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Product Design & CommercializationServices
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Minimally Invasive Device Solutions
Make your device concept a reality and achieve yourmilestones with support from our expert design team,proven systems and ready-to-go infrastructure.
Whether you are looking for full product development,concept design or you need to meet a specific milestone,our services are customized to deliver your goals on timeand within budget.
From initial engagement, our focus is to add value to your development project. We bring the latest ideas andtechnologies to your project. With the support of an in-house supply chain of quality components, regulatoryconsulting and global contract manufacturing capability,we deliver your product to market. We are experts in thefollowing therapy areas:
Cardiovascular
Structural Heart
Electrophysiology & CRM
Peripheral Vascular
Neurovascular
MI Orthopaedic
Pulmonary
Oncology
Endoscopy
Laparoscopy
Urology & Gynecology
Project Overview
Laparoscopic device - focus on humanfactors inputs, mechanical & industrialdesign and plastics design for molding. Line set-up for volume ramp
Low profile RX delivery system andhandle for novel implant device.Technical, industrial & mechanicaldesign. Concept development, quick turnprototyping, review & testing
Development of catheter system to deliver cardiac bio therapeutics. Focus on catheter, deployment mechanism,sheath & needle devices
Kyphoplasty device - Industrial & mechanical design and prototyping,human factors design, ergonomics andvideo ethnography
Novel steerable peritoneal access system- sheath, balloon device, needle accesssystem
Specialty catheter delivery system- rapid development cycle
Development of new deploymentmechanism and handle for existingdevice shaft. Technical, industrial & mechanical design. Conceptdevelopment, quick-turn prototyping,review & testing
PTCA balloon catheter - from conceptdesign to market launch
Sample ProjectPortfolio
Laparoscopic Devicefor SILS
Self Expanding Stentand HandleDevelopment
Stem Cell DeliveryCatheter
Kyphoplasty Balloonand Stent DeliverySystem
NOTES Access Device
CTO Catheter
Implant DeliverySystems - DFM
PTCA Balloon Catheter
Client Profile
World's leading medical devicecompany
US based start-up, medicaldevice company
European based start-up:medical biotechnology company
US emerging medical devicecompany
A world leading global medicaldevice company
Start-up company, EMEA
A world leading global medicaldevice company
A world leading global medicaldevice company
Achievements
Project delivered with full designhistory file and supporting 510ksubmission - from conceptdevelopment to steady statecommercial manufacture
Enabled customer to focusresources on implant device whileCreganna Medical led catheterdevelopment to achieve FIH trialsand CE mark approval
Working in parallel with therapeuticdevelopment project, supportedcustomer through GLP testing,product verification/validation andCE mark submission process
Product was brought from conceptto initial European market release
Concept & product development,supported client through initial IDEsubmission and FIH builds
CE mark achieved, client acquiredin major buyout by world leadingmedical device company
Handle design delivered, includingfull drawing specification for eachcomponent
510k submission, FDA approval,steady-state manufacture & sterilization management
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Manufacturing l DFMA assessmentl Cost modelling
Regulatory l Regulatory strategy
A concept design that "works like" yourintended designl Concept prototypes and initial testingl Preliminary cost modelling
Infrastructure across the US, Latin America, Europe & Asia Prototyping labs & dedicated class 100,000 pilot manufacturing cleanroom State of the art catheter testing and analysisCertified to ISO and registered with the FDA and Japan MHLWCAD, rapid prototypingVertically integrated component sourcing Low volume to high volume manufacturing capacity
Concept Design l VOC & performance benchmarkingl Concept developmentl Prototyping & performance testing
Dedicated Project TeamDedicated project manager and project core team with industrial & mechanical design experts
ConceptGeneration
Design Feasibility
Design Verification& Validation
Commercialization& Ramp
ProductManufacture
Dedicated Project TeamDedicated project manager and projectcore team with device development anddesign for manufacturability expertise
Dedicated Project TeamDedicated project manager and project core team with manufacturing, quality andtesting experts
Dedicated Project TeamDedicated project manager and project coreteam with design for manufacturing, quality,supply chain and customer support expertise
Dedicated Project TeamDedicated manufacturing cell, continuousimprovement team and customer support
Design Feasibilityl Design optimizationl Device testingl Design freezel Packaging design
Design Verification & Validationl Verification & Validation testing & reportsl Product risk managementl Predicate testing l Support human use product releasel DHF/Technical file compilation
Design Transferl Product validationl Ramp support
Product Reviewl Next generation design
Outputs
Team
Services
Manufacturing l Preclinical prototyping & pilot buildsl Value engineeringl DFM planning
Regulatory l Preclinical testing
A frozen design that "works like and lookslike" the final devicel Functional prototypes & testing reportl Design freeze specificationl Estimated unit costl Draft product risk assessment l Detailed commercialization proposal
Manufacturing Build design verification units - l FMEAl Quality planningl Prove critical processesl FIH builds & pilot linesl DFM, lean manufacturing review
& implementation
Regulatoryl Clinical strategies & study design l Clinical trial management l Regulatory submissions
Proof that design outputs meet design inputs by verification testing of products that"work like, look like and are made like" thefinal productl Verified product design freeze specificationl Product and packaging validationsl Risk assessment documentation l Technical File/Design History Filel Clinical validation report
Manufacturing Process validation IQ,OQ,PQl Equipment validationl Packaging validation l Finalize supply chainl Build launch volumel DFM, lean manufacturing review
& implementation
Regulatory l Field complaint managementl Complaint handling l Safety
Proof that the product can be transferred tolarge-scale manufacture - repeatable & reliable processesl A stable source of product supplyl Validated manufacturing line
- commercially readyl Product ramp
Manufacturing l Operational management & metricsl Continuous improvementl Process improvements
Regulatoryl Field complaint managementl Complaint handling l Safety
l Steady state manufacturingl Supply chain managementl Continuous improvement projects
Product Development Process
Infrastructure
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Technologies:
Catheter technologies
Metal shafts
Wire & coil
Braided shafts
Extruded shafts
Medical balloons
Injection molding
Device manufacture & assembly
Speciality needles
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www.creganna.com
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