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Paragon Innovations


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Introduction to Paragon Innovations, Inc.

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Paragon Innovations

  1. 1. When You Want It Done Right Innovation Delivered™
  2. 2. Paragon Innovations, Inc. <ul><li>1990 </li></ul><ul><ul><li>Started at home </li></ul></ul><ul><li>2010 </li></ul><ul><ul><li>Owns 17,000 sf facility </li></ul></ul><ul><li>Concept to production ™ </li></ul><ul><ul><li>Requirements gathering </li></ul></ul><ul><ul><li>System architecture </li></ul></ul><ul><ul><li>Lead systems integrator </li></ul></ul><ul><ul><li>Development </li></ul></ul><ul><ul><li>Verification </li></ul></ul><ul><ul><li>Manufacturing </li></ul></ul><ul><li>Experienced with Medical, Wireless, and Video products </li></ul><ul><li>ISO 13485:2003 compliant </li></ul>
  3. 3. The Best Rely on Paragon
  4. 4. <ul><li>Development Partners </li></ul><ul><li>Technology Alliances </li></ul>The Best Work with Paragon
  5. 5. GSCS / Paragon Partnership <ul><li>Global Supply Chain Solutions </li></ul><ul><ul><li>Global Supply Chain Solutions services are tailored to increase our Customers Speed to Market, Flexibility and Profitability while Reducing Risk. Our Customer Promise is: We will deliver low-risk, high-value sourcing and supply chain management with competitive prices, consistent execution, intelligent tools and unswerving customer service levels </li></ul></ul>
  6. 6. Balance Design Partner <ul><li>Cequent partnered with Balance to create a new packaging system: </li></ul><ul><ul><li>Representative of the Reese brand </li></ul></ul><ul><ul><li>Flexible to accommodate a variety of SKU’s </li></ul></ul><ul><ul><li>Space-efficient on the planogram </li></ul></ul><ul><li>Balance partnered with RSI, Inc., to help develop Navage-a revolutionary new product that automates nasal irrigation. </li></ul>
  7. 7. Balance Design Partner <ul><li>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. </li></ul><ul><li>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. </li></ul>firstSEAT
  8. 8. Medical Portfolio Insulin Pump Design Electroporation Medical Device -- Animal Application Electroporation Medical Device -- Human Application Pneumothorax Detector Infusion Pump Development Project
  9. 9. Video/LED Portfolio Video Wall Display Vide o Phone LED Signs Airport Video Docking System Vigilance Continuous Cardiac Monitor
  10. 10. 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
  11. 11. Additional Successes
  12. 12. Have you experienced this?
  13. 13. WHY DOES IT GO WRONG? <ul><li>No Partner …reduces your development risks, …documents it processes, …and delivers projects better than Paragon Innovations. </li></ul>Paragon Commitment WHY DOES IT GO SO WRONG?
  14. 14. <ul><li>Focused on managing the product development. </li></ul><ul><li>Right talent on the right job </li></ul><ul><li>Attention to risk management </li></ul><ul><li>Refined written processes </li></ul><ul><ul><li>Conception to completion </li></ul></ul><ul><li>Continuous checks and balances </li></ul><ul><li>Client participation </li></ul><ul><li>Client IP ownership </li></ul>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 Quinn VP of Research and Development
  15. 15. <ul><li>Minimal Management Hassles </li></ul><ul><ul><li>Proven management tools </li></ul></ul><ul><ul><li>Single project interface </li></ul></ul><ul><li>Fills in the Gaps </li></ul><ul><ul><li>Product planning and definition </li></ul></ul><ul><ul><li>Management </li></ul></ul><ul><ul><li>Additional talent </li></ul></ul><ul><li>Traceability </li></ul><ul><ul><li>Requirements to testing to production </li></ul></ul><ul><ul><li>Issue resolution </li></ul></ul><ul><li>Accountability </li></ul><ul><ul><li>Internal quality assurance </li></ul></ul><ul><ul><li>Internal and external processes </li></ul></ul>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 Perkins Chief Electrical Engineer
  16. 16. Product Development <ul><li>Planning </li></ul><ul><ul><li>No ad hoc design practices </li></ul></ul><ul><ul><li>Understand all design parts </li></ul></ul><ul><ul><li>Continuous risk analysis and mitigation planning </li></ul></ul><ul><li>Processes </li></ul><ul><ul><li>Full understanding of tasks </li></ul></ul><ul><ul><li>Written processes ensure consistency </li></ul></ul><ul><ul><li>Quality isn’t an accident </li></ul></ul><ul><li>People </li></ul><ul><ul><li>Talented </li></ul></ul><ul><ul><li>Committed </li></ul></ul><ul><ul><li>Caring </li></ul></ul>“ 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
  17. 17. <ul><li>MPT and Engineer-in-a-Notebook </li></ul><ul><ul><li>Email groups </li></ul></ul><ul><ul><li>Secure project web page </li></ul></ul><ul><ul><li>Weekly project conferences </li></ul></ul><ul><ul><li>Action/issue tracker </li></ul></ul><ul><ul><li>Requirements traceability </li></ul></ul><ul><ul><li>Weekly status reports </li></ul></ul>Superior Documentation
  18. 18. The Paragon Advantage <ul><li>Business Analysis </li></ul><ul><li>Brand Identity </li></ul><ul><li>Technology Assessment </li></ul><ul><li>Risk Analysis </li></ul><ul><li>User Needs Assessment </li></ul><ul><li>Product Strategies </li></ul><ul><li>Engineering </li></ul><ul><li>Industrial Design </li></ul><ul><li>Mechanical Engineering </li></ul><ul><li>Electrical Engineering </li></ul><ul><li>Firmware Development </li></ul><ul><li>RTOS Development </li></ul><ul><li>Linux Development </li></ul><ul><li>Quality & Certification </li></ul><ul><li>Requirements Analysis </li></ul><ul><li>Product Specification Refinement </li></ul><ul><li>Acceptance Test Specification </li></ul><ul><li>Certification Management </li></ul><ul><li>Alpha, Beta, and Production Build Management </li></ul><ul><li>FMEA and MTBF analysis </li></ul>
  19. 19. Engineered Solutions <ul><li>Infusion pumps </li></ul><ul><li>Pulse oximeters </li></ul><ul><li>Electroporation devices </li></ul><ul><li>Surgical lasers </li></ul><ul><li>Continuous Cardiac Output Monitor </li></ul><ul><li>Insulin pumps </li></ul><ul><li>Breathalyzers </li></ul><ul><li>Wireless & bar coding devices </li></ul><ul><li>Smart phone medical applications </li></ul><ul><li>Pneumothorax detection </li></ul><ul><li>Ear effusion </li></ul>Medical Wireless/Portable Video <ul><li>Video projectors </li></ul><ul><li>Extreme off axis projection </li></ul><ul><li>Rear Projection HDTV </li></ul><ul><li>Video compression </li></ul><ul><li>Video scaling </li></ul><ul><li>Set top box </li></ul><ul><li>Flight Information Display Systems </li></ul><ul><li>Airline Video Docking Systems (VDOCKS) </li></ul><ul><li>LED displays </li></ul><ul><li>Insulin pumps </li></ul><ul><li>Gas compressor lubrication monitor </li></ul><ul><li>GPS based tracking devices </li></ul><ul><li>GSM telephony </li></ul><ul><li>CDMA telephony </li></ul><ul><li>Electroporation devices </li></ul><ul><li>Panasonic PDA </li></ul><ul><li>Breathalyzers </li></ul><ul><li>Weather stations </li></ul>
  20. 20. MEDICAL DEVICES <ul><li>Client Portfolio </li></ul>
  21. 21. Infusion Pumps <ul><li>“ 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.” </li></ul><ul><li>Gale White </li></ul><ul><li>General Manager </li></ul><ul><li>Challenge </li></ul><ul><li>B.Braun first came to Paragon for verification & </li></ul><ul><li>validation testing. Based on success of first project: </li></ul><ul><li>Redesign infusion pump that assists in reducing the primary source of drug delivery mistakes: human error. </li></ul><ul><li>FDA Class II design </li></ul><ul><li>Built in scanner improves patient safety </li></ul><ul><li>Wireless connectivity for remote monitoring and reporting </li></ul><ul><li>Solution </li></ul><ul><li>Added barcode reader that would read label with patient ID, drug name and required dosage </li></ul><ul><li>Upgrade electronics to support FDA approved system </li></ul><ul><li>On-going validation testing </li></ul>
  22. 22. Insulin Pumps <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Paragon took the lead role to help manage the project to completion. </li></ul><ul><li>Initial step was a prototype board to test before the final board produced. </li></ul><ul><li>As a result of the successful project, MiniMed returned to Paragon to develop the Paradigm pump. </li></ul>Paragon’s initial design and software of the insulin pump is still used today.
  23. 23. Veterinary Product <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Designed high-voltage pulse current control </li></ul><ul><li>Redesigned product from an unreliable, old technology to microprocessor-based design </li></ul><ul><li>Reduced PCBs from four to one by utilizing the latest microprocessor technology </li></ul>“ 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
  24. 24. Pneumothorax Detection <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Developed software to trigger radar, analyze reflection and identify air pockets (pneumothorax) in chest cavity </li></ul><ul><li>Developed all electronics in portable device </li></ul><ul><li>Created all FDA documentation </li></ul><ul><li>Performed all FDA regulatory approval successfully </li></ul>“ 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
  25. 25. Cardiac Monitor <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>1st electronic FDA device to secure approval on its first submission </li></ul><ul><li>Stringent verification and validation </li></ul><ul><li>Developed a diagnostic system to allow animal and human studies to occur 6 to 9 months ahead of normal schedules </li></ul><ul><li>Solved problem of transferring critical data between monitors in different hospital sectors </li></ul><ul><li>Provided complete hardware and software documentation that became a standard procedure in other Baxter design and development projects. </li></ul><ul><li>“… We ended up with a good solid design and innovative ways to implement solutions.“ </li></ul><ul><li>Mike Quinn </li></ul><ul><li>Vice President R&D </li></ul>Vigilance Continuous Cardiac Monitor
  26. 26. Myocardial Protection System <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Brought disciplined approach to aiding design solution, documenting the development process and producing prototype for FDA testing. </li></ul><ul><li>Within 12 months, Quest began marketing new product which remain industry standard and highly successful brand for company </li></ul><ul><li>Established Quest’s in-house engineering lab with new staff, new equipment and new processes </li></ul>Within 12 months, Paragon produced a device that remains an industry standard and established a complete lab and process solution employing 30 engineers.
  27. 27. VIDEO DISPLAYS & LED <ul><li>Client Portfolio </li></ul>
  28. 28. Digital Wallboard Display <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Assumed design control mid-stream </li></ul><ul><li>Interviewed 17 3M managers and technicians to streamline design to develop turn-key solution and accelerate product’s time to market </li></ul><ul><li>Exceeded high standards of quality and innovation </li></ul><ul><li>Integration with expansion controller board </li></ul><ul><li>“… (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.” </li></ul><ul><li>Steve Saxe </li></ul><ul><li>Technical Program Manager </li></ul><ul><li>Visual Systems Division </li></ul>
  29. 29. IP Video Phone <ul><li>Challenge </li></ul><ul><li>Viseon wanted to dramatically change global consumer communications with a digital home video phone offered at an affordable price. </li></ul><ul><li>Solution </li></ul><ul><li>Development efforts included conquering a complex network of communication technologies used throughout the world </li></ul><ul><li>Designed and developed the product up to pre-production: </li></ul><ul><ul><ul><li>Designed IETF – SIP RFC 3261 </li></ul></ul></ul><ul><ul><li>Video (H.263, H.264, MPEG-2 and MPEG-4) </li></ul></ul><ul><ul><li>Audio (G.711, G.723.1, G.728, G.729e, G.729a/b) </li></ul></ul><ul><ul><li>VoIP throughout home </li></ul></ul>The VisiFone is a top-quality videophone that is easy to use and offers Web capabilities.
  30. 30. LED Signs <ul><li>Challenge </li></ul><ul><li>Design a proprietary product that would produce the most light for the least amount of power per dollar of cost to the sign company. </li></ul><ul><li>Solution </li></ul><ul><li>Engineers went to the field and learned first hand from the lighting experts how lights were installed and replaced. </li></ul><ul><li>Designed the product to be clearly superior to anything offered by major competitors </li></ul><ul><li>Developed the product so that it is virtually copy-proof </li></ul><ul><li>Recommended sources and negotiated terms with vendors for quality parts and to maximize cash flow </li></ul><ul><li>Development efforts included conquering a complex network of communication technologies used throughout the world </li></ul>“ 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 Farmer CEO
  31. 31. VDOCKS <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Met several critical deliverables with aggressive deadlines </li></ul><ul><li>LED display system superior to anything else on the market </li></ul><ul><li>Simplified assembly and reduced production cost by incorporating multiple boards into a single board </li></ul><ul><li>Improved serviceability and reduced costs. </li></ul><ul><li>Designed and implemented system rated for proper range of temperature and humidity levels. </li></ul>Paragon transitioned the product to Siemens through the manufacturing stage – a crucial handover phase for any new product.
  32. 32. PORTABLE WIRELESS DEVICES <ul><li>Client Portfolio </li></ul>
  33. 33. Pet Tracker <ul><li>Challenge </li></ul><ul><li>Entrepreneur had idea for pet tracking product -- a small, durable, GPS device for a pet collar combined with a monthly subscription service. </li></ul><ul><li>Solution </li></ul><ul><li>GPRS reporting of location </li></ul><ul><li>Automatic notification when leaving identified area </li></ul><ul><li>Map of location and travel </li></ul><ul><li>AAA battery-powered for convenience </li></ul><ul><li>Product sold to Pfizer Animal Health . </li></ul><ul><li>“ 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.” </li></ul><ul><li>Jennifer Durst </li></ul><ul><li>President </li></ul>
  34. 34. Gas Compressor <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>AA batteries were selected for their long life and worldwide availability </li></ul><ul><li>Device detects if compressor is over or under lubricated </li></ul><ul><li>The device will shut down the compressor and visually signals the alarm in the event of dangerous under lubrication </li></ul><ul><li>Device stores up to the last 12 months of lubrication records which can be downloaded via a Palm device </li></ul><ul><li>“ 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.” </li></ul><ul><li>Curtis Roys </li></ul><ul><li>President </li></ul>
  35. 35. ADDITIONAL SUCCESSES Client Portfolio
  36. 36. HVAC Misting System <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Cables connect directly to AC unit’s thermostat or attach to intake and outtake pipes to detect AC operation </li></ul><ul><li>Sensor to read outside temperature </li></ul><ul><li>Programmable features to provide timers to determine frequency and times, and temperature parameters for misters </li></ul><ul><li>LCD display for easy programming </li></ul>“ 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 Jensen Vice President
  37. 37. Protective Relay Processor <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>3-Alarm Module fits in a wide-range input supply </li></ul><ul><li>It has the ability to detect and sound alarms for excessive run-time, power failures and humidity levels above 7% relative humidity (RH) </li></ul><ul><li>Module still in production today </li></ul>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.
  38. 38. Building Access Control System <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Complete hardware and software documentation – including IP rights. </li></ul><ul><li>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. </li></ul><ul><li>Development was performed remotely, with the client located in another geographical area. </li></ul>“ 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 available in the industry.”
  39. 39. Breathalizer <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Identified and corrected the design and manufacturing problems of the initial design firm </li></ul><ul><li>Recommended and implemented improvements which enhanced the product </li></ul><ul><li>InterLock is sold in over 20 states </li></ul>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.
  40. 40. Robotics <ul><li>Challenge </li></ul><ul><li>Design and development of several embedded systems components for the Quest, an underwater remotely-operated vehicle ROV (Roll-Over Valve) </li></ul><ul><li>Solution </li></ul><ul><li>Manufactured by ALSTOM Automation Schilling Robotics. Paragon helped Schilling Robotics develop customized power supply, valve and motor control systems for the ROV. </li></ul><ul><li>&quot; 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 .&quot; </li></ul><ul><li>Carroll Perkins </li></ul><ul><li>Chief Electrical Engineer </li></ul>
  41. 41. Surgical Laser <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Design and development prototype that allowed user to test usability of product so that refinements could happen easily </li></ul><ul><li>Since design did not have to follow FDA protocol, development and modifications were expedited </li></ul>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.
  42. 42. Protective Relay Processor <ul><li>Challenge </li></ul><ul><li>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. </li></ul><ul><li>Solution </li></ul><ul><li>Product designed to save board space, reduce emissions and crosstalk, and improve serviceability </li></ul><ul><li>Product architecture that placed the PCI interface within the FPGA </li></ul><ul><li>Assumed an aggressive design timeline and delivered ahead of schedule </li></ul>“ 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 Petty Senior Electrical Engineer
  43. 43. We are here for you <ul><li>Mike Wilkinson </li></ul><ul><li>Founder & CEO </li></ul><ul><li>[email_address] </li></ul><ul><li>Trish Cook </li></ul><ul><li>Business Development </li></ul><ul><li>[email_address] </li></ul>Paragon Innovations Inc. 3305 Matrix Drive Richardson, Texas 75082 (972) 680-2900