Innovation & Commercialisation

Dr. Mark BruzziBioInnovate Ireland

National University of Ireland Galway

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

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

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

•Exports of over €7.2billion annually(8% of Total Irish Exports)

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:• Fellowship:• Modular Industry / Graduate Training

GALWAY

Limerick

Cork

Dublin

Why Medical Devices?

Biotech Medtech

Technology Drugs – Molecular / Genetic research

Devices, implants & Diagnostics

Company Examples PfizerMSD

Medtronic,Stryker

Product Development cycle

5-12 years 2-7 years

Capital requirements

€300m - €1bil €10-€100m

BioInnovate Ireland Fellows

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

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!

Phase

Primary OutputsPhase Description

Timeline

I

III

IV

5 Wk

8 Wk

II

8 Wk

Identify

Invent

Implement

Invent8 - 12

Proposed Concepts

Implement2 - 4

Evolved Concepts

12- 16 Wk

Identify200-300 “Needs”

Distil to 12-16

“ Needs Statements”

Intensive Introduction “Bootcamp”

Needs Screening

Clinical ImmersionNeeds Identification

& Verification

Solution Refinement

BioInnovate Fellowship Programme

Clinical Area 2011/12: Cardiology Interventional

CardiologyCardiothoracic

SurgeryVascular Surgery

Ambulance – Croi Calls

A&E-Triage Wards

Specialist UnitsCCUICUHDU

Non-invasive testingEcho

Stress Test

Cath-Lab

Cardiothoracic surgery

Vascular surgery

Cardiac Rehab Physiotherapy

Occupational Therapy

Outpatients-Diabetes

Specialist Clinics -Cheat pain/Heart Failure /Lipid/ Smoking Cessation

INDUSTRY

Impact on MedTech Ecosystem

IndustryWorkforce SkillsR&D capability

Connectivity for Innovation

ClinicPatient-care

HCPsHealthcare

Collaboration

AcademiaGraduate Education

Structured PhDTranslational Research

Specialist Training

Connectivity ● MedTech Cluster Sustainability ● ● Increased MedTech Value ● International Competitiveness

Generation of highly skilled graduates for the Irish MedTech Sector Increase in collaboration between Industry, Academia and the Clinic Help generate a culture of innovation

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

Defining Innovation …

“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

Framing the Problem

http://www.nuigalway.ie/

Perspectives on Medical Device Innovation

• 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

Philosophy

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 a sustainable (and preferably growing) business around it

You need:

Ross Jaffe, Versant Ventures, CA, USA

• 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

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

23

Ross Jaffe, Versant Ventures, CA, USA

Where can Clinical Needs by Identified?

Patient MorbidityInvasive SurgeryBlood, pain, infectionICULong recovery“Inoperable”

Poor OutcomesLow success ratesHigh / expensive reintervention ratesComplications

Expensive Treatments

Cost vs Effectiveness

• 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?

Understanding the Problem

Identifying Problems

Observation

Problem Identification

Need Statement

A statement that focuses on the goal or endpoint not the problem“The genetic code of the solution”

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 sternotomy.”• Best: “A way to revascularize heart muscle without access

morbidity.”

Define a Needs Statement

Get Specific

• 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

Define a Needs Statement

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!

Why Needs Identification / Specification is so Important

Greg Lambrecht, Intrinsic Therapeutics

Desired Outcomes - ObjectivesDesired 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

Accelerated patient recovery Length of hospital stay, recovery period, and/or days out of work

Ross Jaffe, Versant Ventures, CA, USA

From Clinical Needs to Market Opportunities:

The Big Questions

The Big Questions

Market

Regulatory

Stakeholders

Sales

Clinical StrategyTechnology

IP

Reimbursement

Competition

Funding

(2) Market

(1) Disease State•Understanding Causes (Biology to molecular level)•Effects & Symptoms (Patient Impact: Pain, Mortality)•Classical Patient Populations & Sub-classical cohorts

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

Determining the ‘Right Need’

(4) Stakeholders

(3)Technology

•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

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”:In general, an attractive market size is, at minimum,10X capital required to get product to cash flowbreakeven

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 OpportunityOrPatient Benefit + Market Opportunity

Leveraging Existing Technology is quicker!

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) deviceApprox: > 8 years for PMA device

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

43

Needs Finding and Early Concept Assessment

Pietzsch, J. B., Pate-Cornell, M. E., Yock, P. G., Aquino, L. M., Linehan, J. H., Medical Device Development Process, Journal of Medical Devices 3: 2009

• Product doesn’t work• No one willing to pay for it• Not enough patients

• Bad IP, management, luck• The FDA & US-only strategy

Why Med Tech’s Fail

Bad Need!

• $10-$200 million

• 20-120 people’s time

• Between 3-20 years

• 3-25% of your life

The Cost of Failure

Solve the right need!

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

• Text: Biodesign By Zenios, Makower, Yock

• www.ebiodesign.org

• www.bioinnovate.ie

Resources

BioInnovate ClassesBioInnovate 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!