Medical devices – partnering for success

Karen Reynolds

Professor of Biomedical EngineeringDirector, Medical Device Partnering Program

Medical Device Innovation & Collaboration• Medical device industry - innovative, highly diversified,

competitive, dominated by SMEs; R&D inherently multidisciplinary

• Australia - high research expertise, poor innovation/commercialisation history (nationally)

• Need for improvement in collaboration between research institutions and local industry has been identified

Unfortunately for SMEs, there is neither a single model for interaction with a particular institution, nor a single clearing house representing them all. The task for SMEs in identifying, contacting, learning how to deal with and successfully negotiating collaboration or technology transfer deals with a particular RO is too time consuming for most to justify.

AIC Discussion Paper - ‘Overcoming the Industry - Research Sector Divide’

The Medical Device Partnering Program (MDPP)The MDPP increases innovation through improved collaboration •Provides an entry point for SMEs wanting to work with research organisations, researchers interested in working with local companies, and clinicians wanting to work with either•Develops, co-ordinates and manages those relationships •Undertakes early-stage technical exploration projects to develop concept models, demonstrate product potential and establish relationships •Encourages on-going collaborative research

Project Workshop / Project Plan

Project Summary Next Steps

Preliminary Meeting

•Clinicians or client service groups identify needs

•Companies identify potential pipeline products

•Does this project meet the criteria?

•How can the MDPP add value to this project?

MDPP

Product Opportunity Assessment

Preliminary Meeting

Project Workshop / Project Plan

Project Summary Next Steps

Product Opportunity Assessment

•Is this product really needed? Who is it a need for? Why is it a need?

•Is there a market? How big is the potential market?

•Can the MDPP team add value to this idea?

•Decision to accept project into MDPP

MDPP

Preliminary Meeting

Product Opportunity Assessment

Project Summary Next Steps

Project Workshop / Project Plan

•Multidisciplinary brainstorming

•How can the problem be overcome?

•What functions will the product have?

•What user requirements need to be addressed?

MDPP

Preliminary Meeting

Product Opportunity Assessment

Project Workshop / Project Plan

The MDPP brought together a multi-skilled team who workshopped the project to a level unachievable by any other scheme in Australia.

Matt HarrisTM Ventures

Project Workshop / Project Plan

Summary Next Steps

Project

•6 – 8 weeks full-time

•Dedicated Research Officer

•Access to diverse research expertise & facilities

•Proof-of-concept, prototype development, feasibility studies

MDPP

Preliminary Meeting

Product Opportunity Assessment

Project

Project Workshop / Project Plan

Project Summary Next Steps

Summary

•Commercial Viability Assessment, results, plan for further development

•What further research needs to be undertaken?

•How can further research be funded? e.g. ARC-Linkage

MDPP

Preliminary Meeting

Product Opportunity Assessment

Project Workshop / Project Plan

Project Summary Next Steps

Next Steps

•Further product development

•Funding

•Product to market

MDPP

Preliminary Meeting

Product Opportunity Assessment

Facts, figures etc• Over 100 approaches by companies / inventors since July

2008 (predominantly SA-based)• 47 companies / inventors assisted:

− 10 new prototype medical devices designed, developed and constructed;

− 9 proof-of-concept / technical validation studies undertaken; − 9 companies provided with expert technical consultation &

advice; − 17 companies provided with input from end-users or market

advice; − 27 introductions / linkages made for product commercialisation.

Who do we work with?• Start-up Companies: MDPP provides concept models,

undertakes feasibility studies, establishes product viability

• Early Stage Companies: MDPP provides independent product validation to assist in TGA approval and to improve sales and marketing outcomes

• Established Companies: MDPP assists established companies by investigating new product opportunities

• Technology Transfer & Spin-outs: MDPP works with University commercial arms to assist in the commercialisation of University-based research

Case Study 1 – Start-up company• RemoBelt - provides protection to

prevent pressure sores; developed by Aged Care nurse

• MDPP undertook evaluation of pressures experienced with or without the belt, through UniSA’s Ergolab

• MDPP made introductions to various manufacturers and potential distributors

• Company formed; application for commercialisation funds submitted

Case Study 2 – Early stage company• StaminaLift: MDPP independently validated

effectiveness of their powered bed mover• Data used for marketing in Europe• Researchers from the UniSA’s Ergolab

undertook study at Flinders Medical Centre• Follow-up research project• MDPP introduced StaminaLift and RemoBelt;

shared market information and bed

“Access to the bed has been very beneficial for our study, and we are thankful to StaminaLift for this introduction.”

Remo Di SottoRemo Belt

Case Study 3 – Established company• rL Solutions – Canadian-based company

specialising in software for risk management and infection control

• MDPP designed, constructed and installed prototype hand washing detection product into local hospital

• System provides data to enable further development of their infection alert system

• Project resulted in a successful Linkage Grant from the Australian Research Council

“MDPP rocks!”Phil CheneyDirector, Australasian office

Case Study 4 – University spin-out• Re-Time glasses use bright light therapy to assist in the

treatment of insomnia, jet lag and SAD • MDPP designed & built a low cost market entry product that

utilises existing safety glasses incorporating new electronics• Low volume production option, to grow market acceptance

ahead of a full release• Introductions to manufacturer, designer, regulatory strategy

“the low volume production model will allow Re-Time Pty Ltd to introduce their glasses into the professional market and allow us to test consumer feedback and gain acceptance from sleep professionals. It’s a strategy that would be hard to achieve without the MDPP”

Anthony FrancisManaging Director

What we’ve learnt

• Inventors often have poor understanding of path to market• Takes a long time to tease out best value-add• Common lack of engagement with end-users (‘technology

push’)• Companies very willing to engage with research

organisations & vice-versa (deal flow continues)

The MDPP has, and is, successfully breaking through traditional cultural differences and provides a pathway for companies and the University to communicate and work together in a way that was previously achieved only rarely.

Andrew Riggs, Healthcare Industry Development Manager, Innovate SA

MDPP outcomes

• Barriers between companies & research institutions reduced• Collaborations established between research organisations• Companies have a single point of contact to access the

expertise they require• University research is more application-focussed• Practical outcomes achieved• MDCP announced in SA• MDPP nationally recognised

Making plans to extend to a National Model

The MDPP is possibly the best model for fostering University/Industry collaboration that I have encountered in an Australian University

Dr Steven FarrugiaVice President Technology, ResMed Ltd