In my opinion it seems that the DHF could be a combination of the two. There could be some things that do not change throughout the design process, and then there could be things that are updated. Considering how much information the DHF holds, it seems unusual to limit its capabilities. Based on the lecture this week a DHF is supposed to contain all documents, which is why even all the changes should be included. It is almost impossible to begin a project and not expect anything to change, so a DHF should be able to facilitate that as well.

The school of thought that appeals to me the most, is the process where once the design transfer occurs the DHF is sealed. I say this mainly because I only have experience doing it this way. After the design transfer, any changes to any design specifications, or software updates must undergo a Design Change Process (DCP). In this it details the change, what is being affected, what inputs/outputs are affected, the risk, priority level, and a verification/validation that verifies that the change has been implemented.

I would agree that the DHF is considered a living document due to its importance in holding all the required information during the design controls. However, after the design transfer process is completed, the DHF should be utilized as a reference document to demonstrate the required production specifications. Some of these include how to test the device for safety and efficacy and still check with the various verification and validation steps. At the completion of the design transfer it denotes the line where implementation starts and anything that required changes were all done and concluded within the design controls. Also, it also assists in maintaining a quality and consistent product during the manufacturing and launch phase.

http://www.mastercontrol.com/newsletter/medical_device/medical-device-design-history-file-0710.html

Hi All,

I would say that the school of thought that appeals to me most is that the DHF is not a living document. As small processes change over time they can be inserted into the DMR, but not change the nature of the device. I believe this because a device is designed with a specific purpose and use; however if that use changes a new DHF should be created. It may take pieces form the old, but to keep the most up to date files a new DHF should be created rather than simply continually updating the old.

-Andrew Nashed

Hello,
I also believe that a DHF is not a living document from my experience and just from the purpose of it. It is for the initial design and any changes that will be made shouldn't alter the initial design. Once that happens you have a new device and proper measures should then be taken. The SOP example provided is a tricky one. If the changes in the SOP affect the design and device in a dramatic way then I think a change process needs to be don for a new device but if it is a change that result sin the same device but maybe in a quicker way or safer way then it shouldn't matter and can be added to the DMR.

I think that the DHF should be a live document. The reason being that from experience, the original idea of the device is rarely ever the outcome. While it may be useful to have a document of the thought process, it is more useful to have a record of what the device ultimately became, on the production line. The document would most likely be more useful being a live document to keep track of the final decisions. Very rarely will people refer back to documents to check the development process. This is often done with memory, word of mouth, and experience. Referring back to incorrect/outdated documents can cause more confusion than clarification.

-Michelle

I believe that the DHF should be a living document. This is due to the fact that many other components of a product may be interlinked. If any part of this product were to change, the DHF should be updated to reflect this. Whether it be a material change, a tolerance adjustment or a simple process parameter update all these are minor (or major!) changes that can drastically change the outcome and documentation of a product. Creating a new DHF to capture a small change in the grand scheme of things is not in line with a forward thinking organization in terms of documentation and quality.

I am one of the people that believe that DHF is a living document. Any changes to the Device Must be included in the DHF. I also believe that any changes have to go through a design transfer especially changes to the SOPs and work instructions. This in fact is to ensure that knowledge affected by this change have been transferred to the people systemically. The other reason behind my decision is that the change have to evaluated in the context of the whole design. The DHF have to be evaluated to determine the impact of the change on other aspects of the design and add an impact statement of the change with regulatory rationale behind why no additional verification or validation processes are needed after implementing this change.
Finally, The idea of capturing all changes in the DHF will allow the organization to maintain a whole design history in one place without the need to inspect multiple location to determine the change impact or change details.

In my opinion I would consider the DHF to be a living document. Often times in a products life span there could be changes in materials/processes and its good to look back at historical data in order to compare data sets. I know in my experience I have looked at historical data and compared different aspects of validation/verification of equipment or devices. I have had instances where the DHF wasn't consistently updated and it becomes very hard to determine what the thought process for particular changes within a process or equipment.

Chris

Yes it is a living document and i agree with everyone here. However, you can't look at this like a file on your laptop. These changes and processes actually cost money and time. When you are hired for a project, you are expected to meet the client's requirements. Client's don't change their minds on a regular basis, because every change they want to do essentially is costing them money and revision of all the paperwork. This can be challenging if you have worked on a device for a long time. The most common time for revisions would be if there is an actual demand on the market. That my thought on this is it depends on the business and satisfying the client. This industry is driven by money so some companies may advise for multiple revisions due to the fact that is more money and time. So it depends.

I believe that the DHF should be a living document that reflects the current state of the device. Keeping track of the changes (SOP'S, material, packaging, labeling..etc) and updating the DHF gives an appropriate and up-to-date information to anyone who needs to refer back to it for any given reason. As Chris mentioned, if the DHF is consistent, looking at historical data from a consistent DHF makes it easier to compare data sets.

I agree with the students who believe the DHF is a living document. If any change is made to the medical device, the information should be included in the DHF. If a certain part of the device is altered—such as a material change—then the change has to be looked at in terms of how it’s going to effect the entire product. Since the DHF is a compilation of records which described the design history of a finished device, it has to be closely assessed to determine whether or not the change had an impact on other aspects of the design. Additionally, the beauty of having a DHF is to have ONE document for companies to look back on, instead of flipping through multiple sets of documents. That being said, the DHF should be updated regularly as things within it change. Quality documentation is key to producing a successful medical device.

In my opinion, the first thought where the DHF is sealed and any updates after the design transfer are added to the DMR seems more logical. Technically, DHF is put together initially when the product was being planned, researched and prototyping it. Once the design is transferred, then any change needed to the product goes through a process and hence it should be recorded in the DMR. The change process evaluates the what it is that is being affected and the risks involved with it. Since, the DMR is an extension to the DHF it makes the DMR more of a living document. The DHF should remain a record of the initial thought process and the DMR can be used for ongoing changes.

A follow-up question from Dr. Simon's post:

As I mentioned earlier, once the DHF is sealed any ongoing changes should be added to the DMR seems more logical to me.

For those of you who are currently working in the medical device industry or have had previous experience with this, which of those two thoughts does your company follow? Is one preferred over the other or does it change for specific cases?