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Ideagen Workshop

                                          Dr Peter Donnelly
                                          Chief Executive Officer
                                          BioBusiness Ltd.

                                          Chief Technology Officer
                                          Bluescope Medical Technologies Ltd.




Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Background
  Development of Medical Device and Technology Platform

          Bluescope                           Bluescope
                           IQ Medical
           Medical                             Medical                              Axellis
                            Systems
         Technologies                        Technologies




         Support to the Life and Health Technology Sector


              IQ Solutions                      BioBusiness


Life and Health Technologies Sector in Ireland
                                                Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Bluescope Medical Technologies
  First patent filed in 2002
  Bluescope established as QUB spin-out in 2004.
  Partner (CEO) and I bought out other parties in
  2006.
  Opened office in Lisburn May 2006
  Funded by Invest NI April 2007
  Acquired by Axellis in November 2007
  HQ London, 3 offices in the US, 1 office SW
  England, 1 office in NI.
  Axellis Product Platforms:
   •   Compensators and Immobilisers for Radiotherapy
       Treatment.
   •   Cardio-respiratory Platform for Vital Sign Monitoring


Life and Health Technologies Sector in Ireland
                                                       Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Clinical Need – Critical Care
                                                       Acute Trauma Patient
  Non-invasive and unobtrusive
  Continuously monitor lung sounds
  to assess respiratory condition.
  Identify trends in disease, and
  treatment states.
  Provide an ‘easy-view’ user
  interface to provide real time
  feedback on lung condition.
  Provide access to key respiratory
  sites.
  Diagnostically consistent.




Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Nightingale® Monitor




                                                                  Provides continuous visual
                                                                  anatomical representation of
                                                                  lung condition, respiratory rate
                                                                  and trended information




Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Clinical Need – General Ward
                                                        Deteriorating Patient
  Respiratory condition and rate is
  an important vital sign & an
  indicator of deterioration.
  Increasing prevalence of
  respiratory conditions in aging
  patients.
  Provide a glanceable user interface
  for real-time feedback of lung
  condition for nursing support.
  Hospital Scoring Systems to
  identify at-risk patients.
  Wireless capability



Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Clinical Need – Home-Based
                                                 Chronically Ill Aging Patient
  Reduction in hospital admissions,
  hospital bed days and A&E visits.
  Healthcare cost savings.
  Improved quality of life for aging
  and chronically ill patients.
  Improved disease management
  and life trending analysis.
  Carer alert facility.
  Integration into telemedicine and
  telecare systems.
  Wireless capability




Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Problems with current solutions
  Entirely subjective.
  Quantification difficult.
  Cross infection.
  Lack of access.
  Poorly recorded.
  No continuous trend assessment.
  Difficulty operating in noisy environments.
  No continuous, unobtrusive, robust method
  of assessing respiratory condition currently
  exists.




Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Key Lessons Learned
  Academic prototypes are not ready for market.
  Clinicians do not make good business people.
  Business conditions and models are constantly
  changing.
  Investment timelines are much much longer than
  you anticipate.
  1 Golden Rule –
         He who has the gold makes the rule.


Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

BioBusiness
  Established May 2004 as Northern Ireland organisation
  All-Island organisation in 2010 with All-Island membership
  Sector representation covers:
   •   Medical Devices, Diagnostics, Pharmaceuticals, Biotechnology, Agri-Foods and
       Support Companies
  Funding Support
   •   Invest NI, InterTradeIreland & Enterprise Ireland
   •   Dept Employment & Learning (NI)
   •   European (FP7, NPP, Interreg, Eurostars)
  Capability
   •   Trained facilitators
   •   Experienced project managers
   •   Clinical advisor on staff



Life and Health Technologies Sector in Ireland
                                                       Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Strategic Goals
  Provide a strong advocacy role for the industry.
  Contribute to the competitiveness and size of Life
  and Health Technology Sector in Ireland.
  Facilitate and broker opportunities in innovation
  and collaboration.
  Play an industrial role in the skills development of
  the Sector.
  Champion Ireland and UK Connected Health and
  Personalised Medicine activities.

Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Programmes & Initiatives
  Current Programmes
   •   ABC Collaborations
   •   Medical Devices in Connected Health
   •   ABC Ireland                                                                   ABC
                                                                                     Ireland
   •   Healthy Living
   •   Medilink UK
   •   Health Tech & Medicines KTN
   •   Skills Academy
  Connected Health Initiatives
   •   All-Island Connected Health Review
   •   Connected Health Clinical Trials
   •   UK Connected Health @ IBIZ
   •   All-Island Connected Health Mission to Boston

Life and Health Technologies Sector in Ireland
                                                 Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

ABC Innovation Model
                             Academia                Clinical

                                                                                              HSC Innovations
 Universities /                                                                               HSC R&D Office
 Colleges and                                                                                 RCS in Ireland
 Institutes of                                                                                RCP in Ireland
 Technology                                                                                   GP Consortia
                                    Priority Areas



Priority areas have strong                                                       Connected Health and
All-Island capability                                                            Personalised Medicine
                                                                                 Healthy Living
                                        Business
           BioBusiness &
              Members
                                   ABC Interface


Life and Health Technologies Sector in Ireland
                                                          Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

ABC Innovation Model
                             Academia                Clinical

                                                                                              Identify Clinical
 Applied research
                                                                                              Need
 for medium term
                                                                                              Provide Clinical
 innovation.
                                                                                              Efficacy
 Blue skies
                                                                                              Early Adopters
 research for long
 term innovation
                                    Priority Areas



Priority areas have strong                                                       Connected Health and
All-Island capability                                                            Personalised Medicine
                                                                                 Healthy Living
                                        Business
                Commercial
                Regulatory
                 Approved          ABC Interface
                 Products



Life and Health Technologies Sector in Ireland
                                                          Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Innovation
  Key to any Innovation Strategy is the correct insights and
  knowledge of the:
   •   Market,
   •   Customer base,
   •   Technologies,
   •   Regulatory environment and
   •   Internal capability.
  Collaboration is often the easiest way to gain knowledge,
  find solutions and source capability.
  Successful ABC collaborations are very important to
  successful commercial opportunities and initiatives.

Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Capability Building


                                                                                         Sales and
                                                                                         Marketing
                                                               Clinical Trials
                                                               • Statistical
                                                                 Requirements
                                            Regulatory         • Trial Protocols
                                            Environment        • Ethics Approval
                                            • FDA, MDD, GxP,

                               Investment




             Innovation
             • Insights
             • Collaboration
             • Intellectual
               Property




Life and Health Technologies Sector in Ireland
                                                                        Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Academic & Clinical Engagement
  Altnagalvin Hospital
  Beacon Hospital
  Beaumont Hospital
  Belfast Hospital Trust
  Cork University Hospital
  Craigavon Area Hospital
  HSC Innovation and R&D Division
  Nenagh Hospital
  RCSI & RCPI
  St James’ Hospital
  St Vincent’s Hospital
  Tallaght Hospital
  Ulster Hospital
  General Practitioners (GPs)



Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

BioBusiness Projects
  Doctor Office Laboratory
  Cardiac Care in the Community
  Connected Health Monitoring Centre
  Addressing Rural Isolation using Telecare
  Clinical Trial Network
  Remote Vital Sign Monitoring
  mHealth Applications for Mental Illness
  Stroke Screening
  Thrombolysis Automated Work Practice
  Respiratory Database Development
  Tissue Sample Database



Life and Health Technologies Sector in Ireland
                                              Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

McElwaine Smart Case Study
  McElwaine Smart offers tele-health and
  tele-care solutions.
  International partnership established
  with Bosch GmbH.
  Academic research collaborations
  established with UU, QUB, DkIT and
  Limerick University.
  Commercial links established with
  McElwaine SMART, Friendly Call Service.
  Invested £3.5 million in new staff,
  products, infrastructure and marketing.
  Leverage of funding ratio 1:35



Life and Health Technologies Sector in Ireland
                                             Copyright © 2010 BioBusiness Ltd.
Ideagen Workshop

Intelesens Case Study
  Intelesens company providing remote vital
  sign monitoring devices.
  First home-based clinical trial.
  Clinical trial protocols developed and ethics
  approval achieved.
  Commercial links established between
  device company and communication
  platform company –Valentia Technologies.
  Invested £800,000 with public grant
  support.
  Leverage of funding ratio 1:30




Life and Health Technologies Sector in Ireland
                                              Copyright © 2010 BioBusiness Ltd.

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Dr peterdonnellybiobusinessei letterkenny

  • 1. Ideagen Workshop Dr Peter Donnelly Chief Executive Officer BioBusiness Ltd. Chief Technology Officer Bluescope Medical Technologies Ltd. Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 2. Ideagen Workshop Background Development of Medical Device and Technology Platform Bluescope Bluescope IQ Medical Medical Medical Axellis Systems Technologies Technologies Support to the Life and Health Technology Sector IQ Solutions BioBusiness Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 3. Ideagen Workshop Bluescope Medical Technologies First patent filed in 2002 Bluescope established as QUB spin-out in 2004. Partner (CEO) and I bought out other parties in 2006. Opened office in Lisburn May 2006 Funded by Invest NI April 2007 Acquired by Axellis in November 2007 HQ London, 3 offices in the US, 1 office SW England, 1 office in NI. Axellis Product Platforms: • Compensators and Immobilisers for Radiotherapy Treatment. • Cardio-respiratory Platform for Vital Sign Monitoring Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 4. Ideagen Workshop Clinical Need – Critical Care Acute Trauma Patient Non-invasive and unobtrusive Continuously monitor lung sounds to assess respiratory condition. Identify trends in disease, and treatment states. Provide an ‘easy-view’ user interface to provide real time feedback on lung condition. Provide access to key respiratory sites. Diagnostically consistent. Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 5. Ideagen Workshop Nightingale® Monitor Provides continuous visual anatomical representation of lung condition, respiratory rate and trended information Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 6. Ideagen Workshop Clinical Need – General Ward Deteriorating Patient Respiratory condition and rate is an important vital sign & an indicator of deterioration. Increasing prevalence of respiratory conditions in aging patients. Provide a glanceable user interface for real-time feedback of lung condition for nursing support. Hospital Scoring Systems to identify at-risk patients. Wireless capability Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 7. Ideagen Workshop Clinical Need – Home-Based Chronically Ill Aging Patient Reduction in hospital admissions, hospital bed days and A&E visits. Healthcare cost savings. Improved quality of life for aging and chronically ill patients. Improved disease management and life trending analysis. Carer alert facility. Integration into telemedicine and telecare systems. Wireless capability Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 8. Ideagen Workshop Problems with current solutions Entirely subjective. Quantification difficult. Cross infection. Lack of access. Poorly recorded. No continuous trend assessment. Difficulty operating in noisy environments. No continuous, unobtrusive, robust method of assessing respiratory condition currently exists. Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 9. Ideagen Workshop Key Lessons Learned Academic prototypes are not ready for market. Clinicians do not make good business people. Business conditions and models are constantly changing. Investment timelines are much much longer than you anticipate. 1 Golden Rule – He who has the gold makes the rule. Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 10. Ideagen Workshop BioBusiness Established May 2004 as Northern Ireland organisation All-Island organisation in 2010 with All-Island membership Sector representation covers: • Medical Devices, Diagnostics, Pharmaceuticals, Biotechnology, Agri-Foods and Support Companies Funding Support • Invest NI, InterTradeIreland & Enterprise Ireland • Dept Employment & Learning (NI) • European (FP7, NPP, Interreg, Eurostars) Capability • Trained facilitators • Experienced project managers • Clinical advisor on staff Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 11. Ideagen Workshop Strategic Goals Provide a strong advocacy role for the industry. Contribute to the competitiveness and size of Life and Health Technology Sector in Ireland. Facilitate and broker opportunities in innovation and collaboration. Play an industrial role in the skills development of the Sector. Champion Ireland and UK Connected Health and Personalised Medicine activities. Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 12. Ideagen Workshop Programmes & Initiatives Current Programmes • ABC Collaborations • Medical Devices in Connected Health • ABC Ireland ABC Ireland • Healthy Living • Medilink UK • Health Tech & Medicines KTN • Skills Academy Connected Health Initiatives • All-Island Connected Health Review • Connected Health Clinical Trials • UK Connected Health @ IBIZ • All-Island Connected Health Mission to Boston Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 13. Ideagen Workshop ABC Innovation Model Academia Clinical HSC Innovations Universities / HSC R&D Office Colleges and RCS in Ireland Institutes of RCP in Ireland Technology GP Consortia Priority Areas Priority areas have strong Connected Health and All-Island capability Personalised Medicine Healthy Living Business BioBusiness & Members ABC Interface Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 14. Ideagen Workshop ABC Innovation Model Academia Clinical Identify Clinical Applied research Need for medium term Provide Clinical innovation. Efficacy Blue skies Early Adopters research for long term innovation Priority Areas Priority areas have strong Connected Health and All-Island capability Personalised Medicine Healthy Living Business Commercial Regulatory Approved ABC Interface Products Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 15. Ideagen Workshop Innovation Key to any Innovation Strategy is the correct insights and knowledge of the: • Market, • Customer base, • Technologies, • Regulatory environment and • Internal capability. Collaboration is often the easiest way to gain knowledge, find solutions and source capability. Successful ABC collaborations are very important to successful commercial opportunities and initiatives. Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 16. Ideagen Workshop Capability Building Sales and Marketing Clinical Trials • Statistical Requirements Regulatory • Trial Protocols Environment • Ethics Approval • FDA, MDD, GxP, Investment Innovation • Insights • Collaboration • Intellectual Property Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 17. Ideagen Workshop Academic & Clinical Engagement Altnagalvin Hospital Beacon Hospital Beaumont Hospital Belfast Hospital Trust Cork University Hospital Craigavon Area Hospital HSC Innovation and R&D Division Nenagh Hospital RCSI & RCPI St James’ Hospital St Vincent’s Hospital Tallaght Hospital Ulster Hospital General Practitioners (GPs) Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 18. Ideagen Workshop BioBusiness Projects Doctor Office Laboratory Cardiac Care in the Community Connected Health Monitoring Centre Addressing Rural Isolation using Telecare Clinical Trial Network Remote Vital Sign Monitoring mHealth Applications for Mental Illness Stroke Screening Thrombolysis Automated Work Practice Respiratory Database Development Tissue Sample Database Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 19. Ideagen Workshop McElwaine Smart Case Study McElwaine Smart offers tele-health and tele-care solutions. International partnership established with Bosch GmbH. Academic research collaborations established with UU, QUB, DkIT and Limerick University. Commercial links established with McElwaine SMART, Friendly Call Service. Invested £3.5 million in new staff, products, infrastructure and marketing. Leverage of funding ratio 1:35 Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.
  • 20. Ideagen Workshop Intelesens Case Study Intelesens company providing remote vital sign monitoring devices. First home-based clinical trial. Clinical trial protocols developed and ethics approval achieved. Commercial links established between device company and communication platform company –Valentia Technologies. Invested £800,000 with public grant support. Leverage of funding ratio 1:30 Life and Health Technologies Sector in Ireland Copyright © 2010 BioBusiness Ltd.