BIOMEDevices 2011 Managing Design Risk Dec. 7, 2011
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©Product Realization Group, Inc., 2011 Pg 1
BIOMEDevices 2011
Managing Design RiskDec. 7, 2011
©Product Realization Group, Inc., 2011 Pg 2
Experienced Risk Management Panel
• Barbara Roberts, President & CEOWright Engineered Plastics
• Mark Brinkerhoff, President Fusion Design
• Mike Silverman, Managing PartnerOps A La Carte
• Walt Maclay, President Voler Systems
©Product Realization Group, Inc., 2011 Pg 3
Barbara Roberts
President & CEOWright Engineered PlasticsPrecision Injection MoldingCleanroom assemblyInsert and overmoldingISO 13485
Collaborate ◦ Innovate ◦ Realize
©Product Realization Group, Inc., 2011 Pg 4
Mark Brinkerhoff
President, Fusion DesignMechanical Development ProductsEquipmentPrototypesTurnkey Systems
Accelerating Concepts to Creation
©Product Realization Group, Inc., 2011 Pg 5
Mike Silverman
Managing PartnerOps A La CarteReliability SolutionsReliability TrainingReliability Testing / HALT
and HASS Labs
We provide Confidence in Reliability
©Product Realization Group, Inc., 2011 Pg 6
Walt Maclay
President, Voler SystemsElectronic Circuit DesignSensorsAnalog
System DesignTest Systems
Software & Firmware
We are the “Sensitive Engineers”
©Product Realization Group, Inc., 2011 Pg 7
Moderator: Mike Keer
Founder and CEOProduct Realization GroupReduce Time-to-MarketMinimize Investment Lower Cost and Risk Improve ROI
Bridging the Product Development Gap
©Product Realization Group, Inc., 2011 Pg 8
Engineering Is About Tradeoffs
We Make Decisions or Tradeoffs on
• Time• Appearance • Performance• Cost
©Product Realization Group, Inc., 2011 Pg 9
Yet, We Want To Avoid
Undesirable Outcomes!
©Product Realization Group, Inc., 2011 Pg 10
Manage Risks
What is one technique you use to manage risks?
©Product Realization Group, Inc., 2011 Pg 11
Tips for Managing Risks
• Rigorous design review and effective prototyping
• Finding the best fabricator for that tough part
• Develop and monitor the goal & reliability plan
• Select components that are in stock at a top tier distributor
©Product Realization Group, Inc., 2011 Pg 12
Communicating Risks
What is one technique you use for communicating risk at the design team level?
©Product Realization Group, Inc., 2011 Pg 13
Tips for Communicating Risk
• Monitor risk during development team meetings
• Focus and brainstorm solutions weekly
• Use reliability integration and design reliability techniques
• Over communicate
©Product Realization Group, Inc., 2011 Pg 14
For Your Industry
What is no longer a risk?What is an emerging risk?
©Product Realization Group, Inc., 2011 Pg 15
Plastic Molding
No longer a risk:• Unexpected part fill problems
Emerging risk:• Tool construction and sampling in
remote locations• Condensing timelines by skipping
verification steps
©Product Realization Group, Inc., 2011 Pg 16
Mechanical
No longer a risk:• Rapid Mock ups to align development
path with customer needs
Emerging risk:• Global single sourcing
©Product Realization Group, Inc., 2011 Pg 17
Reliability
No longer a risk:• Design for Reliability
Emerging risk:• Standard IEC60601-1 Rev 3
©Product Realization Group, Inc., 2011 Pg 18
Electronic Design & Software
No longer a risk:• Wireless modules
Emerging risk:• Regulatory requirements for medical
cell phone apps
©Product Realization Group, Inc., 2011 Pg 19
Other Considerations
• Plan carefully
• Perform feasibility studies
• Do the riskiest activity first
• Have a backup plan
• Involve all the stakeholders
©Product Realization Group, Inc., 2011 Pg 20
Audience Questions
Visit us at Booth #1015
©Product Realization Group, Inc., 2011 Pg 21
Visit us at Booth #1015
Michael KeerFounder and CEOProduct Realization Groupmkeer@productrealizationgroup.comwww.productrealizationgroup.com(408) 427-4645
©Product Realization Group, Inc., 2011 Pg 22
BIOMEDevices 2011
Managing Design RiskDec. 7, 2011
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