Date post: | 28-Jul-2015 |
Category: |
Engineering |
Upload: | aaron-joseph |
View: | 131 times |
Download: | 3 times |
h"p://smesv.org
Lean & Compliant Accelera'ng Medical Device
Product Development
SME, Silicon Valley Chapter 98 May 21, 2015
1
h"p://smesv.org
Workshop Presenters Aaron Joseph, Sr. Consultant, Product RealizaKon Group
20 years in new product development; medical device product validaKon and risk analysis [email protected]
Geetha Rao, Ph.D., CEO, Springborne Life Sciences 25 years in high-‐risk technologies; regulatory strategy, risk management, medical device quality systems, business strategy [email protected]
Roger Tang, Ph.D., Principal, H R Tang ConsulKng 15 years in research and new product development; medical imaging, opKcal technologies, biotechnology [email protected]
2
h"p://smesv.org
Start Topic Speaker 1:10 PM IntroducKon Aaron Joseph
1:20 PM Myth BusKng Regulatory PerspecKves Geetha Rao
1:30 PM Knowledge-‐Driven Product Development Roger Tang
1:40 PM Exercise: IdenKfying Knowledge Gaps Roger Tang
1:55 PM Reconciling Lean with RegulaKons 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
3
h"p://smesv.org
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 socware management consultants (Craig Larman and Bas Vodde) who include aspects of socware agile methods as well.
• www.leantechnologydevelopment.com/ -‐ lots of easy-‐to-‐read arKcles on different aspects of lean product development, knowledge management, and tacKcs for implementaKon (managed by Katherine Redeker of Whiger ConsulKng)
• h"p://theleanthinker.com/ -‐ a blog by Mike Rother with lots of good observaKons and real-‐life issues involved in changing an organizaKon 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 InsKtute (consulKng firm and forum); large collecKon of arKcles 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 contribuKons from many of the thought leaders in the lean community
• h"p://playbookhq.co/blog/ -‐ lots of good blog posKngs on concepts and methods for lean product development; links to lots of addiKonal resources
4
h"p://smesv.org
Suggested Resources for Lean Product Development Books: • "Mastering Lean Product Development" by Ronald Mascitelli -‐ a collecKon of pracKcal methods to
improve everything a product development organizaKon does from product strategy to running efficient design reviews (includes extensive bibliography).
• "The Principles of Product Development Flow" by Donald Reinertsen -‐ detailed explanaKons 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 presentaKon 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 presentaKon of the ideas from Ward's book, based on the real-‐life experiences of Kennedy's consulKng clients. Includes case studies of two companies going through lean transformaKons.
• “Managing to Learn” by John Shook – an excellent introducKon to the use of the ‘A3 method’ for problem solving, communicaKon, learning, and lean management.
• “The Lean Startup” by Eric Ries – a must read for entrepreneurs and anyone managing projects to create something new under condiKons of extreme uncertainty.
5
h"p://smesv.org
Introduc'on
Aaron Joseph Sr. Consultant, Product RealizaKon Group
6
h"p://smesv.org
What is “Lean Product Development”? Fewer Employees
Very Aggressive
Schedules
Outsourced
Engineering
Maximizing Value for the Customer
7
h"p://smesv.org
Lean Methods Accelerate Product Development
• Earlier product launch translates into $millions more in sales
• 2-‐3X decrease in development cycle Kme
• 2-‐4X decrease in development cost • 2-‐5X decrease in development risk • Strong arguments for qualitaKve improvements
8
h"p://smesv.org
Why Lean for Medical Devices?
• Product development teams at medical device companies are caught “between a rock and a hard place” – Increasing regulatory scruKny (in US and overseas markets) – Changes to US healthcare market from ACA (Obamacare) – Greater compeKKon (new products from India and China) – Increasing challenges of managing globalized supply chains
• Companies cannot pass along increased costs to their customers
• Challenge to efficiently develop new, innovaKve medical devices and sKll maintain rigorous compliance
9
h"p://smesv.org
Can Lean Product Development work for Medical Devices?
• Medical devices are a regulated product • Medical device regulaKons govern:
– Product tesKng – Product manufacturing – Product development (“design controls”)
• Each company decides how to implement design controls as part of their quality system
• The quality system procedures can either support lean methods or obstruct them
10
h"p://smesv.org
Two Real Life Medical Devices New Product Development
11
30
Average
20 18 12
Product Development Cycle Time (months)
2-‐3x
Average
1x .8x
Budget ($)
Record Goal Lean Planned Lean
~$3M Addi'onal Profit ~$500K
Cost Savings
h"p://smesv.org
Actual PracKce
• Lean methods do not conflict with the requirements of FDA regulaKons, ISO 13485, or other standards
• Lean methods do conflict with the quality systems of many medical device companies
12
h"p://smesv.org
Myth-‐bus'ng “You can’t use lean methods to develop a regulated product”
Geetha Rao, Ph.D. CEO, Springborne Life Sciences
13
h"p://smesv.org
The infamous waterfall
14
Design Plan
Design Transfer
h"p://smesv.org
Typical Design Control ImplementaKon
• Design Phases – Input, Output, VerificaKon, ValidaKon
• Life Cycle – Research, Development, Pre-‐producKon, ProducKon
• Stage gates between phases – Comprehensive phase review – Commi"ee approval to proceed to next stage
15
h"p://smesv.org
True or False? • The design control SOP must follow the waterfall diagram
• The design team cannot proceed to the next development stage without compleKon of required design and phase-‐gate reviews
• VerificaKon must be completed before validaKon is performed
• All product development engineers must be trained to the design control SOP
• All product documentaKon generated during the design process is a controlled record
16
h"p://smesv.org
FDA’s comment on the waterfall “Although the Waterfall Model is a useful tool for introducing Design Controls, its usefulness in pracKce is limited. The model does apply to the development of some simpler devices. However, for more complex devices, a concurrent engineering model is more representaKve of the design processes in use in the industry approach.” h"p://www.fda.gov/MedicalDevices/DeviceRegulaKonandGuidance/GuidanceDocuments/ucm070627.htm
17
h"p://smesv.org
Concurrent Engineering DefiniKons “a method of designing and developing products, in which the different stages run simultaneously, rather than consecuKvely. It decreases product development Kme and also the Kme to market, leading to improved producKvity and reduced costs.”[John Stark, 1998] “integraKng a new product development process to allow parKcipants making upstream decisions to consider downstream and external requirements. Central characterisKcs … are acKvity overlapping, informaKon transfer in small batches, and use of cross-‐funcKonal teams” [Gerwin and Susman 1996]
18
h"p://smesv.org
Workflow in a concurrent/lean approach
19
Requirements
Analysis & Design
Tes'ng
Evalua'on
Planning
Deployment
h"p://smesv.org
Cycles of Increasing Knowledge
20
Planning
Requirements
Analysis & Design
Tes'ng
Evalua'on
Deployment
h"p://smesv.org
Knowledge-‐Driven Product Development
Roger Tang, Ph.D. Principal, H R Tang ConsulKng
21
h"p://smesv.org
Knowledge-‐Driven Product Development
• Successful new product development demands deep knowledge of: – Product applicaKon – Product technology – Manufacturing process technology
22
h"p://smesv.org
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
23
h"p://smesv.org
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!
24
h"p://smesv.org
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
25
h"p://smesv.org
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…
26
h"p://smesv.org
Lean Product Development
• Test before Design Paradigm
Concept Phase
Planning Phase
Design Phase
Test Phase
Launch Phase
Customer Use
Difficult technical work done here!
27
h"p://smesv.org
A Famous Example* The Wright Brothers conquered manned, controlled, heavier-‐than-‐air powered flight when countless others failed
• When: 1899-‐1903 • Where: Dayton, Ohio • EducaKon: High school • OccupaKon: Bicycle sales and repair
• How?
*Credit to Ron Marsiglio
28
h"p://smesv.org
Before Designing Their First Airplane… • Began with a knowledge search
– Wrote the Smithsonian InsKtuKon for available informaKon in 1899
– Studied lic tables from O"o Lilienthal – Corresponded with Octave Chanute, railroad engineer and leading aviaKon expert
Lilienthal in flight Octave Chanute
29
h"p://smesv.org
Before Designing Their First Airplane…
• IdenKfied 3 key knowledge gaps
– Lic
– Propulsion
– Control
30
h"p://smesv.org
Before Designing Their First Airplane…
• Closed knowledge gaps by performing analyses and experiments
Wind Tunnel TesKng
Model Kites
Manned Gliders
31
h"p://smesv.org
Before Designing Their First Airplane…
“SomeKmes the non-‐glamorous lab work is absolutely crucial to the success of a project.”
-‐Wilbur Wright
32
h"p://smesv.org
“Success Assured”
• December 17, 1903
Test before Design
Especially if you are the Test Pilot!
33
h"p://smesv.org
Lessons Learned
• Understand exisKng knowledge • Divide challenge into logical subsystems • IdenKfy 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
34
h"p://smesv.org
Lean Product Development
• Test before Design Paradigm
Concept Phase
Planning Phase
Design Phase
Test Phase
Launch Phase
Customer Use
Difficult technical work done here!
35
h"p://smesv.org
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, communicaKon, documentaKon, etc.)
36
h"p://smesv.org
Exercise #1 IdenKfying Knowledge Gaps in New
Product Development
1. You are responsible for planning the development of a new handheld x-‐ray imager
2. Read the descripKon of the situaKon on your handout 3. Split into teams of 2-‐3 people 4. Together idenKfy:
1. Key knowledge gaps for the new product 2. How to address each gap (tesKng or other invesKgaKon)
37
h"p://smesv.org
Handheld X-‐ray Imaging Systems • Typical product development
constraints – Known “standard” and “advanced”
technologies • For the purposes of this exercise, assume equal funcKonal performance for technologies and equal COGs
• Only differences are development costs and weight impacts on the final system
• Same development Kme (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)
38
h"p://smesv.org
Scenario • You are the product development VP of ImageX • Your system seems to be heavier than most of the
compeKKon • This year, your CEO would like to reduce the weight of the
system to be at least compeKKve with the exisKng compeKKon
• 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
39
h"p://smesv.org
Exercise #1 IdenKfying Knowledge Gaps in New
Product Development
1. You are responsible for planning the development of a new handheld x-‐ray imager
2. Read the descripKon of the situaKon on your handout 3. Split into teams of 2-‐3 people 4. Together idenKfy:
1. Key knowledge gaps for the new product 2. How to address each gap (analysis, tesKng, or other invesKgaKon)
40
h"p://smesv.org
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?
41
h"p://smesv.org
Reconciling Lean with Regula'ons
Geetha Rao, Ph.D. CEO, Springborne Life Sciences
42
h"p://smesv.org
Regulatory Elements for Product Development QSR & ISO 13485
43
Design Plan
Design Transfer
Design Plan
Design Transfer
User Needs
Design Input
Design Output Verifica'on
Valida'on
Review
h"p://smesv.org
• “…the quality system regulaKon is premised on the theory that the development, implementaKon, and maintenance of procedures designed to carry out the requirements will assure the safety and effecKveness of devices.”
• “…the regulaKon gives the manufacturer the flexibility to determine the controls that are necessary commensurate with risk.”
• “It is lec to manufacturers to determine the necessity for, or extent of, some quality elements and to develop and implement specific procedures tailored to their parKcular processes and devices.”
CFR 820 QSR preamble
44
h"p://smesv.org
Lean Product Development
45
Planning
Deployment
Requirements
Analysis & Design Tes'ng
Evalua'on
= Design Output = Verifica'on
= Planning
= Design Input = Valida'on
= Transfer
h"p://smesv.org
NavigaKng the ‘Regulatory Fog’ • Take advantage of the shic to process model for requirements
• Appropriately interpret the regulatory speak • Focus on understanding the intent more than implemenKng “the required procedure”
• Treat the required elements of design control like building blocks to be configured in a manner “suitable to the method and operaKons of the company”
• Design your SOPs with as much care as you design your product
• OpKmize knowledge gain and knowledge transfer
46
h"p://smesv.org
Knowledge-‐Driven Product Development for Medical Devices
Aaron Joseph Sr. Consultant, Product RealizaKon Group
47
h"p://smesv.org
Knowledge-‐Driven Product Development
• Lean product development idenKfies 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 = commercializaKon of knowledge*
48
h"p://smesv.org
Knowledge-‐Driven Product Development
• Successful new product development demands deep knowledge of: – Product applicaKon – 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 regulaKons and standards)
49
h"p://smesv.org
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
50
h"p://smesv.org
What’s special about medical devices?
• Double challenge: design a successful new product and do it according to approved procedures (quality system)
• ExponenKal increase in compliance/documentaKon effort near product launch
51
h"p://smesv.org
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!
ValidaKon Phase
52
h"p://smesv.org
Causes for Medical Device Loopbacks Some examples parKcular to medical devices: • Device malfuncKons acer sterilizaKon • Clinicians find user interface confusing • Device fails electrical safety tesKng (leakage) • Incomplete tesKng and documentaKon for intended markets
• InstrucKons in user manual do not match final device
53
h"p://smesv.org
What knowledge gaps need to be closed ... …to fly? Lic / Thrust / Control
…to get regulatory approval?
Wind Tunnel TesKng
Model Kites
Manned Gliders
• Approval pathway (510k, PMA, De Novo, etc.)
• TesKng demanded by FDA – BiocompaKbility – Cleaning and sterilizaKon – Human Factors
• Key concerns of regulators
54
h"p://smesv.org
Knowledge Gaps Lead to ‘Crashes’
Lack of regulatory approval = no commercial product!
Failing an audit (serious compliance problem) = stop producKon! = recall product!
55
h"p://smesv.org
Learning and Knowledge Management
• Where does knowledge come from? Examples: – Studying customers – MeeKng with FDA – TesKng
• Is there a proven tool for knowledge management? – Tackling knowledge gaps – CommunicaKng new knowledge – Storing and managing knowledge
56
h"p://smesv.org
A3 Method for Knowledge Management
Roger Tang, Ph.D. Principal, H R Tang ConsulKng
57
h"p://smesv.org
A3 Tool
• “A3” refers to size of a single sheet of paper • Facilitates structured
– communicaKon – problem solving – knowledge management – mentoring
• Different types of A3 templates for different purposes
58
h"p://smesv.org
A3 Example
(From: Managing to Learn: Using the A3 management process by John Shook) 59
h"p://smesv.org
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 compeKKve analyses in your
handout (done by your markeKng and R&D team) 4. With the informaKon you know, please try to complete the
rest of the secKons of the A3 – AlternaKves – AcKon Plan – Follow-‐up Plan
60
h"p://smesv.org
Handheld X-‐ray Imaging Systems • Typical product development
constraints – Known “standard” and “advanced”
technologies • For the purposes of this exercise, assume equal funcKonal performance for technologies and equal COGs
• Only differences are development costs and weight impacts on the final system
• Same development Kme (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)
61
h"p://smesv.org
Scenario • You are the product development VP of ImageX • Your system seems to be heavier than most of the
compeKKon • This year, your CEO would like to reduce the weight of the
system to be at least compeKKve with the exisKng compeKKon
• You have a limited development budget of $2M and one year to get this new product developed
• Your CEO wants you to develop a ra'onal product development plan in an A3 format
62
h"p://smesv.org
Background
Handheld X-ray Imaging Product ReleasesDecember 2027
0
0.5
1
1.5
2
2.5
3
3.5
4
GeneralFusion
CareDev Engage FocusImaging
Domain Abler ImageX BaselineImaging
Estimated Development Cost [$M]
Wei
ght [
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 TechnologiesPower "A-Type" Battery PackMaterials Lead BodyForm Factor Integrated SensorSource Electron gun-based X-rayDisplay/Readyout OLED DisplayThermal Control "Zero-Energy" CoolerDetection 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
ReactorUnobtainium
BodyTethered Sensor
"Accelotron" X-ray
Retinal Projector
"Zero-Energy" Cooler
Einsteinium-based
DetectorsGeneral FusionCareDevEngageFocus ImagingDomainAblerImageXBaseline 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:
63
h"p://smesv.org
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 compeKKve analyses in your
handout (done by your markeKng and R&D team) 4. With the informaKon you know, please try to complete the
rest of the secKons of the A3 – AlternaKves – AcKon Plan – Follow-‐up Plan
64
h"p://smesv.org
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 quesKons 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 acKon plan make sense based on the knowledge and data? – Have you jumped to soluKons without enough data?
65
h"p://smesv.org
Background
Handheld X-ray Imaging Product ReleasesDecember 2027
0
0.5
1
1.5
2
2.5
3
3.5
4
GeneralFusion
CareDev Engage FocusImaging
Domain Abler ImageX BaselineImaging
Estimated Development Cost [$M]
Wei
ght [
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 TechnologiesPower "A-Type" Battery PackMaterials Lead BodyForm Factor Integrated SensorSource Electron gun-based X-rayDisplay/Readyout OLED DisplayThermal Control "Zero-Energy" CoolerDetection 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
ReactorUnobtainium
BodyTethered Sensor
"Accelotron" X-ray
Retinal Projector
"Zero-Energy" Cooler
Einsteinium-based
DetectorsGeneral Fusion 6.3 1.25 1 1 1 1 1 1CareDev 3.5 2 1 1 1 1 1Engage 3.8 2.25 1 1 1Focus Imaging 3.5 2.5 1 1 1 1 1Domain 3.8 2.75 1 1 1 1Abler 3.3 2.75 1 1 1 1ImageX 1.8 3.5 1 1Baseline Imaging 1.3 3.75 1
Key Advanced Technologies
From Analysis and/or Experiments
• Standard Technology Development Cost = $0.3 • Standard Technology Weight = 3.75 kg
Standard Technology Advanced TechnologyExtra Dev Cost [$M]
rWeight [kg]
"A-Type" Battery Pack Fusion Reactor 2 1Lead Body Unobtainium Body 0.2 0.25Integrated Sensor Tethered Sensor 1 0.5Electron gun-based X-ray "Accelotron" X-ray 0.5 0.5OLED Display Retinal Projector 1 0.25TEC Cooler "Zero-Energy" Cooler 1 0Semiconductor Detectors Einsteinium-based Detectors 0.5 0.25
Action Plan • Use Standard Technologies as starting set
Proposed Advanced Technologies
rCost[$M]
rWeight [kg]
Unobtainium Body 0.2 0.25Tethered Sensor 1 0.5"Accelotron" X-ray 0.5 0.5Total Extra Cost [$M] 1.7Total Weight Reduction [kg] 1.25+Standard cost and weight 0.3 3.75Totals 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!
66
h"p://smesv.org
Lean & Compliant: Real Life Examples
Aaron Joseph Sr. Consultant, Product RealizaKon Group
“Sounds good, but will this really work for medical device product development?”
67
h"p://smesv.org
TradiKonal Product Development
• How well does the tradiKonal approach work for medical devices?
• What does a loopback look like for a real medical device project?
• How bad could it be?
68
h"p://smesv.org
Zap! RF Cautery Catheter Design Flaw
• design completed and V&V tesKng underway—failed electrical tesKng (insufficient insulaKon due to capaciKve coupling)
• Effect (giant loopback!): switch to teflon-‐based design which triggered … – change in sterilizaKon method (EtO instead of Gamma) which triggered …
– re-‐do of sterilizaKon validaKon and funcKonal tesKng (DVT) which triggered …
– expensive build (expedited) of new test arKcles
69
h"p://smesv.org
CircuVentTM HME/HCH Bypass
Successful Product Launch (unKl …): DHD is pleased to announce the addiKon of CircuVentTM …. UnKl now, providing aerosolized medicaKons to mechanically venKlated paKents meant removing the HME/HCH -‐ a procedure that can increase the risk of alveolar derecruitment, drying of airway secreKons, and contaminaKon to both paKents and clinicians. Now you can reduce these risks with new CircuVent -‐ the breakthrough device that lets you provide aerosol without breaking the circuit!
70
h"p://smesv.org
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 venKlator 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 distribuKon of this product should cease immediately.
71
h"p://smesv.org
Lean Product Development Success Story -‐ Arthrex
• Arthrex produces tools for minimally invasive surgery (arthroscopy) • They needed to develop a next-‐generaKon endoscopic imaging system in record Kme (< 10
months) to debut at annual surgical conference • Product team incorporated mulKple lean techniques to speed development and maximize
predictability of launch date (“no late surprises!”) • Learned Quickly by Failing Fast
• Earlier InformaKon is More Valuable • Minimized Batch Size / Maximized IteraKons • Leveraged Clinical Training FaciliKes (for early feedback from clinical users)
• Sytem Architecture: High Risks are isolated; modular design for flexibility and testability • CriKcal Chain Project Mgmt
– Schedule opKmized for speed – CriKcal path and resources are clear – Shared schedule buffers promote teamwork
• SystemaKc management of project risks (“knowledge gaps”): – characterizaKon (high/med/low), – MiKgaKon and tracking
72
h"p://smesv.org
Lean Product Development Success Story -‐ Arthrex
Product team was successful! – New imaging system was ready in Kme for conference – Company made millions more in sales with on-‐Kme launch
• More informaKon is available at – h"p://playbookhq.co/case-‐studies/ – h"p://www.arthrex.com
• (or search online for “Craig Speier” and “Lean Product Development”)
73
h"p://smesv.org
Lean & Compliant Summary
Aaron Joseph Sr. Consultant, Product RealizaKon Group
74
h"p://smesv.org
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 gegng 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, communicaKon, documentaKon, etc.)
• IteraKons 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
75
h"p://smesv.org
Dos and Don’ts Knowledge • Do: SystemaKcally manage knowledge for every product
development project and apply to future projects • Don’t: Throw away precious knowledge!
Project Risk • Do: IdenKfy project risks (technical, regulatory,
manufacturing, etc.) early and tackle them aggressively • Don’t: Allow project risks to conKnue to late stages of
project (leave unresolved knowledge gaps)
76
h"p://smesv.org
Dos and Don’ts
Itera'on • Do: Become efficient at repeaKng tasks and execuKng parKal
tasks and incorporate agile socware development into product development
• Don’t: Assume key tasks will be done only once (i.e. building prototypes, product tesKng)
Tes'ng • Do: Test early and repeatedly; invest in test equipment and
test beds/parKal prototypes; (“test then design”) ; incorporate testability into the HW and SW architecture
• Don’t: Wait unKl end of development to do most tesKng
77
h"p://smesv.org
Dos and Don’ts Documenta'on • Do: Incorporate agile methods for documentaKon (examples: write user
manual early and repeatedly; begin compiling contents of 510k submission early and communicate gaps/risks to team early)
• Don’t: Leave documentaKon to be compiled at late stages of product development (“do the paperwork at the end”)
Project Management • Do: Develop new products iteraKvely to idenKfy 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 sequenKal and insKtute batched hand-‐offs (via rigid phase gates) where lots of work and lots of knowledge is transferred at one Kme across groups
78
h"p://smesv.org
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 cugng corners 6. Minimizing tesKng = minimizing knowledge gained
79
h"p://smesv.org
Q & A
Aaron Joseph, Sr. Consultant, Product RealizaKon Group Geetha Rao, Ph.D., CEO, Springborne Life Sciences Roger Tang, Ph.D., Principal, H R Tang ConsulKng
80