Product Design & CommercializationServices

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

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

Technologies:

Catheter technologies

Metal shafts

Wire & coil

Braided shafts

Extruded shafts

Medical balloons

Injection molding

Device manufacture & assembly

Speciality needles

www.creganna.com

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