SEO Medical Device Workshop
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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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SEO Medical Device Workshop
- 3. h"p://smesv.org 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 3
- 4. 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 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 4
- 5. h"p://smesv.org 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. 5
- 8. h"p://smesv.org Lean Methods Accelerate Product Development • Earlier product launch translates into $millions more in sales • 2-3X decrease in development cycle Lme • 2-4X decrease in development cost • 2-5X decrease in development risk • Strong arguments for qualitaLve improvements 8
- 9. h"p://smesv.org Why Lean for Medical Devices? • Product development teams at medical device companies are caught “between a rock and a hard place” – Increasing regulatory scruLny (in US and overseas markets) – Changes to US healthcare market from ACA (Obamacare) – Greater compeLLon (new products from India and China) – Increasing challenges of managing globalized supply chains • Companies cannot pass along increased costs to their customers • Challenge to efficiently develop new, innovaLve medical devices and sLll maintain rigorous compliance 9
- 10. h"p://smesv.org Can Lean Product Development work for Medical Devices? • Medical devices are a regulated product • Medical device regulaLons govern: – Product tesLng – Product manufacturing – Product development (“design controls”) • Each company decides how to implement design controls as part of their quality system • The quality system procedures can either support lean methods or obstruct them 10
- 11. h"p://smesv.org Two Real Life Medical Devices New Product Development 11 30 Average 20 18 12 Product Development Cycle Time (months) 2-3x Average 1x .8x Budget ($) Record Goal Lean Planned Lean ~$3M Addi'onal Profit ~$500K Cost Savings
- 15. h"p://smesv.org 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 15
- 16. 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 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 16
- 28. 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 • EducaLon: High school • OccupaLon: Bicycle sales and repair • How? *Credit to Ron Marsiglio 28
- 29. h"p://smesv.org 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 29
- 32. h"p://smesv.org Before Designing Their First Airplane… “SomeLmes the non-glamorous lab work is absolutely crucial to the success of a project.” -Wilbur Wright 32
- 34. h"p://smesv.org 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 34
- 37. h"p://smesv.org 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) 37
- 38. 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 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) 38
- 39. h"p://smesv.org 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 39
- 40. h"p://smesv.org 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) 40
- 41. 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
- 42. h"p://smesv.org Reconciling Lean with Regula'ons Geetha Rao, Ph.D. CEO, Springborne Life Sciences 42
- 46. h"p://smesv.org 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 46
- 49. h"p://smesv.org 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) 49
- 50. 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
- 53. h"p://smesv.org 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 53
- 54. h"p://smesv.org 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 54
- 56. h"p://smesv.org 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 56
- 58. h"p://smesv.org 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 58
- 59. h"p://smesv.org A3 Example (From: Managing to Learn: Using the A3 management process by John Shook) 59
- 60. 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 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 60
- 61. 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 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) 61
- 62. h"p://smesv.org 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 $2M and one year to get this new product developed • Your CEO wants you to develop a ra'onal product development plan in an A3 format 62
- 63. h"p://smesv.org Background Handheld X-ray Imaging Product Releases December 2027 0 0.5 1 1.5 2 2.5 3 3.5 4 General Fusion CareDev Engage Focus Imaging Domain Abler ImageX Baseline Imaging Estimated Development Cost [$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: 63
- 64. 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 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 64
- 65. 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 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? 65
- 66. h"p://smesv.org 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! 66
- 68. h"p://smesv.org 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? 68
- 69. h"p://smesv.org 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 69
- 71. 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 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. 71
- 72. h"p://smesv.org 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 72
- 73. h"p://smesv.org 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”) 73
- 74. h"p://smesv.org Lean & Compliant Summary Aaron Joseph Sr. Consultant, Product RealizaLon Group 74
- 75. 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 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 75
- 76. h"p://smesv.org 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) 76
- 77. h"p://smesv.org 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 77
- 78. h"p://smesv.org 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 78
- 79. 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 cueng corners 6. Minimizing tesLng = minimizing knowledge gained 79