Why Does it Take So Long to Write a Design History File?
Creating a Design History File (DHF) for a medical device is an intricate and time-consuming process.
Those of you with experience know what I am talking about. The DHF, this comprehensive compilation of documents that detail the history of a medical device's design, development, and manufacturing, similar to the MDR/IVDR Technical File, requires a significant effort to write and, sometimes, an even larger effort to maintain.
On the surface, it’s a documentation exercise that swamp your best and brightest with seemingly menial tasks. However, it is also a non-optional activity required to ensure compliance with stringent regulatory requirements and, in essence, your ticket to the market.
I have yet to meet a medical device manufacturer that did not wish this process to go faster. So let’s take a look at the reasons why compiling a DHF takes such a long time and what can be done about it.
You might not know which documents to include
A Design History File consists of a large number of documents, often in the hundreds, each serving a specific purpose in detailing the device's development history. How do you know which documents to include?
Regulatory bodies like the FDA, through their Quality System Regulation (QSR) 820, prescribe the specific documents that constitute the required baseline.
However, compliance with the FDA's requirements is only part of the equation. You should also consider what your own quality management system requires as well as the requirements from the various medical device standards you, voluntarily or not, follow in your process.
Known “Summary Technical Documentation” (STED) frameworks, such as those from the Global Harmonization Task Force (GHTF) Study Group 1 (SG1), serves as a table of content like structure for your DHF and provide additional guidance and I would recommend that you either follow a provided STED or develop your own.
Design History File Documents are Interdependent
One thing that makes the DHF particularly difficult to manage is the interdependence between the documents. Each document contains information that depends on information in other documents.
This interdependency means that changes in one document often necessitate updates in several others. If you update a design requirement, you may need to revise verification plans, risk assessments, and possibly even user manuals.
Managing these updates manually can be a real nightmare. You might not even know which documents are dependent on, and therefore potentially become inconsistent due to the information changes you make.
Manual processes are prone to oversight and errors, which further prolongs the DHF compilation. Given the sheer volume of documents and references, it’s impossible to keep all the current content of DHF documents in your head at once and trust your knowledge of the documents to keep them consistent.
Software tools such as Application Lifecycle Management (ALM) systems (e.g. Aligned Elements) can aid by automating change impact assessments and ensuring that all dependent documents are updated accordingly. This significantly reduce the effort required for these activities.
No-one is responsible for DHF efficiency
Ensuring regulatory compliance is paramount in the medical device industry, often taking precedence over process efficiency. A designated compliance officer typically oversees the documentation to ensure it meets regulatory standards. However, this focus on compliance can sometimes overshadow opportunities to streamline the documentation process. A compliance officer success is measured by the level of compliance, not efficiency.
The fear of jeopardizing compliance often leads to inefficiencies being overlooked or outright ignored. Even though that it is obvious to everybody involved that documentation efficiency is a tremendous economic opportunity, a QM might prefer to have engineers spend on hours creating exhaustive documentation rather than risk an additional hour spent on explaining an optimal but leaner documentation approach to an auditor.
Compliance checks and validations, such as tedious reviews and the creation of exhaustive verification data might be motivated from a compliance perspective, but are resource-intensive. Not having a dedicated responsible person for compliance efficiency is a sure-fire way of assuring that this topic will never receive the necessary attention it needs.
Finding and Fixing Errors Takes Time
Errors in DHF documentation are a natural effect of the large number of interdependent documents. Examples include unsigned or unapproved documents, missing traces between design controls, unmitigated risks, and use of outdated or obsolete information.
Identifying and rectifying these errors is a meticulous and time-consuming task, especially when done manually through reviews and checklists. Manual error detection is prone to human error and can be exhaustive.
Utilizing ALM software such as Aligned Elements can help by automatically detecting discrepancies and performing impact assessments, which can significantly reduce the time required to find and fix errors.
Conclusion
Each medical device engineering team may have their own reasons for spending more time than necessary on Design History File Activities. I hope that these tips might shed some light on your particular situation, and that they might help you to make the changes necessary to accelerate your Design History File process.
