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![Page 1: Planning and Executing the Product Development and Manufacture of Medical Devices - MaRS Best Practices](https://reader034.fdocuments.net/reader034/viewer/2022042907/5881e0521a28ab36088b4c97/html5/thumbnails/1.jpg)
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D e s i g n , I n n o v a t i o n , M e d t e c h
ISO 13485 Certified
Lahav Gil
![Page 2: Planning and Executing the Product Development and Manufacture of Medical Devices - MaRS Best Practices](https://reader034.fdocuments.net/reader034/viewer/2022042907/5881e0521a28ab36088b4c97/html5/thumbnails/2.jpg)
XOR Labs Toronto
Commercializing Medical DevicesA. Evidence based adoption B. Heavily regulated C. Health economics D. About 10 years
Medical DevicesProduct Development & Manufacturing
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XOR Labs Toronto
Medical DevicesProduct Development & Manufacturing Howdoyougetfromthis?(technology)
tothis?(product)
tothis?(business)
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VISIUS Intra-operative MRI by IMRIS
What is an ISO 13485 QMS? And can you commercialize a med device without one?
Medical DevicesProduct Development & Manufacturing
1.
A. ISO 13485 compliant QMS (FDA, HC, CE) B. No C. Yes (if you accelerate through leaning on an existing system)
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VISIUS Intra-operative MRI by IMRIS
What makes a medical device, a medical device?The SOP for medical devices product development
Medical DevicesProduct Development & Manufacturing Ultrasonix Medical, Ergosonix 500
2.
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VISIUS Intra-operative MRI by IMRIS
What makes a medical device, a medical device?A. The FDA B. Safety and effectiveness C. Design controls, V and V
TheFDA
Concep
tion
Commercial
ValidateCreativity
Process
◇Va
lidationBu
ild
V&Vreport
DesignControls
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VISIUS Intra-operative MRI by IMRIS
What makes a medical device, a medical device?
Makesscientificsense
Makesbusinesssense
MakesproductsenseMakesclinicalsense
MakesFDAsense
MakesMFCsense
Makescommercialsense
Concep
tion
Commercial
ValidateDevelopDefine
Feasibility ◇PR
S
◇DM
R
◇Alph
aBu
ild
◇Qua
lificationBu
ild
User
proo
fpo
ints>>
Clinical
proo
fpo
ints>>
Comm.
proo
fpo
ints>>
MFCCreativity
Process
Transfer/NPI
◇Va
lidationBu
ild
Concept
ProjectCharter
Req.gathering
Traceability
Hazardanalysis
V&Vreport
DFMEA
◇SR
S
◇Seria
lProdu
ction
◇PilotP
rodu
ction
◇PO
P
◇PO
C
◇Bu
sine
ss
Justificatio
n
Requ
iremen
ts
DesignControls
A. The FDA B. Safety and effectiveness C. Design controls, V and V
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VISIUS Intra-operative MRI by IMRIS
What makes a medical device, a medical device?
Commercial
Validate
◇PR
S
◇Alph
aBu
ild
Creativity
Process
◇Va
lidationBu
ild
Traceability
Hazardanalysis
V&Vreport
DFMEA
DesignControls
0 A B C D E
A. The FDA B. Safety and effectiveness C. Design controls, V and V
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Tommy Pavia
How to align core technology, design & business architectures during the product development process?A. Cathedral Model TM - culture and methodologies B. Fast paced customer development iterations C. Look outside your comfort group D. Manage everything by requirements E. Building flexibility and change management into your process
Medical DevicesProduct Development & Manufacturing
3.
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Application
Distribution
Invention
CathedralModelTM
MBA.Speak
Threedistinctdimensionstoatechnologyinnovationventure
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Technology
ProductBusiness Application
Distribution
Invention
Therelationshipiskey.Therelationshipbetweenthesedimensionsisofconcentricspheres,oneimmersedintheother,onesurroundedbytheother.Effectivelyactingascascadingwombsthroughwhichanideaorinventionisbornintotheworldandhasimpactinpeople’slife.
Lay.Speak
CathedralModelTM
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Scientists
EngineersBusiness folk
The “cultural” divide
CathedralModelTM
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JVs
Research, Science, (scientific) technology, proof of principle - POP, interests, experiments, posters, publications, labs, grants, students, academic career planing, conferences
Requirements, technical specs, problem formulation, needs assessment, productization (product development), industrial design, engineering, systems integration, applications testing, prototypes - POC, product management, program management, ISO, QMS, 60601,
Commercialization, corporate development, markets, verticals, Investments, deals, ROI, distribution, channels, clinical development, RA, manufacturing transfer, ramp up and scale up, operations, serial production, contracts and deals, sales projections, exits, logistics, value proposition, shareholders, supply chain
T
P
B
The “cultural” divide CathedralModelTM
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Getting the science right is the only thing that mattersWe think that…
We perceive success as…
POP, publications, recognition, funds and grants for more research
• Meeting the requirements• Getting more investment dollars,
now we can do some real R&D
Building a company, sales, ROI, liquidity events, acquisitions
Engineering is the real thing!after this its only…. sales
Selling and shipping is the only real thing. Before that its only…engineering
Core Technology Product
Business
We understand commercialization to mean…
We have built a few prototypes and other researchers are using it and really liking it!
Manufacturing• Sales, return sales, more sales• Scaling• Operational excellence
The “cultural” divide
We love… PerformanceDiscovery The Deal
CathedralModelTM
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The Cathedral Model story….Two stone masons chipping away at a pile of rocks…
CathedralModelTM
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Playmobil's inventor Hans Beck
• Innovation can begin in any one of the dimensions. This one began with the oil crisis of the 70s• The ability to think holistically, simultaneously and synergistically within these three dimensions
is key to successful commercialization of innovation
CathedralModelTM
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The rose
Core Technology
Product
Business
The Money
The Rose Theatre example from the movie “Shakespeare is in Love”:The story, the play itself (and actors), the theatre.
CathedralModelTM
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Stakeholders
User
Meaningful and relevant need
Customer
Advocate groups
Employees
Economics
Shareholders
Nurse
Surgeon
Partnerships
Payers
Brand enthusiasts
Direct decision maker
CathedralModelTM
Insurers
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Technology
Product
Business• Business model/revenue stream/recurring/margin analysis
• Path to market • Channels • Customers • Partnerships • Logistics/supply chain • Regulatory • Cost to revenue
• Users • Technical/engineering • Industrial Design/ Product • MFC • Supply chain • QMS • Cost to develop
• Clinical/science • core technology • IP • Scientific validity
Designinputs;Needsassessment,ValuedriversandRequirementsStreams
CathedralModelTM
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Businesstypes,businessstages
TP
B
CathedralModelTM
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Product leader
Technology leader/inventor
Business Leader/management/marketing
CathedralModelTM
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T
P
B
Team
the“bundle”
• At the heart of the C method is the “bundle”; the technology, product, business and leadership team as an integrated architecture.The C model views the evolution of a venture as a synchronous evolution of the “bundle”
CathedralModelTM
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Company Formation, Shaping & Architecture
Science/Clinical Leadership
Opperational ExcellenceScience discovery and POC
Technical/Product Leadership
Business Leadership
Putting an emphasis on the formation of the company and the product at the special moment in time, when leaderships overlap
The value-core of the company is formed in
the window of overlapping leaderships
Scientists
Engineers
Business people
Privateandconfidential
Interdependent Leadership CathedralModelTM
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Privateandconfidential
Interdependent Leadership
Customer Development can still influence the core technology shaping
Very late Customer Development
TP
B
T
T
P
P
B
B
CathedralModelTM
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Itsneveraboutthecoolnessofyourtechnology.Itsonlyaboutit’susefulness(cathedral)
CathedralModelTM
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TPBarchitecturemodellingi. Circlerepresentsintuitiveprocessii. Trianglerepresentsanalyticalprocess
Technology
Product
Business
Astartupisatemporaryorganization,lookingforaVentureModelTM;anintegratedtechnology,productandbusinessarchitecture
CathedralModelTM
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TechnologyProduct Business
TPBarchitecturemodellingi. Connectedvesselsii. Keepthewaterline
CathedralModelTM
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Duocheck Validation build
How to communicate with investors about your technology readiness?A. Know the product development SOP - the only real map for de-
risking and technology readiness B. De-risking is the process of taking portions of uncertainty off
the table, one spoonful at a time C. Truth is the only sustainable language
Medical DevicesProduct Development & Manufacturing Duocheck Validation build
4.
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How to communicate with investors about your technology readiness?
VISIUS Intra-operative MRI by IMRIS
Makesscientificsense
Makesbusinesssense
MakesproductsenseMakesclinicalsense
MakesFDAsense
MakesMFCsense
Makescommercialsense
Concep
tion
Commercial
ValidateDevelopDefine
◇PR
S
◇DM
R
◇Alph
aBu
ild
◇Qua
lificationBu
ild
Creativity
Process
◇Va
lidationBu
ild
◇SR
S
◇Seria
lProdu
ction
◇PilotP
rodu
ction
◇PO
P
◇PO
C
◇Bu
sine
ss
Justificatio
n
Requ
iremen
ts
A. Do you have a requirements document? (user, technical, clinical, RA, QA, market) B. Do you have an Alpha prototype test report? C. Do you have a V&V test report? D. Do you have a DMR that has been validated? (Accepted/quoted by a CM) E. Have you completed your qualification build with a CM or internally?
Youarehere
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Doucheck
How much does it really cost to transfer a medical device into manufacturing?
Medical DevicesProduct Development & Manufacturing Fio, Deki Reader assembly line
5.
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How much does it really cost to transfer a medical device into manufacturing?
Closing off the design TransferManufacturing
ValidationBuild
DMRcloseoff
DesignTransferprocess NPI
QualBuild
Troubleshooting
CAPAs
ProductionQA
Purchasing
Stocking
PilotProduction
BOM+Markups
Warrantiesandserviceagreements
Volumepurchasing
Financing
ProductionQA
Recalls
Packaging
Logistics
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Paediatric Head coil
What are the two most valuable assets to develop in your medtech company?
A. Deep and profound knowledge of your customer’s pain B. Leadership skills for Capital-Efficient, Networked Teams
Medical DevicesProduct Development & Manufacturing
6.
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MOVES user testing
What are the three secrets to building a successful medical device?A. Requirements B. Requirements C. Requirements
Medical DevicesProduct Development & Manufacturing
7.
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MOVES user testing
How to know when to build internal capacity (institutional knowledge) and when to outsource
Three types of knowledge and capacity: 1. Core knowledge 2. Specialized knowledge 3. Generic knowledge
Medical DevicesProduct Development & Manufacturing Kangaroo team and office
8.
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D e s i g n , I n n o v a t i o n , M e d t e c h
ISO 13485 Certified
Lahav Gil
Thank You!Lahav Gil [email protected] mobile: 647 2975380