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White Paper:
How to Address the Top 6 Pains
in DHF Management
By Matthew M. Lowe
Executive Vice President, MasterControl Inc.

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Introduction
Noncompliance among medical device developers typically falls under two areas: design control and document
management. These two critical elements intersect in one place: the design history file (DHF).

The DHF serves as a repository for all of the documentation generated throughout the design and development process—
drawings, protocols, reports, and other documents. It serves as a complete record of the development of a device.

In my experience working in medical device product development and product management, maintaining the 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 for various reasons. Perhaps the
product is undergoing iteration or being launched in another part of the world.

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. It is a unique
position to be in, and I will share some of my insights that might help you address your DHF challenges.

Top 6 Pains
Here are some of the biggest hurdles I’ve experienced and seen pertaining to DHF management in a paper or hybrid
environment and my recommendations for addressing them.

#1 The Organization is Unprepared for Audits

For startups, an audit by the U.S. Food and Drug Administration (FDA) might come five years down the road from the
time the DHF was created. What are the chances that the same staff members are doing exactly the same work within that
five-year period? If there’s a change in personnel, a paper or hybrid system will make it difficult to find the documents you
need during an audit.

For the established medical device firm with a product in the market, an inspection might occur every two years. The
inspection might come sooner for manufacturers of Class II or Class III devices whose products have received adverse-
events complaints. The higher the risk of the product, the more frequent an FDA audit is likely to occur.

Come inspection time, an FDA investigator is likely to ask to review one DHF. Even if you have multiple products and
multiple DHFs, the focus will likely be on just one DHF, unless the auditor finds problems in which case many more could
be inspected. So it’s critical to have all of your DHFs always ready for inspection since you don’t know which one will
be scrutinized. The technical lead would usually sit with the investigator as he or she looks through the records. Speaking
from experience, it is excruciating for the technical lead to be unable to find the exact document and information required
by the regulator. Even worse is to find a document that has not been properly signed and dated.

In addition to FDA inspections, medical device firms also undergo internal audits and ISO audits regularly. This begs the
question: Is your organization always ready for an audit?

Recommendation: I will make this premise right off the bat: 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.

If your immediate concern is just improving your DHF and your organization is not in a position to consider an
enterprise platform, find an out-of-the-box tool that will help you quickly transition to an electronic DHF. For example,
MasterControl DHF Jumpstart provides preconfigured tools that can be installed in a matter of days, with minimal system
administrator or user training. It automates routing, collaboration, follow-up, and approval of design control documents.

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With an electronic DHF, you will be a step ahead of any audit because all your documents can be easily found in a single
repository. They will be visible to the auditor. For example, MasterControl has a tool called Organizer, which makes it
easy for users to find and access documents in a familiar DHF structure. With the help of the Organizer, you can structure
your DHF in a way that design reviews can be conducted entirely from within the application.

For Class I and Class II manufacturers, MasterControl DHF Express provides all the necessary tools for collecting,
organizing, and reviewing documents in a compliant manner. The tools come preconfigured so you will be able to
automate your design control process easily and quickly. This solution is cloud-based, which means you will get the same
robust and secure QMS without the large up-front cost of owning and maintaining a system. You can deploy it quickly
without the need to hire a full IT staff.

#2 The Design Review Process is Bumpy

The design review process can be bumpy at best and nightmarish at worst with a paper or hybrid system. I have
participated in many “signing parties”—lasting anywhere from four to eight hours— in which all affected staffers and
executives are frantically going over documents and signing them off at the last minute, when those tasks should have
been completed long before the Review Board comes in.

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 at the signing party just how many documents and signatures are missing. Unless and
until the Review Board is satisfied with the state of the DHF, the team can’t move on to the next phase.

The design review process must be conducted repeatedly throughout the product lifecycle, from concept phase to
feasibility phase to pre-510(k) to post-510(k). Just imagine how many signing parties you’re going to need!

Recommendation: A solution like MasterControl Projects can automate project management tasks common in the design
control process, eliminating the need for a signing party. For every product you’re developing and every project you
have, the system will manage all tasks, documents, schedules, and resources from start to finish. Every time a document
is approved, a process is completed, or a milestone is achieved, the system will update the project plan without manual
intervention. It will provide you with a best-practice workflow that incorporates all the steps in a typical development
project and automates the creation and population of the DHF.

#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 be up to date in order to
sign off on documents.

When I was a technical lead, I used to literally run from building to building and room to room looking for people to sign
off. Sometimes documents are simply lost during the shuffle. When that happens, we had to start from scratch, wasting
valuable time.

Recommendation: When you switch to an electronic DHF system, you will no longer have to physically run after people
because routing for signature, follow-up, and escalation will be automatic. A solution like MasterControl provides a time-
stamped audit trail and electronic signature capabilities that fully satisfy 21 CFR Part 11 requirements and will greatly
improve your document approval process. Also, MasterControl is web-based, which means top executives who travel a lot
will be able to access the DHF and sign off on documents 24/7 from virtually anywhere, avoiding unnecessary delays.

#4 It’s Difficult to Implement Postmarket Change Control or CAPA

On the average, development of a new medical device takes anywhere from 18 months for a 510(k) product to five years
for a device requiring a PMA. After a product is approved by regulators and launched in the market, the DHF for that
device is typically stored in a collection of fire-proof cabinets commonly known as the document control room.

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The lifecycle of the device includes iterative improvements over time. It’s likely that within a year or two, there will be
iterations, which would require a revisit of the DHF to implement changes and maybe corrective action and preventive
action (CAPA). 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.

If there is a personnel change, the challenge of a paper environment is double because it would mean the new employees
are unfamiliar with the documents for which they are looking.

Recommendation: An electronic platform will facilitate a smooth iterative process over the long haul. If your company
is iterating a product every two years, it probably means your needs are expanding. In this case, you are better off with
an enterprise platform that would connect your electronic DHF and project management tool to your CAPA, complaints,
nonconformance, and other processes. For example, MasterControl All Access was designed with such a need in mind. It
is flexible enough to be used not just by one department but the whole enterprise, including any overseas facilities. It is
scalable, configurable, and there is room for adding more solutions and addressing future quality needs.

#5 Finding Documents through a “Gatekeeper” is Inefficient

In a paper-based process, the technical lead for the product development team is usually the DHF “gatekeeper.” Anybody
who needs anything from the DHF typically has to go through this person because it is unlikely that anyone else will be
able to find that for which you are looking. 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. Since the technical lead is usually an engineer, we can
assume that this person is not particularly interested in becoming knee-deep in administrative work. It is an unwelcome
role that easily sucks time and effort.

From the point of view of users, who really wants to go through a gatekeeper to be able to do one’s job? It’s inconvenient,
time-consuming, and aggravating for everybody concerned.

Recommendation: An electronic DHF means your users will be able to access documents directly. If the system is web-
based, they will have access 24/7 using a robust search mechanism from virtually anywhere, greatly increasing efficiency.
It means your technical lead will be free from tedious administrative tasks in order to focus on his or her role as an
engineer.

#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. If the firm is still in a paper environment, it means it would have to
maintain the DHF for its FDA submissions and it would need to establish a variant of the DHF for a technical dossier for
Europe and Japan.

The FDA’s design control requirements are significantly different from the technical dossier required to obtain a CE Mark
in Europe and Shonin (pre-market approval) in Japan. For both Europe and Japan, regulatory requirements and audits are
based on ISO 13485 standards.

While the information required is essentially the same for these submissions, the preparation, presentation, and the depth
of information included vary greatly. Also, you can expect the respective auditors to look for different things.

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, which means you are duplicating your efforts and
wasting scarce staffing resources.

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Recommendation: By automating your DHF, you will eliminate duplication of effort from the get-go. For example,
MasterControl Projects self-populates the technical dossier and DHF. So, as you establish your DHF for your 510(k) or
PMA, you are also creating your technical dossier. This means you are saving time and manpower.

MasterControl Document Collections is a supplementary module that a device manufacturer could use in conjunction
with MasterControl Projects. It provides the capability to collect, review, and approve a group of related documents but
still treat them as separate documents. This module links related documents so when one is revised, the whole group is
automatically restructured for re-approval. It allows users to work in up to seven different languages without having to
worry about keeping the documents in sync—an ideal tool for European and Japanese submissions.

Conclusion
The main challenge of medical device companies like yours is to develop and manufacture products that are safe and
compliant, and at the same time remain competitive in the market. The focus of your operations on a day-to-day basis
should be on building your core competency, not on coping with the pains of an inefficient and ineffective paper or hybrid
DHF.

Having worked in medical device firms, I will say this unequivocally: Automating your manual or hybrid DHF is a huge
step that will help you increase efficiency, reduce waste, boost productivity, and accelerate time to market.

Related Videos

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About the Author

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.

About MasterControl Inc.

MasterControl produces software solutions that enable regulated companies to get their products to market faster,
while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company’s critical
information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate,
and easy to use. MasterControl solutions include quality management, document management, product lifecycle
management, audit management, training management, document control, bill of materials, supplier management,
submissions management, and more. Supported by a comprehensive array of services based on industry best practices,
MasterControl provides our customers with a complete information management solution across the enterprise. For more
information about MasterControl, visit www.mastercontrol.com or call 1.800.825.9117 (U.S.); +44 (0) 1256 325 949
(Europe); or +81 (03) 5422 6665 (Japan).

© 2014 MasterControl Inc. All rights reserved.

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MasterControl Inc.
Corporate Headquarters:
MasterControl Inc.
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United States
Phone: 1 866 747 8767

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MasterControl KK
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Contact information and addresses for

other regional MasterControl offices
and MasterControl partner offices are
listed on the MasterControl website at
www.mastercontrol.com.