smta/meptec medical electronics symposium · smta/meptec medical electronics symposium ......

©Product Realization Group, Inc., 2010

SMTA/MEPTEC Medical Electronics Symposium

Outsourced Product Development to a Multidisciplinary Team of Specialists - A

Success Story

September 22-23, 2010


Agenda

• Introductions- Mark Brinkerhoff, President, FusionDesign- Walt Maclay, President, Voler Systems- Mike Silverman, Managing Partner, Ops A La Carte- Michael Keer, President, Product Realization Group

• Company Backgrounds - AlterG- Product Realization Group

• Presentation

• Questions and Discussion


Mark Brinkerhoff Bio

Mark Brinkerhoff, PE, is president and part owner of Fusion Design, Inc. in Campbell, Calif. Mark has obtained seven patents for mechanical devices and systems. Previously, Brinkerhoff was an engineering and model shop manager at Amdahl Corporation and a manufacturing engineer at Hewlett Packard Company. He has 25 years of experience developing both products and production machines mostly in the medical field over the last 8 years.

Since joining Society of Manufacturing Engineers in 1995, he has been active in Silicon Valley Chapter 98, where he has coordinated many factory tours throughout the Bay Area.


Walt Maclay Bio

Walt Maclay is President/Chief Engineer of Voler Systems, aDivision of Strawberry Tree Inc. Walt has 37 years of engineering experience managing the design and delivery of technical projects.

He founded Strawberry Tree Inc in 1979, which developed data acquisition products that were sold world wide.

In 1999 Walt founded Voler Systems, an engineering consulting company that develops electronics and software such as medical devices and test systems. Voler offers specialized expertise in analog and sensor-based designs.


Michael Silverman Bio

Mike is founder and managing partner at Ops A La Carte, a Professional Consulting Company that helps customers with end-to-end reliability. Mike has over 25 years experience in reliability engineering, reliability management and reliability training. Through Ops A La Carte, Mike has had extensive experience as a consultant to high-tech companies, and has consulted for over 500 companies in 90 different industries in most of the United States and 13 countries around the world. Mike has recently completed his first book on entitled “50 Ways to Improve Your Product Reliability”. He has authored and published 25 papers on reliability techniques.

Mike has a BS degree in Electrical and Computer Engineering fromthe University of Colorado at Boulder, and is a Certified Reliability Engineer. Mike is a member of ASQ, IEEE, Stanford PRN, PRG, SME, ASME, PATCA, and IEEE Consulting Society. Mike is currently the IEEE Reliability Society Santa Clara Valley Chapter Chair.


Michael Keer Bio

Michael Keer is founder and CEO of the Product Realization Group and has over 20 years of High Technology business leadership experience in bringing products to market. As founder of the Product Realization Group (PRG) he created the end-to-end services model that supports high-technology clients bring products to market.

Prior to the PRG, Michael held a variety of management positions at SofTEQ, a Business Systems Integrator, and Paramit Corporation, an EMS provider, and also held Operations Management and Engineering positions for SemiPower Systems, Ericsson/Raynet, and NCR.

Mike received a B.S. in Industrial Engineering and Masters in Manufacturing Engineering from Northwestern University in Evanston, IL. He is an active Mentor for Stanford University’s Product Realization Network.


AlterG – Company Background

AlterG, Inc. is pioneering a market using innovative technologies to sustain a healthy and active life. AlterG is reinventing rehabilitation by advancing recovery from injury, surgery or disability and enhancing performance as well as reducing the frequency of injury in athletics and sports

The AlterG Anti-Gravity Treadmill® is the first FDA-cleared medical device of its kind and is used by major medical centers, leading physical therapy clinics and professional, collegiate, and individuals


Product Realization Group –Company BackgroundProduct Realization Group, Inc. offers a “one-stop-shop” of outsourced services that enable rapid and cost effective introduction of products to the market, regulatory compliance, manufacturing, and lifecycle support.

Engagements are tailored to fit business and product profiles. Partners work together to deliver services that range from initial concept through global logistics and repair. PRG members serve over 400 companies in 20 markets.


AlterG - Design Review

Outsourced Product Development to a Multidisciplinary Team of Specialists

ProcessMethodologyKey FindingsBenefits


Design Review – Overview

Background: AlterG is transitioning from a low volume/high cost outsourced product to a high volume/lower cost in-house built product

Client Need: Mitigate design, production, and quality risks to meet rapidly growing sales

Support: Product design analysis and recommendations using outsourced mechanical, electrical, reliability, and operations resources


Design Review – ChallengesProduct Development

Lack of Technical Expertise: Internal resources often lack sufficient or appropriate technical expertise to support projects.

Project Management and Integration: Internal resources have limited bandwidth to manage multiple outside partners effectively.

Resource Availability: Internal resources are not always available in the timeframe required to meet project goals.


Design Review – NPIProduct Transition

First Commercial Product Volume Product

Target: Rehabilitation

In-House Manufacturing~ 1/3 Price

Target: Pro Athletes

Outsourced Manufacturing


Design Review – FrameworkOutsourced Expertise

MechanicalDesign

ProductReliability

Operations /Supply Chain

ElectricalDesign

Outsourced Partners (PRG)

Project Lead


Design Review – ProcessDesign and Process Analysis

Product Review: Full breakdown and re-assembly of the product plus detailed review of AlterG’s manufacturing and test processes

Analysis: Identified and ranked 117 issues in 6 critical categories - reliability, quality, installation, service, aesthetics, and cost using Failure Modes and Effects Analysis (FMEA) methodology

Technical Expertise: Each outsourced partner had 20+ years of experience in area of focus


Design Review – FMEACategories and Rankings

1. Reliability2. Supplier Quality3. Installability4. Serviceability5. Manufacturability6. Aesthetics7. Cost

1 = Must Fix2 = Should Fix3 = Critical Future Fix –

Need Plan4 = Recommended Fix5 = Enhancement

Categories Severity Ranking


Design Review – CollaborationDevelopment of Findings

MechanicalDesign

ProductReliability


ElectricalDesign

Outsourced Experts (PRG)

MechanicalDesign

ProductReliability


ElectricalDesign

Inside Resources (AlterG)

PRG Project Lead

AlterG Project Lead

PRG Project Lead

AlterG Project Lead


Design Review – FMEAPreliminary Findings (sample)


Design Review – ReportConsolidation of Findings

MechanicalDesign

ProductReliability


ElectricalDesign

Outsourced Partners (PRG)

Project Lead

Final ReportFinal Report




Key Findings:- Mechanical - Reliability- Electrical - Operations


Design Review – MechanicalLoosening Connectors

Issue: Connectors loosen over time causing system to stop working.

Resolution: Source alternative clip-type connectors that do not loosen over time.

Benefits: Higher reliability, faster assembly, and easier to service.


Design Review – MechanicalHeavy Lifting for Assembly

Issue: Large system components lifted by personnel.

Resolution: Add lifting aids as appropriate.

Benefits: Less damage to product, and reduce worker fatigue.


Design Review – MechanicalLots of fasteners / typesIssue: Too many fastener types (inventory & tools).Resolution: Use integrated hardware like KEPS and PEM types. Add hook/align feature between parts.Benefit: Faster assembly, lower inventory, faster service (lower product and service cost).

• KEPS® PREASSEMBLED NUTS AND WASHERS


Design Review – ElectricalPart Mounting

Issue: Solid State Relays need better support.

Resolution: Attach heat sink for stability.

Benefit: Higher reliability. Parts will not break off during vibration.


Design Review – ElectricalPotentiometers

Issue: Potentiometers are subject to drift.

Resolution: Replace with fixed resistors, and calibrate in software. Store settings in nonvolatile memory.

Benefit: Higher quality and reduced support calls. Stable measurements with temperature change and vibration.


Design Review – ElectricalCable Routing

Issue: Cables can run near noise generating parts, such as motors, because routing not documented.

Resolution: Document cable routing to improve assembly process.

Benefit: Improved operating performance, consistent accuratemeasurements, and reductionof noise.


Design Review – ReliabilityFlexing on Board

Issue: Board can flex if you push on it (during installation).

Resolution: Add support behind the board to reduce the amount of flexing at the center.

Benefit: Greatly reduce possibility of trace cracking on Printed Circuit Assembly (PCA).


Design Review – ReliabilityTemp/Vibration on Board

Issue: Lifetime of vibration on board due to bag inflation motor, along with elevated temperature because it is inside the bag which heats up.

Resolution: Subject board to Highly Accelerated Life Testing (HALT) to determine weak points & add supports as needed.

Benefit: Significantly increase life of board in the field.


Design Review – ReliabilityMotor and Bag Life

Issue: Motors / mechanical components as well as bag have not been proven through life testing.

Resolution: Perform Accelerated Life Test (ALT) to determine life of mechanical components and bag.

Benefits: More accurate warranty projection information. Future design improvement possibility.


Design Review - OperationsData Management

Issue: Business data is currently managed with manual systems which results in increased entry errors / wasted time, and data integrity problems.

Resolution: Implement business systems to manage customer (CRM), product (PLM), and enterprise (ERP) data

Benefits: Quality, compliance, ability to scale

Marketing/Sales(CRM)

Operations/Fin.(ERP)

Document Control(PLM)


Design Review - OperationsSupplier Quality

Issue: Problems with key parts were identified later in the assembly process which caused delays and added overhead time for resolution.

Resolution: Implement supplier quality management and incoming inspection processes.

Benefits: Higher quality and faster throughput


Design Review – OperationsRoHS and REACH Compliance

Issue: No documented plan for RoHS and REACH compliance.

Resolution: Incorporate environmental compliance plans as part of product development roadmap.

Benefits: Environmental compliance, ability to ship into regulated markets such as the European Union.




Follow on SupportSummaryBenefits


Summary – SupportOutsourced Expertise

Short Term: Leverage product knowledge gained and partner capabilities to implement changes identified not supported internally

Long Term: Leverage company knowledge and relationships gained to provide technical expertise for future iterations of product and new product releases


Summary - Integrated ModelOutsourced Development

Marketing & Business Development

Product Design

Test &Reliability

DataManagement

Supply Chain /Operations

RegulatoryCompliance

ContinuousImprovement

BusinessProcess

Logistics & Returns

Established Partners Experienced Project Leads


Summary - BenefitsOutsourced Development Model

Improved Product Quality: By implementing key FMEA findings, AlterG improves product quality and reduced potential for field failures

Partner Integration: By working with a group of integrated partners, AlterG reduces the risks of managing multiple unknown partners

Return on Investment (ROI): By augmenting internal resources, AlterG is able to focus on core competencies and gain a higher ROI than with dedicated internal resources


Audience Questions

smta/meptec medical electronics symposium · smta/meptec medical electronics symposium ......

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