Symbient Product
Development
Telephone: + 1 (760) 687-4030
New Project Inquiries: Extension 2
All Other Inquires: Extension 11
symbientpd.com
linkedin.com/company/1293869
Luke@symbientpd.com
1061 La Mirada Court
Vista, California 92081
1
Focus
Specialization leads
to excellence.
Experience
The name “Symbient” comes from the word
“symbiosis” – an interaction between two organisms
that work together for mutual benefit. We strive to
replicate the symbiotic relationship seen in nature by
synergistically working with our customers to rapidly
develop successful product designs.
Scott
Castanon:
CEO
Bioengineer
Nothing can
replace it.
Flexibility
Large or small projects,
we can help.
Speed
When you need it done.
Yesterday.
Results
Learn how we
deliver them.
Symbient Product Development
Luke Helm:
Director of
Business
Development
Lisa Coyne:
Business
Development
Manager
Specializes in design engineering and design-for-manufacturing of innovative medical and
life science devices that use plastics. Our highly experienced team consists of mechanical and biomedical engineers,
industrial design talent, machinists and molding technicians. They leverage our in-house rapid prototyping, prototype tooling fabrication and injection molding
to create proven, manufacturable designs with unmatched speed, efficiency and quality. These designs form our deep portfolio of over 300 successful devices
that have generated hundreds of millions of dollars for
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our clients. They include FDA Class I, II and III devices, developed under our ISO 13485 certified quality management system.
Pages
Topic
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2
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11-28
29-37
38-45
46-54
Symbient Intro and Contact Page
Contents
Symbient Overview
Fluidics Examples
Sample Collection and Processing Examples
Clinical Tools and Drug Delivery Examples
Lateral Flow Cassette and Reader Examples
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FACILITY
Our facility is specifically
designed for the rapid
design and development
of medical and life science
devices that use plastics.
4
ENGINEERING TEAM
Scott Castanon
Dylann Ceriani
Founder/CEO
Bio Engineer
19 years
in the industry
*Hudson RCI and
Dura Pharmaceuticals
Director of Engineering
Product Development
Bio Engineer
19 years in medical
product development
*Breg, DJO Global
Bob Eisele
Vince So
Senior Product Development
Engineer
Bob has 35 years of medical
product development and
engineering experience
*Integra Life Sciences, Lapyx
Medical, Reva Medical, Elan
Pharmaceuticals and Shiley
Laboratories
Senior Product
Development Engineer
Vince has 10 years of
experience designing and
developing medical and life
science devices.
*ViaCyte, Applied Medical,
Life Technologies (now
Thermo Fisher Scientific)
and Boston Scientific
Michael Williams
Industrial Designer
14 years of experience,
that includes extensive work in anthropometrics,
human factors engineering and usability
Joe Baker
Director of Engineering, Operations
7 years experience developing
medical products *Life Technologies
(Now Thermo Fisher Scientific)
Tom Rachlin
Senior Product Development
Engineer
Tom has over 6 years of
experience developing
medical devices
* 4 years at Covidien where
he won multiple awards for
innovation and R&D
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DEVELOPMENT
PROCESS Overview
Phase 1
Define Product
Requirements
For more information visit:
http://www.symbientpd.com/
our-process-symbients-stepsto-success
Develop Concepts
Phase 4
Phase 2
Design Verification
Testing
Develop Detailed
Design
Individually Prototype
Critical Functions
Develop Integrated
Prototype
Phase 5
Phase 3
Fabricate
Prototype Molds
Mold and Assemble
Test and Iterate
Transfer to
Manufacturing
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DEVELOPMENT TOOLS: PROTOTYPING
CNC Machining
 3 full time expert
machinists
 4 Haas CNC mills and 2
lathes.
 Precise machining
tolerances and
fabrication of complex
geometry.
Stereolithography (SLA)
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Rapid design iterations; SLAs in hours
vs days.
Enables efficient high-risk function
development.
Transparent material with mechanical
properties of ABS plastic, making it
ideal for functional testing.
Most accurate SLA available –
tolerance .003” (75 microns). High
quality prototypes yield valid test
results.
SLA is an invaluable development tool
to have in-house and our team uses
daily.
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DEVELOPMENT TOOLS: PROPRIETARY PROTOTYPE MOLDING SYSTEM
Steel Mold Base – MUD Compatible | Brass Inserts – Easily Modifiable | Stainless Steel Core Pins – Robust
Benefits:
•
•
•
•
Closely replicates
production
Robust – 100K + parts
Quickly fabricated –
2 week
Quickly iterated –
1 day
•
•
Transferrable – to any
molder
• Bridge tooling –
continue molding
• Learning – for
production tooling
• Mitigates scale up risk
Inexpensive to fabricate
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DEVELOPMENT TOOLS:
INJECTION MOLDING
Arburg 38
Ton Horizontal
 Production grade molding
machines replicate
manufacturing
 Production quality parts
 Quantities:100’s to low 1000’s
 Invaluable for design
verification testing, user
studies, clinical trials
Arburg 55
Ton Vertical
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Custom Test
Methods
and Fixture
Development
Ultrasonic welding,
UV Bonding, Heat
sealing
– all in house.
Experts in all plastic
assembly methods.
INTERNAL ASSEMBLY, TESTING,
AND TEST METHOD DEVELOPMENT
Fully Equipped Engineering Lab
Inspection and
Imaging CMM
for measuring
critical
dimensions for
product release
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Leverage Our
Material Selection
Expertise
There are thousands different materials used in
injection molding, making selection of the right
material for your device a potentially daunting
task.
Our medical device specialization combined with
our injection molding expertise streamlines the
process of finding the right combination of
materials for your product.
We maintain a stock of approximately 150 injection
molded materials and have access to thousands more.
Combined with our onsite injection molding capabilities,
this stock enables our engineers to quickly sample and
test multiple material candidates for your application. For
products with more unique requirements, we research
and source specialized materials, material additives and
surface treatments to suit your product’s requirements.
Considerations:
Biocompatibility and Regulatory Requirements
Sterilization
Environment
Moisture Vapor Transmission Rate (MVTR)
Cost
Availability
Assembly Method
Tolerance
Electrical Applications
Leachable Content
Transparency
Special Requirements
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INDUSTRIAL
DESIGN
ID THAT WORKS
Conceptual design for human factors,
ergonomics and ease of use.
Designing devices that are intuitive and
easy to use, including those intended to be
CLIA waived or for use at the Point of Care.
Incorporating user feedback, voice of the
customer, brand identity conformity and
photo-realistic renderings for your use in
presentations and marketing material.
Our industrial design (ID) services will help you achieve the look, feel and usability that is critical to the success of your product
in the marketplace while ensuring full functional performance.
We achieve this by employing highly experienced ID talent that not only works closely with the engineering team, but has an
engineering background. This combination ensures that the concepts we generate for you not only represent great ID, but will not
conflict with your device’s functions and requirements, including design for manufacturing.
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COMMITMENT TO QUALITY
ISO 13485 is a set of international standards published in 200 3 that specifies requirements for
a quality management system that demonstrates our ability to provide medical devices development
services that consistently meet customer and regulatory requirements.
• Enables us to maintain the documentation required for FDA and CE regulatory submission.
• Critical for non-ISO certified clients who plan to seek regulatory approval.
• For clients with a quality system, we can provide the needed inputs.
• Annual audits by BSI Group to ensure compliance.
• Calibrated equipment
• Continuously improved standards and procedures for every process.
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Fluidics
Examples
This is a small sample from our
deep portfolio of over 300
successful devices.
BACTERIAL ANALYSIS
CARTRIDGE
Instrument driven cartridge that performs an assay of sample
division, capture, imaging and processing of several
reagents in order to identify bacteria and measure reaction
to antibiotics.
Developed a injection molded flow cell made of COC to which
capture antibodies were bonded.
Developed a method to divide sample into 8 equal volumes.
Building on the success, developed a method to divide
sample into 64 equal volumes.
Designed and prototyped fluidic channels that are 400 𝜇
(microns) wide.
Integrated injection molded components with multiple
laminate structures in a unique design.
Developed a heat seal method to assemble the laminate
structures with the injection molded cartridge body.
Developed unique valve that is actuated within the laminate
structure using compressed air.
Designed cartridge to accept mechanical inputs from an
instrument in order to complete the assay.
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Bacterial Analysis Device
64 WAY SAMPLE
SPLITTING,
REAGENT WELLS
PROTOTYPE
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ELECTROCHEMICAL DX, SAMPLE PREP AND DELIVERY CARTRIDGE
Cartridge functions:
• Whole blood mixes
with anticoagulant,
filters red blood cells,
meters the serum,
mixes with onboard
reagents and delivers 5
μl (microliters) to the
silicon chip for
measurement.
• Precise (6 to 8 μm)
alignment features
between sensing chip
and optical head inside
the reader
Sample port,
blood filtration
media
Channel on
sliding valve with
pneumatic ports
2nd channel
delivers
sample to
chip
Silicon
Chip
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DIAGNOSTIC CARTRIDGE
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•
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•
•
Microfluidic control using a sliding valve
Precision engagement requirements between the instrument
and cartridge
Multiple pressure and vacuum interfaces to the instrument
Fluid control accomplished by instrument actuated linear
valve
Ultrasonic welding assembly
Hermetically sealed internal filter media
Geared mechanism engaged by the instrument to deploy a
100 mm tubing for collection of sample from the bottom of
the sample container
Developed unique method to reduce velocity of cartridge
output while maintaining pressure requirements
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MICROFLUIDIC DIAGNOSTIC CARTRIDGE
•
•
•
Instrument driven
cartridge,
pneumatically
actuated
Fluidic channel,
valves, wells that
achieve mixing,
metering, heating,
distribution.
Sample separation
into 16 equal wells
for imaging
Heat Seal
Surface
Mixing and heating well.
Sonic welded
hydrophobic membrane
to surface
Sample input well.
Critical seal surface
Normally closed
valve
Sonic weld
membrane
16 well
sample
distribution
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Microfluidic Diagnostic Cartridge
Silicone Diaphragm
valves and interface
Instrument
Sonically Welded
pneumatic ports
Living Hinge
Surface
clarity
critical for
imaging
Sonic weld
hydrophobic
membrane
Heat
Seal
Surface
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POINT OF CARE DIAGNOSTIC PLATFORM
Developed multiple fluidic
cartridges for use with
controller/reader instrument.
User inserts a blood collection
tube into cartridge, and the
cartridge into
the instrument, which runs the
diagnostic protocol.
Developed unique methods to:
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•
•
Meter precise volumes
Split samples equally
Rehydrate reagents
Perform static and active mixing
Incorporate normally open and closed valves
Integrate with imaging components
Separate plasma from whole blood
Transfer the contents of blood collection tube
to the cartridge without removing the cap.
Dry reagents in a channel and then rehydrate
them during the test protocol.
US Patent Applications
60,165,558;
60,079,003;
60,078,471
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PCR CARTRIDGE
On-board dried reagents
Instrument interface and imaging
Temperature cycling
Sample separation into 4 equal parts using
hydrophobic vent plugs
• Includes sliding valve to prevent fluid motion
during temperature cycling
• Closed system, no external venting permitted
•
•
•
•
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AGILENT / STRATAGENE - PFIZER
Instrument-Driven
Cartridge
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
Input: Whole blood
Output: RNA suspended
in water
Features


On-board reagent
storage/delivery
Fluidic channels, wells
and valves that mix,
meter and dwell.
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Unique rotary valve with
elastomer overmold
Onboard filtration
Pneumatically actuated
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MICROFLUIDIC CARD
• X/Y Coordinate
addressable card
• Instrument driven
inputs
• Micron scale channels
• Microliter scale
reaction wells
• Injection moldable
design
CONFIDENTIAL
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BIOHAZARD SAMPLE TESTER
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2-D microfluidic laminate card
Interfaces with 3-D molded structure
5 molded reagent storage and delivery wells
Heat sealed top
Foil sealed pierce-able bottom
Fluidic circuitry to transport fluids to mixing / lysing chambers
with electric motor driven rotor
 Sample introduction port with cap
 Challenges solved: small channels in close proximity, layers are thin for
injection molding, many interfaces and interaction between parts of different materials.
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VIRUS IMAGING CARTRIDGE
100% sealed system used for testing hazardous
viruses, tested to 120 PSI.
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
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The test administrator connects a syringe-like
device to the intake port and actuates it, injecting
sample that flows through filter media and mixes
with dried reagents. A metered amount of the
solution fills two small chambers which feature
lenses for imaging with a reader.
The larger protruding features are overflow
chambers that receive excess pressure, allowing the
sample to travel through the sealed cartridge. The
inlet area to these chambers has a hydrophilic
membrane that allows air to pass through,
pressurizing the chambers, but prevents sample
from entering them.
Transparent top housing and black bottom housing
for laser welding. Also designed to be compatible
with ultrasonic welding.
CONFIDENTIAL
26
SMALL VOLUME METERING WITH PUMP
FOR EWOD CHIP FLUID DELIVERY
• Meters down to 5 μl, 10% CV using low cost, disposable silicone or elastomer pumps and valves, and
permanent actuators.
• With valve 2 open and valve 1 closed, an actuator deflects the silicone diaphragm pump into a channel
void, then valve 2 closes and valve 1 opens, actuator releases diaphragm, which pulls volume from
reservoir into the channel void. Valve 1 is closed, valve 2 is opened and pump pushes volume past valve
2 for dispense.
Pump
Reservoir
Valve 2
Valve 1
Actuators
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ELECTROCHEMICAL BIOSENSOR MICROFLUIDIC
DIAGNOSTIC
• A module collects a metered quantity of
whole blood using capillary, is inserted into
the cartridge.
• The instrument actuates a plunger that flows
buffer through the capillary and then through
filtration that separates plasma.
• The metered mixtures flows across a
semiconductor microchip.
• An identical second module flows a rinse
buffer across the chip.
Capillary
Chip
Buffer
Chamber
Plungers
Section View
CONFIDENT
IAL
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ROTARY VALVE
 Fluid control method developed for
use in customer products. Rotary
valves feature a PBT substrate with
a LIM silicone over-mold.
 A retaining ring is used to
compress the valve against the
cartridge face. Rotation of the
valve determines which channels
are open or closed.
 Non-patented, available for
customer use royalty-free.
 Used by Illumina, Agilent / Pfizer
and other customers.
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PROTOTYPE BLISTER EXAMPLES
Back side of sealed blister –
same size as blisters at bottom
 Blisters shown range from 200 μl to 1.5
mL
 We form, fill and seal prototype blisters
in-house down to 25 μl
 Blister foils of varying thicknesses and
coatings are available.
 Solutions for consistent dispensing
volume
 Relationships with high-volume blister
manufacturers.
 Experienced with various types (i.e. burst
valves) and shapes (i.e. kidney)
Frangible Seal
Dispense Port
Formed, before
filling and sealing
Formed, before
filling and sealing
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BREADBOARD FOR PCR CONSUMABLE CONTROL
 Representative of our extensive
experience developing breadboards
to test instrument-driven microfluidic
cartridges.
 Uses programmable controllers such
as electronic prototyping platforms
and OEM motor/actuator controller
software.
 Achieves protocol requirements
using solenoids, pneumatics,
transducers, pumps, valves, heaters,
chillers, mixers, imaging systems,
data loggers, etc.
 Valuable for testing protocols,
cartridge functions and helps to
define requirements for instrument
developers.
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SAMPLE
COLLECTION &
PROCESSING
EXAMPLES
This is a small sample from our
deep portfolio of over 300
successful devices.
32
CARDIAC MARKER TEST
Integrated lateral flow IVD platform
Blood collection sample pad
 25 ul, +/- 1 ul
Onboard buffer storage and delivery
Developed novel, patentable method for
rapid flow through plasma separation
 Achieved using custom filter stack
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Point of Care Flu Test
Developed the sample processing device
and lateral flow cartridge that
integrates with custom reader
Sampling uses a nasopharyngeal swab
Custom 2 ml sample tube with filtration
media in dispensing tip, which
includes unique features to control the
drop volume
VERITOR SYSTEM
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NASOPHARYNGEAL SAMPLE COLLECTION
AND PROCESSING DEVICE
• Swab with hollow tube
• Buffer introduced
through valve flushes
samples from swab tip
• Port at bottom allow
aspiration of sample
with syringe
CONFIDENTIAL
35
FECAL OCCULT BLOOD SAMPLE
COLLECTION DEVICE
Redesigned device to improve ergonomics and
user interface and dispense accuracy.
Design a break off tip with precise residual
dispensing tip geometry to allow metered
sample dispensing.
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QUIDEL IFOB TEST – CLIA WAIVED
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Incorporates a dry lateral flow strip with a wet buffer in the same device.
Required materials expertise employed in specifying customized polymer
with optimal MVTR (moisture vapor transmission rate)
Designed for manufacturability meeting product cost targets with a minimal
number of components.
Subject uses sampling device to collect the sample and insert it into the
main device body, which meters and mixes the sample with buffer. Subject
then mails the device to a test lab or doctor’s office.
Test administrator actuates the device by pulling base down from body
introducing the buffer/sample mixture onto the lateral flow strip and
producing the test results.
Product utilizes a custom molded desiccant to maintain the low humidity
environment necessary for the lateral flow test strip over its shelf life.
37
SALIVA SAMPLE COLLECTION AND
PROCESSING DEVICE FOR DRUGS OF ABUSE
Customer required the sample collection media to be
expressed twice to ensure the sticky molecule is removed
from the media. The sample collection and processing
device is turned by the test administrator. Each turn
expresses the media twice and releases a buffer
pack. The test administrator then shakes the device and
connects it to the cartridge.
The bottom of the sample collection and processing device
includes a septum which is opened automatically when
docked to the cartridge. Sample passes through the
septum and is distributed evenly to 3 lateral flow strips in
the cartridge and the result is read by the test
administrator.
38
URINE CUP WITH INTEGRATED
MULTIPLEX LATERAL FLOW TEST
39
CLINICAL
TOOLS AND
DRUG
DELIVERY
EXAMPLES
This is a small sample from our
deep portfolio of over 300
successful devices.
40
ACON LANCET DEVICE
Achieved all functions with
fewer components
(lower cost) than
competitive products.
Patented and sold with
ACON glucose tests.
Uses two springs, whose
force we optimized to
create the puncture
needed for a wide variety
of patients, from people
who bleed easily to those
people who have thick
calluses. Accomplished
through research of
anthropomorphic data,
force testing and user
studies.
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AUTO INJECTOR
• Aspirates water, re-suspends a powdered drug
• Button deploys the needle, injecting the
medication automatically
• Uses 2 - 27 gauge insert molded needles
• One needle was used to pierce a drug vial
septum. The second needle that automatically
deploys for patient injection
• Resolved challenges to complete design for
manufacturing, including excessive actuation
force, latching and release of shield, needle
occlusion
42
GAS CELL POWERED SAFETY SYRINGE
•
•
•
•
Retractable-needle safety syringe that uses a gascell technology that provides a low-cost,
disposable power source for medical products.
Uses the stored energy in the gas-cell to propel the
needle back into the body of the syringe.
Key features include:
• Usage procedures that mimics those of a
regular syringe
• Cost competitive with other safety syringes
• Superior safety and lower actuation force
than other safety syringes
Creative, readily-manufacturable features that
accomplish a five-step needle retraction operation
that is actuated in a single step when the user
depresses the plunger at the end of travel.
See Videos of It In Action:
http://www.symbientpd.com/portfolio-item/gas-cell-poweredsafety-syringe
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SAFESHOT – SAFETY SYRINGE
From an early prototype, designed a fully functional 3 mL autoretracting safety syringe
Unique pressure driven retraction (no spring)
 Plunger engages needle hub at end of travel
 Disengages the braking mechanism.
 Uses vacuum to retract needle into barrel
Developed braking mechanism.
Developed a custom non-coring needle with external texture at
the blunt end, allowing for insert molding
Developed a 1 mL version using same IP
44
BRAIN CHILLER PAD - SILICONE
• Reduces temperature of the
brain tissue during surgery
(found to improve surgical
outcomes)
• Input and output port for
coolant
• Insert molded soft aluminum
sheet captured inside
silicone enabled pad to be
bent to conform to surface
of the brain.
• Thermocouples are insert
molded for measuring
coolant temperature.
• Bottom of chiller pad sealed
using a thin sheet of
material.
Inlet
Thermocouple
location #1
Top View
Outlet
Thermocouple
location #2
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DURA PHARMACEUTICALS DRY POWER INHALER
• Developed advance and dispense mechanism.
• Uses an impeller, activated by a Venturi switch, to
suspend the drug.
• Two different versions were made: blister (shown on
left) and chambers (shown on right)
• Blisters were required with formulations that were
more sensitive to the ambient environment
46
ALKERMES –
INSULIN DELIVERY SYSTEM
Developed aerosol functionality and confirmation
of performance for insulin dry powder inhaler
in collaboration with Eli Lilly
Resolved issues on an accelerated schedule by
utilizing our in-house prototyping and
prototype molding capabilities.
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SELECTED
LATERAL
FLOW
CASSETTE
AND READER
EXAMPLES
This is a small sample
from our deep portfolio of
over 300 successful
devices.
48
Bio-Rad HIV Test –
Cartridge Designed for Reader
• Developed a dual strip cartridge for use with a
pre-existing reader
• Read window set per specifications to ensure
reader compatibility
• Made compatible with either a barcode or RFID
tag for testing
• Industrial design work for attractive design and
functional ergonomics.
49
FIRST RESPONSE
PREGNANCY
TEST
WITH DIGITAL
READER AND
DISPLAY
CONFIDENTIAL
50
SALIVA
LATERAL
FLOW TEST
WITH
MIRROR
Salvia sample collection pad is integrated and delivers sample to lateral flow test strip.
Sufficiency of sample quantity achieved through visual confirmation via integrated mirror.
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CRITICAL DIAGNOSTICS LATERAL FLOW CARTRIDGE
MADE FOR LRE READER
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ASTUTE MEDICAL – NEPHROCHECK
CARTRIDGE FOR LRE READER
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WHOLE-BLOOD LATERAL FLOW
CARTRIDGE FOR LRE READER
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Lateral Flow Cartridge Concepts
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Lateral Flow Cartridge Concepts
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