I work in an organization that is both Functional and a Matrix organization. We essentially use project managers within departments that lead the projects with a staff beneath them. Most of the project managers pertain to Engineering. There is definitely silos that form behind the departments in which it becomes “tribal” knowledge since some…[Read more]

A lot of companies and regulators such as BSI, put a lot of time and effort to ensure that the IFUs and graphic labels on the product match. I can see both sides why this is important and why this could potentially be unnecessary. I’ve run into issues with labels in which we couldn’t sell product because the legal entity was mismatched and the…[Read more]

It helps if a similar product is already approved in whatever country the company is trying to release their product. If it is a whole new product that is being brought to market most of the cost are going to be exorbitant. If it is a high risk PMA expect to pay millions of dollars. Part of this is due to the FDA process of reviewing in which…[Read more]

Point #4 – Risk Management is not a lifecycle process is one of the most common errors that occurs for most companies when they assess risk management. Risk management is done at the beginning stages of product development and theoretically should be updated accordingly and periodically as the product moves toward complete development. From my…[Read more]

In agreement with this post. AQL levels for most companies are the guideline for identifying what the sample size should be depending on the risk. However, further analysis such as power level, significance level, confidence intervals, etc can be applied to potentially explain why that sample level isn’t necessary for that level of risk. Usually…[Read more]

Agree with this in terms of having an established amount of lots, units, and time for running the validation. If you are conducting a validation you would want to prove that a set amount of lots or units is sufficient in proving the output equals the input. You run these trials during the Operational Qualification and Performance Qualification…[Read more]

From my experiences determining the duration of each task is highly important. Through past projects within industry, I have found that project managers are sometimes over optimistic about how long a task takes. Finally, when that task exceeds the amount of allotted days, there is debate about why this happens or why it happened. I always highly…[Read more]

I fully agree with this. There are various test that can be done to physically test a device. Instron testing to test mechanical properties, environmental testing to test how a product reacts in certain temperature conditions and for shelf life, packaging testing to test how a product that is packaged reacts to wear and tear as it is delivered.…[Read more]

To have an adequate Design Control System – one that will pass audits at the minimum, you must have Design Inputs, Design Outputs, Verification, Validation, Design Transfers, Risk Analysis, the DHF.

For Design Input this includes physical appearance of the device, labeling and packaging, maintenance, functionality, safety. Essentially it is the…[Read more]

I recently went through an internal audit in which we reviewed the DHF of one of our product lines. There was heavy debate on information within the Design Specification Document (DID). The DID contains specific specifications and tolerances for drawings of the actual product that is to be manufactured. Each product must be made to the drawing…[Read more]

I don’t believe it is completely necessary to have a clinical background to work in this field. To say you need have a clinical background for a role is highly limiting the talent pool that would potentially be interested in the company or role. Engineers that are solid in solving problems, have an extensive background in math and science, and…[Read more]

From a Big Pharma standpoint in terms of clinical research, it is very money driven and results driven. For example, for a double blind test, the intent is to remove as much bias from the test subject and investigator as possible. However, because of this, statistical test can be fabricated and systematically wrong. Many test can give false…[Read more]

SWOT Analysis for Boston Scientific –

Boston Scientific is a global developer of interventional medical devices that target cardiac rhythm management, cardiac and vascular surgery, electrophysiology, tumor reduction, cancer treatments, hearing reduction; and pain management

Strengths:
Broad Product Portfolio in Specific Fields – Well known for…[Read more]

I feel this video clearly depicts that there tends to be disconnect from the customer and the supplier. I believe most of this can either be attributed to lack of communication – the customer doesn’t clearly communicate what they desire vs what the supplier or business understands and translates their need as. From a business perspective, I…[Read more]

In China, the country offers Wholly Foreign Owned Enterprises. This is the most popular form of incorporation of foreign companies in China. WFOE allows an LLC company that is owned by foreign to open their company in China, usually for manufacturing purposes, without the involvement of a Chinese partner.

The advantages include:
-…[Read more]

Depends.

If you are looking to work in medical devices and it is a well established company such as a conglomerate like Johnson and Johnson, then you don’t need to worry about their stability or financial history since it is been around for years. In terms of stock price and revenue, this is a very small part of indicating how well a company is…[Read more]

As many have mentioned, it highly depends on what type of business you are trying to conduct.

If I was creating a tech start up I would most likely go the route of an LLC. With an LLC it will be relatively cheap and easy to set up. As stated in the lecture videos, the members divide the ownership percentage and because the LLC is not taxed as an…[Read more]