Accelerating Medical Device Product Development - SME Conference - MAY2015

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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, 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]

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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

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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 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

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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.

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Introduc'on

Aaron Joseph Sr. Consultant, Product RealizaKon 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 Kme

•  2-‐4X decrease in development cost •  2-‐5X decrease in development risk •  Strong arguments for qualitaKve 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 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

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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

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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 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

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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 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

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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 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

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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 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

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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]

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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 ConsulKng

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•  Successful new product development demands deep knowledge of: – Product applicaKon – 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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•  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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Concept Phase

Planning Phase

Design Phase

Test Phase

Launch Phase

Customer Use


The Inevitable Design Loopbacks

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Concept Phase

Planning Phase

Design Phase

Test Phase

Launch Phase

Customer Use


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


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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 •  EducaKon: High school •  OccupaKon: 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 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

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Before Designing Their First Airplane…

•  IdenKfied 3 key knowledge gaps

– Lic

– Propulsion

– Control

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•  Closed knowledge gaps by performing analyses and experiments

Wind Tunnel TesKng

Model Kites

Manned Gliders

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“SomeKmes 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 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

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•  Test before Design Paradigm

Concept Phase

Planning Phase

Design Phase

Test Phase

Launch Phase

Customer Use


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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, communicaKon, documentaKon, etc.)

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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)

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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 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)

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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

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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)

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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 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

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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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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

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Knowledge-‐Driven Product Development for Medical Devices


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•  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*

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•  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)

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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)

•  ExponenKal increase in compliance/documentaKon 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!

ValidaKon Phase

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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

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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

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Knowledge Gaps Lead to ‘Crashes’

Lack of regulatory approval = no commercial product!

Failing an audit (serious compliance problem) = stop producKon! = recall product!

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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

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A3 Method for Knowledge Management

Roger Tang, Ph.D. Principal, H R Tang ConsulKng

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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

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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 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

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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 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)

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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

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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:

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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

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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?

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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!

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Lean & Compliant: Real Life Examples


“Sounds good, but will this really work for medical device product development?”

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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?

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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

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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!

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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 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.

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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

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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”)

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Lean & Compliant Summary


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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 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

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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)

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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

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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

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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 cugng corners 6. Minimizing tesKng = minimizing knowledge gained

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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

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Accelerating Medical Device Product Development - SME Conference - MAY2015

Engineering

pm exercise

services hp

pm introduckon aaronjoseph

pm summaryandqa panel

workshoppresenters aaronjoseph

risk management

basedontheoryofcons

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