Innovation &

Commercialisation
Dr. Mark Bruzzi
BioInnovate 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

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:

GALWAY
Limerick

Cork

Dublin

Why Medical Devices?

Biotech

Medtech

Technology

Drugs Molecular /
Genetic research

Devices, implants &

Diagnostics

Company Examples

Pfizer
MSD

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!

Timeli
ne
5
Wk

BioInnovate Fellowship
Programme

Phase
Description

Phas
e

Intensive IntroductionI
Bootcamp

Primary Outputs
Identify
200-300 Needs
Distil to

8
Wk

Clinical Immersion
II
Needs Identification
& Verification

12-16
Needs Statements

Invent

8 Wk

Needs Screening
12- 16
Wk

Identify

III

Solution Refinement IV

Invent

8 - 12
Proposed Concepts

Implement

Implement
2-4
Evolved Concepts

Clinical Area 2011/12:

Cardiology
Interventional
Cardiology

Cardiothoracic
Surgery

Ambulance
Croi Calls

A&E
-Triage

Specialist Units
CCU
ICU
HDU

Vascular
Surgery

Wards
Cath-Lab

Cardiothoracic
surgery

Non-invasive testing
Echo
Stress Test

Vascular
surgery
Cardiac
Rehab

Physiotherapy
Occupational
Therapy

Outpatients
-Diabetes
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
Connectivity
MedTech
Cluster Sustainability
Help
generate aculture
of innovation
Increased MedTech Value International
Competitiveness
Industry
Workforce Skills
INDUSTR
R&D capability
Y Connectivity for Innovation

Academia
Graduate Education
Structured PhD
Translational Research
Specialist Training

Clinic
Patient-care
HCPs
Healthcare
Collaboration

Defining
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

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.
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
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:
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
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
23

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

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 not the
problem
The genetic code of the
solution

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 doesnt
deliver result
Good: A way to close sternotomy quickly and
securely.
Better: A way to perform CABG without

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

Why Needs
Identification /
Specification is so
Needs Innovation Product Innovation
Important

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 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
Competition

Market
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
Size & Trends

(2) Market

Severity & Impact on the patient population

Current Treatments
Available Technology: Existing & Emerging

(3)Technology

Status of the competition in this space: Patents, IP

etc
What are the barriers to technology advancement

(4) Stakeholders

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 flow
breakeven

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 Opportunity
Or
Patient 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) device

Approx: > 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

Needs Finding and Early Concept

Assessment

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

cal Device Development Process, Journal of Medical Devices 3: 2
43

Why Med Techs Fail

Product doesnt work
No one willing to pay for it
Not enough patients
Bad IP, management, luck
The FDA & US-only strategy

Bad Need!

The Cost of Failure

$10-$200 million
20-120 peoples 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
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

www.ebiodesign.org
www.bioinnovate.ie

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!