Xcellences Engineering offers full-service product development capabilities that integrate business and user insight with design and engineering expertise. Our integrated team is comprised of product development specialists - experts in research, design, engineering, and manufacturing implementation.

By fusing informed innovation with integrated development expertise, Xcellences Engineering's approach is geared for making the ideal, real.

Our team promises to provide excellent engineering design consulting service in support of your product development. Excellent in service, quality and result.

Duran Yetkinler, CEO, Pacific Bioceramics

Xcellences Engineering has tremendous knowledge in all aspect of product development efforts, designing product parts, supply chain management, hands on experience, report writing, help communicating with suppliers and client. I would recommend Xcellences Engineering to all start-up companies or just need spot-help from product design to manufacturing.

Jerry Okikawa, Sr. Dir. of PD, MAP Pharmaceuticals

"I found the work that Xcellences Engineering done to be accurate and fully developed when presented. Considerable thought goes into their decision making to produce innovative solutions."

Services

Xcellences Engineering provides consulting, fabrication, and subcontracting service for all of your product development needs, from conceptual/feasibility all the way through marketed product.

Subcontracting

Xcellences Engineering provides contracting services to companies which are looking to temporarily expand their in-house design, manufacturing, quality, operation resources. As a contractor, we will represent your company while working with clients.

R&D Consulting

  • Market and Product Research
  • Brainstorming / Ideation
  • Build Prototyping, Working Models
  • CAD Design - SolidWorks & Pro-E
  • Engineering Drawings
  • Bill of Materials (BOM)

Project Management

  • Develop and/or maintain timeline and budget
  • Vendors, CMOs and Customers liaison
  • Supply chain development

Quality and Regulatory

  • Develop SOP per ISO 13485, QSR 820, ISO 14971
  • Develop and/or maintain Design Control per 21 QSR 820 Part 30
  • Perform Quality Audit and Vendor Qualification
  • Design / Process Verification & Validation

Manufacturing & Packaging

Xcellences Engineering Teams have experience in a wide range of product materials and manufacturing techniques. These range from 3D CAD program to the product. Our teams have designed, prototyped, and produced products incorporating plastic, urethanes, silicon, aluminium, sheet metal, steel, wood, fabric, and many more.

Our production knowledge includes machining, injection molding, extruding, thermoforming, casting, welding, etc.

We also can assemble and package your product inside the clean room Class 10,000 and Class 1000.

Xcellences Engineering is experience in developing products from concept through market.

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Methodology

Our methodology creates high quality products that are poised for success in the market.

Portfolios

Inhaler "PREMAIRE"

Sheffield Pharmaceuticals, Inc.
Inhaler \

Sheffield is developing a range of products to treat respiratory and systemic diseases in its proprietary meter solution inhaler, PREMAIRE™ Delivery System and pressurized meter dose inhaler, TEMPO™ Inhaler. Sheffield focuses on improving clinical outcomes with patient-friendly alternatives to inconvenient or sub-optimal methods of drug administration.

PREMAIRE™ is handheld ultrasound liquid atomizer with piezoelectric system. This meter solution inhaler (MSI) is using a multi-doses cartridge that easily interchanges with different drugs.

Highlights
IndustryPharmaceuticals - Combination Product
Development Stages
  • Conceptual
  • Phase 1
  • Phase 2
Manufacturing ProcessMachining, Rapid Prototyping, Injection Molding
CAD Software
  • Solid Edge
  • SolidWorks
Project ManagementManage CMOs, plans, timelines and budget.

"End Form" Electrolux

Hahn Elastomer Corp.

Hahn Elastomer is a second tier supplier of plastic extrusion, die cutting and corrugated profiles to the automotive and appliance industries. Located in SE Michigan with 4 plants, Hahn is the 10th largest extruder in the U.S. for the auto/appliance markets.

Developed "Pin Placement Assurance" for Ford and proof of concepts "End Form" project for Electrolux.

Highlights
IndustryAutomotive & Appliances
Development Stages
  • Conceptual
Manufacturing ProcessMachining
Plastic Extrusion
CAD Software
  • SolidWorks
Project ManagementManage CMOs, plans, timelines and budget.

Inhaler "TEMPO"

MAP Pharmaceuticals, Inc.

LEVADEX™ / TEMPO™ inhaler is a next generation pressurized meter dose inhaler (pMDI) or MDI. It dispenses drug automatically, using breath-actuated mechanism, when the patient inhales. TEMPO™ inhaler delivered more drugs into the lung and less deposition on the mouth.

Key engineer who responsible for the design and development as well as production and releasing of TEMPO™ Inhaler.

NOTES:
  • MAP Pharmaceuticals, Inc bought Sheffield Pharmaceuticals, Inc asset' in the end of 2003
  • Allergan had purchased MAP Pharmaceuticals, Inc. in April 2013
Highlights
IndustryPharmaceuticals - Combination Product
Development Stages
  • Conceptual
  • Phase 1
  • Phase 2
  • Phase 3 / To be Marketed
Manufacturing ProcessMachining, Rapid Prototyping, Injection Molding
CAD Software
  • SolidWorks
  • Pro-E
Project Management
  • Manage CMOs, plans, design control activities, timelines and budget.
  • Manage production and releasing of cGMP clinical supplies.

Syringe Positioning Device "SPD"

Geron Corporation

Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The company is advancing an anti-cancer drug and cancer vaccine that target the enzyme telomerase through multiple clinical trials in different cancers.

Lead the development of delivery devices to support the application of Human Embryonic Stem Cell (hESC) related therapies for Spinal Cord Injuries, Cardiac and Diabetes applications.

For more information about Geron Corporation, visit www.geron.com

Highlights
IndustryBiotech - Combination Product
Development Stages
  • Conceptual
  • Phase 1
Manufacturing Process
  • Injection Molding
  • Thermoforming
  • CNC Machining
  • Welding
CAD Software
  • SolidWorks
Project Management
  • Manage CMOs, plans, timelines, design control activities, and budget.
  • Manage production and releasing of cGMP clinical supplies.

"Vessel Closure" Devices

Abbott Vascular

Abbott Vascular, a pioneer in closure technologies, offers Suture-mediated and clip-based vessel vascular closure products designed to facilitate secure closure of the vascular access site after coronary and peripheral catheterizations., including the PERCLOSE PROGLIDE™ Suture-Mediated Closure System and STARCLOSE SE™ Vascular Closure System.

For more information about:
Highlights
IndustryMedical Device
Development Stages
  • Manufacturing Production
Manufacturing Process
  • Injection Molding
  • CNC Machining
  • Welding
  • Verification and Validation (V&V)
CAD Software
  • SolidWorks
Project Management
  • Manage CMOs, plans, timelines, ECO activities, and budget.
  • Manage production and Product PIPO.

"Phase Change" Packaging

CardioDX, Inc.

CardioDx is a cardiovascular genomic diagnostics company which develops clinically validated genomic tests to aid in assessing and tailoring care of individuals with cardiovascular disease, including coronary artery disease (CAD), cardiac arrhythmias, and heart failure.

Highlights
IndustryMedical Diagnostics
Development Stages
  • Conceptual
Manufacturing Process
  • Packaging, Phase Changed Materials
Project Management
  • Supply Chain Management.
  • Improved cost on Controlled Temperature Packaging Solutions.

"Physiotrace Smart" ECG

NimbleHeart, Inc.

NimbleHeart has built an FDA-approved, proprietary, Internet-connected, wireless ECG medical device and platform to enable both real-time and post-session cardiac monitoring and analysis.

For more information about NimbleHeart, Inc., visit www.nimbleheart.com

Highlights
IndustryMedical Device - Wearable
Development Stages
  • Prototype, Pilot and Production
Manufacturing Process
  • Injection Molding, Insert Molding
  • Thermoforming
  • CNC Machining
  • Packaging
CAD Software
  • SolidWorks
Project Management
  • Manufacturing and Quality System Advisor for wearable ECG Monitoring Device.

Calcium Sulfate InterSep Kit

Pacific Bioceramics, LLC.

Pacific Bioceramics is medical device company who develops and manufactures osteobiologics for use in regions of compromised cancellous and cortical bone. These products are used in many different skeletal applications in and around the human skeleton.

For more information about InterSep™ Calcium Sulfate Bone Void Filler, visit
Highlights
IndustryMedical Device
Development Stages
  • Conceptual
  • Production
Manufacturing Process
  • Injection Molding
  • Thermoforming
  • CNC Machining
  • UDI / Labeling
  • Packaging
CAD Software
  • SolidWorks
Project Management
  • Manage plans, timelines, budget and supply chain activities.
  • Manage Customer, CMOs, and Manufacturing Production of Sterile Kits.

RF Generator

Apical Instruments, Inc.

Apical Instruments is a medical device contract manufacturing (CMO) company which specializing in all stages of the development process from conceptualization to production of energy based controller such as Radio Frequency “RF” Generators.

For more information about Apical Instruments, Inc., visit www.apicalinstruments.com

Highlights
IndustryMedical Electrosurgical Generator
Development Stages
  • Production
Manufacturing Process
  • Injection Molding
  • Machining
  • Sheet Metal Forming
  • Fab, PCB, PCA
  • Packaging
  • Capital Equipment Manufacturing
CAD Software
  • SolidWorks
Project Management
  • Manage Customer, Supply Chain, and Manufacturing Production.
  • Manage plans, timelines, design control activities, and budget.

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