how to manage and mitigate risk in medical device new product development

How to Manage and Mitigate Risk in Medical Device New Product Development (NPD)

December 8th, 2015

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.


Our Topics - Risk

Risk and the new product development process

We’ll discuss three primary types of risk

Summary and key insights


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.


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


1) Product Risk Management Process Overview


Establish a Framework

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

http://greenlight.guru/risk-webinar-offer


Risk Analysis


Risk Evaluation


Risk Control


Risk Acceptability


Risk Management Report


Production & Post-production Info


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


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


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


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


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


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

Presenter

Presentation Notes

This framework attempt to summarize the discussion on the various sources of uncertanity, and based on the level of complexity, provide a rough guide on how to approach managing the project There are several other comments on this framework: First, remember when we discussed the various types of projects: extensions, new, radical, and then also whether the project is an I incremental project or a “mega” project. The type of project will obviously influence greatly the type of project uncertainty you will face. An incremental project of and existing product will have different source of uncertainty compare to a radical mega-project! The architectural decisions that get made up front on a project will have a tremendous influence on the sources of uncertainty. As I mentioned at the outset of this module, there will likely be an iterative process in terms of defining the project, considering the uncertainty that results, which leads to how much risk the business wants to take (particularly in terms of schedule risk, but other risk as well), and then maybe modifying the project definition accordingly. Second, remember that with any project, you could have sources of uncertanity that relate not only to the product technology but also to the process, or mfg. technologies that you need to take into consideration. Then, on top of that, especially in radical projects, there may be marketing or organizational sources of uncertainty. For instance, does the customer understand how to use it? Is there “missionary selling” that will be required? Are there internal organizational issues that need to be resolved in terms of marketing, servicing, or distributing the product? Remember that different parts of the project may have different forms of uncertanity. Maybe one of the subsystems is basically going to be a re-use of an existing sub-system, but another system is going to be brand new, maybe even radical. While the entire project is not “radical” in that sense, the one subsystem may drive the whole project. The point is, you really need to understand all the different parts of the project and how each part may have to be managed differently. Finally, remember that the sources of uncertainty will change over the project life. Even in a radical project, as time goes on and more questions get answered, then you can switch from managing using iterate and learn or parallel trials, to a more structured project management structure. That of course has implications on the the project manager and the team, in terms of being able to switch from one mode of operating to another. So now that we have a framework to think about risk in a project, the next question is how you can determine what kind of uncertainty you have. We have talked about that throughout the section, but let’s try and summarize that.


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.


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

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)


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)

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


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


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


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


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


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

http://greenlight.guru/risk-webinar-offer

how to manage and mitigate risk in medical device new product development

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