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Innovation & Commercialisation

Dr. Mark Bruzzi BioInnovate Ireland National University of Ireland Galway

Agenda • Introduction to BioInnovate Ireland • Defining Innovation • Perspectives on Medical Device Innovation •

Agenda

Introduction to BioInnovate Ireland Defining Innovation Perspectives on Medical Device Innovation Identifying Problems From Clinical Need to market opportunity Filters for Successful Medical Device Innovation Examples

Medical Technology Industry in Ireland • Ireland is home to a significant medical device industry cluster
Medical Technology Industry in Ireland • Ireland is home to a significant medical device industry cluster
Medical Technology Industry in Ireland
Medical Technology Industry
in Ireland

Ireland is home to a significant medical device industry cluster

(11 of top 13 Medical Device Companies are located in Ireland)

Approx. 250 Med Tech companies in Irl (50% indigenous), 25,000 people

Medical Technology Industry in Ireland • Ireland is home to a significant medical device industry cluster

Exports of over €7.2billion annually

BioInnovate Ireland • Medical Device Innovation Training Programme • BioInnovate Ireland is a consortia of 4
BioInnovate Ireland • Medical Device Innovation Training Programme • BioInnovate Ireland is a consortia of 4

BioInnovate Ireland

Medical Device Innovation Training Programme

BioInnovate Ireland is a consortia of 4 Universities

Medical, Engineering, Business Schools

(NUI Galway, UL, UCC, DCU)

Industry Sponsors : Medtronic, Boston Sci, Creganna Tactx, Lake Region Medical, Steripack

Activity:

GALWAY Dublin Limerick Cork
GALWAY
Dublin
Limerick
Cork

Fellowship:

 

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Why Medical Devices?

 

Biotech

Medtech

Technology

Drugs – Molecular / Genetic research

Devices, implants & Diagnostics

Company Examples

Pfizer

Medtronic,

MSD

Stryker

Product Development cycle

5-12 years

2-7 years

Capital

€300m - €1bil

€10-€100m

requirements

BioInnovate Ireland Fellows 2011 Fellows – CV Disease 2012 Fellows – Urology / Radiation Oncology

BioInnovate Ireland Fellows

BioInnovate Ireland Fellows 2011 Fellows – CV Disease 2012 Fellows – Urology / Radiation Oncology
BioInnovate Ireland Fellows 2011 Fellows – CV Disease 2012 Fellows – Urology / Radiation Oncology

2011 Fellows – CV Disease

2012 Fellows – Urology / Radiation Oncology

BioInnovate Ireland Fellowship • 10 month fellowship programme for medical device innovation • Based on Stanford
BioInnovate Ireland Fellowship • 10 month fellowship programme for medical device innovation • Based on Stanford

BioInnovate Ireland Fellowship

10 month fellowship programme for medical device innovation

Based on Stanford Biodesign programme: Identify – Invent – Implement

Active partnership between Academia, Industry and Clinicians

Building on existing strengths and activities in the MedTech Ecosystem Clinical Immersion - Provide an environment for Needs Identification Accessing Research centres Introduction to a Network of Leaders Mentorship from Industry, Clinicians, VCs

Learning by Doing!

BioInnovate Fellowship Programme Timeli Phase Phas Primary Outputs ne Description e Intensive Introduction “Bootcamp” I Identify
BioInnovate Fellowship
Programme
Timeli
Phase
Phas
Primary Outputs
ne
Description
e
Intensive Introduction
“Bootcamp”
I
Identify
5
Wk
200-300 “Needs”
Distil to
12-16
Identify
8
II
“ Needs Statements”
Wk
Clinical Immersion
Needs Identification
& Verification
Invent
8 Wk
Invent
8 - 12
III
Needs Screening
Proposed Concepts
Implement
12- 16
Implement
Wk
Solution Refinement
IV
2 - 4
Evolved Concepts

Clinical Area 2011/12:

Cardiology

Interventional

Cardiology

Cardiothoracic

Surgery

Vascular

Surgery

Clinical Area 2011/12: Cardiology Interventional Cardiology Cardiothoracic Surgery Vascular Surgery Ambulance – Croi Calls A&E -Triage

Ambulance – Croi Calls

Clinical Area 2011/12: Cardiology Interventional Cardiology Cardiothoracic Surgery Vascular Surgery Ambulance – Croi Calls A&E -Triage
A&E -Triage
A&E
-Triage
Clinical Area 2011/12: Cardiology Interventional Cardiology Cardiothoracic Surgery Vascular Surgery Ambulance – Croi Calls A&E -Triage
   

Wards

Wards
Clinical Area 2011/12: Cardiology Interventional Cardiology Cardiothoracic Surgery Vascular Surgery Ambulance – Croi Calls A&E -Triage

Cath-Lab

Cardiothoracic

surgery

Vascular

surgery

Clinical Area 2011/12: Cardiology Interventional Cardiology Cardiothoracic Surgery Vascular Surgery Ambulance – Croi Calls A&E -Triage
Clinical Area 2011/12: Cardiology Interventional Cardiology Cardiothoracic Surgery Vascular Surgery Ambulance – Croi Calls A&E -Triage
  • Non-invasive testing

  • Echo Stress Test

Specialist Units CCU

ICU HDU

Clinical Area 2011/12: Cardiology Interventional Cardiology Cardiothoracic Surgery Vascular Surgery Ambulance – Croi Calls A&E -Triage
Clinical Area 2011/12: Cardiology Interventional Cardiology Cardiothoracic Surgery Vascular Surgery Ambulance – Croi Calls A&E -Triage

Outpatients

-Diabetes

Cardiac

Cardiac

Rehab

Rehab
 

Physiotherapy

Occupational

Therapy

Clinical Area 2011/12: Cardiology Interventional Cardiology Cardiothoracic Surgery Vascular Surgery Ambulance – Croi Calls A&E -Triage

Specialist Clinics

-Cheat pain/Heart

Failure /Lipid/ Smoking

Cessation

Impact on MedTech Ecosystem

Generation of highly skilled graduates for the Irish MedTech

Sector

Increase in collaboration between Industry, Academia and

the Clinic

Help Connectivity generate a culture MedTech of innovation Cluster Sustainability ●

● Increased MedTech Value ● International

Competitiveness

Industry

Workforce Skills R&D capability

INDUSTR

Y
Y
Impact on MedTech Ecosystem  Generation of highly skilled graduates for the Irish MedTech Sector 

Connectivity for Innovation

Impact on MedTech Ecosystem  Generation of highly skilled graduates for the Irish MedTech Sector 

Academia

 

Clinic

Graduate Education

Patient-care

Structured PhD

HCPs

 

Translational Research

 

Healthcare

Specialist Training

Collaboration

Defining

Innovation

Defining Innovation … "Innovation is creativity with a job to do“ Innovation is people creating value

Defining Innovation …

"Innovation is creativity with a job to do“

Innovation is people creating value by implementing new ideas

Innovation = Invention + Exploitation

Innovation is a process that transforms ideas into outputs, which increase customer value

“Identifying and defining a problem to be solved”

Mir Imran, InCube

Framing the Problem “The formulation of a problem is far more essential than its solution, which

Framing the Problem

“The formulation of a problem is far more essential than its solution, which may be merely a matter of mathematical or experimental skills. To raise new questions, new possibilities, to regard old problems from a new angle requires creative imagination and marks real advances in science”

Albert Einstein

Perspectives on Medical Device Innovation

Philosophy • Everyone can innovate if given access to a great problem and a great team.

Philosophy

Everyone can innovate if given access to a great problem and a great team.

Innovation is a collaborative process that brings together multiple disciplines.

Innovation starts with a problem looking for a solution NOT with a solution looking for a problem.

Innovation is iterative: as you develop and test solutions you learn more about the problem.

Innovators should be willing to take risks, fail, and learn from their failures. Fail Fast and Fail Early

Aligning Objectives & Motivation Patient Benefit Vs Successful Business? Clinical need must have financial plan to

Aligning Objectives & Motivation

Patient Benefit Vs Successful Business?

Clinical need must have financial plan to get the solution to patients

i.e. Patient benefit + Market

Medical Device Innovation in Context You cannot have a successful medical product unless you can build
Medical Device Innovation in Context You cannot have a successful medical product unless you can build
Medical Device Innovation in
Context
You cannot have a successful medical product unless you can
build a sustainable (and preferably growing) business around
it

You need:

A patient who needs and wants the product

A provider who wants to use the product

Someone who will pay for the product

An organization that can develop, make, and deliver

the product at a profit

Someone willing to invest resources to develop the

product and build the business

Ross Jaffe, Versant Ventures, CA, USA

Medical device success is as much about business as it is about clinical issues or technology

Medical device success is as much about business as it is about clinical issues or technology

Technical/clinical innovation is necessary, but not sufficient

You must build a successful business around the technology

Ross Jaffe, Versant Ventures, CA, USA

Identifying

Problems

What Creates Medical Device Opportunities?

Unmet clinical need – diagnostic and/or therapeutic

New insight into physiology of a disease

New insight into diagnostic or therapeutic approach

Technological innovation that improves an existing diagnostic

or therapeutic approach

Change in healthcare delivery system that creates pressure to

change diagnostic or therapeutic approach

Some combination of the above

Ross Jaffe, Versant Ventures, CA, USA

Where can Clinical Needs by Identified? Patient Morbidity Invasive Surgery Blood, pain, infection ICU Long recovery

Where can Clinical Needs by Identified?

Patient Morbidity

Invasive Surgery Blood, pain, infection

ICU Long recovery “Inoperable”

Poor Outcomes

Low success rates High / expensive reintervention rates Complications

Expensive Treatments

Cost vs Effectiveness

Cost vs Effectiveness

Cost vs Effectiveness
Understanding the Problem • What are the signs and symptoms? • Who are the patients? •

Understanding the Problem

What are the signs and symptoms? Who are the patients? How many patients are there? How and where do the Patients present? What is the Flow of care? Current treatments: Are they addressing the actual problem without causing additional complications? Will you target the cause or the effects?

Identifying Problems Observation Problem Identification Need Statement A statement that focuses on the goal or endpoint

Identifying Problems

Observation

 
Observation Problem Identification Need Statement

Problem

Identification

   
 
Observation Problem Identification Need Statement

Need Statement

A statement that focuses on

the goal or endpoint not the

problem

“The genetic code of the

solution”

Define a Needs Statement Focus On Goal, Not Problem • Need Statement: “A way to close

Define a Needs Statement

Focus On Goal, Not Problem

Need Statement: “A way to close sternotomy without risk of sternal-wire breaking.”

Focuses on sternal-wire, closes out other approaches

Focuses on part of the procedure that doesn’t deliver result

Good: “A way to close sternotomy quickly and securely.”

Better: “A way to perform CABG without ”

t

t

Get Specific Define a Needs Statement • Need Statement: “A way to improve outcome of spine

Get Specific

Define a Needs Statement

Need Statement: “A way to improve outcome of spine surgery.”

Not clear which surgery, initial diagnosis, or how to improve

Better: “A way to reduce risk of re-herniation after lumbar discectomy for sciatica.”

Clear about procedure, diagnosis and complication

Why Needs Identification / Specification is so Important Needs Innovation → Product Innovation • Guides Brainstorming

Why Needs Identification / Specification is so Important

Needs Innovation → Product Innovation

Guides Brainstorming Facilitates Concept Screening Forms part of IP strategy Focusses Clinical Trial Guides Marketing Basis for reimbursement argument

Getting it wrong is really bad & expensive!

Greg Lambrecht, Intrinsic

Desired Outcomes - Objectives Desired Outcomes As measured by … Improved Clinical Efficacy Treatment Success Rates
Desired Outcomes - Objectives Desired Outcomes As measured by … Improved Clinical Efficacy Treatment Success Rates
Desired Outcomes -
Objectives
Desired Outcomes
As measured by …
Improved Clinical
Efficacy
Treatment Success Rates in
Clinical Trials
Increased Patient
Safety
Rate of adverse events in clinical
trials
Reduced Cost
Total cost of procedure relative to
available alternatives
Improved Physician/
facility productivity
Time and resource required to
perform the procedure
Improved physician
ease of use
Solution of complexities
Improved patient
convenience
Frequency and occurrence of
required treatment, change in
treatment venue

Ross Jaffe, Versant Ventures, CA,

USA

From Clinical Needs to Market Opportunities:

The Big Questions

The Big Questions

Funding Market Competition Regulatory Reimbursement Stakeholders IP Sales Technology Clinical Strategy
Funding
Market
Competition
Regulatory
Reimbursement
Stakeholders
IP
Sales
Technology
Clinical Strategy

Determining the ‘Right Need’

(1) Disease State

Understanding Causes (Biology to molecular level)

Effects & Symptoms (Patient Impact: Pain, Mortality) Classical Patient Populations & Sub-classical cohorts

(2) Market

Size & Trends Severity & Impact on the patient population Current Treatments

(3)Technology

(4) Stakeholders

Available Technology: Existing & Emerging

Status of the competition in this space: Patents, IP

etc

What are the barriers to technology advancement

Identify the Decision makers/Purchasing power

Who are the Key Opinion Leaders & Health Care Providers

Identifying Opportunities
Identifying Opportunities
Identifying Opportunities
Large Market Opportunity Market Size = # of Patients X $ per Patient How large a

Large Market Opportunity

Market Size = # of Patients X $ per Patient How large a market is attractive?

Market size has to be considered in light of capital

required to

get product to cash flow breakeven

“Rule of Thumb”:

“Rule of Thumb”:

In general, an attractive market size is, at minimum,

In general, an attractive market size is, at minimum,

10X capital required to get product to cash flow

10X capital required to get product to cash flow

breakeven

breakeven

Intellectual Property Is your concept: •Novel? •A method or a product / technology? •Can it be

Intellectual Property

Is your concept:

•Novel? •A method or a product / technology? •Can it be protected (patentable)?

Does your concept have Freedom to Operate?

•When / where should you protect a concept?

First to file, costs, where

Technology Vs Science •What are you trying to achieve? •In what timeframe? Patient Benefit Vs Market

Technology Vs Science

•What are you trying to achieve? •In what timeframe?

Patient Benefit Vs Market Opportunity

Or

Patient Benefit + Market Opportunity

Leveraging Existing Technology is quicker!

Regulatory Affairs •FDA • Class I → Device Exemption Pathway • Class II → 510(k) Pathway

Regulatory Affairs

•FDA

• Class I → Device Exemption Pathway

• Class II → 510(k) Pathway

• Class III → Premarket Approval (PMA) pathway

•Europe (Medical Device Directive)

• Class I

• Class IIa

• Class IIb

• Class III

What is the burden of proof required?

Approx: 5 years for 510 (k) device Approx: > 8 years for PMA device

Stakeholders & Gap Analysis •Who are the Stakeholders? •How will they be affected? •How influential are

Stakeholders & Gap Analysis

•Who are the Stakeholders? •How will they be affected? •How influential are they? • Effects of your innovation on patient/ clinician/ buyer/ payer/ supplier/manufacturer in terms of benefits and costs/turf wars etc

•What ‘gap’ are you targeting?

Filters for Successful Medical Device Innovation

Needs Finding and Early Concept Assessment

Needs Finding and Early Concept Assessment sch, J. B., Pate-Cornell, M. E., Yock, P. G., Aquino,

sch, J. B., Pate-Cornell, M. E., Yock, P. G., Aquino, L. M., Linehan

cal Device Development Process, Journal of Medical Devices 3:

Why Med Tech’s Fail • Product doesn’t work • No one willing to pay for it

Why Med Tech’s Fail

Product doesn’t work

No one willing to pay for it

Not enough patients

• Bad IP, management, luck

Bad Need!

• The FDA & US-only strategy

The Cost of Failure • $10-$200 million • 20-120 people’s time • Between 3-20 years •

The Cost of Failure

$10-$200 million

20-120 people’s time

Between 3-20 years

3-25% of your life

Solve the right need!

Successful Medical Device Innovations ‘Ticking the Boxes’ • Device addresses an important clinical need well •

Successful Medical Device Innovations

‘Ticking the Boxes’

• Device addresses an important clinical need well

• Large market with attractive market dynamics

• Reasonable clinical and regulatory pathway

– Clinical proof required for FDA

– Clinical proof required for market

• Reasonable path to attractive reimbursement

• Proprietary technology

• Knowledgeable and experienced management

• Reasonable capital requirements to achieve positive

cash flow from product

Resources

Text: Biodesign

By Zenios, Makower, Yock

Resources • Text: Biodesign By Zenios, Makower, Yock • <a href=www.ebiodesign.org • www.bioinnovate.ie " id="pdf-obj-46-25" src="pdf-obj-46-25.jpg">
BioInnovate Classes BioInnovate I • Identifying Problems Needs Finding, Needs Filtering • Inventing Solutions Concept Generation,info@bioinnovate.ie " id="pdf-obj-47-2" src="pdf-obj-47-2.jpg">

BioInnovate Classes

BioInnovate I

Identifying Problems

Needs Finding, Needs Filtering

Inventing Solutions

Concept Generation, Concept Selection

BioInnovate II

Implementation

Project development strategies and planning

For More Information Contact info@bioinnovate.ie

Thanks!