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 Design Controls – Joe Tartal

Slide 1 

Hello. Design controls are important. In my experience, I have found that how things start 

are how they go, and this is also true when bringing a medical device to market. If you 

begin with effective design controls, you dramatically increase your ability to meet user 

needs and ensure your device will be safe and effective. My name is Joseph Tartal and 

I'm the Postmarket and Consumer branch chief in the Division of Industry and Consumer 

Education. I have designed medical devices while working in industry and I understand 

the difficulties of bringing a medical device to market. Having worked at FDA, I 

understand the importance of design controls in ensuring that all medical devices are 

safe and effective. When design controls are established correctly, we all share in the 

benefits that the right medical device was brought to market and that it meets user 

needs, its specifications, and it works as intended. 

Slide 2

By the time I'm finished, I want you to know the following learning objectives:

understand the importance of design controls in device quality and in the quality system 

regulation; know the Quality System Regulation requirements for design controls and 

learn how its sections interact with one another and the rest of the quality system; and 

finally, understand the continual role that design controls play in both premarket and 

postmarket device development.

Slide 3

Design controls are a set of quality practices and procedures incorporated into the 

design and development process. They are a systematic way to assure that medical 

devices meet user needs, intended use needs and all specified requirements, thereby 

ensuring the medical device is safe and effective. They are a directed controlled action, 

something you do. They are not retrospective. Properly established design controls can 

improve your medical device and prevent foreseeable issues and problems, both in the 

device and in device manufacturing. 

Slide 4 

Why were design controls added to the quality system regulation when the current good 

manufacturing practices were revised? From the fiscal year 1983 to the fiscal year 1989, 

FDA conducted a six year study to determine the causes of voluntary recalls. What the 

study found was that forty four percent of all voluntary recalls could have been 

prevented if adequate design controls were used. Basically, poor design was a leading 

cause of voluntary recalls. 

Forward to another study performed on recall data from fiscal year 2003 to fiscal year 

2012, and design is still cited as one of the most frequent causes of recalls. 
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That tells us that design has an important and direct real world impact on device quality, 

safety and effectiveness. Many postmarket problems with medical devices can be traced 

back to poor design. As I noted earlier, how it starts is how it goes. 

Slide 5

After the recall study of the 1980s, there were discussions between the medical device 

industry, FDA and Congress about the inclusion of preproduction requirements in the 

current good manufacturing practices. Industry was concerned that such requirements 

would stifle research, while FDA wanted to ensure that once research entered into a 

development phase, the development would be defined and controlled. With the passage 

of the Safe Medical Device Act of 1990, FDA was given authorization by Congress to add 

design control requirements to medical devices. They were subsequently written into 

the 1996 Quality System Regulation, which became effective June 1, 1997. The preamble 

to the regulation provides a lot of useful information about industry's concerns at the 

time, FDA's intent, and the context for design control expectations. 

Slide 6

Design Controls are codified in the Code of Federal Regulation 820.30. FDA uses a riskbased approach with the application and requirement for design controls. Design 

Controls apply to all Class II and Class III medical devices. Design Controls also apply to 

a small number of Class I medical devices. They are medical devices automated with 

computer software, tracheobronchial suction catheters, surgeons' gloves, protective 

restraints, manual radionuclide applicator systems, and sources for radionuclide 

teletherapy. 

Slide 7 

Now that we know what types of medical devices require design controls, when should 

they begin? Manufacturers should document the flow of the design process so that it's 

clear where research ends and design begins. Per the preamble, they are not intended to 

apply to development of concept and feasibility studies. A good rule of thumb is that 

design controls begin after feasibility and when the decision has been made to bring the 

medical device to market. They are required prior to any investigational device 

exemption, and are premarket. They are also used when design changes are made to the 

device. Again, design controls are not intended to be retroactive. 

Slide 8 

Next, I will review the quality system regulatory requirements for design controls. 

Slide 9

Since we now know when, the question becomes where to start? I recommend starting 

with design planning. Planning is important as both a requirement and a practical tool to 

control the design process. Establish, which means define, document and implement 

the following--First, describe or reference design and development activities to keep 

track of all requirements, their status and completion. 
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Next, identify, describe, and define interfaces, responsibilities, functions and activities 

that impact the device design. I recommend using cross functional teams with 

appropriate representation from all parts of the organization. Define who has what 

responsibility and the authority to make decisions. Last, review, document, approve, and 

update the plans as development and design changes evolve. The plan will provide a 

road map of where the design is and where it's going, and help to make it an efficient and 

effective process.

Slide 10

Once there's a plan, then start with design inputs. Design inputs are the physical and 

performance characteristics of a device that are used as a basis for the device design. 

Questions to consider at this stage are -- who are the users? What are the user needs? 

In what environment is the device intended to be used, and with what other kinds of 

devices will it be used? Manufacturers are required to establish and maintain procedures 

for design input to ensure requirements are appropriate by addressing user needs and 

intended uses in terms that are measurable. Also, any incomplete, ambiguous, or 

conflicting requirements must be addressed. Last - document, review, and approve all 

design input requirements.

Slide 11

Next, let's use an example to further illustrate a design input. We can take a user need, 

such as "portable", and further narrow it down that the end user must hand carry the 

device. To define this aspect of "portable" into measureable specifications, we can use 

criteria such as dimensions and weight. We can have the design input for a weight 

specification be five pounds, plus or minus one kilogram. Next, we must address any 

incomplete, ambiguous, or conflicting requirements. For example, we cannot use a 

conflicting unit of measure, such as five pounds plus or minus one kilogram. The 

measureable specification must use a single unit of measure, for example, pounds. The 

design input is now a specification of five pounds, plus or minus one pound. Last, the 

design input is documented, reviewed, and approved.

Slide 12

The design inputs should include human factors. Human factors are the study of the 

interactions between humans and the device, such as the interface end users and 

patients have with the device, and the subsequent design of that interface. This is 

important, since human factors can lead to improved ease-of-use, appropriate 

instructions for use, increased proper use, and decreased use error. 

Also, human factors can help to increase the device reliability, durability and life, and 

decrease maintenance and repair. Last, taking human factors into consideration during 

design can lead to fewer adverse events and recalls.
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Slide 13

Design inputs can come from many sources, such as customers, standards, guidance 

documents, complaints, and adverse event reports to name a few. Examples of design 

inputs from these sources can include device functions, physical characteristics, 

performance, safety and reliability among those listed and others that are not. Spending 

enough time upfront capturing the right information to develop design inputs will help to 

get your design process off to a successful start.

Slide 14

Design outputs are the results of a design effort at each design phase and at the end of 

the total design effort. In general, design outputs are the design specifications which 

must meet design input requirements, as confirmed during design verification and 

validation, and ensured during design review. The finished design output is the basis for 

the Device Master Record, or DMR. The total finished design output consists of the 

device, its packaging, labeling, and the Device Master Record. Also, manufacturers must 

identify design outputs essential for the proper functioning of the device. Using our 

previous design input example of a weight specification, one design output would be the 

physical hand held device itself that weighs five pounds, plus or minus one pound. Last, 

manufacturers are required to review, approve, and document design outputs before 

release. Design outputs are included as part of a premarket submission as device 

specifications. And a premarket submission, such as a 510(k) or Premarket Approval, 

could be included as a design output.

Slide 15

Establish and maintain procedures for design reviews. Plan and conduct formal 

documented design reviews of the design results at appropriate stages. Design reviews 

are not ad-hoc meetings. They are documented, comprehensive and systematic. 

Manufacturers determine the frequency and stages for design review. For a more 

complex and higher risk device, more design reviews will be needed, while for a simple 

lower risk device, fewer or a single design review may be acceptable. At each design 

review, include representatives of all functions involved, specialists as needed, and at 

least one individual without direct responsibility for the stage being reviewed. During 

the review, evaluate the adequacy of the design requirements and the capability of the 

design to meet those requirements. Identify and correct any problems that need to be 

resolved. Document results of the design review in the Design History File, or DHF, and 

include the identification of the design, the date, and the names of the individuals 

performing the review.

Slide 16

Design verification is confirmation by objective evidence that design output meets 

design input. Manufacturers are required to establish and maintain procedures for 

design verification. Continuing on with our example, I can use a calibrated scale to 

weigh the device from my design output, and using the measurement on the scale, I can 

verify that the device weighs five pounds, plus or minus one pound. 
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The design output meets the design input, and is verified and confirmed by measureable 

means. The verification is reviewed, approved and documented as part of the design 

history file.

Slide 17

The next section that follows design verification is design validation. Design validation 

is establishing, again, by objective evidence, that specifications conform to user needs 

and intended uses. Manufacturers are required to establish and maintain procedures for 

design validation. These procedures must include performing the design validation 

under defined operating conditions, on initial production units or their equivalent, and 

under actual or simulated use conditions. If the plan is to use equivalent production 

units or simulated use conditions, then the manufacturer must also document how these 

units are equivalent to initial production units, and how the simulated use conditions are 

similar to the real world conditions. 

Slide 18

Think about verification and validation in this way. Design verification - does the design 

output meet the input? The design output - the device - is measured on a scale and 

weighs five pounds, plus or minus one pound, which is the specification as noted in the 

design input. I made the product correctly. This is in contrast to design validation, 

where the five pound device is put into the actual use environment with intended users, 

and they confirm that it is portable. Using the example, the intended users can carry the 

device by hand in the intended use environment. Therefore, the intended use and user 

need for portable are met. I made the correct product. Both are important to the design

process. 

Slide 19

Continuing on with design validation, risk analysis is noted one time in the quality 

system regulation and it's in design validation. Risk is noted many times though out the 

preamble. 

Design validation shall include software validation and risk analysis, where appropriate. 

Where appropriate means it is appropriate unless the manufacturer can document a 

justification for why it is not appropriate. It's almost always appropriate to perform risk 

analysis. It will likely take more effort to justify why it's not appropriate to perform a risk 

analysis than not doing so. Also, while risk analysis is noted in design validation, it's 

more practical to perform initial risk analysis earlier during design input. Then, as more 

information and data are gathered, the initial risk analysis is updated. 

Slide 20 

That being said, what does FDA mean by "risk analysis"? Regardless of the risk analysis 

tool used, the preamble is clear that manufacturers are to identify possible hazards, 

including use errors. Evaluate and calculate the risk under both normal and fault device 

operating conditions. Determine the risk acceptability. 
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Reduce all unacceptable risks to acceptable levels and ensure those changes do not 

introduce new hazards. This is the expectation for risk analysis in order to meet the 

regulatory requirement. 

Slide 21

While risk analysis is the regulatory requirement, the current industry practice goes one 

step further and utilizes risk management. This slide shows two resources that will help 

you better understand risk management. The first is a guidance document, titled 

"Implementation of Risk Management Principles and Activities within a Quality 

Management System". It was written by the global harmonization task force, which has 

since been replaced by the international medical device regulator forum. And the second 

is ISO 14971, which is the standard for the application of risk management to medical 

devices. ISO 14971:2007 is a FDA recognized voluntary consensus standard. 

Slide 22

Now that the design team has done a great job and the verification and validation 

activities are completed can we just throw it over the wall to our manufacturing staff? 

No. Manufacturers are required to establish and maintain procedures to ensure that the 

correct design is transferred into production. From a practical standpoint, there's a real 

need to address production scale-up issues; the completion of process validation 

protocols; finalization of purchasing controls; and training and qualifying manufacturing 

personnel, among other transfer considerations. This is one area where design controls 

interact with other parts of the quality system, and a worst case scenario is to have an 

effectively designed device not manufactured correctly. And while design transfer 

should happen throughout the design process, frequently, there's a final stage of 

development intended to ensure all outputs are adequately transferred to production. 

The term I've heard used to stop the continuation of a design is a "design freeze".

 

Slide 23

Over time, the one thing I can guarantee is that things will change. Next, I'll discuss the 

continual role design controls play in premarket and postmarket device development. 

This will also include the rest of the quality system regulatory requirements for design 

controls. 

Slide 24

Manufacturers are required to establish and maintain procedures for the identification, 

documentation, validation or, where appropriate, verification, review, and approval of 

design changes before their implementation. Make sure there is a system in place to 

enact future changes. As a device is improved, or more information becomes available 

after it's on the market, there has to be a system for change. Also, depending on its 

scope and impact, the change may require a premarket submission, such as a new 

510(k), a new PMA, or a PMA supplement. 
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Slide 25

Last, let's discuss the Design History File, or DHF. This is a compilation of records which 

describes the design history of a finished device. It's a record of all design actions, from 

start through transfer, including any changes. It's the totality of the entire design effort 

for the life of the device. Manufacturers are required to establish and maintain a design 

history file for each type of device. The DHF can be specific to a single device, or a 

family of devices. Include in the DHF the information necessary to demonstrate that the 

design was developed in accordance with the design plan and quality system 

requirements. It can be a single notebook, several books, or an index reference to other 

records. The design history file becomes very important as researchers, engineers, 

quality and regulatory personnel leave, and time goes by and activities completed years 

ago become a memory. 

Slide 26

Additional information on design control guidance and human factors can be found at 

the links on this slide. 

Slide 27

In concluding this presentation, I now ask you to take on the following call to action: 

Meet your regulatory requirements for design controls per 21 CFR 820.30. Use cross 

functional teams to design your device. Ensure your design controls address user needs 

and intended use, and define appropriate device specifications. And last, use design 

controls to build quality, safety, effectiveness and savings into your medical device.

Slide 28

This presentation and other helpful videos and educational resources can be found at 

CDRH Learn. For text based information on premarket and post market topics, including 

how to bring a medical device to market, please visit Device Advice. For additional 

information on these or any other medical device regulatory topics, feel free to call us at 

the Division of Industry and Consumer Education Monday thru Friday from 9AM to 

4:30PM eastern standard time.

Slide 29

Thank You for watching.

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