Planning and Executing the Product Development and Manufacture of Medical Devices - MaRS Best...

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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

XOR Labs Toronto

Commercializing Medical DevicesA. Evidence based adoption B. Heavily regulated C. Health economics D. About 10 years

Medical DevicesProduct Development & Manufacturing

XOR Labs Toronto

Medical DevicesProduct Development & Manufacturing Howdoyougetfromthis?(technology)

tothis?(product)

tothis?(business)

VISIUS Intra-operative MRI by IMRIS

What is an ISO 13485 QMS? And can you commercialize a med device without one?


1.

A. ISO 13485 compliant QMS (FDA, HC, CE) B. No C. Yes (if you accelerate through leaning on an existing system)


What makes a medical device, a medical device?The SOP for medical devices product development

Medical DevicesProduct Development & Manufacturing Ultrasonix Medical, Ergosonix 500

2.


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


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


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

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


3.

Application

Distribution

Invention

CathedralModelTM

MBA.Speak

Threedistinctdimensionstoatechnologyinnovationventure

Technology

ProductBusiness Application

Distribution

Invention

Therelationshipiskey.Therelationshipbetweenthesedimensionsisofconcentricspheres,oneimmersedintheother,onesurroundedbytheother.Effectivelyactingascascadingwombsthroughwhichanideaorinventionisbornintotheworldandhasimpactinpeople’slife.

Lay.Speak

CathedralModelTM

Scientists

EngineersBusiness folk

The “cultural” divide

CathedralModelTM

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

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

The Cathedral Model story….Two stone masons chipping away at a pile of rocks…

CathedralModelTM

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

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

Stakeholders

User

Meaningful and relevant need

Customer

Advocate groups

Employees

Economics

Shareholders

Nurse

Surgeon

Partnerships

Payers

Brand enthusiasts

Direct decision maker

CathedralModelTM

Insurers

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

Businesstypes,businessstages

TP

B

CathedralModelTM

Product leader

Technology leader/inventor

Business Leader/management/marketing

CathedralModelTM

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

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

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

Itsneveraboutthecoolnessofyourtechnology.Itsonlyaboutit’susefulness(cathedral)

CathedralModelTM

TPBarchitecturemodellingi. Circlerepresentsintuitiveprocessii. Trianglerepresentsanalyticalprocess

Technology

Product

Business

Astartupisatemporaryorganization,lookingforaVentureModelTM;anintegratedtechnology,productandbusinessarchitecture

CathedralModelTM

TechnologyProduct Business

TPBarchitecturemodellingi. Connectedvesselsii. Keepthewaterline

CathedralModelTM

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.

How to communicate with investors about your technology readiness?


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

Doucheck

How much does it really cost to transfer a medical device into manufacturing?

Medical DevicesProduct Development & Manufacturing Fio, Deki Reader assembly line

5.

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

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


6.

MOVES user testing

What are the three secrets to building a successful medical device?A. Requirements B. Requirements C. Requirements


7.

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

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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

mailto:[email protected]

Planning and Executing the Product Development and Manufacture of Medical Devices - MaRS Best...

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