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 by reading and discussing with other colleagues, it seems that the biggest con is the actual execution of the protocol and study…[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 that happen across all medical device companies. Therefore, the simulation did its job in teaching…[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 see a course done on the startup/entrepreneur side of medical device development. These two courses, are definitely necessary…[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 a suture that applied topically on smaller wounds and removed which would have non significant risk.…[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 product go to market. All of this is bad press and is a circumstance that most companies and employees of companies seem to…[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 clinical trails on a drug that targets malaria, you can argue that you should conduct the clinical trial…[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 procedure or standard in the production of that product. It seems counterintuitive. A medical device company that would choose not…[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 will have a set budget for the year. When additional resources are needed they will reach out…[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.
– CAPAs are meant to resolve issues by ideally identifying the root cause. I have seen firsthand CAPAs that have been…[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 this sense it is a positive for GMPs to be ambiguous.

The negative aspect of having ambiguous GMPs is…[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, Material, Measurement, Mother Nature (Environment), and Machine). The…[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 when moving over changes to a new quality system you are…[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 department initiates more Lean projects to try and cut cost within manufacturing. I believe this is a very good way for a team…[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 ask. In negotiations, you don’t want to be swayed by feeling without having any logic to back up your…[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 point, would rather focus on making current manufacturing practices more efficient. Creating efficient and streamlined processes…[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 my experience, the investigation usually involves QC rejecting the lot after in process manufacturing inspection. Many times…[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 driving sales versus what is declining in sales. Through my experience there are 3 challenging…[Read more]