how to manage and mitigate risk in medical device new ... · new product visions provides a variety...
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How to Manage and Mitigate Risk in Medical Device New Product Development (NPD)
December 8th, 2015
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Copyright 2015|New Product Visions & Greenlight Guru
Your Speakers Today
Jon Speer, Founder & VP QA/RA, greenlight.gurugreenlight.guru produces beautifully simple quality, design control and risk management software exclusively for medical device manufactures.
Jeff Groh, President, New Product VisionsNew Product Visions helps companies improve their innovation management practices, focusing on processes, organization and culture.
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Copyright 2015|New Product Visions & Greenlight Guru
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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Copyright 2015|New Product Visions & Greenlight Guru
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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Copyright 2015|New Product Visions & Greenlight Guru
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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Copyright 2015|New Product Visions & Greenlight Guru
1) Product Risk Management Process Overview
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Copyright 2015|New Product Visions & Greenlight Guru
Establish a Framework
Free Risk Management Plan Template: http://greenlight.guru/risk-webinar-offer
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Copyright 2015|New Product Visions & Greenlight Guru
Risk Analysis
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Copyright 2015|New Product Visions & Greenlight Guru
Risk Evaluation
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Copyright 2015|New Product Visions & Greenlight Guru
Risk Control
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Copyright 2015|New Product Visions & Greenlight Guru
Risk Acceptability
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Copyright 2015|New Product Visions & Greenlight Guru
Risk Management Report
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Copyright 2015|New Product Visions & Greenlight Guru
Production & Post-production Info
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Copyright 2015|New Product Visions & Greenlight Guru
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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Copyright 2015|New Product Visions & Greenlight Guru
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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Copyright 2015|New Product Visions & Greenlight Guru
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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Copyright 2015|New Product Visions & Greenlight Guru
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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Copyright 2015|New Product Visions & Greenlight Guru
2) Project Risk and Project Management
1. Variation, foreseeable uncertainty, and residual risk
2. Complexity3. Unforeseeable uncertainty (unk unks)
Key insights:1) Understanding nature of project risk influences project management tools
required2) Nature of risk changes as project proceeds, therefore, tools change
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Copyright 2015|New Product Visions & Greenlight Guru
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 unksSources of Uncertainty
Few
inte
ract
ions
Man
y in
tera
ctio
ns
Com
plex
ity
Source: “Managing the Unknown”; Loch; 2006
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Copyright 2015|New Product Visions & Greenlight Guru
3) Overall Market Success
Ultimately, market success is all that mattersBut 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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Copyright 2015|New Product Visions & Greenlight Guru
NPD-RiskAssessor™-What is it?
Qualitative Component:1) Key qualitative issues
and opportunities2) Research based and
team introduced
Quantitative Component:1) Based on a statistical model from a very large number of NPD success
and failures2) Provides insight on (9) key influencers that drive
success or failure
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22
New Product Experience Data
Empirically Validated through independent studies
Key Influencers
1. Product Superiority / Quality2. Economic Advantage to
Customer3. Overall Company fit4. Technological Compatibility 5. Newness to Firm6. Market Need, Growth and Size7. Market Competitiveness8. Defined Opportunity9. 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 projectRisk 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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Copyright 2015|New Product Visions & Greenlight Guru
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, and2. Score their confidence in their rating. (7 means 70% confident)
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Team input to NPD-RiskAssessor’s
numerical evaluation
Single Project Risk AssessmentQuestions 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
OverallProject
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Copyright 2015|New Product Visions & Greenlight Guru
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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Copyright 2015|New Product Visions & Greenlight Guru
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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Copyright 2015|New Product Visions & Greenlight Guru
Team Process
Second iterationof statistical survey
Measuring awarenessand consensus:
Statistical model surveyof cross-functional team
Exploring team memberdisagreements and perceptions
Developing issue awarenessand consensus
Exploring key challengesand determinants of risks
Creatively generating andcritically examining
best concurrent activities
Developing team consensus onand commitment to
best concurrent activities
Team MeetingFacilitated
Pre-Meeting
Summary reportbenchmarking project attributes
and team perceptionsPost-Meeting
A Highly FocusedTeam Activity
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Copyright 2015|New Product Visions & Greenlight Guru
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
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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, [email protected](317) 762-5311
Jeff Groh, President, New Product [email protected](302) 367-3160