1. Creganna Medical
Design – Galway, Ireland

2. Design Center – Galway, Ireland
Delivering a full spectrum service from a single site, supporting customers from initial concept to regulatory approval and commercial ramp. We are specialists in advanced access and delivery systems for a range of minimally invasive and advanced therapies.
145 dedicated design centre team
Proven design partner serving the world’s Top 10 MI device companies
On average, 2.9 days from first contact to technical discovery
A medical device originating from the team is shipped every 1.3 minutes
Products approved and managed in 35 countries
Established in 2015 – one of the first design centres to be developed in the world
People – 145, experienced, cluster effect in Galway, many former customers
Proven – Top 10 brands
Speed – contact to technical discovery
Velocity – translating concepts to design
Full spectrum – regulatory approval and mgt in field – zero complaints or recalls

3. Global Design Capability
> 5,000 product concepts
> 950 years engineering experience
> 150+ design engineers globally
> $1/4 BN contract development
> 50+ FIH devices support US
Plymouth, MN MI-Structural Heart, Electrophysiology & Advanced Energy
San Jose, CA Advanced catheter
development group
Europe
Galway, Ireland Minimally Invasive & Advanced Therapies
Asia
Japan High density connectors & PCBA
TE Connectivity Confidential & Proprietary. Do not reproduce or distribute.

4. Accelerating your success
PEOPLE
Expert project management
PROCESS
Professional design control
TRACK RECORD
Product quality
Stable manufacturing environment

5. Global Design Leaders 24 YEARS 30 YEARS 30 YEARS 28 YEARS 13 YEARS
Scott Larson - Director of Design Services
B.S. Mechanical Engineering, University of MN
MBA, University of St. Thomas
R&D leadership roles, Boston Scientific & Olympus
Specialist in product development, Interventional & Surgical
YEARS
Bee Xiong - Senior Technical Advisor
B.S. Engineering, Wisconsin-Platteville
Founding partner, Medical Engineering & Design Inc & AdvancedCath Technologies
Specialist in advanced delivery systems, Structural Heart
YEARS
Greg Smith - R&D/Product Development Manager
Associate of Applied Science in Plastics Technology
Former Boston Scientific engineering
Specialist in catheter delivery systems
YEARS
Jeff Pumper - Director of Quality
& Global Compliance
B.S Bachelor of Science Management, MN State University
MBA, Concordia University
Former Cordis (J&), Lake Region Medical (Integer) – quality compliance & design assurance
YEARS
Suresh Sainath - Portfolio Manager, Balloons
& Catheter Systems
M.S Mechanical Engineering, Stanford, CA
Founding partner AdvancedCath Technologies. Acquired by TE Connectivity
YEARS
Ken Koen - Portfolio Manager, Extrusion & Tubing
Former C.R. Bard, Advanced Cardiovascular Systems, Infinity Extrusion and Engineering & Tactx Medical.
Founding partner AdvancedCath Technologies, acquired by TE Connectivity
YEARS
Jeff Kraus - Principle Engineer
B.S. Mechanical Engineering, San Jose State
Founding partner Danforth Biomedical & Tactx Medical
YEARS
RENA DALY - Senior Manager Design Assurance & Regulatory Affairs
BSC Science & Quality Mgt Post Graduate
Former Abbott Vascular
Guiding design verification & validation, CE & FDA submissions, regulatory affairs registrations and regulatory audits worldwide.
YEARS

6. Galway, Ireland - Design Leaders
JOHN MUGAN – Design Operations Manager
Bsc Polymer Science, Msc Mechanical Eng, PDip Innovation Management
Expert in Design for Manufacturing excellence, specialist in translating innovative design to volume builds
YEARS
JOHN GILBERT – Emerging Technologies Manager
BTech Mechanical Engineering, MSc Polymer Engineering
Specialist in new product development and polymer technologies
YEARS
DERMOT O’REILLY– R&D Product Development Manager
BAI Mechanical Engineering, MSc Engineering
Product development specialist for innovative medical device technologies
YEARS
DAMIEN ROSNEY – Design R&D Manager
BSc Engineering Design &
Professional Certificate In Management
Design life cycle management specialist, core expertise in MI access & delivery systems
YEARS
BERNARD MCDERMOTT – Senior Principal Engineer
BSc Mechanical Engineering
Structural heart delivery systems specialist, innovation expert for catheter design & metal based laser processed delivery systems
YEARS
WILLIAM CANNON – R&D Product Development Engineer
B.S Manufacturing Technology & B.S Biomedical Engineering
Specializing in catheter based delivery systems for early stage concept development and prototyping
YEARS
GONCALO SANTOS – Prototypes Development Manager
B. Eng. Industrial Engineering & Project Management
Expert in product development of MI delivery systems – vascular & structural heart
YEARS
DAMIEN MULDOON – R&D Product Development Engineer
Qualification in production engineering & tool design
Oversees CAD team, specialising in mechanical design & articulation systems for MI access & delivery
YEARS

7. 1 2 3 4 5 Capabilities CONCEPT GENERATION & DEVELOPMENT Products
Specialist in complex & technically challenging designs
Delivery & access systems - MI devices
Vascular catheters & stent delivery systems
Microcatheters
Steerable delivery systems
Advanced access devices
Connected & smart catheters 1
CONCEPT GENERATION
A concept design that ‘works like’ your intended design 2
DESIGN FEASIBILITY
A frozen design that ‘works like & looks like’ the final device
DESIGN FOR MANUFACTURE
WORKS
LIKE
WORKS LIKE
+ LOOKS LIKE 3
DESIGN VERIFICATION & VALIDATION
Validation that design outputs meet design inputs, comprehensive testing
PILOT MANUFACTURING
OUTPUTS = INPUTS:
SPECIFICATIONS
& CLINICAL 4
COMMERCIALIZATION & RAMP
Product & process validation, regulatory approval, transfer & ramp
VALIDATION & RAMP
FINAL
PRODUCT 5
PRODUCT LIFE CYCLE MANAGEMENT
Steady state manufacturing of approved product. Next generation product planning
VOLUME MANUFACTURING
Design Supports
Brainstorming & ideation
3D printing & additive design
Rapid catheter prototyping
Benchtop testing
GLP
In-house tooling
Regulatory support
COMMERCIALIZATION

8. Expertise through experience
Articulating sheath &
handle – transseptal access
TAVR access sheath
& dilator
Advanced endoscopic
needle
Ablation balloon
catheter
Laparoscopic stabilization
device
Structural heart
guidewire
Transcatheter valve
delivery system
Hi load steerable catheter –
structural heart
Distal valve
delivery system
Neurovascular
microcatheter

9. GALWAY, IRELAND CURRENT DESIGN PORTFOLIO Structural Heart
27 development programs
TAVI - access sheaths & steerable delivery systems
TMV - access sheaths & steerable delivery systems
Tricuspid - valve delivery
Advanced delivery systems - LVAD, PFO, shunts
Regenerative stem cell delivery
Interventional
PTCA & PV balloon catheter & stent delivery systems
Microcatheters - neurovascular, oncology, occlusion
Advanced catheters - aspiration, lithotripsy, thrombectomy, filters, ablation, AV fistula, AAA/TAA, imaging – IVUS, OCT
Embolic coil delivery - neurovascular
Liquid biopsy system
Advanced Therapies
EP/A Fib - steerable access systems, ablation & cryoablation catheters
CRM - lead access & delivery, transcatheter pacemaker delivery
Targeted drug delivery systems
GI/Endoscopy - specialized scopes, sheaths, catheters - compression, dilation, occlusion, measurement, drainage
Laparoscopy – stabilization & surgical access systems
Pulmonary - catheters for access, ablation, thermoplasty via scope
Urology - balloon catheters & stent delivery

10. DELIVERY ACCESS CLOSURE Structural Heart Introducers & access sheaths
Visualization, marker brands & fillers
Tapered atraumatic tips
Coating, lower insertion forces
Advanced Delivery Sheaths
Steering & deflection
Thin wall, high axial stiffness
Transseptal steering
Deflection force >30lbs
Deployment Handles & Systems
Low profile introducers & dilators
Custom hemostasis valves
Ergonomic hubs, needle stylets
Deployment handles,
precision actuation
Custom proximal
designs
Transseptal Needles
Visualization enhancements, left heart access
Tip shaping
Balloons
Extruded shafts
Large OD,
complex shapes
Advanced Guidewires
Atraumatic tips
Optimized push & torque
Wire coating
Metal shafts & components
Overmolding solutions
Vascular closure devices

11. IMAGING DIAGNOSTIC THERAPEUTIC Electrophysiology & Advanced Energy
IVUS
Catheter
Transducer
Rotational tip
High torque rotational shaft
Laser profiled metal shaft
OCT
Catheter
Optical imaging
Multi-lumen
Extruded
shaft
Vulnerable Plaque
Detection Catheter
Micro thermocouple – temperature measurement
Soft atraumatic
tip
Needle deployment
Mapping Catheter
Precious metal electrodes
Fine wire,
braid integration
Shape set tip
Fibre optic
integration
Pressure Sensing Wire – Optical, FFR
Guidewire
core
Pressure sensor housing
Flexible distal tip
Cables & connectors
Ablation
Catheter
RF electrode
Temperature monitoring – thermistor, thermocouple
Electrode
Fine wire termination to electrode, laser welding
Steerable braid
Smart Balloon
Catheter
SmartForm
balloons
Printed conductive ink
Wrapped flexible circuit
Integrated electronics
Soft flexible tip
Pressure Sensing Catheter – Piezo, FFR
Flexible distal tip
Pressure sensing housing
Fine wire termination
Flex circuit integration
HANDLE
Power
Actuation
Signal
Data

12. TE Connectivity Confidential & Proprietary
TE Connectivity Confidential & Proprietary. Do not reproduce or distribute.