This document outlines an event hosted by SME, Silicon Valley Chapter 98 on May 21, 2015 about accelerating medical device product development using lean principles and regulatory compliance. The event featured presentations from three speakers with experience in medical device product development, regulatory strategy, and new product development. The agenda included topics such as myth-busting regulatory perspectives, knowledge-driven product development, identifying knowledge gaps, reconciling lean with regulations, lean product development for medical devices, knowledge capture and management, and real-life examples. Resources for lean product development included recommended books, websites, and the Toyota A3 technique for problem solving. The Wright brothers' approach to conquering flight was presented as a famous example of knowledge-driven product development,

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Lean & Compliant
Accelera'ng Medical Device
Product Development
SME, Silicon Valley Chapter 98
May 21, 2015
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Workshop Presenters
Aaron Joseph, Medical Devices Consultant
20 years in new product development; medical device product
validaLon and risk analysis
aaronanswers@gmail.com
Geetha Rao, Ph.D., CEO, Springborne Life Sciences
25 years in high-risk technologies; regulatory strategy, risk
management, medical device quality systems, business strategy
geetha@springborne.com
Roger Tang, Ph.D., Principal, H R Tang ConsulLng
15 years in research and new product development; medical
imaging, opLcal technologies, biotechnology
hrogertang@gmail.com
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Start Topic Speaker
1:10 PM IntroducLon Aaron Joseph
1:20 PM Myth BusLng Regulatory PerspecLves Geetha Rao
1:30 PM Knowledge-Driven Product Development Roger Tang
1:40 PM Exercise: IdenLfying Knowledge Gaps Roger Tang
1:55 PM Reconciling Lean with RegulaLons Geetha Rao
2:10 PM Lean Product Development for Medical Devices Aaron Joseph
2:20 PM Knowledge Capture and Management Roger Tang
2:25 PM Exercise: A3 Method for Knowledge Management Roger Tang
2:40 PM Real Life Examples Aaron Joseph
2:55 PM Summary and Q&A Panel
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Suggested Resources for Lean Product Development
Websites:
• h"p://www.leanprimer.com/downloads/lean_primer.pdf - good overview of lean principles
wri"en by two soaware management consultants (Craig Larman and Bas Vodde) who include
aspects of soaware agile methods as well.
• www.leantechnologydevelopment.com/ - lots of easy-to-read arLcles on different aspects of lean
product development, knowledge management, and tacLcs for implementaLon (managed by
Katherine Redeker of Whieer ConsulLng)
• h"p://theleanthinker.com/ - a blog by Mike Rother with lots of good observaLons and real-
life issues involved in changing an organizaLon to lean
• h"p://www.coe.montana.edu/IE/faculty/sobek/A3/index.htm - a short tutorial on the Toyota A3
technique for problem solving by Durward Sobek
• h"p://www.lean.org/ - Lean Enterprise InsLtute (consulLng firm and forum); large collecLon of
arLcles and online forums discussing aspects of lean product development, lean mfg, and lean
services
• h"p://theleanedge.org/ - a forum for discussions of lean management issues with contribuLons
from many of the thought leaders in the lean community
• h"p://playbookhq.co/blog/ - lots of good blog posLngs on concepts and methods for lean product
development; links to lots of addiLonal resources
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Suggested Resources for Lean Product Development
Books:
• "Mastering Lean Product Development" by Ronald Mascitelli - a collecLon of pracLcal methods to
improve everything a product development organizaLon does from product strategy to running
efficient design reviews (includes extensive bibliography).
• "The Principles of Product Development Flow" by Donald Reinertsen - detailed explanaLons of
key principles to accelerated product development, based on Theory of Constraints, queuing
theory, and more.
• "Lean Product and Process Development" by Allen C Ward - a spirited presentaLon of the
philosophy and techniques for lean product development from the guy who inspired many others
(published posthumously)
• "Ready, Set, Dominate" by Michael Kennedy et al - a more evolved presentaLon of the ideas from
Ward's book, based on the real-life experiences of Kennedy's consulLng clients. Includes case
studies of two companies going through lean transformaLons.
• “Managing to Learn” by John Shook – an excellent introducLon to the use of the ‘A3 method’ for
problem solving, communicaLon, learning, and lean management.
• “The Lean Startup” by Eric Ries – a must read for entrepreneurs and anyone managing projects to
create something new under condiLons of extreme uncertainty.
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Introduc'on
Aaron Joseph
Sr. Consultant, Product RealizaLon Group
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What is “Lean Product Development”?
Fewer Employees
Very Aggressive
Schedules
Outsourced
Engineering
Maximizing Value for the Customer
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Lean Methods Accelerate Product
Development
• Earlier product launch translates
into $millions more in sales
• 2-3X decrease in development
cycle Lme
• 2-4X decrease in development cost
• 2-5X decrease in development risk
• Strong arguments for qualitaLve
improvements
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Why Lean for Medical Devices?
• Product development teams at medical device
companies are caught “between a rock and a hard place”
– Increasing regulatory scruLny (in US and overseas markets)
– Changes to US healthcare market from ACA (Obamacare)
– Greater compeLLon (new products from India and China)
– Increasing challenges of managing globalized supply chains
• Companies cannot pass along increased costs to their
customers
• Challenge to efficiently develop new, innovaLve medical
devices and sLll maintain rigorous compliance
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Can Lean Product Development work
for Medical Devices?
• Medical devices are a regulated product
• Medical device regulaLons govern:
– Product tesLng
– Product manufacturing
– Product development (“design controls”)
• Each company decides how to implement design
controls as part of their quality system
• The quality system procedures can either support
lean methods or obstruct them
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Two Real Life Medical Devices
New Product Development
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30
Average
20 18
12
Product Development Cycle Time (months)
2-3x
Average
1x .8x
Budget ($)
Record Goal Lean Planned Lean
~$3M
Addi'onal
Profit ~$500K
Cost
Savings

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Actual PracLce
• Lean methods do not conflict with the
requirements of FDA regulaLons, ISO 13485,
or other standards
• Lean methods do conflict with the quality
systems of many medical device companies
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Myth-bus'ng
“You can’t use lean methods to
develop a regulated product”
Geetha Rao, Ph.D.
CEO, Springborne Life Sciences
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The infamous waterfall
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Design
Plan
Design
Transfer

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Typical Design Control ImplementaLon
• Design Phases
– Input, Output, VerificaLon, ValidaLon
• Life Cycle
– Research, Development, Pre-producLon, ProducLon
• Stage gates between phases
– Comprehensive phase review
– Commi"ee approval to proceed to next stage
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True or False?
• The design control SOP must follow the waterfall
diagram
• The design team cannot proceed to the next
development stage without compleLon of
required design and phase-gate reviews
• VerificaLon must be completed before validaLon
is performed
• All product development engineers must be
trained to the design control SOP
• All product documentaLon generated during the
design process is a controlled record
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FDA’s comment on the waterfall
“Although the Waterfall Model is a useful tool
for introducing Design Controls, its usefulness
in pracLce is limited. The model does apply to
the development of some simpler devices.
However, for more complex devices, a
concurrent engineering model is more
representaLve of the design processes in use
in the industry approach.”
h"p://www.fda.gov/MedicalDevices/DeviceRegulaLonandGuidance/GuidanceDocuments/ucm070627.htm
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Concurrent Engineering DefiniLons
“a method of designing and developing products, in
which the different stages run simultaneously, rather
than consecuLvely. It decreases product
development Lme and also the Lme to market,
leading to improved producLvity and reduced
costs.”[John Stark, 1998]
“integraLng a new product development process to
allow parLcipants making upstream decisions to
consider downstream and external requirements.
Central characterisLcs … are acLvity overlapping,
informaLon transfer in small batches, and use of
cross-funcLonal teams” [Gerwin and Susman 1996]
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Workflow in a concurrent/lean approach
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Requirements
Analysis
& Design
Tes'ng
Evalua'on
Planning
Deployment

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Cycles of Increasing Knowledge
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Planning
Requirements
Analysis
& Design
Tes'ng
Evalua'on
Deployment

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Knowledge-Driven Product
Development
Roger Tang, Ph.D.
Principal, H R Tang ConsulLng
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Knowledge-Driven Product Development
• Successful new product development
demands deep knowledge of:
– Product applicaLon
– Product technology
– Manufacturing process technology
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What’s Usually Wrong with Product
Development?
• Phase-Gate Development Process
• Design, Build and Test Paradigm
Concept
Phase
Planning
Phase
Design
Phase
Test
Phase
Launch
Phase
Customer
Use
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What’s Usually Wrong with Product
Development?
• Design, Build and Test Paradigm
Concept
Phase
Planning
Phase
Design
Phase
Test
Phase
Launch
Phase
Customer
Use
Difficult technical
work done here!
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What’s Usually Wrong with Product
Development?
• Design, Build and Test Paradigm
Concept
Phase
Planning
Phase
Design
Phase
Test
Phase
Launch
Phase
Customer
Use
Difficult technical
work done here!
The Inevitable Design Loopbacks
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What’s Usually Wrong with Product
Development?
• Design, Build and Test Paradigm
Concept
Phase
Planning
Phase
Design
Phase
Test
Phase
Launch
Phase
Customer
Use
Difficult technical
work done here!
In real life, it can be worse…
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Lean Product Development
• Test before Design Paradigm
Concept
Phase
Planning
Phase
Design
Phase
Test
Phase
Launch
Phase
Customer
Use
Difficult technical
work done here!
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A Famous Example*
The Wright Brothers conquered manned, controlled,
heavier-than-air powered flight when countless
others failed
• When: 1899-1903
• Where: Dayton, Ohio
• EducaLon: High school
• OccupaLon: Bicycle sales and repair
• How?
*Credit to Ron Marsiglio
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Before Designing Their First Airplane…
• Began with a knowledge search
– Wrote the Smithsonian InsLtuLon for available
informaLon in 1899
– Studied lia tables from O"o Lilienthal
– Corresponded with Octave Chanute, railroad engineer and
leading aviaLon expert
Lilienthal in flight Octave Chanute
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Before Designing Their First Airplane…
• IdenLfied 3 key knowledge gaps
– Lia
– Propulsion
– Control
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Before Designing Their First Airplane…
• Closed knowledge gaps by performing analyses and
experiments
Wind Tunnel
TesLng
Model Kites
Manned Gliders
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Before Designing Their First Airplane…
“SomeLmes the non-glamorous lab work
is absolutely crucial to the success of a
project.”
-Wilbur Wright
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“Success Assured”
• December 17, 1903
Test before Design
Especially if you are the Test Pilot!
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Lessons Learned
• Understand exisLng knowledge
• Divide challenge into logical subsystems
• IdenLfy key knowledge gaps
• Perform analyses or experiments on components
• Validate design choices based on knowledge
• Only then…did they design and build the full airplane
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Lean Product Development
• Test before Design Paradigm
Concept
Phase
Planning
Phase
Design
Phase
Test
Phase
Launch
Phase
Customer
Use
Difficult technical
work done here!
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Knowledge Gaps
• If the team can’t solve the technical challenge of ‘X’ then all
other work on the product is useless (therefore, focus all
resources early on ‘X’)
• Flow of Knowledge: make knowledge easily available to
everyone who needs it (through training, communicaLon,
documentaLon, etc.)
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Exercise #1
IdenLfying Knowledge Gaps in New
Product Development
1. You are responsible for planning the development of a new
handheld x-ray imager
2. Read the descripLon of the situaLon on your handout
3. Split into teams of 2-3 people
4. Together idenLfy:
1. Key knowledge gaps for the new product
2. How to address each gap (tesLng or other invesLgaLon)
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Handheld X-ray Imaging Systems
• Typical product development
constraints
– Known “standard” and “advanced”
technologies
• For the purposes of this exercise, assume
equal funcLonal performance for
technologies and equal COGs
• Only differences are development costs and
weight impacts on the final system
• Same development Lme (1 year)
• Varying development cost
– Form factors and industrial design vary
(Image courtesy of John Wells) (Image courtesy of Vasile Cotovanu)
(Image courtesy of donielle)
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Scenario
• You are the product development VP of ImageX
• Your system seems to be heavier than most of the
compeLLon
• This year, your CEO would like to reduce the weight of the
system to be at least compeLLve with the exisLng
compeLLon
• You have a limited development budget of $2M and one year
to get this new product developed
• Your CEO wants you to develop a product development plan
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Exercise #1
IdenLfying Knowledge Gaps in New
Product Development
1. You are responsible for planning the development of a new
handheld x-ray imager
2. Read the descripLon of the situaLon on your handout
3. Split into teams of 2-3 people
4. Together idenLfy:
1. Key knowledge gaps for the new product
2. How to address each gap (analysis, tesLng, or other invesLgaLon)
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Exercise #1
Knowledge Gaps Means for Closing Gaps
Who are my competitors? Market analysis
How much do their systems weigh? Specs research, acquire systems to test
What components are in the competitive
systems and how much to they weigh?
Specs research, acquire systems to test,
interview customers
What other performance criteria do we need
to meet?
Market/customer analysis
What cost and performance tradeoffs are we
making to get to a lighter weight?
Technical analysis
Do we have the expertise in those
technologies? Can we get it? Develop it?
Technology/capability gap analysis--Can it be
outsourced?
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Reconciling Lean with Regula'ons
Geetha Rao, Ph.D.
CEO, Springborne Life Sciences
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Regulatory Elements for Product Development
QSR & ISO 13485
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Design
Plan
Design
Transfer
Design
Plan
Design
Transfer
User
Needs
Design
Input
Design
Output
Verifica'on
Valida'on
Review

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• “…the quality system regulaLon is premised on the
theory that the development, implementaLon, and
maintenance of procedures designed to carry out the
requirements will assure the safety and effecLveness
of devices.”
• “…the regulaLon gives the manufacturer the
flexibility to determine the controls that are
necessary commensurate with risk.”
• “It is lea to manufacturers to determine the necessity
for, or extent of, some quality elements and to
develop and implement specific procedures tailored
to their parLcular processes and devices.”
CFR 820 QSR preamble
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Lean Product Development
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Planning
Deployment
Requirements
Analysis & Design
Tes'ng
Evalua'on
= Design Output
= Verifica'on
= Planning
= Design Input = Valida'on
= Transfer

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NavigaLng the ‘Regulatory Fog’
• Take advantage of the shia to process model for
requirements
• Appropriately interpret the regulatory speak
• Focus on understanding the intent more than
implemenLng “the required procedure”
• Treat the required elements of design control like
building blocks to be configured in a manner “suitable
to the method and operaLons of the company”
• Design your SOPs with as much care as you design your
product
• OpLmize knowledge gain and knowledge transfer
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Knowledge-Driven Product
Development for Medical Devices
Aaron Joseph
Sr. Consultant, Product RealizaLon Group
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Knowledge-Driven Product
Development
• Lean product development idenLfies
knowledge gaps early and tackles them
aggressively
• How do these lean principles apply to medical
device development?
*from Mastering Lean Product Development (2011) by Ron Mascitelli
New product development = commercializaLon of
knowledge*
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Knowledge-Driven Product
Development
• Successful new product development
demands deep knowledge of:
– Product applicaLon
– Product technology
– Manufacturing process technology
Medical Devices: understand
the clinical environment and
the needs of clinicians
• For Medical Devices:
– Regulatory Approval (approval process and key
concerns of regulators)
– Compliance (requirements of all applicable
regulaLons and standards)
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What’s special about medical devices?
• Product development for 2 customers: clinical
users and FDA (or other regulatory body)
• Challenging for product development team to
fully understand the needs of either group
(different mindset from engineering…)
• Late breaking problems with a new product
trigger a cascade of issues for a medical device
company—can lead to regulatory problems on
top of technical problems
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What’s special about medical devices?
• Double challenge: design a successful new
product and do it according to approved
procedures (quality system)
• ExponenLal increase in compliance/
documentaLon effort near product launch
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Loopbacks when Launching New
Medical Devices
• Even more expensive to fix…
Concept
Phase
Planning
Phase
Design
Phase
Test
Phase
Launch
Phase
Customer
Use
Difficult technical
work done here! With medical products,
loopbacks can trigger even more
delays and extra work!
ValidaLon
Phase
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Causes for Medical Device Loopbacks
Some examples parLcular to medical devices:
• Device malfuncLons aaer sterilizaLon
• Clinicians find user interface confusing
• Device fails electrical safety tesLng (leakage)
• Incomplete tesLng and documentaLon for
intended markets
• InstrucLons in user manual do not match final
device
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What knowledge gaps need to be closed ...
…to fly?
Lia / Thrust / Control
…to get regulatory approval?
Wind Tunnel TesLng
Model Kites
Manned Gliders
• Approval pathway (510k, PMA, De
Novo, etc.)
• TesLng demanded by FDA
– BiocompaLbility
– Cleaning and sterilizaLon
– Human Factors
• Key concerns of regulators
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Knowledge Gaps Lead to ‘Crashes’
Lack of regulatory approval
= no commercial product!
Failing an audit (serious compliance problem)
= stop producLon!
= recall product!
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Learning and Knowledge Management
• Where does knowledge come from? Examples:
– Studying customers
– MeeLng with FDA
– TesLng
• Is there a proven tool for knowledge
management?
– Tackling knowledge gaps
– CommunicaLng new knowledge
– Storing and managing knowledge
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A3 Method for
Knowledge Management
Roger Tang, Ph.D.
Principal, H R Tang ConsulLng
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A3 Tool
• “A3” refers to size of a single sheet of paper
• Facilitates structured
– communicaLon
– problem solving
– knowledge management
– mentoring
• Different types of A3 templates for different
purposes
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A3 Example
(From: Managing to Learn: Using the A3 management process by John Shook) 59

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Exercise #2
Knowledge Management Using the A3
Method
1. Work with a neighbor to share ideas
2. You are the VP of Product Development
3. There are some data and compeLLve analyses in your
handout (done by your markeLng and R&D team)
4. With the informaLon you know, please try to complete the
rest of the secLons of the A3
– AlternaLves
– AcLon Plan
– Follow-up Plan
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Handheld X-ray Imaging Systems
• Typical product development
constraints
– Known “standard” and “advanced”
technologies
• For the purposes of this exercise, assume
equal funcLonal performance for
technologies and equal COGs
• Only differences are development costs and
weight impacts on the final system
• Same development Lme (1 year)
• Varying development cost
– Form factors and industrial design vary
(Image courtesy of John Wells) (Image courtesy of Vasile Cotovanu)
(Image courtesy of donielle)
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Scenario
• You are the product development VP of ImageX
• Your system seems to be heavier than most of the
compeLLon
• This year, your CEO would like to reduce the weight of the
system to be at least compeLLve with the exisLng
compeLLon
• You have a limited development budget of $2M and one year
to get this new product developed
• Your CEO wants you to develop a ra'onal product
development plan in an A3 format
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Background
Handheld X-ray Imaging Product Releases
December 2027
0
0.5
1
1.5
2
2.5
3
3.5
4
General
Fusion
CareDev Engage Focus
Imaging
Domain Abler ImageX Baseline
Imaging
Estimated Development Cost [$M]
Weight[kg]
6.3 3.5 1.8 1.33.5 3.8 3.33.8
Improvement Objective
Objectives:
• Lower system weight by 25% (target 1-kg reduction)
• Spend no more than $2M for development
Current State
Functions ImageX Technologies
Power "A-Type" Battery Pack
Materials Lead Body
Form Factor Integrated Sensor
Source Electron gun-based X-ray
Display/Readyout OLED Display
Thermal Control "Zero-Energy" Cooler
Detection Einsteinum-based Detectors
=$1.8M to develop
• Based on competition, there appear to be lighter options for most functions
Alternatives
Company
Total
Dev Cost
[$M]
Total
Weight
[kg]
Fusion
Reactor
Unobtainium
Body
Tethered
Sensor
"Accelotron"
X-ray
Retinal
Projector
"Zero-
Energy"
Cooler
Einsteinium-
based
Detectors
General Fusion
CareDev
Engage
Focus Imaging
Domain
Abler
ImageX
Baseline Imaging
Key Advanced Technologies
Action Plan
• Collect key technology information
• Quantify costs and benefits
• Conduct tradeoff studies: development cost vs. potential benefit in weight reduction
• Experiment if needed
• Finalize top alternatives to implement in next iteration
Follow-up Plan
Results
ImageX
PRODUCT
DEVELOPMENT PLAN
Version:
2
Date Last Revised:
1/15/2028
Subject:
Reduce Handheld X-ray Imaging System Weight by >25%
Keywords:
2028 Plan, Technology Tradeoff
Author: Roger Veep Date:
Reviewed: Joe Ceo Date:
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Exercise #2
Knowledge Management Using the A3
Method
1. Work with a neighbor to share ideas
2. You are the VP of Product Development
3. There are some data and compeLLve analyses in your
handout (done by your markeLng and R&D team)
4. With the informaLon you know, please try to complete the
rest of the secLons of the A3
– AlternaLves
– AcLon Plan
– Follow-up Plan
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Exercise #2
Knowledge Management Using the A3
Method
1. Work with a neighbor
2. One of you plays the role of CEO
3. Ask your VP these quesLons about the A3
– Is it clear what needs to be achieved? Is it measurable?
– Is the problem and opportunity clear (and visual)?
– Did you talk to others, go to Gemba, gather appropriate data?
– Are the root causes backed up with data?
– Does the acLon plan make sense based on the knowledge and data?
– Have you jumped to soluLons without enough data?
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Background
Handheld X-ray Imaging Product Releases
December 2027
0
0.5
1
1.5
2
2.5
3
3.5
4
General
Fusion
CareDev Engage Focus
Imaging
Domain Abler ImageX Baseline
Imaging
Estimated Development Cost [$M]
Weight[kg]
6.3 3.5 1.8 1.33.5 3.8 3.33.8
Improvement Objective
Objectives:
• Lower system weight by 25% (target 1-kg reduction)
• Spend no more than $2M for development
Current State
Functions ImageX Technologies
Power "A-Type" Battery Pack
Materials Lead Body
Form Factor Integrated Sensor
Source Electron gun-based X-ray
Display/Readyout OLED Display
Thermal Control "Zero-Energy" Cooler
Detection Einsteinum-based Detectors
=$1.8M to develop
• Based on competition, there appear to be lighter options for most functions
Alternatives
Company
Total
Dev Cost
[$M]
Total
Weight
[kg]
Fusion
Reactor
Unobtainium
Body
Tethered
Sensor
"Accelotron"
X-ray
Retinal
Projector
"Zero-
Energy"
Cooler
Einsteinium-
based
Detectors
General Fusion 6.3 1.25 1 1 1 1 1 1
CareDev 3.5 2 1 1 1 1 1
Engage 3.8 2.25 1 1 1
Focus Imaging 3.5 2.5 1 1 1 1 1
Domain 3.8 2.75 1 1 1 1
Abler 3.3 2.75 1 1 1 1
ImageX 1.8 3.5 1 1
Baseline Imaging 1.3 3.75 1
Key Advanced Technologies
From Analysis and/or Experiments
• Standard Technology Development Cost = $0.3
• Standard Technology Weight = 3.75 kg
Standard Technology Advanced Technology
Extra Dev
Cost [$M]
rWeight
[kg]
"A-Type" Battery Pack Fusion Reactor 2 1
Lead Body Unobtainium Body 0.2 0.25
Integrated Sensor Tethered Sensor 1 0.5
Electron gun-based X-ray "Accelotron" X-ray 0.5 0.5
OLED Display Retinal Projector 1 0.25
TEC Cooler "Zero-Energy" Cooler 1 0
Semiconductor Detectors Einsteinium-based Detectors 0.5 0.25
Action Plan
• Use Standard Technologies as starting set
Proposed Advanced
Technologies
rCost
[$M]
rWeight
[kg]
Unobtainium Body 0.2 0.25
Tethered Sensor 1 0.5
"Accelotron" X-ray 0.5 0.5
Total Extra Cost [$M] 1.7
Total Weight Reduction [kg] 1.25
+Standard cost and weight 0.3 3.75
Totals Dev Cost and Weight $2M 2.5kg
Follow-up Plan
• Complete development and launch by December (Roger Veep)
• Gather relevant data at next year's tradeshow (Roger Veep and Joe Ceo)
• Analyze data (Product Development Team and Roger Veep)
o Verify weight reduction against competitors
o Look for potential improvements for following year (relative to competition)
• Create new plan for next year (Roger Veep)
Results
• TBD
ImageX
PRODUCT
DEVELOPMENT PLAN
Version:
5
Date Last Revised:
1/27/2028
Subject:
Reduce Handheld X-ray Imaging System Weight by >25%
Keywords:
2028 Plan, Technology Tradeoff
Author: Roger Veep Date: 1/27/2028
Reviewed: Joe Ceo Date: 1/27/2028
Hypothesize that
we will meet
objectives with this
plan!
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Lean & Compliant:
Real Life Examples
Aaron Joseph
Sr. Consultant, Product RealizaLon Group
“Sounds good, but will this really work for medical device product development?”
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TradiLonal Product Development
• How well does the tradiLonal approach work for
medical devices?
• What does a loopback look like for a real medical
device project?
• How bad could it be?
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Zap! RF Cautery Catheter Design Flaw
• design completed and V&V tesLng underway—
failed electrical tesLng (insufficient insulaLon due
to capaciLve coupling)
• Effect (giant loopback!): switch to teflon-based
design which triggered …
– change in sterilizaLon method (EtO instead of
Gamma) which triggered …
– re-do of sterilizaLon validaLon and funcLonal tesLng
(DVT) which triggered …
– expensive build (expedited) of new test arLcles
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CircuVentTM
HME/HCH Bypass
Successful Product Launch (unLl …):
DHD is pleased to announce the addiLon of CircuVentTM ….
UnLl now, providing aerosolized medicaLons to
mechanically venLlated paLents meant removing the HME/
HCH - a procedure that can increase the risk of alveolar
derecruitment, drying of airway secreLons, and
contaminaLon to both paLents and clinicians. Now you can
reduce these risks with new CircuVent - the breakthrough
device that lets you provide aerosol without breaking the
circuit!
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URGENT: MEDICAL DEVICE RECALL
• … there is a chance that a few units may have been shipped to
the field with labels applied incorrectly …
• When the label is applied incorrectly, the unit will indicate that
airflow in the venLlator circuit is directed through the HME,
when it is actually directed through the bypass around the
HME.
• This defect would not be obvious or readily detectable by the
clinician and could lead to improper therapy.
• We have decided to recall all CircuVent product, Part Number
68-1000 …
• Further distribuLon of this product should cease immediately.
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Lean Product Development Success Story - Arthrex
• Arthrex produces tools for minimally invasive surgery (arthroscopy)
• They needed to develop a next-generaLon endoscopic imaging system in record Lme (< 10
months) to debut at annual surgical conference
• Product team incorporated mulLple lean techniques to speed development and maximize
predictability of launch date (“no late surprises!”)
• Learned Quickly by Failing Fast
• Earlier InformaLon is More Valuable
• Minimized Batch Size / Maximized IteraLons
• Leveraged Clinical Training FaciliLes (for early feedback from clinical users)
• Sytem Architecture: High Risks are isolated; modular design for flexibility and testability
• CriLcal Chain Project Mgmt
– Schedule opLmized for speed
– CriLcal path and resources are clear
– Shared schedule buffers promote teamwork
• SystemaLc management of project risks (“knowledge gaps”):
– characterizaLon (high/med/low),
– MiLgaLon and tracking
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Lean Product Development Success Story - Arthrex
Product team was successful!
– New imaging system was ready in Lme for conference
– Company made millions more in sales with on-Lme launch
• More informaLon is available at
– h"p://playbookhq.co/case-studies/
– h"p://www.arthrex.com
• (or search online for “Craig Speier” and “Lean Product Development”)
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Lean & Compliant Summary
Aaron Joseph
Sr. Consultant, Product RealizaLon Group
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Lean & Compliant Medical Device
Development
• If the team can’t solve the technical challenge of ‘X’ then
all other work on the product is useless (focus all
resources early on ‘X’)
• If the team is not confident of geeng regulatory approval
then all other work on the product is useless
• Flow of Knowledge: make knowledge easily available to
everyone who needs it (through training, communicaLon,
documentaLon, etc.)
• IteraLons during early development can improve
compliance
– everyone learns more about the quality system processes
– make sure the final output is complete and consistent
– refine procedures as needed before product is finalized
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Dos and Don’ts
Knowledge
• Do: SystemaLcally manage knowledge for every product
development project and apply to future projects
• Don’t: Throw away precious knowledge!
Project Risk
• Do: IdenLfy project risks (technical, regulatory,
manufacturing, etc.) early and tackle them aggressively
• Don’t: Allow project risks to conLnue to late stages of
project (leave unresolved knowledge gaps)
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Dos and Don’ts
Itera'on
• Do: Become efficient at repeaLng tasks and execuLng parLal
tasks and incorporate agile soaware development into
product development
• Don’t: Assume key tasks will be done only once (i.e. building
prototypes, product tesLng)
Tes'ng
• Do: Test early and repeatedly; invest in test equipment and
test beds/parLal prototypes; (“test then design”) ;
incorporate testability into the HW and SW architecture
• Don’t: Wait unLl end of development to do most tesLng
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Dos and Don’ts
Documenta'on
• Do: Incorporate agile methods for documentaLon (examples: write user
manual early and repeatedly; begin compiling contents of 510k
submission early and communicate gaps/risks to team early)
• Don’t: Leave documentaLon to be compiled at late stages of product
development (“do the paperwork at the end”)
Project Management
• Do: Develop new products iteraLvely to idenLfy problems early and
aggressively resolve them; Use progressive design freeze to allow
maximum flexibility to the project team to make design changes up to
the “last responsible moment”
• Don’t: Expect product development to be sequenLal and insLtute
batched hand-offs (via rigid phase gates) where lots of work and lots of
knowledge is transferred at one Lme across groups
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Lean & Compliant
1. Lean methods accelerate product development
2. For medical devices, lean methods are not only possible, but
preferable
3. Knowledge-driven product development means decisions are
based on knowledge instead of ‘wishful thinking’
4. If the team can’t solve the technical challenge of ‘X’ then all
other work on the product is useless
5. Lean = Learning, not cueng corners
6. Minimizing tesLng = minimizing knowledge gained
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Q & A
Aaron Joseph, Medical Devices Consultant
Geetha Rao, Ph.D., CEO, Springborne Life Sciences
Roger Tang, Ph.D., Principal, H R Tang ConsulLng
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