A company’s ability to understand and manage risk can mean the difference between financial success and disaster. (You can view the full webinar here: http://www.greenlight.guru/risk-in-medical-device-new-product-development-webinar) In this webinar you'll learn: - How to understand the true nature and impact of project and product risk - How to effectively measure risk quantitatively - How to use risk management as a tool to accelerate NPD - What you need to know about the upcoming risk-based changes to ISO 13485 to ensure compliance

1. How to Manage and Mitigate
Risk in Medical Device New
Product Development (NPD)
December 8th, 2015

2. Copyright 2015|New Product Visions & Greenlight Guru
Your Speakers Today
Jon Speer, Founder & VP QA/RA, greenlight.guru
greenlight.guru produces beautifully simple quality, design control
and risk management software exclusively for medical device
manufactures.
Jeff Groh, President, New Product Visions
New Product Visions helps companies improve their innovation
management practices, focusing on processes, organization and
culture.

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Our Topics - Risk
 Risk and the new product
development process
 We’ll discuss three primary
types of risk
 Summary and key insights

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The New Product Development (NPD)
Process
Workflow, decision, and
information flow across multiple
functions within an organization…
…that seeks to mitigate and
manage risk of NPD projects…
…in order to generate new,
positive cash flows quickly.

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Risk in Medical Device Development
Product risk
management and the
regulations
Project risk and
implications for project
management
Overall market success
and how to measure,
manage and mitigate

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1) Product Risk Management Process
Overview

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Establish a Framework
Free Risk Management Plan Template: http://greenlight.guru/risk-webinar-offer

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Risk Analysis

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Risk Evaluation

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Risk Control

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Risk Acceptability

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Risk Management Report

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Production & Post-production Info

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ISO 14971:2007 vs. EN ISO
14971:2012
• Normative standard the same
• 2012 added “Z” annexes
• 2012: reduce risk as far as possible
• 2012: risk controls required for all risks
• 2012: risk / benefit analysis required for all risks

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Risk Management + Design Controls
• Understand the importance of Intended Use
• Product Risk Management is a cycle – even during
product development
• Risk Management & Design Controls have the
same purpose

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Risk Management as a Tool
• The longer you wait, the harder is gets
• Understand the purpose
• The value of documentation
• Keep Risk Management & Design Controls simple

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ISO 13485:201X – What’s New
• Terms “risk” & “regulatory” used >200 times
• Alignment with regulations; expectation QMS
complies with all applicable regulatory requirements
• Concept of risk-based QMS

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2) Project Risk and Project
Management
1. Variation, foreseeable uncertainty, and
residual risk
2. Complexity
3. Unforeseeable uncertainty(unk unks)
Key insights:
1) Understanding nature of project risk influences project management tools
required
2) Nature of risk changes as project proceeds, therefore, tools change

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A Risk Management Framework
Control & Fast Response
Project
Buffers
Risk Lists
Iterate and learn
Parallel trials
Some
combination
Complexity can lead
to unk unks
Variation Foreseeable events Unk unks
Sources of Uncertainty
FewinteractionsManyinteractions
Complexity
Source: “Managing the
Unknown”; Loch; 2006

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3) Overall Market Success
Ultimately, market success is all that
matters
But how do you quantitatively measure,
manage and mitigate the risk of market
success?
NPD-RiskAssessor™ is a trademark of The Adept Group Limited, Inc.

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NPD-RiskAssessor™-What is it?
Qualitative Component:
1) Key qualitative issues
and opportunities
2) Research based and
team introduced
Quantitative Component:
1) Based on a statistical
model from a very large
number of NPD success
and failures
2) Provides insight on (9)
key influencers that drive
success or failure

22. 22
New Product
Experience Data
Empirically Validated
through independent studies
Key Influencers
1. Product Superiority / Quality
2. Economic Advantage to
Customer
3. Overall Company fit
4. Technological Compatibility
5. Newness to Firm
6. Market Need, Growth and Size
7. Market Competitiveness
8. Defined Opportunity
9. Product Definition
/Specifications
Reduction to 9
“Key Influencers”
driving success /
failure
• 300+ New Product
Outcomes
• 150+ perceived successes
• 150+ perceived failures
• Ratings large set of
possible risk factors
derived from research
(>75)
• Company rating of degree
of success / degree of
failure
Field/Trial/Validation on over 500 NPD project
Risk Model relating nine key factors to probable
success R2= 80-85%
Added to, modified and adjusted
over the history of the model
13
Selection of
statistically
significant, actionable
risk factors (30)

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Risk Factor Statements
• Team members score statements regarding each Risk Factor.
• For example: one Risk Factor is:
“Market Research & Voice of the Customers”.
• This Risk Factor statement reads:
“The project has or will gain adequate Market Research and Voice of the
Customer in order to develop and launch this product successfully and in a timely
manner.”
• Notice the dimensions of the statement: adequacy (quality and quantity),
success, and timing.
Using a 0 to 10 (Likert Scale) evaluators provide two scores.
1. “Rate” their agreement with the risk factor statement, and
2. Score their confidence in their rating. (7 means 70% confident)

24. Team input to
NPD-RiskAssessor’s
numerical
evaluation
Single Project Risk Assessment
Questions 1-24 of 30 each with a rating
score and confidence in rating score.
For all questions: there are 11
evaluators (columns) plus a mean rating
and confidence for the team (Mn
column) and a standard deviation of
rating (Std Dev column)
Yellow boxes for mean confidences
indicate bottom quartile confidence
score (very high uncertainty) for that
risk factor/question.
Yellow boxes in StDev column indicate
very high disagreement on rating scores
for that risk factor/question.
Team Members
Overall
Project

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Single Project Risk Assessment
Key Influences for
“mean of team”
Single Project Risk Assessment
In the statistical model, all 30 risk
factors load with different levels of
impact onto 9 “key influencers.”
This radar chart plots the calculated
percentile scores for each of the 9
key influencers.
Those key influencers greater than
“50” are driving toward success,
those key influencers less than “50”
are driving toward failure
Key Influencers Radar Chart

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How Can NDP-RiskAssessor™ Be
Used?
Project management
tool
• Specific risk identification
and mitigation
• Part of each gate review
• Team building exercise
Portfolio management
tool
• Project comparison tool
• Identify systemic risk in
portfolios

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Team Process
Second iteration
of statistical survey
Measuring awareness
and consensus:
Statistical model survey
of cross-functional team
Exploring team member
disagreements and perceptions
Developing issue awareness
and consensus
Exploring key challenges
and determinants of risks
Creatively generating and
critically examining
best concurrent activities
Developing team consensus on
and commitment to
best concurrent activities
Team Meeting
Facilitated
Pre-Meeting
Summary report
benchmarking project attributes
and team perceptions
Post-Meeting
A Highly Focused
Team Activity

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Summary and key insights
Must address three categories of risk
greenlight.guru software helps manage product safety/efficacy risk and
meeting FDA regulatory requirements
 Schedule a demo, talk to our experts about your challenges
Understanding nature of project risk determines project management tools
 New Product Visions provides a variety of workshops and consulting
Measuring, mitigating and managing the overall risk of market success is
crucial
 New Product Visions can arrange a demo of NPD-RiskAssessor

29. Copyright 2015|New Product Visions & Greenlight Guru
Thanks for Attending!
Free Risk Management Plan Template: http://greenlight.guru/risk-webinar-offer
Jon Speer, Founder & VP QA/RA, greenlight.guru
www.greenlight.guru
jon.speer@greenlight.guru
(317) 762-5311
Jeff Groh, President, New Product Visions
www.newproductvisions.com
jgroh@newproductvisions.com
(302) 367-3160