Foundations of a Good Product Development
Process
Bill Hill
Today’s topics…
§ Foundations of Medical Device Development
§ What do successful device developers do
differently?
§ Discussion and Questions
Research | Commercialisation | Business Growth
Product development is the translation of IP into a finished product – transforming
knowledge into improved patient outcomes and creating commercial value
Research
Initial Applied Research
Ongoing Research
Commercialisation
New Research Directions
Business Growth
Applied
Research
Intellectual Property
• Patents
• Copyright
• Know-How
+
Commercialisation Plan
• Value Proposition
• Market /User Research
• Development Strategy
• Route-to-market
• Funding Methods
Manufacture
&
Distribution
Next
Generation
Product
Market &
Feedback
Research and Product Development | Different Process - Different Outcome
Research
Nature of
project
Commercial
Aspects
Success
Measures
Product Development
• Investigative process
• Well-defined, managed process
• Outcome unlikely to be well defined
• Lower (generally) technical uncertainty
• High (generally) technical uncertainty
• (More) Predictable
• Commercial prospects (may be)
unclear
• Business case defined
• Nature, size (and existence?) of market
unclear
• Route-to-market identified
• Financial: generally none
• Qualitative: leverage core capabilities,
develop a strategic capability
• Market and customers defined
• Financial: eg NPV, profit, sales volumes,
market share
• Qualitative: eg leverage/grow core
competencies
Timeframe
• Highly variable
• 6 months to 3+ years
Outcome
• New knowledge, technology or
platform
SEE NEXT PAGE
• Technical capability
• Potentially (broad) IP
Hydrix modified from “Managing Technology Development Projects”, Robert G Cooper, 2007
Outcome of Product Development
A product design and a manufacturing process that will deliver…
…a user-friendly device
…with reliable and accurate performance
…that is safe
…meets all regulatory requirements
…can be manufactured for a commercially viable cost
…with the lowest possible investment
…in the shortest possible time.
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Outcome of Product Development
All of these things are interrelated and there will be many decisions made
during a development on the way to delivering a final product.
Regulatory Framework
Product
Features
Product
Cost
TRADE OFF
Investment
Time to
Market
What is the processes for delivering this?
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Foundations of a Good Medical Device Development Process
There are 3 key elements that underpin a good medical device
development process:
1. A comprehensive set of Design Inputs (requirements)
2. Good Risk Management
3. A well thought out Development Plan (Project Plan)
getting these correct will build a solid foundation for the device
development project.
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Design Inputs
820.3(f) Design input means the physical and performance requirements of a
device that are used as a basis for device design.
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§
Market
§
User needs
§
Regulations
§
Standards
§
Previous designs
§
Competitor designs
§
Outputs of Risk Management
§
etc.
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Design Inputs
A comprehensive set of Design Inputs allows competing concepts to be
assessed early and significantly reduces the potential lost time
Design
Inputs
Defining the Product:
concept exploration,
easy to experiment
and change
Design
Outputs
Build and test:
difficult to change,
lost time for rework
and expensive
Design Inputs
A clear understanding of the design inputs also helps with any trade-off
decisions that may need to be made at the program level
Regulatory Framework
•
•
•
•
•
•
•
User Needs
Interface
Analyses
Outputs
Safety
Regulations
etc
• Resources
• Funding
• etc
Product
Features
Product
Cost
•
•
•
•
Market Needs
Manufacturing
Process
Regulatory
Testing
etc
TRADE OFF
Investment
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Schedule
• Market window
• Manufacture setup
• etc
Risk Management
Medical device development is an exercise in Risk Management
UNMANAGED RISK
Amount at Risk
Resulting Level of Risk
Probability of Occurrence
X
Time
=
Time
Time
MANAGED RISK
Amount at Risk
X
Time
Resulting Level of Risk
Probability of Occurrence
=
Time
Time
Risk Management
ISO14971:2007 Medical Devices. Application of risk management to medical devices.
•
specifies a process for a manufacturer to identify the hazards associated with medical
devices…estimate and evaluate the associated risks, to control these risks, and to
monitor the effectiveness of the controls
Risk Identification and Management is a structured process and team effort
Systems
Manufacturing
Nurse
Dr
Software
Electronic
Service
Tech
Project
Manager
The first principle is that you must not fool yourself and you’re the easiest person to
fool
Richard P. Feynman, Nobel Laureate
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Risk Management
“Risk management begins with the development of the design input requirements. As the
design evolves, new risks may become evident. To systematically identify and, when
necessary, reduce these risks, the risk management process is integrated into the design
process. In this way, unacceptable risks can be identified and managed earlier in the
design process when changes are easier to make and less costly.”1
Minimise risk by :
• using best practice
development tools and
processes
• iterative testing
• staged development
approach
Minimise risk by:
• developing thorough
understanding of users,
technical options,
regulatory drivers, etc
DEVELOPMENT
RISK
MANUFACTURE
RISK
TECHNOLOGY
RISK
MARKET
RISK
Minimise risk by:
• ensuring manufacturing
requirements have been
included
• manufacturing process tested
1. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS, FDA, 1997.
Minimise Market by:
• thoroughly managing risk
throughout the project.
Development Plan
If you don’t know where you’re going you might not get there!
Yogi Berra
Conceived by Research
Built by Manufacturing
Improved by Marketing
Installed
Designed by Engineering
What the customer wanted
Development Plans define how you will manage the design process to deliver a
product that will meet the customer’s needs
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Development Plan
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Development Plan
820.30(b) Design and development planning.
• describes the design and development activities
• defines the roles and responsibilities for implementation,
• defines the interfaces with different groups or activities providing input
to the design and development process.
Standards
SOPs
RACI
Design Outputs
Design
Inputs
Clinical Marketing Manufacturing Test
Development Plan
Product Development is complex. Hope is not a viable strategy…
.
…you need a well thought out Development Plan to guide your
activities throughout the project.
What do successful product
developers do?
Successful Products are designed differently
Successful companies expend extra effort in some key product development
areas that enables them to better understand and manage their risk
Additional
Effort by
“Winners”
35%
development
30%
financial
analysis
100%
technical
assessment
300%
successes
failures
market
assessment
0
20
40
60
80
100
Relative Effort
Good product development is underpinned by thorough upfront analysis.
source: Kleinschmidt et al “Resource Allocation in the New Product Process”
Industrial Marketing Management 17, 3, (1998)
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The additional effort impacts the whole development process
The additional investment of effort allows the team to develop a clear sense
of risks that need to be managed throughout the whole process.
Financial Analyses
• Product costs
Engineering Development
• System Engineering
• Prototyping
• User | Clinical Testing
• Reliability Testing
• DFM
• Design Reviews
• Prelim Reg Testing
DEVELOPMENT
RISK
Technical Assessment
• System Analyses
TECHNOLOGY
• Technical options
RISK
• Regulatory
• User design
• Concept exploration
Market Assessment
• Users
• Market size
• Distribution channels
Financial Analyses
• Product costs
Financial Analyses
• Component costs
• Manufacturing costs
• Financing costs
MANUFACTURE
RISK
MARKET
RISK
Engineering Development
• System Engineering
• Reliability Testing
• Supplier Assessment
• Manufacturability
Market Assessment
• Users
• Size
• Price points
• Distribution channels
Financial Analyses
• Product pricing
Summary
The foundation for a good product development process:
1.
comprehensive set of Design Inputs – “if you don’t know where you are
going…”
2.
a systematic focus on Risk Management - “…do not fool yourself…”
3.
a well thought out and documented Development Plan – “…bring the
future into the present…”
Getting these right will provide a solid foundation for your development.
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