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This Week In Brief: May 25, 2010

Harland Medical Systems (Minneapolis), which specializes in surface-enhancement products, has partnered with contract manufacturer Tapemark (West St. Paul) to commercialize innovations in medical device coatings. The collaboration will focus on applying medical coatings to high-volume medical devices such as glucose test strips, microfluidic diagnostic strips, introducer patches, wound-management dressings, and other coated medical devices or components.

Full-service contract manufacturer Valtronic Technologies (USA) Inc. (Solon, OH), which specializes in electronics, has been awarded the 2010 Leading EDGE (Economic Development through Growth and Entrepreneurship) Award for the fourth consecutive year. The award recognizes a select group of middle-market companies in Northeast Ohio committed to growth and value creation.

Laser measurement specialist Ophir Optronics (Jerusalem, Israel) has announced the acquisition of Photon Inc. (San Jose, CA), a developer of precision laser beam profiling optical test equipment. Ophir-Spiricon now provides a range of beam profiling equipment and software for medical applications, among others.
Exfo Life Sciences (Quebec City, QC, Canada) has announced that it is one of the first organizations in the industry to achieve ISO 14001 certification, which is an internationally recognized environmental management system standard. The company provides solutions for medical device and optoelectronics assembly, fluorescence microscopy, and other life science sectors.

Minimizing Toxic Materials in Medical Nanotechnology Applications

Nanotechnology presents an array of challenges for researchers: materials that behave differently at the nanoscale than at the macroscale, the manufacture of parts and production of features sizes that are invisible to the naked eye, and, of course, the unknown effects of a new technology when used in medical applications. The latter issue, specifically questioning the toxicity of many nanoscale technologies, is among the most talked about and most controversial, however. In an attempt to minimize the use of toxic materials and advance medical nanotechnology, researchers from the University of Colorado at Denver and Portland State University have identified a way to significantly reduce the use of formaldehyde in the preparation of silver nanomaterials, which could open the door for new cancer treatment options and other metal nanomaterial-based medical applications.

Scientists have traditionally used large amounts of formaldehyde to synthesize metal nanomaterials such as silver-coated gold nanoparticles. "We discovered that most of the formaldehyde used in preparing silver nanomaterials is consumed by formation of a polymer," Scott Reed, an assistant professor of chemistry at the University of Colorado at Denver recently told Nanowerk. "Formaldehyde reacts with ammonium hydroxide to form a previously unnoticed polymer. When we decreased the ammonium hydroxide concentration it became possible to decrease the formaldehyde concentration, too."

This experiment enabled the reduction of formaldehyde use 100-fold compared with previous methods when coating silver onto gold nanoparticles. It also did not sacrifice or compromise the desired optical properties of the material in the near-infrared. As a partial substitute for the formaldehyde, the group successfully employed ascorbic acid.

In addition to allowing for significant toxicity reduction in the synthesis of nanoshells and core-shell nanoparticles, the technique could potentially be applied to the fabrication of other nanomaterials as well. And reduced toxicity in metal nanomaterials could ultimately pave the way for safer, more patient-friendly medical applications. "We expect that this will result in greener syntheses and more biocompatible nanomaterials suitable for medical applications," Reed told Nanowerk.

Read the full report at Nanowerk or see the researchers' abstract in the journal Chemistry of Materials.

Olympus Corp., Terumo Invest in Small Bone Innovations Inc.

In related but separate transactions, SBi Asia Pacific Sdn. Bhd. (SBi APAC) has signed distribution agreements with Olympus Terumo Biomaterials Corp. (66.6% owned by Olympus and 33.4% owned by Terumo) whereby they will exclusively distribute SBi products in Japan and China.

In addition, SBi APAC, a joint venture with Khazanah Nasional Berhad and Malaysian Technology Development Corp. Sdn. Bhd., signed agreements with Olympus Terumo Biomaterials Corp. for the exclusive distribution of SBi products in Japan and China. Olympus Terumo Biomaterials Corporation conducts research and development, manufactures, and sells in the biomaterials and regenerative medicine fields. The company manufactures bone void fillers and tissue engineered products for deep wound healing.

SBi was ranked #24 on the list of the Top 50 U.S. VC-backed companies in the Wall Street Journal article “Sizing Up Promising Young Firms” on March 9, 2010.

In mid 200, the company closed on $144 million in Series D and Series C funding from a host of investors including, Goldman, Sachs & Co., Khazanah Nasional Berhad, (the investment firm of the Government of Malaysia), Malaysian Technology Development Corporation (MTDC), an integrated Malaysian-based venture capital company, The Family Office of Bahrain, Viscogliosi Brothers, LLC, Trevi Health Ventures, NGN Capital, 3i Group, and TGap Ventures, among others.

CareFusion to Acquire Medegen

Medegen is an innovator in infusion therapy, which consists of clinically differentiated needle-less access valves and administration sets that deliver intravenous (IV) medication to patients. CareFusion is a medical technology company formed by the spin-off of the Clinical and Medical Products business of Cardinal Health Inc. The spin-off was completed in 2009 through a pro rata distribution of roughly 81% of CareFusion’s common stock.

CareFusion markets IV infusion devices. Its products are marketed under the brand names Alaris and Guardrails. Medegen markets clinically proven, needle-free IV disposable products under the brand name, MaxPlus and MaxGuard.

Both CareFusion and Medegen products are designed to help hospitals reduce catheter-related blood stream infections and catheter occlusions. It has been tested that catheter-related blood stream infections increase a patient's hospital stay by 10 to 24 days, with roughly 25% of cases resulting in death. Medegen products lower these infections up to 70%.

Federal Jury Finds Medtronic CoreValve Infringes Edwards' Transcatheter Valve Patent

Meanwhile, Medtronic has announced that it will seek an appeal.

The patent involved in this suit is part of the Andersen family of patents, which relates to a valve prosthesis for implantation by means of a catheter. Filed in February 2008 in the U.S. District Court for the District of Delaware, this suit was directed at the manufacture or sale of the CoreValve ReValving System in the United States.

Smiths Selects Novasyte for Implementation Support Services

Smiths Medical Professional Services develops and delivers top-quality, comprehensive education and product training programs for Smiths Medical's customers. Novasyte was chosen after an extensive review process to provide consultant resources to facilitate these programs under the direction of the Smiths Medical Professional Services Team. The new agreement with Smith's contributes to Novasyte's growth trajectory and its mission to be the clear choice for sales and clinical solutions to the medical device industry.

The MX Q&A: Timothy Still, Accumetrics

Timothy Still says the allure of joining Accumetrics as COO early in 2008 is easy to pinpoint. The pluses included a highly promising IVD product and an executive track that drew on his nearly two decades of work with in vitro diagnostics. Still joined the company with the promise of becoming CEO a few months later, a promotion that took place in October of that year.

Now Still and the company’s management team are ready to take the San Diego-based device company to the next level during what the CEO calls “a big year for us.” The CEO was brought on board to complete the company’s transition to a more market-oriented business. It’s a task he managed successfully as executive vice president and chief commercial officer of HemoSense, the San Jose-based manufacturer of a monitor for oral anticoagulant therapy. Still oversaw the device manufacturer’s development into a public traded company that was acquired by Inverness Medical in November 2007 just before he joined Accumetrics.
Still has aggressive plans for Accumetrics and its VerifyNow System, described by the company as a suite of automated tests for assessing the response of platelets to antiplatelet therapy. The device is designed to help doctors accurately monitor and optimize the effectiveness of antiplatelet therapy for patients at risk of thrombosis. VerifyNow could play a lifesaving role for that one-third of the population that doesn’t respond to the use of Plavix, the anticoagulant medication that is the world’s second biggest-selling drug, Stills notes.
In April 2010 Accumetrics completed the enrollment phase for a landmark clinical trial called Gravitas that is designed to show the value of “providing clinicians with actionable information for patients who are poor responders to clopidogrel [sulfate],” or Plavix. The placebo-controlled trial involves approximately 2800 patients at some 80 sites in the United States and Canada. On the business front Still and his team have been pursuing international sales partnerships. Accumetrics signed agreements in September 2009 with Grifols S.A. for exclusive distribution of the VerifyNow System in Spain, Portugal, and Chile and in May 2010 with Medico’s Hirata for Japanese distribution.
Despite the economic headwinds, investors have shown their faith in the company’s promise, Still points out, noting that Accumetrics continues to attract VC attention because of its products’ market potential. In this interview with MX, the chief executive discusses topics that include the investment climate as well as the importance of his company’s “accountable culture,” the challenges facing small device firms following healthcare reform, and regulatory issues.
MX: What attracted you to Accumetrics before you became president and CEO back in October 2008?
Timothy Still: I had known about the opportunity at the start of 2008 and joined them in the spring as COO and then officially became CEO in the fall. I’ve been involved with in vitro diagnostics for over 20 years. As far as being attracted to the company, it would be a number of things. Obviously, they have market-leading technology. It’s in the area of cardiodiagnostics; it’s point-of-care testing. And it also involves monitoring therapy, which is a big opportunity in in vitro diagnostics.
How did you approach taking the reins, given the fact that the Accumetrics’ founder, Robert Hillman, was still with the company when you came on board?
I was brought into the company with the notion that I would be running it within a matter of months. I was fortunate in that I brought in a very seasoned management team. It’s a team that has a lot of experience growing companies and taking them from an R&D type of culture to more of a commercial culture. Obviously, the first quarter or two quarters are key. You definitely need to establish credibility with the investors. I was also in touch with the founder. I knew the founder from my years in in vitro diagnostics, and I think I came in with a lot of credibility, which helped.
As a new CEO, what steps do you want to take to ensure continuity, maintain morale, and also put your stamp on a company’s direction?
We have a goal of building one of the very best small or medium-size diagnostic companies in the industry. We’ve built companies before. For us, an accountable culture is key. That means having a variety of milestones that we’re looking to achieve. We are very open throughout the company with our objectives. All employees directly feel involved with the outcome of the company.
How so?
Everyone knows what our common objectives are, whether they be revenue, whether they be profit, or project delivery dates. Whether you’re the CEO or in the warehouse, people know what our objectives are.
How do you promulgate this approach?
All employee receive updates at least once a quarter or more often than that. Our senior management team is extremely visible throughout the company. We have senior management dealing with customer issues. It’s a very team-focused culture.
You joined Accumetrics after four rounds of funding in 2007 raised a total of about $52 million in venture capital. How would you describe the investment climate today, especially now that healthcare reform bill has been signed into law?
We’re fortunate in that we’ve raised an additional $20 million since then. Overall for the industry, I think it’s a difficult environment for small and unprofitable companies. Venture capital groups are now being extremely diligent with their investments. We’re fortunate in that we have a committed, enthusiastic group of investors.
The positive aspect of healthcare reform is that it’ll bring more patients as customers—some 32 million to 33 million more customers, which is good for a company like Accumetrics. The negative aspect is that with some healthcare legislation the additional taxes that’ll come in future years will make it difficult for smaller companies to stay innovative.
How does a company deal with that challenge?
They’re going to [require] a technology that’s just really a breakthrough or a game-changer versus having a copycat-type of product. It’s really going to need to be novel, it’s going to need to save money, and it’s going to have to be cost effective.
Would you describe Accumetrics’ product as occupying a hot market segment that will attract investors as opposed to some other device segment?
For our situation I think our investors are excited, one, because they know they have a seasoned management team in place to build the company, but, two, we are in a very hot market segment. Plavix is the number two–selling drug in the world, and one out of three people don’t respond to Plavix, so we’re in an extremely hot market. I think that’s one of the reasons our investors are excited. Physicians and patients need to know how to respond to therapy. And we can help them.
On May 18, Accumetrics announced a partnership with Medico’s Hirata for distribution of the VerifyNow System in Japan. How does that deal fit into the company’s overall strategy?
We’re looking to establish distribution relationships with seasoned partners in all major markets. In 2009 we focused primarily on Europe, and in 2010 we’re expanding into the Far East. We still need to get through product registration in Japan, but we’re very excited about working with Medico.
In April 2010 Accumetrics finished enrolling 2800 patients for a clinical trial to gauge the responsiveness of the VerifyNow assay on thrombosis and safety issues. When will the trial be completed, and how would you assess the status of the trials at this point?
Our Gravitas trial is on track, and we expect to present data at the AHA [meeting] in November.

May 2010 Contributors

Andrew Dallas is president and CTO of Full Spectrum Software (Southborough, MA). With more than 18 years of software engineering and executive management experience, he is a leading authority in medical device software. Dallas is a member of MD+DI's Editorial Advisory Board. Reach him via e-mail at [email protected].
Michael Gershberg is an associate in the international department of Steptoe & Johnson LLP (Washington, DC). His practice focuses primarily on counseling clients regarding trade issues arising out of the U.S. antidumping and countervailing duty laws. He represents clients in proceedings before the U.S. Department of Commerce and the U.S. International Trade Commission, including investigations, administrative reviews, sunset reviews, and section 129 proceedings. Gershberg has also successfully represented clients in appellate litigation before the Court of International Trade, the Court of Appeals for the Federal Circuit, and NAFTA binational panels and Extraordinary Challenge Committees. Contact him at [email protected].
Mark Leimbeck is program manager, health sciences, for Underwriters Laboratories (Northbrook, IL). His main responsibilities include the development of an overarching certification model for medical devices, encompassing both regulatory and safety as well as coordinating implementation of the model globally.
Leimbeck earned a bachelor’s degree in electrical engineering technology from Southern Illinois University and a master’s degree in business from the University of Chicago. He continues to pursue postgraduate coursework. Reach him at [email protected].
Shawn O’Dowd is a partner of Kenyon & Kenyon LLP and divides his time between the firm’s Washington, DC, and Silicon Valley offices. His practice focuses on patent prosecution counseling and litigation covering various technical areas. Contact him via e-mail at [email protected].
Sung Pak is senior partner at Value Creation Institute (Laguna Hills, CA), a data analytics and business process reengineering company. He has advised leading medical device companies for more than 10 years.  He has an MBA from UCLA and an MS and a BS in materials science and engineering from the University of Washington. Pak holds seven U.S. patents. Reach him via e-mail at [email protected].
Steven G. Richter, PhD, is founder, president, and chief scientific officer of Microtest Inc. (Agawam, MA). He manages the provision of laboratory testing and contract manufacturing services for the medical device and biotechnology industries. He has more than 25 years experience at all levels of microbiology and medical devices. Previously, Richter held positions at FDA and Hobbs Medical. Contact him at [email protected].
Jay Tourigny is vice president of operations at Microcare Medical (New Britain, CT). His responsibilities include the development and manufacture of specialty cleaning and coating products. He sits on the board for both the Eastern Aerosol Association and the Canton Community Health Fund Tourigny has been awarded five U.S. patents for his work related to precision cleaning applications and has four more pending. Contact him at [email protected].
Ben Yoder is business process designer at Knowledge Universe Technologies (Portland, OR), where he applies his expertise in statistics, human behavior studies, and process reengineering to model and improve organizational and human performance.  He holds a BS in psychology from the University of Oregon and an MS in industrial-organizational psychology from Alliant International University. Previously, Yoder was a consultant at Value Creation Institute. Reach him at [email protected].
Steven Yu, MD, is a patent attorney at Kenyon & Kenyon LLP (Washington, DC). He focuses on assisting medtech companies with intellectual property issues. He has worked on matters involving specialized coatings, electrodes, pacemakers, and nanomedicine. Contact him via e-mail at [email protected].
Tom Zemites is strategic marketing manager, implantable medical and hi rel, for Microsemi’s implantable medical division (Scottsdale, AZ). He is responsible for the development and implementation of market and customer business plans and product roadmaps.  He has more than 20 years experience in engineering, strategic marketing, and new product development in the semiconductor industry. Zemites received his EET degree in industrial electronics technology at Ferris State College. Reach him at [email protected]

Focus on Catheter and Stent Manufacturing Equipment

Fully Automated Catheter Tipping System Doubles Capacity
Tasks such as the loading of catheters and the cutting and loading of separate soft tips into the tipping process have traditionally been manual operations. Touted as the first fully automated system of its kind, however, an automated tipping system (ATS) doubles the capacity of the equipment involved, which can translate into cost savings by reducing labor costs and performing multiple processes per part. Produced jointly by two companies, the ATS draws from one manufacturer's Saffire RF tipping technology and the other's Accu-Cut tube-cutting and Accu-Feed tube-feeding technologies. Capabilities of the system include necking and flaring; singulation; assembly; precision cuts to length; and thermal bonding of two catheter materials for soft-tip applications. In addition to being intuitive and user friendly, the system produces clean, square cuts and precise lengths, according to the manufacturers.
Vante, formerly Sebra
Tucson, AZ

ASG Medical Systems
West Palm Beach, FL

Pneumatic Toggle Press Performs Stent Assembly
A 3-tn medical-grade pneumatic toggle press has been customized to perform a crimping process for the assembly of cardiac stents. The Toggle-Aire model 1030 CSR-G2 is designed with a force-monitoring feature for strict quality control that validates press operation and provides interrupts, alarms, and documentation required for ISO compliance. Designed to ensure lot-to-lot consistency, the system's process controls can incorporate a variety of display and signal-conditioning devices to meet specific customer requirements. The standard press operates on 50 to 125 lb of air pressure with a controlled squeeze capability of more than 6000 lb at 100 psi.
Smithfield, RI

Measurement System Records Radial Forces of Stents
The head of a radial-compression measurement system can be fully submerged in a temperature-controlled water bath to replicate in vivo conditions for testing the radial strength and stiffness of stents. Because of this feature, the system yields more-realistic results compared with conventional flat-plate and V-block methods, according to its manufacturer. The RCM-60-WB uses a crimping head technology that ensures zero gaps and can accommodate a variety of head diameters and stent lengths. Demonstrating good repeatability, the system is suited for measuring the radial forces of stainless-steel, nitinol, and bioabsorbable stents. Its software allows users to generate custom test programs and can produce multiple data reports for easy comparisons.
Medical Product Technology Europe BV
Leek, Netherlands

Coil-Winding Machinery Suited for Metal Catheter Fabrication
Offered in a range of configurations from benchtop models up to 12-ft-long systems, a line of coil-winding machinery can be employed in the manufacture of catheters. Capable of performing mandrel winding, mandrel coiling, and continuous winding, the systems can be supplied in manual, semiautomatic, and fully automatic versions; high-speed spindles can also be provided. They can wind a single filar or multiple filars of round or flat filaments. Bare or coated precious metals, stainless steel, and nitinol, among other materials, can be wound. In-line stress relieving or nitinol annealing is also available. Additional features include high-speed precision movements enabled by linear servo systems with 1-µm accuracy and programmable back angle and lead/lag sensing to adjust coil tension for droop testing.
Machine Control Specialists Inc.
Roselle, IL

Grinder-Polisher Minimizes Surface Damage During Material Analysis
A grinder-polisher and associated power head are engineered to minimize surface deformation and damage during cross-sectional metallographic analysis of stents and catheters. Cross sectioning is performed in order to evaluate the device material's microstructure or to inspect coatings. In the case of drug-eluting stents, manufacturers must section the device without damaging the drug-polymer coating, for example. To prepare the sample for analysis, manufacturers first mount the device in an epoxy and then grind or polish the mount prior to imaging. When coupled with an AutoMet power head, the EcoMet grinder-polisher enables users to prepare the cross-sectioned samples in single or central force modes. It features touch screen controls and repeatable sample preparation.
Buehler, a div. of Illinois Tool Works Inc.
Lake Bluff, IL


Outsourcing Outlook on Packaging and Sterilization

The landscape for medical device sterilization remains much the same as it has been for more than a decade. Ethylene oxide (EtO), radiation (gamma and E-beam), and steam continue to dominate the sterilization industry, followed by hydrogen peroxide, hydrogen peroxide-plasma, and dry heat. In addition, alternative technologies such as bright light and ozone are under development but are not yet widely accepted.

When choosing an outsourcing partner, OEMs should understand both the advantages and disadvantages of these methods. For example, EtO is a complex process with extended processing times; radiation and steam have material-compatibility limitations; and hydrogen peroxide has difficulty penetrating interior spaces. They should also consider the sterilization method for a device early in the design cycle because available technologies will depend on device materials and designs. To that end, the development team should continually evaluate whether a material or design feature will prevent the use of a particular sterilization method. Without such a review, the OEM may design a product that cannot be sterilized using existing methods, resulting in costly and time-consuming design changes.

In addition to product sterilization, medical device OEMs should also be familiar with the changing field of sterile packaging. Although effective sterile barrier packaging materials have been available for years, packaging manufacturers are continuing to improve and expand their offerings to include thinner, stronger films that reduce material costs and weight, and bonding systems that provide clear visual evidence of seal quality.

Packaging suppliers are not required to maintain quality systems, but they must validate their processes to produce sealed packages. OEMs must be aware of potential vendors' quality systems and perform their own in-house validation of final closure seals. Since such validations can be expensive and time consuming, the OEM should look for suppliers who will support the validation process by providing protocols and technical support.
--Brant Gard, manager, Blue Line Sterilization Services, Novato, CA.

Contract Manufacturer Provides Packaging Design Services
A medical device contract manufacturer offers packaging design services based on customer specifications and application requirements. In addition to providing individual device packaging, polybagging, and shrink-wrapping, the company performs sealing services for trays and blister packaging. It also specializes in a range of other operations, such as kit packaging, autobagging, bar coding, overpacking, bulk packing, and pouch sealing. Other offerings include automated count-and-bag, clamshell fill-and-seal, and sterilization and distribution services.
HPC Medx
Hanover, PA

Packaging Specialist Handles Combination Products
Offering contract manufacturing services such as packaging, sterilization, and laboratory operations, a packaging specialist pouches commodity products and handles sensitive combination devices from needles to drug-coated stents. The FDA-registered and ISO 13485:2003-certified company aids customers in the selection of appropriate packaging and sterilization processes for their devices. It also provides a variety of services such as microbiology, medical device biofilm and antimicrobial testing, toxicology, analytical chemistry, biofouling science, and clean-in-place science.
Ethox International Inc.
Rush, NY

Complete Packaging Services Include Sterile Designs
A provider of packaging, labeling, and design and development services for a variety of applications offers Tyvek packs, blister packaging, and vacuum-formed trays. Specializing in the packaging of minimally invasive surgical devices, implantable devices, and accessory kits, the company supports customers' packaging requirements by providing sterile package designs, including tray and pouch specifications; packaging procurement; tray and pouch sealing validation; package integrity testing; package conditioning; validation for EtO and gamma sterilization methods; management; and protocols and release reports.
Cirtec Medical Systems
East Longmeadow, MA

Service Provider Specializes in E-Beam Sterilization Services
Using ionizing energy from accelerated electrons as its sole sterilization source, a contract manufacturer provides E-beam medical device sterilization services for large and small product configurations and virtually any shipment size. The company offers a range of consulting and product testing services to assist customers in validating and maintaining validation in the E-beam sterilization environment as well. Among its services are engineering and feasibility studies, specific-dose studies, maximum-dose studies, verification dose studies, quarterly dose audits, dose mapping, and cross-linking, which enhances products with commercially valuable physical properties.
San Diego

Supplier Focuses on Contract EtO Sterilization Services
Specializing in EtO sterilization services, a contract service provider supports the R&D activities of small medical device companies that are in the process of developing new products. Along with the shorter exposure times that typically can be achieved using 100% EtO over mixed gases, performing small and one-off runs lowers EtO exposure times further while minimizing preconditioning times, according to the company. Customers' sterilization processes can also be transferred to larger facilities. As part of its capabilities, the company provides turnkey validation services, including protocol and report preparation, testing management, and project oversight.
Blue Line Sterilization Services
Novato, CA