09.11.12
Secant Medical has been awarded the 2012 North American Frost & Sullivan Award for Enabling Technology based on the company’s contribution to the implantable textile structures design market. Established in 2002 as a business unit within Prodesco Inc. (part of Fenner PLC), Secant develops biomedical textiles technologies, and is one of the few suppliers that can provide customized design solutions at competitive prices to medical device manufacturers and other notable clients in the biomedical device industry.
The Frost & Sullivan Award is awarded each year to companies that not only have developed a pioneering technology, but whose technology also promises to aid in the development of further, newer technologies. In addition, the award recognizes the high market acceptance potential of a technology.
In a laudatory statement announcing the award, Secant is described as a company able to combine variability in structure, delivery method, performance, physical composition, resorbability, and other unique elements that make up implantable textile construction. The company’s customized approach enables medical device manufacturers to develop a portfolio of more innovative, effective, and commercially successful medical device designs.
“There is an emerging industry need to completely understand the role that material selection plays in realizing component structure design, optimizing the development process, and largely defining the form and function of the end device,” said Prasanna Vadhana Kannan, senior research analyst at Frost & Sullivan. “One of the unique approaches adopted by Secant Medical toward design methodology is its ability to understand the medical device design requirements and leverage its technology to create a customized solution for the client’s device application.”
A combination of established and emerging substrates, along with a carefully structured material selection process, offers an effective path toward enhancing the performance of a medical device design. In line with this trend, Secant Medical is focused on advancing textile constructs built from absorbable and bio-active polymers for tissue engineering and orthobiologics applications that require short-term tissue support while the body repairs itself, followed by long-term biologic integration.
The company’s approach also will enable niche applications for biomedical textiles. For instance, Frost & Sullivan expects that in the near future, spinal applications will benefit from woven structures that contain reinforced holes for screws and other fixative components used for attaching to a bone plate. In effective filtration-involving applications, weaving with wires and other biomaterials paves the way for more open constructions that have highly controlled pore sizes for capturing emboli, while at the same time allowing normal blood flow through the material. Such prospects of woven biomedical textiles are useful in surgical techniques involving high-stroke patients. As such, the potential for Secant’s technology is far-reaching.
“Another crucial capability in woven biomedical textiles is the ability to provide vital properties by altering or modulating the geometry of the structures and the materials from which they are produced,” noted Kannan. “Secant Medical is working toward textile components engineered from materials designed to degrade at varying rates over time, thereby allowing the ability to fine-tune fabric degradation in sync with the desired tissue healing rate of the patient.”
Secant has formed strategic partnerships with leading biomaterial providers to boost innovation in the orthopedics segment involving tissue engineering, tissue scaffolding, and orthobiologics concepts. The firm realizes that with a seemingly endless need to customize materials and form technologies to suit new device applications, investing in biomedical textiles research and development will accelerate innovation and advance medical technologies available for surgical procedures. This foresight was cited as a further reason that made Secant worthy of this year’s Frost & Sullivan Award.
In other news for the company, Secant Medical LLC and its parent company Prodesco Inc. merged under one banner as Secant Medical Inc. at the beginning of September. The name change is intended to support the company’s continued business growth in the medical device industry, company officials said.
“Our company will maintain the same values and collaborative engineering approach while further expanding our business to better serve the needs our clients,” said Erik Nadeau, president. “The name change signifies our commitment to being an innovator in enabling technology platforms and our focus on adapting to the ever changing needs of the medical device industry.”
Prodesco will remain a brand of Secant Medical Inc.
Secant Medical is based in Perkasie, Pa., and produces biomedical textile structures for medical devices. Using polymeric, metallic and resorbable biomaterials, the company develops implantable textile structure technologies for orthopedic, cardiovascular, tissue-engineered, neurovascular and general surgery devices. Secant Medical is a business unit of Fenner plc, a reinforced polymer engineering company based in Yorkshire, England.
Frost & Sullivan is a New York, N.Y.-based company that partners with companies from various industries to aid in growth and innovation. Frost & Sullivan Best Practices Awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.
Millstone Medical Outsourcing Grows Memphis Operations
Millstone Medical Outsourcing is expanding its operations in Memphis, Tenn., to a new facility to broaden services and capacity. The new facility will offer 150,000 square feet of operational space for advanced mechanical inspection, loaner kit processing, bone/tissue storage, packaging services, and distribution. With construction of a new building and state-of-the-art renovations already underway, the expansion to the additional location is expected to be complete by the end of the fourth quarter of 2012.
Millstone is an outsourcing partner to a number of U.S. orthopedic companies, and provides inspection, clean room packaging, loaner kit processing, and distribution services to medical and dental device manufacturers worldwide.
The company’s decision to expand was preceded by growing demand from customers. The new facility will be located in Olive Branch, Miss., which (though in a different state) is a suburb of Memphis. Memphis location professionals and staff will make the move with Millstone Medical, and the company plans to hire an additional 25 employees.
“The additional operational space will allow Millstone to expand programs for existing customers and to bring on new customers,” said Chris Ramsden, CEO of Millstone Medical Outsourcing. “In addition, the new facility is strategically located near the distribution hubs of the area’s major carrier and continues to enable Millstone to provide extended service hours and expedited shipping. We are tremendously excited about all the possibilities the new facility will deliver for the company and our customers.”
Valtronic Opens New Orthopedic Facility in Switzerland
Manufacturing services provider Valtronic has opened a new 1,600-square-meter (approximately 5,249 square feet) orthopedic production facility across the street from its headquarters in the Valley de Joux, Switzerland.
“The mechanical workshop is now up and running in an improved environment and we are looking forward to improving our services for existing customers as well as starting new partnerships,” said Martin Zimmermann, Ph.D., director of the precision manufacturing center, crediting “great team spirit” for the project’s quick turnaround and positive results.
The new building will house production, finishing, control, receipt and storage capacities as well as an engineering and logistics office. Valtronic officials hope the facility will provide its customers with access to increased capabilities such as finishing services and added equipment for medical implant-grade plastics such as PEEK. The company now also will have separate areas for medical and industrial manufacturing and improved process flows.
“Building this new facility is the next step in growing our presence in the orthopedic market,” Zimmermann continued. “Our increased investment in the market began with the acquisition of Geisert Square last year. This new building is a strategic investment with a clear focus on growing our global orthopedics business with full service design and manufacturing and a commitment to providing the market with expertise needed to make smart implants a market reality.”
Smart implants include those that operate wirelessly to transmit information to physicians, and implants that have embedded sensors that can detect problems early.
In addition to its Swiss operations, Valtronic also has locations in the United States, Germany, Romania and Morocco.
Cadence Completes Recent Expansion in Virginia, Adds Jobs
Staunton, Va.-based Cadence Inc. has completed the 25,000-square-foot expansion it announced last year. The company promised to create 65 new jobs in the three years from the announcement, and already has created 50.
According to Cadence, its business is growing at a pace that indicates the need for more than 50 additional employees by the end of 2012, making the total number of new jobs approximately 100. Currently, the company has 300 employees between its Virginia and Rhode Island locations. The company also has invested $8 million in equipment and $3 million in facilities toward the $15.9 million Virginia Governor Bob McDonnell announced that Cadence would be investing to expand its operation in Staunton.
Cadence was founded in 1985 under the name Specialty Blades, addressing the needs of industries, original surgical manufacturers, and medical design engineers requiring high-performance, razor-sharp, custom-made cutting blades. The company now also is focused on new medical technologies such as minimally invasive devices.
“It is tremendous that a company that has thrived in Staunton for more than 25 years continues to excel at a rapid pace,” said McDonnell. “With two years left to meet the measures outlined in the performance agreement, Cadence has already hired nearly all of the committed positions and made a significant investment. The company’s path of success continues, and both Virginia and Staunton are proud of their long-term partnership with Cadence.”
NSF International Acquires Becker & Associates Consulting
NSF International, an independent global public health and safety organization that develops standards as well as tests and certifies products for the food, water, health and consumer products industries, has acquired Becker & Associates Consulting, Inc., a clinical, regulatory and scientific consulting firm that specializes in U.S. Food and Drug Administration (FDA)-regulated industries, specifically medical devices, pharmaceuticals and biologics.
Terms of the deal were not disclosed.
Becker will become part of NSF’s Health Sciences Division, which offers training and education, consulting, good manufacturing practice (GMP) and good laboratory practice testing, certification, research and development and auditing services for the pharmaceutical, dietary supplement and medical device industries throughout the entire product life cycle.
“The partnership between NSF International and Becker comes at a time when the U.S. FDA [Food and Drug Administration] is actively warning manufacturers and patients about the need for enhanced systems to ensure the safety of medical devices and pharmaceuticals,” said Ronald Ginor, M.D., CEO of Becker & Associates Consulting. “With NSF’s role at the forefront of public health for 68 years and its global capabilities, we will be able to enhance and expand the scope and range of services we can offer to our customers.”
Ginor will continue in his role as CEO following the acquisition. President of Becker Consulting and former Director of Compliance at FDA’s Center for Devices and Radiological Health Ron Johnson also will continue his leadership of quality systems and compliance activities for the firm, directing the company’s expanding activities in North America, India, China and South America.
“The medical device and pharmaceutical sectors are in a period of flux following a number of significant regulatory changes,” Johnson said. “As part of NSF’s Health Sciences Division, we are able to help our clients not only meet FDA compliance but to educate their professionals to stay in compliance by leveraging the vast experience and resources of NSF International.”
Headquartered in Washington, D.C., Becker Consulting provides services to help client companies meet FDA requirements for developing, testing and marketing innovative healthcare products. The company specializes in resolving clinical, regulatory and scientific challenges in the life sciences sector. The company also helps assure the safety and efficacy of drugs and medical devices, re-establishes manufacturing facilities after natural disasters, designs manufacturing processes for complex biologics, builds systems for protecting blood banks, and develops testing protocols and clinical programs for the evaluation of novel drugs and devices.
The acquisition will complement Ann Arbor, Mich.-based NSF’s services, which include: training and education for the pharmaceutical, biotech and medical device industries; consulting in quality systems, GMP and compliance/enforcement actions; clinical and regulatory consulting; analytical testing; bioanalytical testing for clinical trials; and product testing and certification.
“This is a singular opportunity for both NSF International and Becker to expand our global biotech, medical device and life science services," said Kevan P. Lawlor, president and CEO of NSF International.
European Medtech Organizations Select Joint CEO
The European Medical Technology Industry Association (Eucomed) and the European Diagnostic Manufacturers Association (EDMA) have named Serge Bernasconi as both organizations’ new CEO. He assumed the role on July 16, succeeding Luciano Cattani at Eucomed and Volker Oeding at EDMA.
Both associations have been collaborating as of late in what has been called a “European industry alliance.” The members of Eucomed represent the in-vitro diagnostics industry, while those of EDMA represent the medical technology industry in Europe. The selection of a joint CEO was sought to help cohesively join the two associations.
“The time is right to further intensify the cooperation between Eucomed and EDMA,” said Eucomed Chairman Guy Lebeau, M.D.
Bernasconi has more than 30 years experience in pharmaceuticals and medical devices, having worked for companies such as Johnson & Johnson, Schering Plough in the United States and Europe, and more recently, Medtronic Inc. In his capacity as president and international regional vice president of Medtronic France, he was elected president of the French Association for the Promotion of Innovation in Medical Devices, and vice president and treasurer of the French Medical Technology Industry Association.
“I am very pleased to welcome Serge to lead the teams at EDMA and Eucomed,” said Jürgen Schulze, Ph.D., president of EDMA. “Serge’s considerable experience will be a great asset to the industries and we are all very much looking forward to building rewarding partnerships that benefit the entire healthcare equation.”
For his part, Bernasconi is enthusiastic about his new role, commenting, “I am convinced that both associations occupy an excellent position to help in advancing healthcare in Europe. As our alliance grows stronger, we will become ever more effective in delivering on this promise.”
The Frost & Sullivan Award is awarded each year to companies that not only have developed a pioneering technology, but whose technology also promises to aid in the development of further, newer technologies. In addition, the award recognizes the high market acceptance potential of a technology.
In a laudatory statement announcing the award, Secant is described as a company able to combine variability in structure, delivery method, performance, physical composition, resorbability, and other unique elements that make up implantable textile construction. The company’s customized approach enables medical device manufacturers to develop a portfolio of more innovative, effective, and commercially successful medical device designs.
“There is an emerging industry need to completely understand the role that material selection plays in realizing component structure design, optimizing the development process, and largely defining the form and function of the end device,” said Prasanna Vadhana Kannan, senior research analyst at Frost & Sullivan. “One of the unique approaches adopted by Secant Medical toward design methodology is its ability to understand the medical device design requirements and leverage its technology to create a customized solution for the client’s device application.”
A combination of established and emerging substrates, along with a carefully structured material selection process, offers an effective path toward enhancing the performance of a medical device design. In line with this trend, Secant Medical is focused on advancing textile constructs built from absorbable and bio-active polymers for tissue engineering and orthobiologics applications that require short-term tissue support while the body repairs itself, followed by long-term biologic integration.
The company’s approach also will enable niche applications for biomedical textiles. For instance, Frost & Sullivan expects that in the near future, spinal applications will benefit from woven structures that contain reinforced holes for screws and other fixative components used for attaching to a bone plate. In effective filtration-involving applications, weaving with wires and other biomaterials paves the way for more open constructions that have highly controlled pore sizes for capturing emboli, while at the same time allowing normal blood flow through the material. Such prospects of woven biomedical textiles are useful in surgical techniques involving high-stroke patients. As such, the potential for Secant’s technology is far-reaching.
“Another crucial capability in woven biomedical textiles is the ability to provide vital properties by altering or modulating the geometry of the structures and the materials from which they are produced,” noted Kannan. “Secant Medical is working toward textile components engineered from materials designed to degrade at varying rates over time, thereby allowing the ability to fine-tune fabric degradation in sync with the desired tissue healing rate of the patient.”
Secant has formed strategic partnerships with leading biomaterial providers to boost innovation in the orthopedics segment involving tissue engineering, tissue scaffolding, and orthobiologics concepts. The firm realizes that with a seemingly endless need to customize materials and form technologies to suit new device applications, investing in biomedical textiles research and development will accelerate innovation and advance medical technologies available for surgical procedures. This foresight was cited as a further reason that made Secant worthy of this year’s Frost & Sullivan Award.
In other news for the company, Secant Medical LLC and its parent company Prodesco Inc. merged under one banner as Secant Medical Inc. at the beginning of September. The name change is intended to support the company’s continued business growth in the medical device industry, company officials said.
“Our company will maintain the same values and collaborative engineering approach while further expanding our business to better serve the needs our clients,” said Erik Nadeau, president. “The name change signifies our commitment to being an innovator in enabling technology platforms and our focus on adapting to the ever changing needs of the medical device industry.”
Prodesco will remain a brand of Secant Medical Inc.
Secant Medical is based in Perkasie, Pa., and produces biomedical textile structures for medical devices. Using polymeric, metallic and resorbable biomaterials, the company develops implantable textile structure technologies for orthopedic, cardiovascular, tissue-engineered, neurovascular and general surgery devices. Secant Medical is a business unit of Fenner plc, a reinforced polymer engineering company based in Yorkshire, England.
Frost & Sullivan is a New York, N.Y.-based company that partners with companies from various industries to aid in growth and innovation. Frost & Sullivan Best Practices Awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.
Millstone Medical Outsourcing Grows Memphis Operations
Millstone is an outsourcing partner to a number of U.S. orthopedic companies, and provides inspection, clean room packaging, loaner kit processing, and distribution services to medical and dental device manufacturers worldwide.
The company’s decision to expand was preceded by growing demand from customers. The new facility will be located in Olive Branch, Miss., which (though in a different state) is a suburb of Memphis. Memphis location professionals and staff will make the move with Millstone Medical, and the company plans to hire an additional 25 employees.
“The additional operational space will allow Millstone to expand programs for existing customers and to bring on new customers,” said Chris Ramsden, CEO of Millstone Medical Outsourcing. “In addition, the new facility is strategically located near the distribution hubs of the area’s major carrier and continues to enable Millstone to provide extended service hours and expedited shipping. We are tremendously excited about all the possibilities the new facility will deliver for the company and our customers.”
Valtronic Opens New Orthopedic Facility in Switzerland
Manufacturing services provider Valtronic has opened a new 1,600-square-meter (approximately 5,249 square feet) orthopedic production facility across the street from its headquarters in the Valley de Joux, Switzerland.
“The mechanical workshop is now up and running in an improved environment and we are looking forward to improving our services for existing customers as well as starting new partnerships,” said Martin Zimmermann, Ph.D., director of the precision manufacturing center, crediting “great team spirit” for the project’s quick turnaround and positive results.
The new building will house production, finishing, control, receipt and storage capacities as well as an engineering and logistics office. Valtronic officials hope the facility will provide its customers with access to increased capabilities such as finishing services and added equipment for medical implant-grade plastics such as PEEK. The company now also will have separate areas for medical and industrial manufacturing and improved process flows.
“Building this new facility is the next step in growing our presence in the orthopedic market,” Zimmermann continued. “Our increased investment in the market began with the acquisition of Geisert Square last year. This new building is a strategic investment with a clear focus on growing our global orthopedics business with full service design and manufacturing and a commitment to providing the market with expertise needed to make smart implants a market reality.”
Smart implants include those that operate wirelessly to transmit information to physicians, and implants that have embedded sensors that can detect problems early.
In addition to its Swiss operations, Valtronic also has locations in the United States, Germany, Romania and Morocco.
Cadence Completes Recent Expansion in Virginia, Adds Jobs
According to Cadence, its business is growing at a pace that indicates the need for more than 50 additional employees by the end of 2012, making the total number of new jobs approximately 100. Currently, the company has 300 employees between its Virginia and Rhode Island locations. The company also has invested $8 million in equipment and $3 million in facilities toward the $15.9 million Virginia Governor Bob McDonnell announced that Cadence would be investing to expand its operation in Staunton.
Cadence was founded in 1985 under the name Specialty Blades, addressing the needs of industries, original surgical manufacturers, and medical design engineers requiring high-performance, razor-sharp, custom-made cutting blades. The company now also is focused on new medical technologies such as minimally invasive devices.
“It is tremendous that a company that has thrived in Staunton for more than 25 years continues to excel at a rapid pace,” said McDonnell. “With two years left to meet the measures outlined in the performance agreement, Cadence has already hired nearly all of the committed positions and made a significant investment. The company’s path of success continues, and both Virginia and Staunton are proud of their long-term partnership with Cadence.”
NSF International Acquires Becker & Associates Consulting
NSF International, an independent global public health and safety organization that develops standards as well as tests and certifies products for the food, water, health and consumer products industries, has acquired Becker & Associates Consulting, Inc., a clinical, regulatory and scientific consulting firm that specializes in U.S. Food and Drug Administration (FDA)-regulated industries, specifically medical devices, pharmaceuticals and biologics.
Terms of the deal were not disclosed.
Becker will become part of NSF’s Health Sciences Division, which offers training and education, consulting, good manufacturing practice (GMP) and good laboratory practice testing, certification, research and development and auditing services for the pharmaceutical, dietary supplement and medical device industries throughout the entire product life cycle.
“The partnership between NSF International and Becker comes at a time when the U.S. FDA [Food and Drug Administration] is actively warning manufacturers and patients about the need for enhanced systems to ensure the safety of medical devices and pharmaceuticals,” said Ronald Ginor, M.D., CEO of Becker & Associates Consulting. “With NSF’s role at the forefront of public health for 68 years and its global capabilities, we will be able to enhance and expand the scope and range of services we can offer to our customers.”
Ginor will continue in his role as CEO following the acquisition. President of Becker Consulting and former Director of Compliance at FDA’s Center for Devices and Radiological Health Ron Johnson also will continue his leadership of quality systems and compliance activities for the firm, directing the company’s expanding activities in North America, India, China and South America.
“The medical device and pharmaceutical sectors are in a period of flux following a number of significant regulatory changes,” Johnson said. “As part of NSF’s Health Sciences Division, we are able to help our clients not only meet FDA compliance but to educate their professionals to stay in compliance by leveraging the vast experience and resources of NSF International.”
Headquartered in Washington, D.C., Becker Consulting provides services to help client companies meet FDA requirements for developing, testing and marketing innovative healthcare products. The company specializes in resolving clinical, regulatory and scientific challenges in the life sciences sector. The company also helps assure the safety and efficacy of drugs and medical devices, re-establishes manufacturing facilities after natural disasters, designs manufacturing processes for complex biologics, builds systems for protecting blood banks, and develops testing protocols and clinical programs for the evaluation of novel drugs and devices.
The acquisition will complement Ann Arbor, Mich.-based NSF’s services, which include: training and education for the pharmaceutical, biotech and medical device industries; consulting in quality systems, GMP and compliance/enforcement actions; clinical and regulatory consulting; analytical testing; bioanalytical testing for clinical trials; and product testing and certification.
“This is a singular opportunity for both NSF International and Becker to expand our global biotech, medical device and life science services," said Kevan P. Lawlor, president and CEO of NSF International.
European Medtech Organizations Select Joint CEO
The European Medical Technology Industry Association (Eucomed) and the European Diagnostic Manufacturers Association (EDMA) have named Serge Bernasconi as both organizations’ new CEO. He assumed the role on July 16, succeeding Luciano Cattani at Eucomed and Volker Oeding at EDMA.
Both associations have been collaborating as of late in what has been called a “European industry alliance.” The members of Eucomed represent the in-vitro diagnostics industry, while those of EDMA represent the medical technology industry in Europe. The selection of a joint CEO was sought to help cohesively join the two associations.
“The time is right to further intensify the cooperation between Eucomed and EDMA,” said Eucomed Chairman Guy Lebeau, M.D.
Bernasconi has more than 30 years experience in pharmaceuticals and medical devices, having worked for companies such as Johnson & Johnson, Schering Plough in the United States and Europe, and more recently, Medtronic Inc. In his capacity as president and international regional vice president of Medtronic France, he was elected president of the French Association for the Promotion of Innovation in Medical Devices, and vice president and treasurer of the French Medical Technology Industry Association.
“I am very pleased to welcome Serge to lead the teams at EDMA and Eucomed,” said Jürgen Schulze, Ph.D., president of EDMA. “Serge’s considerable experience will be a great asset to the industries and we are all very much looking forward to building rewarding partnerships that benefit the entire healthcare equation.”
For his part, Bernasconi is enthusiastic about his new role, commenting, “I am convinced that both associations occupy an excellent position to help in advancing healthcare in Europe. As our alliance grows stronger, we will become ever more effective in delivering on this promise.”