paragon innovations

© 2010 Paragon Innovations, Inc. 1

When You Want It Done Right

Innovation Delivered™


Paragon Innovations, Inc.

• 1990– Started at home

• 2010– Owns 17,000 sf facility

• Concept to production– Requirements gathering– System architecture– Lead systems integrator– Development– Verification– Manufacturing

• Experienced with Medical, Wireless, and Video products• ISO 13485:2003 compliant


The Best Rely on Paragon


Development Partners Technology Alliances

The Best Work with Paragon


Balance Design Partner

• Cequent partnered with Balance to create a new packaging system:

– Representative of the Reese brand– Flexible to accommodate a variety of SKU’s– Space-efficient on the planogram

• Balance partnered with RSI, Inc., to help develop Navage-a revolutionary new product that automates nasal irrigation.


Balance Design Partner

• Balance partnered with firstSEAT to help develop The Revolution: a state of the art forward facing child restraint designed to protect children in frontal and side impact crashes. The patented “Crumple Zone” technology uses a proven energy absorbing material from the automotive and aerospace industry to limit and lengthen the loads transferred to the occupant.

• Balance created I.M.-OK Emergency Communicator- a product concept that utilizes a mobile-phone-based text messaging emergency service called ‘E711.’ The emergency communication system sends guaranteed SMS (Small Message Service) packets to a central emergency server which notifies friends and family of the user’s status during a catastrophe.

firstSEAT


Medical Portfolio

Insulin Pump Design

Electroporation Medical Device -- Animal Application

Electroporation Medical Device -- Human Application

Pneumothorax Detector

Infusion Pump Development Project


Video/LED Portfolio

Video Wall Display

Video Phone

LED Signs

Airport Video Docking System

Vigilance Continuous Cardiac Monitor


Wireless/Portable Portfolio

Insulin Pumps

Electroporation Medical Device -- Animal Application

Electroporation Medical Device -- Human Application

Pet tracking collar

Natural gas compressor protection and monitoring device


Additional Successes


Have you experienced this?


WHY DOES IT GO WRONG?

No Partner …reduces your development risks,

…documents it processes,…and delivers projects

better than Paragon Innovations.

Paragon Commitment

WHY DOES IT GO SO WRONG?


• Focused on managing the product development.

• Right talent on the right job• Attention to risk management• Refined written processes

– Conception to completion• Continuous checks and balances• Client participation• Client IP ownership

Innovation Delivered

“Paragon provided us with a wide range of skills for both hardware and software development. Their engineer was not stuck on one type of a solution, but looked at the overall problem and picked what was most suitable for each situation... We ended up with a good solid design and innovative ways to implement solutions. Paragon ... produced excellent results.”

Mike QuinnVP of Research and Development


• Minimal Management Hassles– Proven management tools– Single project interface

• Fills in the Gaps– Product planning and definition– Management– Additional talent

• Traceability– Requirements to testing to production– Issue resolution

• Accountability– Internal quality assurance– Internal and external processes

Winning Benefits

“Unlike many outsourcing companies, Paragon Innovations knows how to take a concept and turn it into a design and is capable of seeing it through the manufacturing stage... We have used six outsourcing firms this past year, and Paragon Innovations is at the top of the list.”

Carroll PerkinsChief Electrical Engineer


Product Development

• Planning– No ad hoc design practices– Understand all design parts– Continuous risk analysis and mitigation

planning

• Processes– Full understanding of tasks– Written processes ensure consistency– Quality isn’t an accident

• People– Talented– Committed– Caring

“Their value is beyond measure. They helped me, with their expertise and my parameters, to develop a product that has the best combination.”

Ron Farmer CEO


• MPT and Engineer-in-a-Notebook– Email groups– Secure project web page– Weekly project conferences– Action/issue tracker– Requirements traceability– Weekly status reports

Superior Documentation


The Paragon Advantage

Business Analysis• Brand Identity • Technology Assessment • Risk Analysis• User Needs Assessment • Product Strategies

Engineering• Industrial Design • Mechanical Engineering• Electrical Engineering• Firmware Development• RTOS Development• Linux Development

Quality & Certification• Requirements Analysis • Product Specification Refinement • Acceptance Test Specification• Certification Management • Alpha, Beta, and Production Build

Management• FMEA and MTBF analysis


Engineered Solutions

• Infusion pumps• Pulse oximeters• Electroporation devices• Surgical lasers• Continuous Cardiac

Output Monitor• Insulin pumps• Breathalyzers• Wireless & bar coding

devices• Smart phone medical

applications• Pneumothorax detection• Ear effusion

Medical Wireless/Portable Video

• Video projectors

• Extreme off axis projection

• Rear Projection HDTV

• Video compression

• Video scaling

• Set top box

• Flight Information Display Systems

• Airline Video Docking Systems (VDOCKS)

• LED displays

• Insulin pumps

• Gas compressor lubrication monitor

• GPS based tracking devices

• GSM telephony

• CDMA telephony

• Electroporation devices

• Panasonic PDA

• Breathalyzers

• Weather stations


MEDICAL DEVICESClient Portfolio


Infusion Pumps

“Based on the quality of our initial projects, I have asked them to manage the entire project for us, from beginning to end on two new IV pumps.”

Gale WhiteGeneral Manager

ChallengeB.Braun first came to Paragon for verification & validation testing. Based on success of first project:• Redesign infusion pump that assists in reducing the

primary source of drug delivery mistakes: human error.

• FDA Class II design• Built in scanner improves patient safety• Wireless connectivity for remote monitoring and

reporting

Solution• Added barcode reader that would read label with

patient ID, drug name and required dosage• Upgrade electronics to support FDA approved system• On-going validation testing


Insulin Pumps

Challenge• MiniMed’s insulin pumps used a Motorola

processor. The redesign required a Hitachi processor. As part of a three company team, Paragon was recommended by Hitachi (now Renesas) to develop the pump’s firmware.

Solution• Paragon took the lead role to help manage the

project to completion. • Initial step was a prototype board to test before

the final board produced. • As a result of the successful project, MiniMed

returned to Paragon to develop the Paradigm pump.

Paragon’s initial design and software of the insulin pump is still used today.


Veterinary Product

Challenge• Complete the design and development of

electroporation technology used to introduce DNA into muscle fibers without causing cell damage through loss of square-wave function and overheating. VGX Animal Health (formerly ADViSYS) had new concept for an electroporation based on constant current.

Solution• Designed high-voltage pulse current control• Redesigned product from an unreliable, old

technology to microprocessor-based design • Reduced PCBs from four to one by utilizing

the latest microprocessor technology

“ADViSYS wanted to create something totally new, something that hasn’t ever been done in our field. Paragon helped us to break new ground and create a truly unique piece of equipment. The level of technical support we received after development was quite useful.”

Amir Khan, Ph.D.Lead Research Scientist


Pneumothorax Detection

Challenge• Complete the product design and

development of a non-invasive, portable micro-impulse radar (MIR) device to detect a pneumothorax (collapsed lung) in trauma situations in the field. Device must interface with the Motorola MC75 unit, a requirement for all medical personnel in military.

Solution• Developed software to trigger radar,

analyze reflection and identify air pockets (pneumothorax) in chest cavity

• Developed all electronics in portable device

• Created all FDA documentation• Performed all FDA regulatory approval

successfully

“Thank you for all of your assistance with the ISO audit … We were recommended for ISO 13485 registration with NO nonconformities! … PneumoSonics would not have had a successful audit without each of you..”

Alan Greszler


Cardiac Monitor

Challenge• InterFlo/Baxter Healthcare (now Edwards

Lifesciences) sought to develop, design and manufacture a diagnostic device that combined the concepts of a thermo-dilution and revolutionary new catheter.

Solution• 1st electronic FDA device to secure approval on its

first submission • Stringent verification and validation• Developed a diagnostic system to allow animal

and human studies to occur 6 to 9 months ahead of normal schedules

• Solved problem of transferring critical data between monitors in different hospital sectors

• Provided complete hardware and software documentation that became a standard procedure in other Baxter design and development projects.

“…We ended up with a good solid design and innovative ways to implement solutions.“

Mike QuinnVice President R&D

Vigilance Continuous Cardiac Monitor


Myocardial Protection System

Challenge• Quest Medical desired to return to the medical

instrument manufacturing business following a successful focus on developing non-electronic medical products. Retained Paragon to provide turn-key development, FDA approval and manufacturing of a myocardial protection system − a vital component of the heart-lung medical machinery that re-circulates blood during heart surgery.

Solution• Brought disciplined approach to aiding design

solution, documenting the development process and producing prototype for FDA testing.

• Within 12 months, Quest began marketing new product which remain industry standard and highly successful brand for company

• Established Quest’s in-house engineering lab with new staff, new equipment and new processes

Within 12 months, Paragon produced a device that remains an industry standard and established a complete lab and process solution employing 30 engineers.


VIDEO DISPLAYS & LEDClient Portfolio


Digital Wallboard Display

Challenge• Design and develop prototype of a display

controller board for a new DLP presentation electronic whiteboard within expedited timeframe so it could be showcased at major industry tradeshow less than four months away.

Solution• Assumed design control mid-stream• Interviewed 17 3M managers and technicians to

streamline design to develop turn-key solution and accelerate product’s time to market

• Exceeded high standards of quality and innovation• Integration with expansion controller board

“…(Paragon has) a staff of trained and disciplined engineers able to take this kind of project on. They have a rigorous design philosophy, and that was really a critical piece for us.”

Steve SaxeTechnical Program Manager

Visual Systems Division


IP Video Phone

Challenge• Viseon wanted to dramatically change global consumer

communications with a digital home video phone offered at an affordable price.

Solution• Development efforts included conquering a complex

network of communication technologies used throughout the world

• Designed and developed the product up to pre-production:− Designed IETF – SIP RFC 3261− Video (H.263, H.264, MPEG-2 and MPEG-4)− Audio (G.711, G.723.1, G.728, G.729e, G.729a/b)− VoIP throughout home

The VisiFone is a top-quality videophone that is easy to use and offers Web capabilities.


“Their value is beyond measure. They helped me, with their expertise and my parameters, to develop a product that has the best combination of 1. Light output 2. Price 3. Ease of installation and 4. Performance …in the market. “

Ron FarmerCEO

LED Signs

Challenge• Design a proprietary product that would produce the

most light for the least amount of power per dollar of cost to the sign company.

Solution• Engineers went to the field and learned first hand from

the lighting experts how lights were installed and replaced.

• Designed the product to be clearly superior to anything offered by major competitors

• Developed the product so that it is virtually copy-proof• Recommended sources and negotiated terms with

vendors for quality parts and to maximize cash flow• Development efforts included conquering a complex

network of communication technologies used throughout the world


VDOCKS

Challenge• Design and develop a video docking system for airports that

combined high visibility and precise guidance information to accurately and safely guide airplanes to park.

Solution• Met several critical deliverables with aggressive deadlines• LED display system superior to anything else on the market• Simplified assembly and reduced production cost by

incorporating multiple boards into a single board• Improved serviceability and reduced costs.• Designed and implemented system rated for proper range

of temperature and humidity levels.Paragon transitioned the product to Siemens through the manufacturing stage – a crucial handover phase for any new product.


PORTABLE WIRELESS DEVICESClient Portfolio


Pet Tracker

Challenge• Entrepreneur had idea for pet tracking

product -- a small, durable, GPS device for a pet collar combined with a monthly subscription service.

Solution• GPRS reporting of location• Automatic notification when leaving

identified area• Map of location and travel• AAA battery-powered for convenience

Product sold to Pfizer Animal Health.

“What’s beautiful about working with Paragon is that they can take their experience, knowledge, and skills, and transform them into a product that involves complex technology and interfacing systems – and yet is easy enough for a child to use.”

Jennifer DurstPresident


Gas Compressor

Challenge• Design and develop a device to monitor the lubrication

levels of natural gas compressors in the field. Device must be extremely reliable, durable and self powered.

Solution• AA batteries were selected for their long life and

worldwide availability• Device detects if compressor is over or under lubricated• The device will shut down the compressor and visually

signals the alarm in the event of dangerous under lubrication

• Device stores up to the last 12 months of lubrication records which can be downloaded via a Palm device

“For years, people have tried to create a device that provides both trending and shutdown protection for gas compressors. … The software that Paragon developed for the Palm-operated handheld device is the finest, most user-friendly you could ever imagine.”

Curtis RoysPresident


ADDITIONAL SUCCESSESClient Portfolio


“We selected Paragon Innovations as our design team because of the wealth of experience and knowledge they provide in both electrical design and project management. Throughout the project, their communication was excellent.”

Tim JensenVice President

HVAC Misting System

Challenge• Design and develop electronic controller to monitor

ambient temperature and A/C unit operation to activate misting system to cool outdoor compressor and reduce energy use. Unit must be easy to install for the large DIY market.

Solution• Cables connect directly to AC unit’s thermostat or

attach to intake and outtake pipes to detect AC operation

• Sensor to read outside temperature• Programmable features to provide timers to

determine frequency and times, and temperature parameters for misters

• LCD display for easy programming


Andrew Corp. benefited from the Paragon Innovations philosophy of integrated hardware and software engineering processes, innovative feature set analysis, complete documentation and client ownership of IP.

Protective Relay Processor

Challenge• Design and develop a single module that

combined monitoring for excessive run-time, high relative-humidity levels and power failures for Andrew Corp.’s microwave waveguides humidity control systems.

Solution• 3-Alarm Module fits in a wide-range input supply• It has the ability to detect and sound alarms for

excessive run-time, power failures and humidity levels above 7% relative humidity (RH)

• Module still in production today


Building Access Control System

Challenge• Redesign Brivo’s web-hosted access control product

that controls physical access to offices, warehouses, remote/unmanned buildings, or sensitive areas such as computer rooms, where real-time control and accountability of entry are important. Redesign should reduce costs and increase functionality and must be delivered the product in a short timeframe.

Solution• Complete hardware and software documentation –

including IP rights.• The design is for a modular base product. Only a

change in the assembly process is needed to build a variety of products, increasing its ROI.

• Development was performed remotely, with the client located in another geographical area.

“Brivo Systems wanted to take their ACS access control product to the next level – and to reduce production costs in the meantime. Paragon delivered a modular system with the largest expansion capability availablein the industry.”


Breathalizer

Smart Start initially chose an outsource partner with a lower bid price than Paragon. As predicted, the initial design had problems. Smart Start returned to Paragon to solve the problems and produce an improved product.

Challenge• After an unsuccessful experience with another

design firm, Smart Start approached Paragon to help redesign and fix a new breath-testing device that could be installed in vehicles. The InterLock system must be programmable to meet a variety of driving situations, store an abundant amount of information which can be easily downloaded by appropriate personnel.

Solution• Identified and corrected the design and

manufacturing problems of the initial design firm• Recommended and implemented improvements

which enhanced the product • InterLock is sold in over 20 states


Robotics

Challenge• Design and development of several embedded

systems components for the Quest, an underwater remotely-operated vehicle ROV (Roll-Over Valve)

Solution• Manufactured by ALSTOM Automation Schilling

Robotics. Paragon helped Schilling Robotics develop customized power supply, valve and motor control systems for the ROV.

"Unlike many outsourcing companies, Paragon Innovations knows how to take a concept and turn it into a design and is capable of seeing it through the manufacturing stage."

Carroll PerkinsChief Electrical Engineer


Surgical Laser

Challenge• Design and development phase 0 reference

design of a new surgical laser for eye surgery. Alcon went outside to find expertise in specific microprocessor and Ethernet networking.

Solution• Design and development prototype that

allowed user to test usability of product so that refinements could happen easily

• Since design did not have to follow FDA protocol, development and modifications were expedited

Alcon turned to Paragon Innovations for design of new surgical laser device. The knowledge gained through testing of the phase 0 reference design allowed Alcon to develop the final product in-house.


“Paragon delivered the product on a tight schedule with incredible turnaround, given the complexity of design. Their excellent relationships with vendors also proved critical to the project success.”

Scott PettySenior Electrical Engineer

Protective Relay Processor

Challenge• During the design phase of developing a

power switching system for the United States Navy, L-3 Communications identified the need for additional resources to deliver the project on time. Design and develop electronic prototype for a Protective Relay Processor (PRP), a board that trips a circuit breaker when a fault occurs on a combatant ship’s electrical system.

Solution• Product designed to save board space,

reduce emissions and crosstalk, and improve serviceability

• Product architecture that placed the PCI interface within the FPGA

• Assumed an aggressive design timeline and delivered ahead of schedule


We are here for you

Mike WilkinsonFounder & CEO

[email protected]

Trish CookBusiness Development

[email protected]

Paragon Innovations Inc.3305 Matrix Drive

Richardson, Texas 75082(972) 680-2900

www.ParagonInnovations.com

paragon innovations

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