Product Design
& Commercialization
Services
Minimally Invasive Device Solutions
Make your device concept a reality and achieve your
milestones 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 time
and within budget.
Cardiovascular
From initial engagement, our focus is to add value to
your development project. We bring the latest ideas and
technologies to your project. With the support of an
in-house supply chain of quality components, regulatory
consulting and global contract manufacturing capability,
we deliver your product to market. We are experts in the
following therapy areas:
Sample Project
Portfolio
Client Profile
Project Overview
Achievements
Laparoscopic Device
for SILS
World's leading medical device
company
Laparoscopic device - focus on human
factors inputs, mechanical & industrial
design and plastics design for molding.
Line set-up for volume ramp
Project delivered with full design
history file and supporting 510k
submission - from concept
development to steady state
commercial manufacture
Self Expanding Stent
and Handle
Development
US based start-up, medical
device company
Low profile RX delivery system and
handle for novel implant device.
Technical, industrial & mechanical
design. Concept development, quick turn
prototyping, review & testing
Enabled customer to focus
resources on implant device while
Creganna-Tactx Medical led
catheter development to achieve
FIH trials and CE mark approval
Stem Cell Delivery
Catheter
European based start-up:
medical biotechnology company
Development of catheter system to
deliver cardiac bio therapeutics. Focus
on catheter, deployment mechanism,
sheath & needle devices
Working in parallel with therapeutic
development project, supported
customer through GLP testing,
product verification/validation and
CE mark submission process
Kyphoplasty Balloon
and Stent Delivery
System
US emerging medical device
company
Kyphoplasty device - Industrial
& mechanical design and prototyping,
human factors design, ergonomics and
video ethnography
Product was brought from concept
to initial European market release
NOTES Access Device
A world leading global medical
device company
Novel steerable peritoneal access system
- sheath, balloon device, needle access
system
Concept & product development,
supported client through initial IDE
submission and FIH builds
CTO Catheter
Start-up company, EMEA
Specialty catheter delivery system
- rapid development cycle
CE mark achieved, client acquired
in major buyout by world leading
medical device company
Implant Delivery
Systems - DFM
A world leading global medical
device company
Development of new deployment
mechanism and handle for existing
device shaft. Technical, industrial
& mechanical design. Concept
development, quick-turn prototyping,
review & testing
Handle design delivered, including
full drawing specification for each
component
PTCA Balloon Catheter
A world leading global medical
device company
PTCA balloon catheter - from concept
design to market launch
510k submission, FDA approval,
steady-state manufacture
& sterilization management
Structural Heart
Electrophysiology & CRM
Peripheral Vascular
Neurovascular
MI Orthopaedic
Pulmonary
Oncology
Endoscopy
Laparoscopy
Urology & Gynecology
Product Development Process
Concept
Generation
Team
Services
Design
Feasibility
Dedicated Project Team
Dedicated project manager and project
core team with industrial & mechanical
design experts
Dedicated Project Team
Dedicated project manager and project
core team with device development and
design for manufacturability expertise
Concept Design
VOC & performance benchmarking
Concept development
Prototyping & performance testing
Design Feasibility
Design optimization
Device testing
Design freeze
Packaging design
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Design Verification
& Validation
Commercialization
& Ramp
Product
Manufacture
Dedicated Project Team
Dedicated project manager and project
core team with manufacturing, quality and
testing experts
Dedicated Project Team
Dedicated project manager and project core
team with design for manufacturing, quality,
supply chain and customer support expertise
Dedicated Project Team
Dedicated manufacturing cell, continuous
improvement team and customer support
Design Transfer
Product validation
Ramp support
Product Review
Next generation design
Design Verification & Validation
Verification & Validation testing & reports
Product risk management
Predicate testing
Support human use product release
DHF/Technical file compilation
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Manufacturing
DFMA assessment
Cost modelling
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Manufacturing
Preclinical prototyping & pilot builds
Value engineering
DFM planning
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Manufacturing
Build design verification units FMEA
Quality planning
Prove critical processes
FIH builds & pilot lines
DFM, lean manufacturing review
& implementation
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Regulatory
Regulatory strategy
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Regulatory
Preclinical testing
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Regulatory
Clinical strategies & study design
Clinical trial management
Regulatory submissions
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Outputs
A concept design that "works like" your
intended design
Concept prototypes and initial testing
Preliminary cost modelling
A frozen design that "works like and looks
like" the final device
Functional prototypes & testing report
Design freeze specification
Estimated unit cost
Draft product risk assessment
Detailed commercialization proposal
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Proof that design outputs meet design
inputs by verification testing of products that
"work like, look like and are made like" the
final product
Verified product design freeze specification
Product and packaging validations
Risk assessment documentation
Technical File/Design History File
Clinical validation report
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Infrastructure
Infrastructure across US, Europe & Asia
Prototyping labs & dedicated class 100,000 pilot manufacturing cleanroom
State of the art catheter testing and analysis
Certified to ISO and registered with the FDA and Japan MHLW
CAD, rapid prototyping
Vertically integrated component sourcing
Low volume to high volume manufacturing capacity
Manufacturing
Process validation IQ,OQ,PQ
Equipment validation
Packaging validation
Finalize supply chain
Build launch volume
DFM, lean manufacturing review
& implementation
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Manufacturing
Operational management & metrics
Continuous improvement
Process improvements
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Regulatory
Field complaint management
Complaint handling
Safety
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Proof that the product can be transferred to
large-scale manufacture - repeatable
& reliable processes
A stable source of product supply
Validated manufacturing line
- commercially ready
Product ramp
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Regulatory
Field complaint management
Complaint handling
Safety
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Steady state manufacturing
Supply chain management
Continuous improvement projects
Technologies:
Catheter technologies
Metal shafts
Braided shafts
Extruded shafts
Medical balloons
Injection molding
Device manufacture & assembly
Speciality needles
www.cregannatactx.com