|Are you wondering why you are having|
difficulty managing your design history file?
By Matthew M. Lowe
In my experience working in medical device product development and product management, maintaining the design history file (DHF) posed daunting challenges because it was a process that continued throughout the lifecycle of a product. Even years after a medical device is launched, it’s not uncommon for the technical lead to revisit the DHF because the product is undergoing an iteration or it’s being launched in another part of the world.
Executive Vice President, MasterControl Inc.
If your DHF is paper-based or hybrid (part electronic and part paper-based), the challenges grow exponentially. Having worked as a development engineer in medical device firms and now as an executive in a software solutions provider that helps medical device and other regulated companies, I have seen the view from both sides of the fence.
Here are some of the biggest hurdles I’ve experienced and seen pertaining to DHF management in a paper or hybrid environment.
#1 The Organization is Unprepared for Audits: Even if you have multiple products and multiple DHFs, an FDA investigator is likely to ask to review a randomly (or not so randomly) selected DHF. So it’s critical to have all of your DHFs always ready for inspection since you don’t know which one will be scrutinized. In addition, medical device firms also undergo internal audits and ISO audits regularly.
#2 The Design Review Process is Bumpy: During this step, the Review Board’s job is to “pass” or “fail” the design by relying on what is documented in the DHF, and it’s not uncommon to discover just how many documents and signatures are missing. I have participated in many “signing parties,” in which all affected staffers and executives are frantically going over documents and signing them off at the last minute.
This article is a summary from the Whitepaper: How to Address the Top 6 Pains in DHF Management. To get the full details please download your free copy.
#3 It’s Almost Impossible to Get the Signatures of Top Executives: This problem is directly related to #2 because often, what’s missing during the Review Board step are signatures from top executives who are not involved in the design control process on a daily basis, but are required to sign off on documents.
#4 It’s Difficult to Implement Postmarket Change Control or CAPA: It’s likely that within a year or two, a device would have iterations that would require a revisit of the DHF to implement changes and CAPAs. Assuming that the people who worked on the device originally are still with the company, they would need to go back to the documents they created. If the DHF is paper-based, they would start digging into files—a tedious and time-consuming job.
#5 Finding Documents through a “Gatekeeper” is Inefficient
In a paper-based process, the technical lead for the product development team or document control is usually the DHF “gatekeeper.” You can just imagine the time and effort it requires to find a document, hand it to the requestor, check it back in, and replace it in the storage room.
#6 Managing DHF and Technical Dossier Can Require Two Teams
A device firm that’s developing a product for global markets would need to prepare separate submissions for the FDA and for regulators in Europe, Japan, and other geographies. While the information required is essentially the same, the preparation, presentation, and the depth of information included vary greatly. As a result, a company that maintains a paper-based system typically needs two teams to manage the DHF and the technical dossier. These teams are basically doing the same thing, duplicating efforts and wasting staffing resources.
So, how do you address these pains? Switching from a paper or hybrid system to an electronic system is a significant step toward improving your DHF and your entire quality system. An enterprise platform will allow you to address an immediate problem—such as DHF management—with a point solution and at the same time enable you to add solutions within the same platform in the future.
I discuss the abovementioned pains further and also offer a recommendation for each one in my white paper titled “How to Address the Top 6 Pains in DHF Management.” If you’re interested in reading the white paper, you may download it below for free.
Note: The views expressed in this article are those of the author and do not necessarily represent those of his employer, GxP Lifeline, its editor or MasterControl Inc.
Matthew M. Lowe, executive vice president at MasterControl Inc., is a mechanical engineer with over a dozen years of medical device experience in product development, product management, and regulatory compliance. Prior to joining MasterControl in 2006, he worked in product development and product management at Ortho Development Corp. and Bard Access Systems. He has successfully launched more than a dozen medical devices and has four patents issued. His regulatory compliance experience includes writing a 510(k) that was cleared by the FDA and managing a multisite, multiyear postmarket clinical study for orthopedic devices.
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