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

Transcription

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

2 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.

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

4 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.

5 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

6 1) Product Risk Management Process Overview

7 Establish a Framework Free Risk Management Plan Template:

8 Risk Analysis

9 Risk Evaluation

10 Risk Control

11 Risk Acceptability

12 Risk Management Report

13 Production & Post-production Info

14 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

15 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

16 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

17 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

18 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

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

20 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.

21 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 New Product Experience Data 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 Reduction to 9 Key Influencers driving success / failure Field/Trial/Validation on over 500 NPD project Risk Model relating nine key factors to probable success R 2 = 80-85% Added to, modified and adjusted over the history of the model Selection of statistically significant, actionable risk factors (30) 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 22 13

23 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 Team Members Overall Project 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.

25 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

26 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

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

28 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 Thanks for Attending! Jon Speer, Founder & VP QA/RA, greenlight.guru (317) Jeff Groh, President, New Product Visions (302) Free Risk Management Plan Template: