily important to make sure that your testing method itself is valid for testing this case. If the test is invalid, a failure or a pass would mean nothing to the protocol. Once your test method is validated, the…[Read more]

It is most sensible for the DHF to be a living document, as updates are made and the design revised, it must be permanently logged. Even post design transfer, it is important to update the origin of these designs so that it is in a central location, instead of some being scattered in the DMR. While this school of thought is the most logical, it is…[Read more]

I would consider the NB-MED guidance document to be the most useful and most powerful. This is based on the governing power that writes said document. The NB-MED guidance documents are written by the Notified Bodies, which have more central power than the Competent Authorities as they are the central piece of the EU regulatory. They are also the…[Read more]

It is apparent that it is easier to have a medical device approved in the EU versus in the US, possibly due to the simplified yet still effective method of approval. Where the FDA takes into consideration devices being safe and effective, the EU focuses primarily on the risk factors. Whether it is effective is not a necessary criteria as it is…[Read more]

I have not personally had this experience as it is early on in my career. However, I do have a colleague who interned at Zimmer Biomet, and as a result, the non-compete agreement had barred him from applying and working for Stryker for at least a 6 month period. This is understandable as their products are very similar.

From my understanding, you would need to first have a patent to protect your ideas. An NDA protects you from other people that get involved in the project. You may need to have both to fully protect your ideas, especially when involving a third party. A patent, as described above, will ensure that no one can replicate your ideas. An NDA ensures…[Read more]

The restriction of physician’s gifts is a guideline for companies to follow to avoid being accused of bribery or influencing their decision to be involved with a project. While it is a bit strict and some may find it unnecessary, it is for the protection of every party involved. Paying for the physician’s spouse could be considered bribery as…[Read more]