I agree with a lot of the post above in regards to the amount of paperwork that potentially needs to be done within this field. I don’t have experience in working within Clinical Trials, however, as I have found just…   Read more»

The simulations were very helpful because it teaches you different ways to think outside the box in terms of resolving different issues from a very basic and high level approach. The simulations were very practical and are very real situations…   Read more»

MDD and AMDD are very good classes to get your feet wet in understanding the different aspects of medical devices and what can lie ahead in your engineering career. As expansion to these type of courses, I would like to…   Read more»

In agreement with this. You can have two similar functioning products but have different risk. An implantable suture that biodegrades into the body would have significant risk as these sutures are used to sustain life. However, you can also have…   Read more»

I agree with this point. Failed clinical trials is bad press for a company. Articles usually pop up when a company’s clinical trials fail for a medical device or drug. The same issue occurs, when an FDA doesn’t allow a…   Read more»

Outside of the budget and resource issues that others above have pointed out, it would be interesting to consider conducting a clinical study depending on where the issue you are tackling is most prevalent. For example, if you are conducting…   Read more»

I don’t necessarily agree that having zero GMP will lead to lower cost in anything. I’m not sure what type of buyer would want to purchase any product, let alone a medical device or drug, that didn’t follow a certain…   Read more»

This is a very good observation. Contracting employees has long been a solution for big medical device companies to control budget constraints. The way this usually works is a big project comes along for a specific department. The department director…   Read more»

I agree with this. CAPAs are meant to self correcting actions that a quality system intakes to ensure products and processes are in conformance. I would like to add some of the minor cons that may occur with opening CAPAs….   Read more»

In agreement with this. The ambiguity for GMPs established within a start-up opens itself for improvement and new policies that will, in turn, reduce vagueness. At the start of production, this helps as you can keep production going forward. In…   Read more»

At my company most non-conforming issues usually stem from either operator mistakes or product not conforming to QC testing. When non-conforming issue occurs due to operator error an investigation is initiated. The investigation report usually entails a 6M (Man, Method,…   Read more»

Grandfathering a project due to changes in a quality system usually consider the following components: project scope (ex. changes to processes, documentation, drawings, validations) + area of grandfathering (document control, quality, engineering) + Date. The date aspect is key because…   Read more»

From my experience if sales numbers are lagging, there needs to be a way to compensate that by finding ways to SAVE money. Usually if sales at my company are falling behind for the year I have noticed the engineering…   Read more»

Emotional intelligence is highly important in negotiations. I believe this is one of the few things that is difficult to teach as emotional intelligence can vary greatly person to person and is almost a subjective idea depending on who you…   Read more»

I believe I can relate to this. I have noticed that engineers in a leadership role for an extended period of time within a company, can at times, get complacent with innovation and more resistant to change. And to your…   Read more»

Like many have said I have also been involved in root cause analysis to examine the reasoning behind something failing. In many cases, most of the root cause analysis I have done involves a lot for a product failing. From…   Read more»

I have experience with evaluating legacy products and obsoleting products. It is usually a bigger undertaking then one would think. To your point, it is very important that companies continuously evaluate the portfolio of the products to see what is…   Read more»

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,…   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…   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,…   Read more»