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Creganna Medical Design – Galway, Ireland
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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
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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.
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Accelerating your success
PEOPLE Expert project management PROCESS Professional design control TRACK RECORD Product quality Stable manufacturing environment
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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
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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
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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
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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
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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
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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
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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
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TE Connectivity Confidential & Proprietary
TE Connectivity Confidential & Proprietary. Do not reproduce or distribute.
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