Gulf Coast Medical Device Manufacturers Directories RSS Feed

Indus Instruments

Mon, 16 Jan 2012 22:11:34 GMT

TBA

Umbach Consulting Group

Mon, 21 Nov 2011 17:23:47 GMT

Steven R. Umbach, IDSA, HFEs, MBA

After 20-plus years of product design and development experience, Steven Umbach founded the Umbach Consulting Group in The Woodlands, Texas in 2001 with a focus on industrial design and new product development (NPD) for technology products, consumer products, and medical devices. Since founding the company, Mr. Umbach has provided design solutions for Texas-based companies for such medical programs as the human factors interface for the MicroMed DeBakey LVAD patient pack, the NovoSci Ready System minimized cardiopulmonary bypass platform, and the patient interface components for a blood oxygen sensor for UTMB/Noninvasix. Prior to founding the Umbach Consulting Group, Mr. Umbach provided industrial design solutions for such medical devices as; an injection device for cattle for Syntex Agribusiness, a bi-ventricular support machine control panel for AbioMed, an infant apnea monitor and IV food pump for Briox Technologies, prototype construction for a kidney dialysis machine for Cortis Dow, and the control panel and ergonomic seating platform for a sonar-controlled stair-climbing wheelchair for Access Technologies Inc.

Mr. Umbach received his industrial design degree from the Rhode Island School of Design and his MBA from Georgia Institute of Technology. He is currently a long standing member of the Industrial Designers Society of America (IDSA) and the Human Factors and Ergonomics Society (HFES). Since 2004, Mr. Umbach has been an adjunct faculty at the University of Houston and UH Clear Lake where he teaches courses in industrial design and human factors.

Steven Umbach
Steven@Umbach-CG.com

6700 Woodlands Pkwy

The Woodlands, Texas 77382

(936) 273-4342

NovoSci Corporation

Tue, 27 Sep 2011 19:00:00 GMT

NovoSci is a contract manufacturing company providing comprehensive supply chain and order fulfillment services to the medical device industry. Our in-house capabilities include manufacturing, kit assembly, packaging, sterilization, climate-controlled warehousing and worldwide distribution. We assume total quality management of our customer’s production requirements, saving them time and money. We are also an OEM and a direct supplier of disposable plastic components, kits and instruments.

Mike Sorna
mike.sorna@novosci.com

2021 Airport Rd

Conroe, TX 77304

(281) 210-3370

Oracle

Thu, 26 May 2011 14:08:44 GMT

Luanne Jones
luanne.jones@oracle.com

1200 Smith St. s.1500

Houston, TX 77002

Ceutical Labs

Wed, 11 May 2011 17:38:40 GMT

Ceutical Laboratories can provide solutions for individuals and companies to take a product idea and place it into a competitive position within the marketplace. These individuals and companies can continue to deliver product ideas and reap the benefits of their ideas. Ceutical Laboratories provides competitive solutions to product development, clinical evaluation and regulatory submission in both domestic and abroad markets, on-line technology, computer aided systems, sales, marketing, and distribution. We work with suppliers and manufacturers to deliver high quality products to large distributors at competitive prices. Ceutical Laboratories is well positioned in the market through key contacts within major networks to provide goods and services to these markets.

Katie Arlt
karlt@ceuticallabs.com

2300 Valley View Lane

Farmers Branch, TX 75234

(972) 241-8374

OMEDtech

Mon, 09 May 2011 20:00:00 GMT

OMEDtech meets the challenges of new product approvals, identifying and correcting regulatory deficiencies, improving operational systems and filling the gap when resources are limited and schedules are unrelenting. A few areas of expertise include: · IDE (Investigational Device Exemption) and HDE (Humanitarian Device Exemption) Submissions · PMA (PreMarket Approval:) Applications and 51 OK Notifications · Clinical Trial Development and Management, · Quality System Implementation · Manufacturing Process Development and Management · Quality System Reviews, · Engine Stephen Ford sford@omedtech.com 9595 Six Pines, Bldg 8, Level 2, Suite 8210 The Woodlands, TX 77380 (405) 503-4924

LeoMed

Tue, 15 Mar 2011 22:00:00 GMT

LeoMed, LLC. is a medical device company developing products for urology and cardiology. LeoMed was founded by Dr. Bandula Wijay, an entrepreneur with impressive serial start-up success (including PolyTech (1984), LeoCor Inc. (1986), and Binlab Inc. (2000)), along with two leading Urologists in the Houston area, Dr. Ayaz Duranni and Dr. Omar Duranni. LeoMed is also collaborating with top-notch component manufacturers in China for the components of its products.

LeoMed is currently developing, manufacturing, and marketing a Suprapubic Catheter Insertion Kit, a Ureteral Stent, an External Urethral Catheter Valve, and a Ureteral Access Sheath. Future products include a Prostatic Stent for Benign Prostatic Hyperplasia (BHP), a novel contraceptive device for women, and drug delivery devices for targeted drug therapy. LeoMed’s capabilities include extrusion within a clean room environment, contract medical device design, 3-D modeling, and prototype development.

Dr. Bandula Wijay
BW.Leomed@gmail.com

9001 Airport Blvd., Suite 503

Houston, TX 77061

(832) 224-8148

Biotex

Wed, 16 Feb 2011 17:36:32 GMT

Charles Housierre

8058 El Rio St.

Houston, TX 77054

(713) 741-0111

Henkel Corp.

Mon, 17 Jan 2011 15:00:00 GMT

Contact:

George Nelson

(281) 639-1406

george.nelson@us.henkel.com

George Nelson
george.nelson@us.henkel.com

7826 Park Hollow Ct.

Houston, TX 77095

National Instruments

Fri, 03 Dec 2010 14:46:43 GMT

Two opposing pressures drive medical device development. Producing safe, high-quality devices for patient care is a primary concern, but reduced development time is also critical to establishing an early position in a very competitive market. By tightly integrating hardware, software, validation, and reporting tools, the National Instruments graphical system design platform provides the best solution for rapidly developing and testing complex medical devices. Medical Device Design By using the National Instruments graphical system design platform, you can focus on the scientific principles behind treatments as opposed to low-level implementation details. When a quick functional prototype is your goal, NI hardware can provide the fastest path to a real working system. When it comes time to validate, NI provides tools to help streamline the testing, audit, and documentation of your medical device. Medical Device Test For more than...

Krypton Solutions

Tue, 05 Oct 2010 18:35:21 GMT

Krypton Solutions is a full service design, rapid prototyping and low/medium volume turn-key electronic contract manufacturer located in Plano, Texas. We are ISO13485, AS9100 certified and ITAR, minority owned registered. We serve the medical, semiconductor, energy, industrial and aerospace/security/defense market segments. In 2008, 2009 and 2010 we have been awarded Circuit Assembly’s Customer Service Excellence Award for companies under $20 million in sales.

Krypton Solutions provides high speed, precision printed circuit board assembly within our 40,000 S.F. facility. Krypton Solutions works to an AS9100, ISO 9001:2000 and a ISO 13485 Medical Standard. We offer the capability to provide on time delivery of the highest quality. Krypton Solutions is a full service design partner committed to providing Engineering, PCB layout, PCB Fabrication, Prototyping and Testing services that will meet or exceed our customer's needs.

Mark Seggelink
mark@krypton-solutions.com

3060 Summit Ave

Plano, TX 75074

(972) 424-3880

Integrated BioTech Solutions

Mon, 21 Jun 2010 20:00:00 GMT

Biotech Company

Steve Pondell
spondell@ibtsolutions.us

1418 Meadow Bay Ct

Sugarland, TX 77479

(281) 253-7088

ATEK Plastics

Tue, 11 May 2010 17:00:00 GMT

ATEK Plastics
200 Holdsworth Drive
Kerrville, TX 78028-3372
(830) 896-6464

Ryan Haase
RHaase@atekplastics.com

200 Holdsworth Drive

Kerrville, TX 78028-3372

(830) 896-6464

Shadow Polymer Industries, Inc.

Wed, 14 Apr 2010 22:00:00 GMT

Shadow Polymer Industries is a full service design, engineering, analysis, tooling, and manufacturing resource group dedicated to advanced product development and flexible manufacturing. We surpass our customer's expectations by employing a unique combination of real-world experience with advanced problem solving methods to optimize manufacturing productivity. Our customers vary in size from start-up operations through multi-billion dollar corporations. Industries we presently service are: consumer products, automotive, aerospace, electrical, food service, wireless communications, defense, industrial, medical, seating, packaging and construction.

Our mission is to provide our customers with the most professional, comprehensive, and technically sound services in the industry. We believe our people are our greatest strength. Our aim is to provide them with significant challenges, a positive work environment and encourage each team member to realize their full potential. We value diversity, promote teamwork and appreciate creativity. We believe in compensating our people according to their contribution to the company’s overall success. We settle for nothing less than dedication, honesty and integrity.

Our associates have significant hands-on experience in the operation of plastic and metal related businesses. The team members have an average twenty years of experience in the areas of marketing, industrial design and engineering, advanced product development, sales, manufacturing operations, and human resources. Each team member has his/her undergraduate degree with some through the doctoral level in their respective discipline (most have their Masters). Each one has a proven track record in their field of specialization, during high growth and recessionary environments.

Robert Hickman
Rob@shadowpolymer.com

28631 Hidden Lake West

Magnolia, TX 77354

(281) 789-7520

SeprOx Corporation

Thu, 31 Dec 2009 22:30:03 GMT

The medical oxygen generators to be manufactured and sold into the $6 billion (annual) medical devices market by SeprOx will be capable of producing 10 liters per minute of 99.95+ % pure oxygen and are expected to weigh less than 10 pounds, making them the preferred portable oxygen generators for active patients that have chronic obstructive pulmonary disease and who require oxygen therapy. Moreover, these versatile devices will supply oxygen at a rate and purity also required for home use, allowing them to also displace much heavier stationary home oxygen generation systems.

SeprOx anticipates having a commercial prototype ready for FDA approval within 12-15 months and anticipates beginning to manufacture and ship products within 24-30 months.

Robert Schucker
rcschucker@seprox.com

2408 Timberloch

The Woodlands, TX 77380

(281) 296-5585

Synthecon, Inc.

Thu, 31 Dec 2009 22:30:00 GMT

Our manufacturing partner operates a licensed facility under both the Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH) guidelines, and is in good regulatory standing with both. In addition to cGMP manufacturing, customers have availability to monitored cGMP cleanrooms for dispensing product into vials as well as clinical packaging and/or final product configurations. When needed, R&D staff is available on-site to assist customers with drug development and regulatory direction.

William Anderson (President)

abill@synthecon.com

USA SYNTHECON, Inc.
8042 El Rio
Houston, Texas 77054
Tel: 713-741-2582
Fax:713-741-2588
Toll-free: 800-853-0740

E-mail:rccs@synthecon.com

www.synthecon.com

William Anderson
abill@synthecon.com

8044 El Rio

Houston, TX 77054

Texcast, Inc.

Thu, 31 Dec 2009 22:29:33 GMT

ISO 9001:2000 certified.

In business since 1982.

Gary Hinds
garyhinds@texcast.com

706 Lehman

Houston, TX 77018

Tietronix

Thu, 31 Dec 2009 22:29:13 GMT

We specialize in helping commercial customers visualize their innovative concepts, requirements capture, design, and deployment of complex software systems. One of our flagship products is MDA (Medical Device Accelerator) which is a framework built around a work flow engine automating the design and management of Medical Device Companies. This includes providing a set of ready to use process libraries following FDA regulations, a document management system, and integrated tools all built into a hosted web application.

In the government sector, Tietronix has over 10 years of experience developing mission critical systems from NASA from flight software to IT infrastructure. Our company has won numerous awards from our work in this sector, including Phase III SBIR commercialization grants, and has a very stable business based upon long term support contracts.

Additionally, we have extensive experience in creative services (graphics, medical illustration, 3D animation) and have extensive applications currently used by NASA and the medical device community. By combining our skills in graphical communication, education/training, and advanced medical software products, we are developing a compelling line of products based upon “serious game” development. This approach transforms the effectiveness of any computer diagnostic test, static training program or clinical education program into a dynamic, engaging, user-adaptive content delivery vehicle.

Chris Dupont
cdupont@tietronix.com

1331 Gemini Avenue

Houston, TX 77058

USON LP

Thu, 31 Dec 2009 22:28:48 GMT

Uson leak testers and accessories are built to the exacting standards demanded by the world's top companies using the best quality components and materials.

With Uson, you will receive world class products, unbeatable support, and customer care we are proud to say is second to none.

For good measure, there's Uson.

Tyre Oliphant
tyre.oliphant@uson.com

8640 N. Eldridge Parkway

Houston, TX 77041

(281) 671-2000

Pegasus, Inc.

Thu, 31 Dec 2009 22:27:58 GMT

We ship outbound from any point in the US to either a domestic or international location, as well as shipping into the US and also country to country (foreign to foreign) shipments.

We handle shipments from small to large covering a variety of commodities from chemicals and live animals to equipment and other manufactured goods. We are certified to handle hazardous shipments by air and ocean.

We have a highly experienced and knowledgeable staff who are ready to meet your needs and requirements.

Please contact us at:

Pegasus Inc.
15415 International Plaza Drive, Suite 200 Houston, TX 77032
tel: 281-590-7600
fax: 281-590-0600
general email: mail.manager@pfsiglobal.com

Contacts:

Betty Nix - betty.nix@pfsiglobal.com

Judi Copeland - judi.copeland@pfsiglobal.com

Pam Ceravolo - pam.ceravolo@pfsigloba.com

TEST

Debra Capko
debra.capko@pfsiglobal.com

15415 International Plaza Drive

Houston, TX 77032