One key feature of post-launch product management is having a fully trained, knowledgeable, and enthusiastic sales force. It is important to keep a sale and advertising team up to date but also well-i...

In this week’s lecture, Dr. Simon discusses some reasons as to why a product can fail on the market. Can you describe an experience that you have had with a product failure? (Either from a developmen...

That raises a great question. From experience, I was on a project team where we were developing a cough and cold product for the market. At the start of concept, the previous year’s data completely w...

The above posts seem to discuss this well. It is very similar to this week’s simulation: assuming that a machine failed due to machine failure (or nearby machine malfunction), it would most likely not...

This brings up a great point- typically, engineers have limited exposure to technical writing. Personally, as an undergraduate, I was not required to take a technical writing course but it was integra...

I would say that an alternative option to dual sourcing would be to also keep a “cushion” stock or back stock of both the final product and each component. This is often done at times in the industry....

It seems like one of the simplest and most cost effective ways to conduct post-market surveillance would be to request feedback from the patients using the device. For example, if the device is a knee...

Great question, Luisa. From previous experience, I, myself, have been responsible while working in the research phase to create SOP’s. This is important even for research and development because SOP’...

Great question, Chris. I had a similar problem at a previous job when I was responsible for writing and updating SOP’s as well. One problem that I often came across was including troubleshooting instr...

I have heard of holistic qualification before and from my understanding, it is the approach of qualifying a process by qualifying its individual parts. For example if you wanted to qualify a productio...

I have actually run into this at a previous job. We had a similar situation where we would move a piece of equipment from a production area to an R&D area. When needed for production, it would be ...

Syringe Filling Process IQ- Filling machine has working parts, SOP’s, WI’s, calibration schedule, maintenance schedule, meets OSHA standards, has qualified personnel trained on it OQ- Syringes are fil...

From my experience, your product will almost always require both a DHR and a DHF. The reason being is that one is for the design phase (DHF) and one is for the production phase (DHR). A DHR shows how ...

From my experience, the most post-market surveillance we would receive is from the end user, or the patient. People will often call the company’s main hotline if they have any major complaints. Additi...

Hi Everyone, This week, Dr. Simon talked about ECO's (Engineering Change Orders) and how they are used to change something about the medical device after the design controls are finished. This can be...