Tegra Medical Appoints New CEO

Tegra Medical has appointed Robert E. Pietrafesa as its new president and CEO. Pietrafesa brings more than 16 years of experience as a president and chief operating officer (COO) in medical device manufacturing. Most recently, he served as president of the InterV Division of Angiotech Pharmaceuticals after the successful sale of American Medical Instruments (AMI) to Angiotech for $785 million. During the three prior years, while he was president at the InterV Division of AMI, the firm’s revenues tripled and operating income increased by 500 percent.

Previously, he was a group vice president of Medical for The Marmon Group LLC. There, he served as chief strategist of the medical business and led the acquisition of five companies in six years.
Pietrafesa then orchestrated a successful spinoff of most of the medical assets to create a branded
device company principally owned by the private equity firm Roundtable Healthcare Partners, with Marmon continuing as an investor. Prior to that, he served as executive vice president and COO of B.G. Sulzle Inc., which he joined in 1992. In five years, Sulzle grew revenue by $28 million by improving quality, reducing lead times dramatically and increasing exports of surgical needles from 25 percent to 65 percent of sales, becoming the world’s largest independent manufacturers of surgical needles. In 1997 the company was sold to the Marmon Group.

“We’re thrilled to have Rob join the organization to lead the Tegra team,” David Belluck, Tegra board chairman and general partner of Riverside Partners, the majority owner of Tegra, said in prepared remarks. “Tegra is well positioned to serve the growing medical device outsourcing market with a set of manufacturing capabilities and a dedicated workforce.

Attracting a seasoned leader with Rob’s broad industry knowledge and operating experience is exactly what’s needed to ensure that our strategy and execution are well aligned.”

Tegra is no stranger to Philadelphia University-educated Pietrafesa.

“I’ve known Tegra and some of its key principals for a number of years and have always admired the technical prowess, the focus on solving customer problems, and the character and integrity of the team,” said Pietrafesa. “I look forward to leveraging this strong foundation and ensuring that we build on past successes with an unrelenting focus on customer satisfaction. Tegra has a committed and talented workforce. With the Genesis Tech Center to prototype and develop manufacturing processes, a low cost country option with our operation in Costa Rica, and the sophisticated quality system and practices required today, Tegra has the right offering to meet the needs of the most demanding device manufacturers.”

Headquartered in Franklin, Mass., Tegra Medical provides machining and contract manufacturing services to the medical device industry. The company has 200,000 square feet of modern manufacturing space in four locations and is ISO 13485:2003 registered.

Noted Ceramist Bryan McEntire Takes Charge of Technology at Amedica Corp.
Immediately following a tech-heavy year beginning, Bryan J. McEntire has been named Amedica Corp.’s new chief technology officer. He oversees the company’s technology strategies as it expands the use of Amedica’s proprietary medical grade silicon nitride for spine, total joint, dental products and potentially antibacterial coating applications.

Previously serving the role of vice president of manufacturing and research and development,
McEntire will report directly to Amedica’s President and CEO Eric Olson.

“I am very excited about the potential of Amedica’s silicon nitride to dramatically change the development of medical devices,” said McEntire. “I firmly believe in the future of Amedica and the role that silicon nitride will play. The company has a unique technological lead and I look forward to contributing to the commercialization efforts.”

Amedica’s secret weapon, silicon nitride, is a heat-resistant material that has been used in high-performance applications in space shuttles. Believed to be stronger than polyetheretherketone (PEEK) plastic, which commonly is used in medical devices, the material has imaging characteristics more favorable than both PEEK and titanium, the firm claims. Amedica was founded in 1996 by orthopedics device inventor Aaron Hofmann, M.D., and ceramics technology expert Ashok C. Khandkar, Ph.D., who believed silicon nitride would be ideal for orthopedic implants.

Like Khandkar, McEntire is a well respected ceramist and a fellow of the American Ceramic Society. Less than 1,000 individuals have been nominated as fellow during the society’s 114-year history. McEntire will be awarded with his fellowship status at the society’s Honors and Awards Banquet to be held during its 114th Annual Meeting in October this year.

When McEntire joined Amedica in August 2004, he was hired as vice president of manufacturing. It was in 2006 that he was named vice president of research. Prior to Amedica, he was senior director of supply chain management at Applied Materials Inc. in Silicon Valley from 1998 to 2004. There he managed a portion of the supply chain, which included the negotiation of supply contracts and supervision of vendor production of various parts including precision ceramic components, which were integrated into the capital equipment made and sold by Applied Materials. Before joining Applied Materials, he was general manager of Norton Advanced Ceramics, a division of Saint-Gobain Industrial Ceramics Corporation, from 1993 to 1998, where he managed four ceramic product manufacturing plants in the United States. This included the largest U.S.-based production facility for precision silicon nitride bearing components. From 1987 to 1993, McEntire served in various positions for a joint venture between Norton Company and TRW Inc., including vice president and technical director. The purpose of the joint venture was to explore the use of silicon nitride based ceramics in automotive and turbine engine applications. During his tenure with the joint venture, he managed several multi-million-dollar research and development contracts for the U.S. Department of Energy.
From 1978 to 1987, McEntire was successively promoted from manager of ceramic production and development to plant manager for Ceramatec Inc., a small innovative producer of ionic-conducting and structural ceramic components based in Salt Lake City, Utah.

McEntire earned his B.S. in materials science and engineering and M.B.A. in operations management from the University of Utah. He has authored or co-authored more than 30 technical papers on ceramic materials, processing and characterization, and served as an invited short-course lecturer on the forming of ceramics at the annual meeting of the American Ceramic Society from 1986 to 1995.
“Bryan has an extraordinary reputation as a strategic thinker and has an intuitive grasp for how new and existing technologies can benefit patients,” Olson said. “Together with his continued support as the chief technology officer, we will more fully align our development and commercialization efforts to maximize the return on investment from the various silicon nitride projects currently under development.”

The Salt Lake City-based Amedica intends to apply silicon nitride to its orthopedic, spine and dental implant products.

Blue Belt Technologies Forms Scientific Advisory Board
Pittsburgh, Pa.-based Blue Belt Technologies Inc. has formed a Scientific Advisory Board for the development and commercialization of the Navio PFS (precision freehand sculpting) orthopedic surgical system. The Navio PFS is a navigation platform made up of a virtual bone-cutting guide with detailed visualization and a hand-held robotic instrument, which enables the precision of robotics through the hand of a surgeon. Physicians can use the system with any implant they choose.

The new board is co-chaired by Jess H. Lonner, M.D., and Andrew D. Pearle, M.D. Lonner is an attending orthopedic surgeon at the Rothman Institute in Philadelphia, Pa., and associate professor of orthopedic surgery at Thomas Jefferson University in the same city. He has written nearly 200 peer reviewed scientific publications and chapters, and has published several textbooks on knee replacement surgery. His areas of expertise include partial and total knee replacement surgery, and as one of the first surgeons in the United States to use robotic technology for unicompartmental and
bicompartmental knee replacement surgery, he has been a key innovator in this area. Pearle is an orthopedic surgeon at the Hospital for Special Surgery in New York, N.Y. He is a team physician for the New York Mets and currently serves as editor-in-chief of the industry journal Techniques in Knee Surgery. He has authored more than 90 scientific papers focusing primarily on ACL reconstruction as well as computer assisted and robotic surgery, with his main clinical interests being arthroscopic and robotic surgery of the shoulder, knee and ankle.

Other scientific advisory board members include:

• Professor Johan Bellemans, M.D., Ph.D., professor of orthopedic surgery at the Catholic University in Leuven, Belgium, and chairman of the orthopedic department at the Catholic University Hospitals in Leuven and Pellenberg, Belgium;
• Professor David Murray, M.D., professor of orthopedic surgery at the University of Oxford, in Oxford, United Kingdom, and a consultant orthopedic surgeon at the Nuffield Orthopedic Centre in Oxford. Murray specifically is working with Blue Belt to develop applications for the hip using the Navio PFS; and
• S. David Stulberg, M.D., director and founder of the joint reconstruction and implantation service at Northwestern Memorial Hospital in Chicago, Ill., and at the Rehabilitation Institute of Chicago and Rush North Shore Medical Center.

“Blue Belt Technologies is poised to further advance the field of robotically assisted orthopedic surgery,” said Lonner. “We have a uniquely qualified Scientific Advisory Board with surgeon members that offer a breadth of valuable surgical experience and a proven history of commitment to implant development and smart tool innovation.”

Pearle also expressed confidence in the potential for the board to move the company forward:
“Blue Belt has assembled an outstanding group of scientific advisors who have a long track record of innovation. I am honored to be a part of this visionary group,” he said. “Combining the NavioPFS technology with this dynamic Blue Belt team is exciting and I am confident that we can create products that fundamentally impact and improve the care of our patients.”

The company’s goal is to develop the next generation of “smart” surgical instruments for use initially in orthopedic procedures and then for other surgical specialties including neurosurgery, spinal and otolaryngology.