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Partners from Idea to Real y
                         lity

The role of engineering in c
                           company building.
C ega a act
Creganna-Tactx Medic
                ed c
                   ca
                   cal
 A world leader in the provision of technologies and services for
                                  f
 minimally invasive delivery and access devices
                                  a      devices.


 Ranked in the Top 10 global prov
                                viders of medical device
 outsourcing solutions


 830+ staff


 Sales 2009    $
               $110M


 Global footprint


 Not an Intel or a Google but still a world leader in its area.
What got us there?
  a go        e e

 Good
 G d engineering . . . . Not an amazing invention.
        i    i           N t        i   i    ti


 Good governance.


 Good management and bus
                       siness practices.


 Reinvestment of profits.
Global Customers




ving large multinational companies to early stage development companies
Global Operational Reach
                    e
ery & Access Devices
                       Cardiology
                       Peripheral Vascular
                       Neurology
                               gy
                       MI Orthopaedics
                       Endoscopy
                       Oncology
                       CRM
                       Urology
                       Pulmonary
                       Laparoscopy
                       Optometry
                        p        y
                       Biologics Delivery
                       MI Surgery


                       For Minimally &
                       Less Invasive The
What got us there?
  a go        e e

 Good
 G d engineering . . . . Not an amazing invention.
        i    i           N t        i   i    ti


 Good governance.


 Good management and bus
                       siness practices.


 Reinvestment of profits.
Good Engineering
       g ee    g

 We
 W are an engineer owned and managed company.
             i         d   d       d
 We developed our own prod
                         duction equipment, our own
 automation.
        i
                           nciples.
 We applied engineering prin
 We used textbook engineer
                         ring to solve an industry
 p
 problem. [[Example]
                 p ]
 The medical device industry now demands good reliable
                           y
 validated engineering.
  a dated e g ee g
 Practically all our sales can be traced back to our own
 R&D.
 R&D
What got us there?
  a go        e e

 Good
 G d engineering . . . . Not an amazing invention.
        i    i           N t        i   i    ti


 Good governance.


 Good management and bus
                       siness practices.


 Reinvestment of profits.
Good Governance
     Go e a ce

 While Creganna did not h ve a functioning board, it wa
 Whil C                t hav   f   ti i    b   d
 merely a source of income. It was going nowhere.
 14 years ago be began mon hl board meetings with on
              b b        nthly b  d     i     ih
 independent director.
 That was the cause of the b
                           bend in the hockey stick.
 We have never missed a m
                        meeting.
                              g
 Now have a board of 8.
 The board is a resource for the CEO, approves strategy
                           r     CEO
 oversees compliance.
What got us there?
  a go        e e

 Good
 G d engineering . . . . Not an amazing invention.
        i    i           N t        i   i    ti


 Good governance.


 Good management and bus
                       siness practices.


 Reinvestment of profits.
Good Management and Business Practices
      a age e   and us ess     ac ces

 1st b
     board d i i
         d decision: B ild a management.
                     Build            t
 We have been doing it since.
 Managers are free to manage but are accountable.
 – Look for the best.
 Now have a global management structure that is highly
 regarded.
 regarded
 CEO is a civil engineer.
What got us there?
  a go        e e

 Good
 G d engineering . . . . Not an amazing invention.
        i    i           N t        i   i    ti


 Good governance.


 Good management and bus
                       siness practices.


 Reinvestment of profits.
Reinvestment o Profi s
 e   es  e   of  o its

 The
 Th manufacture of device components is capital
            f t  fd i             t i      it l
 intensive.
 We h
 W have large investments in laser technology.
        l     i         si l          h l
 – Our Galway plant is the lar
                             rgest laser site in Ireland after
   Intel.
 We have a full metallurgy laboratory.
 – Our own proprietary alloys.
 Over many years profits we reinvested.
                          ere reinvested
Cus o e s
Customers

 OEM Medical D i compa i
     M di l Device   anies.
 From startups to majors.


 We do not put our own dev
                         vices on the market
                                      market.
Services
-C
 Concept Design & Development
-P
 Prototyping
-D
 Design for Manufacture
-P
 Pre-Clinical & Pilot Manufacturing
-C
 Component, Sub-Assembly & Com
 Device
 D
-F
 Facility Transfer
- S pp y Chain Management
  Supply           g
-F
 Finished Goods – design, manufac
ma
 anagement
Engineers o the Future
  g ee s of   e u u e

 Full understanding of the product design process
                                          process.
 – Business understanding.
 – Healthcare economics.
 – Regulatory affairs.
 – Product lifecycle.
    •   Design for production.
    •   Design disposal/recycling.
    •   Design for sterilisation.
    •   Ergonomic design
                   design.

 We need to teach product d g at a p
                  p       design   postgraduate lev
                                       g
 Good mix of the theoretical and the practical.
                           l
Technologies

- Metal Shafts
- Medical Balloons
- Extruded Shafts
- Braided/Coiled Shafts
- Injection Molding & Micro Mo
- Innovative Technologies
- Materials Science
- Advanced Laser Technologie
sourced Services

ple Projects:
Steerable EP catheters
Endoscopic Biopsy Devices
Balloon & St t C th t System – C
B ll      Stent Catheter S t ms Coronary,
Peripheral, Aortic, Neurovascular
                                r
Cardiac Transseptal Needles
NOTES Access Systems
IVUS & Imaging Systems
Intravascular Sh th
I t        l Sheaths
Valve Repair/Replacement Delive Devices
                                ery
Engineering in C eganna-Tactx now.
  g ee    g    Cregan a ac     o

 Multiple
 M lti l engineering t
            i    i   teams.
 – R&D for customers.
   • Doing major projects for the Majors as well as smaller
                                e
     companies.
 – R&D for Creganna-Tactx.
       fo C eganna Tact
   • Platform technologies for de
                                evices.
   • New metallurgies
          metallurgies.
   • New composite shafts.
 – Production engineering
              engineering.
   • Automation.
   • Reliability
     Reliability.
nnovations
Cregannatactx

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Cregannatactx

  • 1. Partners from Idea to Real y lity The role of engineering in c company building.
  • 2. C ega a act Creganna-Tactx Medic ed c ca cal A world leader in the provision of technologies and services for f minimally invasive delivery and access devices a devices. Ranked in the Top 10 global prov viders of medical device outsourcing solutions 830+ staff Sales 2009 $ $110M Global footprint Not an Intel or a Google but still a world leader in its area.
  • 3. What got us there? a go e e Good G d engineering . . . . Not an amazing invention. i i N t i i ti Good governance. Good management and bus siness practices. Reinvestment of profits.
  • 4. Global Customers ving large multinational companies to early stage development companies
  • 6. ery & Access Devices Cardiology Peripheral Vascular Neurology gy MI Orthopaedics Endoscopy Oncology CRM Urology Pulmonary Laparoscopy Optometry p y Biologics Delivery MI Surgery For Minimally & Less Invasive The
  • 7. What got us there? a go e e Good G d engineering . . . . Not an amazing invention. i i N t i i ti Good governance. Good management and bus siness practices. Reinvestment of profits.
  • 8. Good Engineering g ee g We W are an engineer owned and managed company. i d d d We developed our own prod duction equipment, our own automation. i nciples. We applied engineering prin We used textbook engineer ring to solve an industry p problem. [[Example] p ] The medical device industry now demands good reliable y validated engineering. a dated e g ee g Practically all our sales can be traced back to our own R&D. R&D
  • 9. What got us there? a go e e Good G d engineering . . . . Not an amazing invention. i i N t i i ti Good governance. Good management and bus siness practices. Reinvestment of profits.
  • 10. Good Governance Go e a ce While Creganna did not h ve a functioning board, it wa Whil C t hav f ti i b d merely a source of income. It was going nowhere. 14 years ago be began mon hl board meetings with on b b nthly b d i ih independent director. That was the cause of the b bend in the hockey stick. We have never missed a m meeting. g Now have a board of 8. The board is a resource for the CEO, approves strategy r CEO oversees compliance.
  • 11. What got us there? a go e e Good G d engineering . . . . Not an amazing invention. i i N t i i ti Good governance. Good management and bus siness practices. Reinvestment of profits.
  • 12. Good Management and Business Practices a age e and us ess ac ces 1st b board d i i d decision: B ild a management. Build t We have been doing it since. Managers are free to manage but are accountable. – Look for the best. Now have a global management structure that is highly regarded. regarded CEO is a civil engineer.
  • 13. What got us there? a go e e Good G d engineering . . . . Not an amazing invention. i i N t i i ti Good governance. Good management and bus siness practices. Reinvestment of profits.
  • 14. Reinvestment o Profi s e es e of o its The Th manufacture of device components is capital f t fd i t i it l intensive. We h W have large investments in laser technology. l i si l h l – Our Galway plant is the lar rgest laser site in Ireland after Intel. We have a full metallurgy laboratory. – Our own proprietary alloys. Over many years profits we reinvested. ere reinvested
  • 15. Cus o e s Customers OEM Medical D i compa i M di l Device anies. From startups to majors. We do not put our own dev vices on the market market.
  • 16.
  • 17. Services -C Concept Design & Development -P Prototyping -D Design for Manufacture -P Pre-Clinical & Pilot Manufacturing -C Component, Sub-Assembly & Com Device D -F Facility Transfer - S pp y Chain Management Supply g -F Finished Goods – design, manufac ma anagement
  • 18. Engineers o the Future g ee s of e u u e Full understanding of the product design process process. – Business understanding. – Healthcare economics. – Regulatory affairs. – Product lifecycle. • Design for production. • Design disposal/recycling. • Design for sterilisation. • Ergonomic design design. We need to teach product d g at a p p design postgraduate lev g Good mix of the theoretical and the practical. l
  • 19. Technologies - Metal Shafts - Medical Balloons - Extruded Shafts - Braided/Coiled Shafts - Injection Molding & Micro Mo - Innovative Technologies - Materials Science - Advanced Laser Technologie
  • 20. sourced Services ple Projects: Steerable EP catheters Endoscopic Biopsy Devices Balloon & St t C th t System – C B ll Stent Catheter S t ms Coronary, Peripheral, Aortic, Neurovascular r Cardiac Transseptal Needles NOTES Access Systems IVUS & Imaging Systems Intravascular Sh th I t l Sheaths Valve Repair/Replacement Delive Devices ery
  • 21.
  • 22. Engineering in C eganna-Tactx now. g ee g Cregan a ac o Multiple M lti l engineering t i i teams. – R&D for customers. • Doing major projects for the Majors as well as smaller e companies. – R&D for Creganna-Tactx. fo C eganna Tact • Platform technologies for de evices. • New metallurgies metallurgies. • New composite shafts. – Production engineering engineering. • Automation. • Reliability Reliability.