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THE BEGINNER’S GUIDE TO DESIGN VERIFICATION AND DESIGNVALIDATION FOR MEDICAL DEVICES

EBOOK

JON SPEER,

FOUNDER & VP OF QA/RA GREENLIGHT.GURU

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TABLE OF CONTENTS

THE BEGINNER’S GUIDE TO DESIGN VERIFICATION AND DESIGNVALIDATION FOR MEDICAL DEVICES

2. The Beginner’s Guide

4. Design Verification & Design Validation – What?

6. Design Verification Is More Than Testing

8. Importance of a Design Verification Plan

11. Yes, Design Validation Planning Is Important

THE BEGINNER’S GUIDE TO DESIGN VERIFICATION AND DESIGN VALIDATION FOR MEDICAL DEVICES

– When your medical device product development project gets to Design

Verification and Design Validation, do you feel like it’s almost there?

– Meaning, finally, you can see the goal of market release coming soon?

– Or is it more like being stuck in the middle?

From my product development experiences, entering into Design Verification

and Design Validation is always bittersweet.

Exciting because yes, to get to Design Verification means that we have

accomplished quite a bit.

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FOR MEDICAL DEVICES

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Terrifying because the work ahead can be frustrating, time consuming,

and sometimes ambiguous.

Let me share a few perspectives from a recent project.

Then I’ll get into explaining exactly what Design Verification and Design

Validation are, how they are the same, and how they are different.

The device is an electronic medical device with firmware. Early design

and development activities were trying. The team changed, the design changed.

Lots of back and forth, with seemingly little to no progress at times.

But then we found ourselves at the edge of Design Verification and preparing

a 510(k) submission.

As project manager, I realize getting to this point in the project is a significant

milestone. But I’m not a complacent person. The goal is market launch.

And when you are about to enter into Design Verification and Design

Validation, you quickly realize how important the earlier Design Controls

activities are to your project.

– Did you capture the right User Needs?

– Are your Design Inputs written well-enough?

– Do you have sufficient Design Outputs?

– What happened during Design Reviews?

– Does the Design Plan specify enough detail (or too much detail)?


FOR MEDICAL DEVICES

So here we were, about to begin Design Verification. We had a loosely defined

plan for all the Design Verification activities. And then we just dove right in.

While we were addressing Design Verification, the startup CEO only heard that we

were preparing the 510(k), which in his mind was more meaningful and significant.

Should I have explained the importance of Design Verification and

Design Validation to the CEO? Or was he right to focus on the 510(k)?

Maybe it’s a matter of semantics. Not sure it matters either way.

Regardless, let’s now get into the specifics of Design Verification and Design

Validation that the startup CEO didn’t want to.

Let me dive into explaining what they are, how they are the same, and how they

are different.

All too often in medical device product development, the terms “verification”

and “validation” are thrown around. Many times they are lumped together

as “V&V” as kind of one thing or phase. I’m not here to debate whether this

thinking is right or wrong.

DESIGN VERIFICATION & DESIGN VALIDATION – WHAT?


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There are times when I see Design Verification as something very different from

Design Validation. And plenty of other times when I refer to V&V.

First, let’s clear up a bit of terminology about “verification” and “validation”.

These “V” words without descriptive adjectives are too vague.

For instance, if someone asks you about verification, you need them to clarify

what they mean.

There are multiple types of verification and validation: Design, Process, and

Software are the most common in the medical device industry.

And each means something different. Also, to complicate matters a bit, outside

the medical device industry, verification and validation also mean different things.

The focus of this post and the relevant terms for Design Controls are Design

Verification and Design Validation.

I’m only focusing on these versions for the time being. (So from this point forward

in this post, if you read “verification” I’m referring to Design Verification and

“validation” refers to Design Validation.)

Even with this Design Verification and Design Validation can be

confusing. To help clarify, remember these two simple questions:

• Design Verification: Did you design the device right?

• Design Validation: Did you design the right device?

Be sure to note the subtle, but extremely important, difference.


FOR MEDICAL DEVICES

DESIGN VERIFICATION IS MORE THAN TESTING

I suspect when most medical device engineers hear the term “Design

Verification” they think of one thing: testing.

While it is true and very likely that Design Verification will involve testing, there

are other acceptable verification activities. Design Verification activities can

include tests, inspections, and analyses (for a full list, refer to FDA Design Control

Guidance section “Types of Verification Activities” on page 30).

The natural tendency and trap is to fallback and rely too heavily on testing

for Design Verification.

Don’t fall into this.

Design Verification activities include analysis and inspection


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Remember, the purpose of Design Verification is to confirm your Design Outputs

meet your Design Inputs. This is why you have to think about Design Verification

when defining Design Inputs.

TESTING PITFALLS

Design Verification testing has pitfalls. There are plenty of cases where

inspection and analysis activities are just not sufficient for verification and testing

is the only way.

Keep in mind, though, that testing is often very expensive, time consuming,

and subjective.

Expensive because you usually have to have lots of test articles. Expensive

because you may need to involve third party testing resources.

Time consuming because testing multiple test articles, especially if third party

testing firms are involved.

Subjective because you may try to do the testing yourself to save money

and time. But if you don’t test to an accepted method or protocol, your tests

are not objective.

Again, there are plenty of times where testing is the only way to verify.

My advice is to also consider other verification activities.


FOR MEDICAL DEVICES

Design Verification – testing is often necessary

IMPORTANCE OF A DESIGN VERIFICATION PLAN

For the reasons described above, a Design Verification Plan is important.

And the time to construct a verification plan is when you define Design Inputs.

If you wait to construct a Design Verification plan right before starting verification,

this is too late.

This is why I stress over and over the importance of considering how you will

verify Design Inputs when you are defining Design Inputs.


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Consider that instead of rushing to Design Verification, the opposite approach

might be more beneficial. Spend more time defining Design Inputs so that

Design Verification becomes smoother.

Implementing this approach will help you to become a better Design Input artist

and your ability to better manage medical device product development (click

here to get my free 5 phase medical device product development checklist).

DESIGN VALIDATION PROVES THE RIGHT DEVICE WAS

DESIGNED

The purpose of Design Validation shall prove the medical device meets the User

Needs and intended uses.

And Design Validation is a Design Controls activity that happens pretty late in the

product development process.

But yet validation is a measure of one of the first activities--defining User Needs.

Design Validation Musts

Design Validation must include initial production units.

This means the medical devices used for validation have to be built in the

production environment, using drawings, specifications, etc. (i.e. Design Outputs)

by production personnel.


FOR MEDICAL DEVICES

Design Validation must involve clinical evaluation.

This means that the end-user(s) should be involved and the device should be

tested either under simulated use or actual use.

The medical device should be used under the specific environmental conditions.

“Clinical evaluation” does not just mean actual use.

NOTE:

Actual use requires quite a bit of additional criteria for most devices.

You can’t just go and have your medical device used in actual use without

addressing this first.

Clinical Evaluation can be simulated use


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YES, DESIGN VALIDATION PLANNING IS IMPORTANT

Like Design Verification, it is important to plan Design Validation and to do

so earlier in the project. I advise planning validation at about the same time

as Design Verification planning.

There is a definite relationship between verification and validation. If planned

properly, there are ways you can accomplish Design Verification and Design

Validation with the same activities.

Thinking about how you will validate a particular User Need can happen when

these are defined.

Design Validation must involve testing.

Tests are required to demonstrate your medical device functions as expected

and meets the User Needs. You can also incorporate inspections and analyses

as part of validation in addition to testing.

Design Validation must include packaging and labeling.

Your medical device includes everything from the label, the instructions for use, the

packaging, and everything inside your packaging. Validation must include all of it.


FOR MEDICAL DEVICES

Design Validation, though, can be a bit tricky, especially in determining if you

have effectively demonstrated your medical device meets User Needs.

There is usually more of a human element to validation and subjectivity can be

an issue. Plus, the ways you choose to solicit end-user feedback is important.

Are you going to be present and observe the end-user?

Are you going to send the medical device, complete with packaging,

labeling, and IFU, to the end-user and require a survey be completed?

How will you know you successfully completed Design Validation?

These are all considerations of validation planning.


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THE BEGINNER’S GUIDE TO DESIGN VERIFICATION AND DESIGN VALIDATION FOR MEDICAL DEVICES

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