Outsourcing Product Development to a Multidiscipline Team of Specialists - a Success Story

SMTA/MEPTEC
Medical Electronics Symposium
Outsourced Product Development to a
Multidisciplinary Team of Specialists - A
Success Story
September 22-23, 2010

©Product Realization Group, Inc., 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, a
Division 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 from
the 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 Background
Product 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

Multidisciplinary Team of Specialists

Process
Methodology
Key Findings
Benefits

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 – Challenges
Product Development
Lack of Technical Expertise: Internal
resources often lack sufficient or appropriate
technical expertise to support projects.
Resource Availability: Internal resources are
not always available in the timeframe required
to meet project goals.

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

Design Review – NPI
Product Transition

First Commercial Product Volume Product

Target: Pro Athletes Target: Rehabilitation

Outsourced Manufacturing In-House Manufacturing
~ 1/3 Price


Design Review – Framework
Outsourced Expertise
Project Lead

Outsourced Partners (PRG)

Mechanical Electrical Product Operations /
Design Design Reliability Supply Chain


Design Review – Process
Design and Process Analysis
Technical Expertise: Each outsourced partner
had 20+ years of experience in area of focus
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

Design Review – FMEA
Categories and Rankings
Categories Severity Ranking

1. Reliability 1 = Must Fix
2. Supplier Quality 2 = Should Fix
3. Installability 3 = Critical Future Fix –
4. Serviceability Need Plan
5. Manufacturability 4 = Recommended Fix
6. Aesthetics 5 = Enhancement
7. Cost


Design Review – Collaboration
Development of Findings
Outsourced Experts (PRG)


PRG Project Lead

AlterG Project Lead


Inside Resources (AlterG)


Design Review – FMEA
Preliminary Findings (sample)


Design Review – Report
Consolidation of Findings
Project Lead

Outsourced Partners (PRG)


Final Report




Key Findings:
- Mechanical - Reliability
- Electrical - Operations


Design Review – Mechanical
Loosening 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.


Heavy 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.


Lots of fasteners / types
Issue: 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 – Electrical
Part Mounting
Issue: Solid State Relays need better support.
Resolution: Attach heat sink for stability.
Benefit: Higher reliability. Parts will not break off
during vibration.


Potentiometers
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.


Cable 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 accurate
measurements, and reduction
of noise.


Design Review – Reliability
Flexing 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).


Temp/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.


Motor 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 - Operations
Data 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 Operations/Fin. Document Control
(CRM) (ERP) (PLM)

Design Review - Operations
Supplier 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 – Operations
RoHS 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 Support
Summary
Benefits


Summary – Support
Outsourced 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 Model
Outsourced Development

Established Partners Experienced Project Leads

Product Data Regulatory Business
Design Management Compliance Process
Marketing &
Business
Development
Test & Supply Chain / Continuous Logistics &
Reliability Operations Improvement Returns


Summary - Benefits
Outsourced 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


Outsourcing Product Development to a Multidiscipline Team of Specialists - a Success Story

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