Hi All,

Thank you very much for this interesting topic. I have not worked too much with ECOs; however I do have a bit of experience. I have needed an ECO in the past for a change of an SOP. In most cases I have worked with it was a change in a SOP, where a newer procedure was created or a new technology was created or better utilized that needed to be changed. I never had to complete one myself; however it seemed to be a fairly straight forward process as most were minor changes to SOPs.

-Andrew Nashed

Hi all,
I have not had any experience with any ECO since I still do not have experience in the medical device industry. But to my understanding. some examples in which ECO is needed could be when a modification will have an effect:
- On the product- Maybe a correction of a design error that doesn't become evident until testing and modeling, or customer use reveals it.
- On the manufacturing process- probably a change in material or manufacturing method. This can be caused by a lack of material availability, a change in vendor, or to compensate for a design error.

I have no experience in the industry, but based on what I know about ECO from Dr. Simon's course, I would only use an ECO for profits. For example, if there is a major change that needs to occur in the device or protocol, yes by all means submit an ECO. However, one of the main reasons If it was my own product, I would use the ECO if the device or product were going to increase the sales and be more competitive in the market. Since all of the regulations and approvals were vetted, and if a new change will perform the same functions that already exist but also adds something and this results in more business for the company.

Another way I look at ECO, if there is a better way to produce the same product with less cost by changing protocols I would highly consider the use of ECO. I would personally use ECO for these main reasons for better product, better market, better competition.

ECO's are not very commonly used once the device is on market due to the main reason of money. However, recently at my company the on market device which is used globally and in specifically in China, the main board of the device was not RoHS compliant. This required a massive ECO to change the material or add a protective layering to the main board because some aspects of it were not RoHS compliant. Another aspect or subset of ECOs are called DCO's (Document Change Orders). This change after design transfer includes documents, Manuals, Getting Started Guides, SOPs, etc. DCOs compared to ECOs do not cost as much money and are mainly focused changes on documentation whereas ECOs are focused on parts of the device such as changing a material or color or part of the device.

Hi All,

In my previous job I had to issue ECOs for many purposes including:
- SOP Changes/updates
- New SOP Release
- Process Changes
- Product Specification Changes
- Documentation Updates

The reason why we used ECOs in everything even in documentation updates is that we needed to make sure that there is no impact on the product safety, performance, or efficacy when that change is executed. ECOs are usually accompanied by Change impact statement which highlights the impact of the change on the design. It also triggers a systematic review of other documents to ensure everything matches your proposed changes. ECOs were sometimes created as part of Corrective and Preventive Actions (CAPAs).

I haven't used an ECO but I think it is used more in manufacturing/ production and not in development as changes made there are much easier. My only question is if it is a major change what are the following steps? If the device design was altered do you have to conduct another safety test or evaluation of materials or is all that included in the eco description?

As mentioned above and within Dr. Simon’s video, the ECO is required when the design controls are finished and the device needs a change. With this, it may create more modifications within the regulatory aspect such as SOP changes, additional work in verification, risk analysis, and even animal studies. And requiring those changes to be added into the 510K or PMA as supporting documentation. Also, a company initiating the ECO must take into account is disposition which means any product that has been manufactured or sold that does not contain the change. If device is in market do you sell it all or do a recall? For the product in stock, do you try to re-work what you can or scrap entire lot.

Hi All,

Engineering change orders are an interesting and important topic. I am currently working on a few change orders for the CAPA that I am working on. I am basically updating test methods for laboratory testing equipment , which are meeting current manufacturing standards. Essentially the ECO is used to address the change of an SOP or document and why is this change being addressed, and as Fady mentioned the ECO is accompanied by a change impact.

Chris

Hello!

To maintain and increase market share, manufactures often must respond quickly with engineering changes to their products. These changes might be necessary to respond to safety issues, market demand, or FDA requirements ECOs are documents that a company uses to track product changes. I currently work in a medical device technology company, but I have not needed an ECO yet. In product development, an ECO is needed if the following changes occur: a change in the method of manufacturing, a change in the material due to a change in retailer or material shortage, a change in the customer needs causing the redesign of a part of the product, updates to documents, changes to an SOP, or improvement of a design error.

I would say that it depends on the severity of the change, if its a major change that all documents should be adjusted and perhaps another safety assessment may be needed if it changes the function of the device. If lets says there is a new supplier/vendor being introduced than an ECO would be needed to address the change and slight modifications would be needed in referenced documents perhaps.

Chris

since already many have talk about some of the examples, there are some benefits of ECO. following good ECO practices it will make thing easier when documenting a full history of what change have been made to a product and when they occurred. In industries with regulatory requirements, like the medical device industry, having a full history of every change to a product is mandatory. (Depending on the industry, change orders and even the change process itself may be audited by a regulatory body.) Keeping a record of product changes will also help you debug any problems that occur after your product launches. The task of identifying and fixing the root cause of any problem is easier when you have a complete product change history.

The purpose of an ECO is to provide a framework for making a change to a product once it is already released to the market. Going through the ECO process makes sure that you check everything that was checked during the design of the product to ensure that the changes you are making will not negatively impact the safety of the product. Sometimes ECOs can be so involved that they are almost like a mini-project, especially when it involves a regulatory submission. Also, Dr. Simon mentioned in his lecture that determining product disposition is a very important part of an ECO, and I would definitely agree with him. There is a lot of time and discussion that goes into determining the disposition of WIP, stock, and product in the field. If it is determined that there is an impact to product in the field it means a much bigger impact and definitely a regulatory impact, as a "market withdrawal" or recall may need to be issued.

ECOs are used to make modifications to components, assemblies, associated documentation and other types of product information.The main reason for ECO (for example) ,product improvements, or companies might want to research other methods better suited to their own operations. For example, if the product or process changes can impact many areas within your company, including:Customer service, tooling, standards, suppliers, Master production schedule,device problems, or product cost.
I don't have experience with completing any ECO, but I think we should avoid unnecessary changes for the product to save time and money. However, if a change in a product pays back in a year, for sure I go for it!.It's all about quality and profit.

ECOs are used to make changes to the device if the SOP's , suppliers, processes have been changed. ECO's are set into place once the design controls are completed. ECO's generally cost a large amount of money to actually process, initially all departments associated with the design controls must agree on the reason behind the request. Personally i have no yet encountered a situation where a ECO had to be requested. In the company i work for, they search for other avenues to solve the problem before having to resort to a ECO. But as many have pointed out, ECOs are very costly and this is the reason why it is heavily avoided.