Texcel Medical Delivers Stimulation Components for Neurotech Firms

by David Pope, editorial director

In the development of new implantable medical devices, Texcel LLC of East Longmeadow, MA has an impressive record for innovative design and manufacturing solutions. With a strong core competency in neurostimulation and neuromodulation, Texcel offers medical device companies confidential contract services, including product design and development, research, verification, mechanical and electronic assembly, precision laser welding and marking, hermetic sealing, testing, and cleanroom packaging—all done in compliance with ISO quality management systems guidelines.

Medical devices developed by Texcel for clients include implantable pulse generators for functional electrical stimulation, cortical stimulation, deep brain stimulation, inner ear stimulation, vagus nerve stimulation, gastric stimulation, carotid artery stimulation, and cardiac rhythm management. Texcel also has experience in developing implantable sensors, urinary incontinence devices, vision restoration devices, ventricular assist devices, total artificial hearts, cardiac bypass assist, combined stimulation-drug delivery devices, infusion port assemblies, orthopedic implants such as replacement joints and spinal disks, surgical tools, endoscopic surgical instruments, laparoscopic devices, and catheter delivery systems

Founded in 1987 by Laurence Derose, the company initially manufactured laser welding and hermetic sealing equipment for the aerospace, electronics, and defense industries. In the 1990s Texcel began selling its laser equipment to medical device OEMs and then transitioned to providing contract laser welding and hermetic sealing of medical devices.

In 1999 Texcel was acquired by Richard Effress of Minneapolis and merged with six other companies to form Medsource Technologies Inc., which was intended to become a major supplier of machining, manufacturing, and packaging services for surgical, orthopedic, and medical device companies. Medsource did not last long and in 2002 Effress began selling off many of the companies he had acquired. In 2003 Derose regained control of Texcel.

Derose, a mechanical engineer, founded Ebtec Corp. in 1969 and was the company’s president and CEO until it was sold in 1987. When he drew up the business plan for Texcel, Derose focused on the medical market but because the demand was there aerospace and defense contractors became the first customers for laser equipment.

However, Derose noted, “Our long-term goal was to use our expertise in the field of medical devices.” Following the re-acquisition of the facilities from Medsource, he was able to pursue his original plans for Texcel. He began expanding Texcel’s capabilities to provide a full range of services from design and development to final product.
In 2004 he brought in Vince Owens as president and CEO. Owens had been president and CEO of Biomec Cardiovascular Inc. and COO of Biomec Inc., the parent company. He decided to move on shortly after BCI was acquired by Enpath Medical Inc. Owens spent about a year structuring Texcel before accepting an offer from Intelect Medical Inc., a startup launched by the Cleveland Clinic and financed by Biomec.

Today Texcel regards itself as a partner for medical device companies. Its goal as a partner is to accelerate the commercialization of emerging device technologies by providing custom engineering and manufacturing services. “We are passionate about the medical device industry,” said Derose, who serves as the company’s president and CEO. He is a member of the American Society of Artificial Internal Organs and the Laser Institute of America.

Services offered by Texcel include early concept evaluation, feasibility engineering analysis, product design, prototyping components, and testing through all development phases. Manufacture of implantable devices for human use is fully documented in accordance to FDA and ISO standards. Quality assurance and regulatory specialists work with Texcel’s development teams to create validated production processes. The company has installed the latest manufacturing equipment for the production of medical devices, from epoxy molding and computer-controlled laser systems for welding titanium to testing and packaging.

Medical devices now account for more than 90 percent of the company’s contracts. The company maintains an FDA registered and ISO certified 20,000-sf facility. The operations in the facility conform to requirements of ISO 9001:2000 and ISO 13485:2003 quality management systems. Richard Raisner is the quality and regulatory manager. The company’s controller is Deb Parys.

Additional working capital was obtained in 2007 from Charter Oak Capital Partners, which was used to grow Texcel’s capabilities in developing and manufacturing medical devices. Also in 2007 Texcel teamed up with Microtest Laboratories to develop combo devices on a contract basis for pharma companies. Combo devices combine a drug or biologic with a medical device.

The company has grown rapidly in the past few years, nearly doubling in size. It now has more than 65 employees, including about 25 engineers and 15 product technicians. Many members of the engineering team have degrees both in biomedical and mechanical engineering.

According to Keith Checca, director of business development, Texcel has grown large enough to take on just about any implantable device development project. “We are big enough to offer everything that is needed, and small enough to be a dynamic partner that is easy to work with,” he said.

Checca also noted that commercialization of a medical device takes many years, so medical device companies have much to gain by working with a trusted supplier—like Texcel—that will remain an active partner for the long term.

A programmable, multi-functional implantable pulse generator that can be customized for a wide range of stimulation applications is being developed by Texcel.