Product Development

and Validation
Medical Device Product
Lifecycle and Design &
Development Planning

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Learning Objectives

1. Overview of Medical
Device Development
Quality Management
Systems
2. Review Development
Program Structures
3. Understand Attributes of
a Design & Development
Plan

3
Design Controls Overview

Medical Device QMS Overview

• ISO 9001: Quality Management Systems – Requirements
• ISO 13485: Medical Devices – Quality Management Systems
• 21 CFR 820: Quality System Regulation (Medical Devices)

International
Organization for
FDA Standardization
(ISO)

21 CFR 820
ISO 13485 ISO 9001
(FDA)

Regulation Standard Standard

4
Design Controls Overview

Why Design Controls?

• 44% of voluntary recalls from October 1983 through September 1989
may have been prevented by adequate design controls.
Source: ‘‘Device Recalls: A Study of Quality Problems’’ (see 55 FR
21108, May 22, 1990) and “QS Regulations (Final Rule)” (see 61 FR
52602, October 07, 1996)

• The most frequent causes for recalls are related to Design, Software, and
Non-Conforming Materials/Components.
Source: “Medical Recall Report FY2003 to FY2012” (CDRH Office of
Compliance, Division of Analysis and Program Operations)

5
Design Controls Overview

What are Design Controls?

A systematic and structured approach to control the design of
the device in order to ensure specified requirements are met

How would you Control the Design

throughout the lifecycle of the Product?

• Establish and maintain procedures to control design

• Ensure people and process are in place
• Provide objective evidence that design meets
requirements and needs
• Ensure that the underlying design is maintained through design changes,
transfer to manufacturing and throughout the total product lifecycle
6
The Device Quality System – Reminder

Corrective & Focusing on Design Controls

Preventative Actions • 21 CFR 820.30: (a) General. (1) Each
manufacturer of any class III or class II
Management Controls

Production & Process device, and the class I devices listed in

Controls paragraph (a)(2) of this section, shall
establish and maintain procedures to
control the design of the device in order
Design Controls to ensure that specified design
requirements are met.

Records, Documents, • BS EN ISO 13485:2016 Section 7 Product

& Change Controls realization: The organization shall plan
and develop the processes needed for
product realization.
Material Controls
• MDR: Regulation (EU) 2017/745

Equipment & Facility • IVDR: Regulation (EU) 2017/746

Controls
7
Food for thought

Nothing New: Design Controls follow the processes used in the familiar Scientific Method

Product Development Scientific Method

Identify a need Observe

Conceptualize product concepts Question/Research

Propose Design Inputs (Requirements)

Hypothesis
That, if fulfilled, address the need

Generate Design Outputs (detailed

Experiment
designs to address the requirements)

Verify outputs meet the inputs

Test
(repeatable, reliable, manufacture…)

Validate that the design addresses the

Analyze
need

Report/Conclusion Report/Conclusion
8
Food for thought

9
Scenario
Introduction for the
Design Controls
Classes

10
Case Study – Carrying Forward from the First
Course
• Note: we will build this example
throughout the Design Controls
classes in this course

• Your name is Sheldon Kaplan,

and it is the 1970’s

• You are working on developing

the first Epinephrine Device

• The device has a chamber that

holds the drug, and a spring
loaded needle that exits the tip
of the device for intramuscular
injection.
11
Case Study

Your device actually has an electromechanical component that includes

audible instructions and a digital readout. It is not a “connected” device
12
Quick Note

• The Epinephrine Device is technically a

Combination Product
• Combination products are therapeutic
and diagnostic products that combine
drugs, devices, and/or biological
products.

• For the purposes of this activity and review of Device

Design Control Requirements, only the Device
requirements of this product example are being
considered at this time.
13
Case Study

You are a Regulatory Affairs professional and have recently been given
the role to Lead the Project Team for this new product.

Why would Regulatory Affairs be a

good Team Leader?

• They know the country requirements for

each market
• They can drive the timing for all the various
filings
• They stay with the product through to the
end

Let’s get started!

14
Concept
Phase

15
Product Design & Development

Concept Phase
Identify a need
Determine
Design Control Conceptualize product concepts whether a new
Requirements product has
Start
Propose Design Inputs (Requirements) potential in the

Design History File

That, if fulfilled, address the need
marketplace
Design & Development Planning

Generate Design Outputs (detailed

designs to address the requirements)

Design Transfer Activities

Freedom from
Verify outputs meet the inputs
(repeatable, reliable, manufacture…) regulations and
requirements
Design Reviews Validate that the design addresses
the need

Flexibility to
Design Changes Approval/Clearance to market
determine design
feasibility within
Production & Post Product Activities your own company

16
Exercise – Epinephrine Device

What do you need to know to scope your product and identify all the
needs of your user, customer, regulatory requirements, market, etc.?

• What is the intended use/intended purpose?

– Intended medical indication
– Patient population
– Part of the body or type of tissue interacted with
– User profile
– Use environment
– Operating principle
• Who are the customers?
• Who are the patients (might be different from the user)?

Remember this is 1970, and See Next Slide for Exercise on

there is no epinephrine Identifying User Needs for
device on the market Devices on the market
17
Concept Phase Activities - Exercise

Search the “FDA Product For products already on the market, you can review the
Classification database” FDA’s MAUDE and TPLC databases to see what types of
for “epinephrine syringe” issues other manufacturers are facing.
to determine what class • MAUDE: Manufacturer and User Facility Experience
device your version of the • TPLC: Total Product Life Cycle
epinephrine syringe will
likely be. 1. Search the FDA TPLC Database for “Pacemaker” as
the device
• Notice the different Device Classes range from I-III

Since this requires 510(k) 2. If you click on “Implantable Pacemaker Pulse-

notification, what class Generator” on the second page:
device is the epinephrine • How many PMAs have been submitted since 2015?
syringe most likely to be? • How many device problems have occurred since 2015?
• What was the reason for the recall that St. Jude had to
conduct in 2018? Will you have to worry about this
Think back to the first issue with your epinephrine device?
course on Device • No. You have electromechanical parts, but your device
Regulatory Submissions is not “connected”, so unauthorized access to your
device through cybersecurity breaches is not an issue
18
Concept Stage Gate
Goal of this stage: To frame the scope of the project and understand targets
based on product and patient needs, and markets served.

What decisions need to be Product Requirements. Should this project proceed into
made: Planning? Charter the development project.
What aspect of Design Review is Look for predicate devices and determine improvement
necessary at this stage? new device offers. Compare against customer/patient need
Identify the need for Risk Review similar products using FDA website's MAUDE and
Evaluation or re-evaluation. TPLC Databases. Identify the timeline for Risk Management
Activities and establish any additional risk management
activities needed from hazard analysis.
FDA interaction that is required Use of FDA databases on predicate devices to begin to scope
or helpful during this stage possible regulatory requirements
Begin to define which parts/components/software will be
Supplier Management activity manufactured /developed in house and which will need
done at this stage outsourced.
Stakeholders who need to be Marketing, R&D, Quality, Regulatory, Manufacturing
involved in this stage, and their
19
role (RACI model):
Concept Stage Gate

Triggers to escalate disputes/decisions: Cost, Timeline, Perceived need/viability

Who is the ultimate decision maker: Project Manager, R&D

Critical metrics/measures: • Date business plan is due

• Profitability projection that must be met
• Sustainability measures that must be met
Critical outcomes - how to measure success What's the business plan. (This is linked to the
of this Stage: Goal and creates specificity).
Did the outcome of this stage contribute to Need to compare the outcome of this step to
the overall project success criteria: the overall project criteria. If so, then achieve
Executive management buy-in for Project
Establishment
Are the requirements and needs being met Identify different customer needs based on
for all intended markets: culture, accessibility, affordability, etc. Identify
different regulatory requirements, clinical
study needs, etc.

20
Case Study – Concept Stage Gate

• Should this project proceed

into Planning?
– Business case
– Status of required elements from
current Phase
– Technical feasibility
– Risks/ assumptions
– Availability of required resources

Identify what information

might be available for
consideration at this
stage gate.
Planning
Phase

22
Design Controls

Design Controls per Now “Design Controls” officially start!

21CFR Part 820.30

(a) General
Next steps in understanding
(b)Design and Development Planning
Just a visual reminder of where
(c) Design Input we are in 21CFR 820.3
(d) Design Output
“Planning” includes the
(e) Design Review
establishment of the design
(f) Design Verification history file, which is used to
essentially document everything
(g) Design Validation
you do throughout the product
(h) Design Transfer lifecycle!
(i) Design Changes
(j) Design History File

23
 Design Controls - Design History File (DHF)
Design History File - 21 CFR 820.30(b)
• Each manufacturer shall establish and maintain a DHF for each type of device.
• The DHF shall contain or reference the records necessary to demonstrate that the design was
developed in accordance with the approved design plan and the requirements of this part.

Design and Development Planning (ISO 13485 – Section 7.3.2)

What is a Design History File? Why is it important?

• Compilation of design records • Demonstrates, with objective
• Establishes a baseline of the evidence, that you did what you
device’s design said you were going to do
• Collectively defines the device • Helps assess the impact of future
and its risks device issues and assessment of
potential design changes
• Evidence for regulatory
compliance and legal liability
21CFR Sec. 820.3 Definition:
(e) Design history file (DHF ) means a compilation of records
which describes the design history of a finished device. 24
 Design Controls - Planning
Design and Development Planning - 21 CFR 820.30(b)
• Each manufacturer shall establish and maintain plans that describe or reference the design and
development activities and define responsibility for implementation.
• The plans shall identify and describe the interfaces with different groups or activities that
provide, or result in, input to the design and development process.
• The plans shall be reviewed, updated, and approved as design and development evolves.

Design and Development Files (ISO 13485 – Section 7.3.10)

What is Design and Development planning? Why is it important?

• It’s a form of communication • Ensures everyone is on the same
• Describes design activities and timing page
• Identifies key responsibilities and • Ensures alignment and
interfaces agreement with design
development and schedule
• Ensures all team members know
their roles and deliverables
21CFR Sec. 820.3 Definitions:
(k) Establish means define, document (in writing or electronically), and implement. 25
Design & Development – Risk Management
File

Design History
Risk Analysis

Risk Assessment
File
ISO
14971:2019 Risk Evaluation

Risk Decisions
Risk Management Plan

Risk Management
are made Risk Control

File (RMF)
throughout
the Product
Development Evaluation of overall residual risk
Lifecycle

Risk Management Review

Engineering File
Plan for these

Usability
assessments!
Production & post-production
activities

26
Design & Development – Human Factors/
Usability

Design History
Identify users, uses, use specification,
and hazard-related use scenarios

File
AAMI/ANSI/IEC
62366-1:2015 Usability Engineering Plan User Interface Specification

Just remember, if

Risk Management
User Interface Evaluation Plan
your device can’t

File (RMF)
be used, you might
as well not have a User Interface Design, implementation
product at all! and Formative evaluations

Need to include

Engineering File
Summative Usability Testing
studies in your plan

Usability
(we’ll explore these
in later classes) Production & post-production
activities

27
Design and Development Plan

How can you ensure consistency in how

your company does design planning?

Build a Procedure!

• The Procedure can be as basic as restating the regulation or it

can be a detailed work instruction
– Keep in mind the more detailed you are, the more opportunity to be out
of compliance with your procedure
– But the less detailed you are, the more likely someone will not
understand their responsibility
– So balance is important!
28
Case Study - Design and Development Plan

• Our Product: Epinephrine

• Fictitious Company: Stick with Us, Inc.

• Let’s begin drafting

our Design and
Development Plan.
• Review the provided
example Design and
Development Plan.

29
Objective and Scope - Exercise
• The Design and Development Plan should clearly define the overall project
objective and the scope of the project.
• It may be beneficial to state what is not part of the scope of the project.
• What should the objective of the device be? Think about how it is intended to
be used? What would be important about how to design it?

Listed in Section
Develop the Scope for the Epinephrine Device 1 of the Project
Plan

How about: to design an epinephrine device that can maintain the sterility of the
epinephrine drug; protect the glass cartridge from breaking; allow proper release of
the needle; complete delivery of the drug upon ejection; provide audible instructions;
provide a digital display to countdown.
And: It shall not be designed for connected use. It shall not be designed for multiple
uses.
30
Project Team and Roles/Responsibilities
and Interfaces
• Each member of the Project’s Core Team should be listed including their role/function
on the Project Team
• For what, specifically, is each functional group responsible?

You are the CEO of Stick with US. Who

would you want to be sure is on this team?
What is the Role
Section 3.1 in Plan
and Responsibility
of the Project
Manager?

Refer to
Section 3.3 of
the Plan

31
Establish the Timeline – Stage Gate Model

Example Product Lifecycle – Stage Gate Model Examples of

Design Input Design Output Production
major milestones
Concept Phase Planning Phase V&V Phase
Phase Phase Phase • Alpha Builds
User Needs
• Design reviews
• Regulatory
Design & Dev. Plan Update Update Update Update
submissions
Design Inputs
Start to estimate
Design Outputs
timelines and cost
Verification
for the scope of
Overview

Design
Review Design
Review Validation the project
Regulatory • Will you need to
Design
Review
Submission do clinical studies?
Production • Are there specific
Design Transfer
regulatory
Design
Review
Surveillance requirements for
this market?
Design Change

Decisions are made

before you can move
Stage Gate

Charter Resource test &

development
Resource Resource
manufacturing
Launch Obsolesce through the gate to
project
project plan development
activities
product product
the next step
32
Design and Development Planning

Approvals
A listing of who
approved the
Design and
Development Plan
• Handwritten
• Electronic

Front Page
of Plan

Revision History
The plan is a living document and will evolve throughout the design and development of
the product
The plan is to be reviewed and updated at a minimum during Design Reviews
33
Exercise

• Design & Development Plan audit:

– Review 21CFR 820.30 (b) and ensure all of the requirements are captured
within the example Design and Development Plan
– Note: Some sections of the Plan do not have regulatory requirements
since they are business related – can you spot those sections?

How about:
But what would  Resources needed, including necessary
you want to make competence of personnel
sure is included in  Scope is accurate
these sections?  Design Verification & Validation Strategy
 Human Factors Strategy
 Assessment methods/Statistical methods
 Design Transfer Strategy
 Design Review Strategy
 Design Change Strategy
 Expectations for DDP updates
34
Stage Gate: Design and Development Planning

Goal of this stage: To develop a controlled document to define roles, responsibilities

and interactions for project team and outline the tasks that will
be completed for acceptable project implementation
What decisions need to be made: Major Milestones and Schedule. Should this project proceed into
Design Inputs? Resource Design Input Phase.
What aspect of Design Review is Ensure that the plan is feasible and appropriate members are
necessary at this stage? assigned to tasks within their competency

Identify the need for Risk Formalize Risk Management Plan. Perform Hazard Analysis and
Evaluation or re-evaluation. Risk Assessment to identify possible risks with device.
FDA interaction that is required or FDA classification of device (513(g) meeting) and Pre-Submission
helpful during this stage meeting (Pre-Sub), identify the regulatory inputs for the device
Supplier Management activity Identify suppliers that will be reviewed for ability to meet
done at this stage upcoming design specifications

Stakeholders who need to be This will define the entire team, so all roles responsible for any
involved in this stage, and their aspect of project completion should be identified. Traditional
role (RACI model): roles would be: R&D, Marketing, Quality, Regulatory,
Manufacturing, Installation, Service, and Sourcing
35
Stage Gate: Design and Development Planning

Triggers to escalate Roles or Responsibilities that cannot be filled internally, but are critical to
disputes/decisions: the project timeline
Who is the ultimate Senior Management
decision maker:
Critical metrics/measures: Project Timeline and estimated project cost.

Critical outcomes - how to Review and approval of the Design and Development Plan.
measure success of this
Stage:
Did the outcome of this If so, then achieve Executive management Project Commitment
stage contribute to the
overall project success
criteria:
Are the requirements and Planning and proper certification testing identified in completed PRD will
needs being met for all need to be identified, budgeted, and timeline planned.
intended markets:

36
Case Study – Concept Stage Gate

• Should this project proceed

into Design Inputs?
– Business case
– Status of required elements from
current Phase
– Technical feasibility
– Risks/ assumptions
– Availability of required resources

Discuss what information

might be available for
consideration at this
stage gate.
Challenges and
Audit Findings

38
Potential Audit Findings

• Failure to ensure that design plans were reviewed,

updated, and approved as design and development
evolves as required by 21 CFR 820.30(b).

• Specifically, your firm's design

plan for the project titled
"Photometer Boards Redesign",
dated October 19, 2007 with
effective date October 29, 2007
was not updated, reviewed
and approved as the design
and development project
evolved.
39
Potential Audit Findings

• Failure to establish and maintain plans that describe or reference

the design and development activities and define responsibility
for implementation as required by 21 CFR 820.30(b).
• For example: neither your firm's design plan
(e.g., Project Tracking Matrix, Development
Timeline) nor design control procedure
(Design Controls, PSOP-6), in effect at the
time the We Go 250 power chair was being
designed, defined responsibility for
implementation of all of the design activities
related to the We Go 250 power chair.
• The responsibility for performing the risk
assessment, compiling the Device Master
Record and performing
verification/validation activities was not
defined. 40
Potential Audit Findings

• Failure to establish and maintain a design history file (DHF) for

each type of device as required by 21 CFR 820.30(j). For
example, the following documentation was not present:
a) Formal documented reviews of the design results
b) The identification, validation, or where appropriate verification of
design changes, and
c) The results of the design validation, including identification of the
design, date, and individuals performing the evaluation

41
Key Takeaways

1. Quality Management
Systems are required for
medical device
development
2. Development efforts scale
with product complexity
3. A robust design &
development plan is not
only required it is
necessary for success

42
Simple can be harder than
complex: You have to work
hard to get your thinking
clean to make it simple. But
it’s worth it in the end
because once you get there,
you can move mountains.

Steve Jobs

43