Originally Published September 2000

INDUSTRY NEWS

Pill with a View

A camera-carrying pill may soon be available as a painless alternative to invasive gastrointestinal endoscopy. The disposable capsule, which will be marketed by Given Imaging Ltd. (Yokneam, Israel), incorporates a sensor that transmits color video signals as it embarks on a fantastic voyage through the stomach and small bowel. The sensor was developed by Photobit Corp. (Pasadena, CA), a supplier of CMOS image sensors for use in a variety of applications.

The sensor's small silicon die size and its low power dissipation enabled development of a pill that provides an alternative to gastrointestinal endoscopy.

Size constraints and power requirements were the primary challenges faced by Photobit in designing the sensor. "The camera needs to transmit the signals to a receiver, so the pill must hold not only the sensor but also a battery and transmitter," says Photobit founder and chairwoman Sabrina Kemeny. The extremely small silicon die size of the sensor (pictured) permitted bundling these components within a digestible pill that measures a scant 11 x 30 mm. "The power dissipation of the device is less than 2 mW," Kemeny adds, "which is to my knowledge the lowest available dissipation in a commercial product. By comparison, conventional CMOS sensors dissipate between 50 and 100 mW of power."

According to Given Imaging, once the patient has swallowed the M2A Swallowable Imaging Capsule, it passes smoothly through the digestive tract and is naturally excreted. A wireless recorder worn around the patient's waist captures the signals, which are transmitted from the capsule to an antenna array that is also attached to the patient. A computer equipped with Given's proprietary software then processes the data. A 10-patient study was recently completed in Great Britain, and the device is currently undergoing clinical trials in the United States. Given hopes to obtain 510(k) clearance by the end of the year.

A camera-carrying pill that transmits images of the digestive tract measures only 11 x 30 mm.

Photobit acquired the rights to high-performance image capture technology from NASA's Jet Propulsion Laboratory, also located in Pasadena CA, and has refined the technology to make it viable in the marketplace. Its CMOS sensors are used in a variety of applications such as Internet and digital still cameras, video cell phones, computers, and toys. "Our main thrust is high-volume consumer electronics," acknowledges Kemeny, but involvement in high-tech applications remains a priority, she adds, "because that is what helps to keep us on the leading edge." —Norbert SparrowDevice Company Suppliers Merge to Provide Single-Source SolutionsRivo Technologies (Arvada, CO) and UTI Corp. (Collegeville, PA) will merge into one company with headquarters in Collegeville, PA. No name has been decided on yet, but with approximately 1000 employees in nine locations across the United States and Europe, the Rivo/UTI organization will be one of the largest suppliers serving the medical device industry. The family of companies includes Uniform Tubes, Noble-Met Ltd., Star Guide Corp., Micro Med Machining, Stent Technologies, Spectrum Manufacturing, and Utitec, in addition to the European-based firms of UTI-SFM (Germany), and Uniform Tubes (United Kingdom).The merger will allow the new organization to provide a comprehensive array of products and services. The UTI family of companies currently provides contract manufacturing with a specialization in metal component fabrication and assembly. While some of these services are also available in the Rivo camp, some capabilities, such as wire applications and working in precious metals, are unique to Rivo. Bill Gaffney, manager of marketing services for Uniform Tubes, explains that "the advantage of the merger to our customers is that we are offering a single source of supply not only for components, but for assemblies, and in some cases complete devices. OEMs no longer have to use a multitude of suppliers for a single project."More additions to the company are scheduled, although the plans remain veiled for now. For the company's future, Gaffney would only comment that "the Rivo Technologies/UTI mission is to be the world's best supplier of comprehensive product solutions to the medical device industry." Although the fledgling company has yet to be named, with the new merger and planned expansionsit's sure to make a name for itself soon. —Jodi TriplettImplantable Material Combines Best Properties of Silicone, PolyurethaneThe use of polyurethane in long-term implantable devices has been compromised by the material's propensity to degrade when it comes into contact with body tissue. In particular, researchers have hit a wall when trying to enhance the material's flexibility without negatively affecting its biostability. Until now. By combining high amounts of silicone with polyurethane, Elastomedic Pty. Ltd. (Chatswood, NSW, Australia) reportedly has developed a material that represents the best of both worlds. Managing director Mike Skalsky presented a paper on Elast-Eon's properties and applications at the recent Medical Design & Manufacturing Exposition and Conference in New York City.Flexible and biostable, Elast-Eon can be extruded, molded, or cast to produce a range of medical devices.
"When we first began the R&D work, our goal was to produce a material as soft and flexible as Pellethane 80A and as stable as Pellethane 55D," says Skalsky. "In addition, we were looking for a material that could be readily processed into new devices." The breakthrough for researchers, who ultimately devoted 10 years to the project, came when they found a way to combine silicone and polyurethane, two materials that are not normally compatible. "The beauty of this polymer is that while it is durable, tear resistant, and can be processed into almost any shape, it is sufficiently stable so that it doesn't react with the body's chemical makeup," says Skalsky.Aor-Tech International, a U.K. company that has developed a mechanical heart valve, saw the potential of the material early on. Elast-Eon is a key component of the firm's Trileaflet valve, which is set to enter clinical trials in 2001. According to the company, the material prevents clotting that typically occurs with other mechanical valves. Aor-Tech acquired Elastomedic in March.Because it is both flexible and biostable and can be processed by means of extrusion, molding, or solvent dip casting, Elast-Eon is suited for the manufacture of a variety of devices, according to Skalsky. Catheters, wound dressings, artificial arteries, orthopedic implants, and cardiac pacing and defibrillation leads are among the applications Skalsky cites. —Norbert SparrowFour-Way Collaboration Showcases Time-Compression TechnologyFour companies pooled their resources at NPE 2000 in Chicago to demonstrate how a well-coordinated manufacturing process chain can dramatically reduce a product's time to market. Bringing their core expertise to the project, Round Mate Systems, PTC, Makino, and Dynisco rallied under the name of RUSH Technology and vowed to build a mold and begin production of a new plastic part during each day of the mammoth plastics exhibition. The exercise was designed to showcase the time-compression potential of RUSH, an acronym for Rapid Use of Shop Hours, as well as the individual companies' capabilities.Round Mate Systems' insert molds were used in the first step of the part-making process.
According to Ron Pleasant, spokesman for RUSH, several elements must come together to achieve such stellar results. Key requirements include designing the product for the manufacturing method, being flexible in product design at the start of the process, using associated and integrated CAD/CAM systems, and fully utilizing standardized mold-making systems and components. In addition, he recommended building only what is needed to do the job and combining mold manufacturing setups by adopting new techniques."The point of the RUSH demonstration is to show that OEMs must commit to the thinking that a project date can be significantly improved if they address the entire process chain," says Pleasant.Round Mate Systems/Team PPI (Kenton, OH) began the process with a standardized insert-mold system. This insert-mold system reduces tooling cost and build time by up to 30%, according to the company. Cavity-ready products help reduce mold-making time even further. Mold inserts can be changed in five minutes while the base remains in the press, and the mold-base construction allows complete flexibility when assembling a master frame. Cavity-ready components and the standard interchangeable system eliminate the chase work required to build a complete mold.The finished molds and molded parts were put on display at the show.
The next step involved the use of an integrated, mold-specialized, and associative CAD/CAM system from PTC (Waltham, MA). Mold tooling and NC data can be developed rapidly when the process is integrated. Associative tooling design and NC functionality are also critical to the rapid execution of the project. This time-saving technology eliminates data translation and automates development of the cavity geometry and the entire mold assembly. The tooling and NC data update automatically when design changes are introduced.The cavity and core details were then machined directly into the Round Mate cavity inserts. This was done by Makino (Mason, OH), whose high-performance CNC vertical machining centers can machine prehardened material to exacting tolerances with finishes that require little if any polishing. Ejector pins, screw holes, and the runner can also be machined during the same setup.The fourth wheel in the project involved Dynisco (Franklin, MA), which manufactures hot-runner systems. The company's Dynamic Feed technology provides real-time, independent, closed-loop process control at each gate. The computer-controlled Dynamic Feed manifold coupled with Round Mate's quick-change tooling enables a reduction in tooling, parts, and setup costs, according to Pleasant.The press is stopped just long enough to place the next insert into the master frame and adjust for process changes due to cavity size and detail complexity. Molding can then immediately begin on a different part.According to Pleasant, the group is considering setting up a lab for teaching and advancing RUSH technology. For now, however, the collaboration is only an example of how companies can work together to develop something greater than the sum of their parts. —Karim Marouf Processing System Improves Digital X-RaysAn image-processing system by Mercury Computer Systems (Chelmsford, MA) is part of a new design for a digital x-ray system to be manufactured by Philips Medical Systems (Best, The Netherlands). The recent technology offers advantages over earlier x-ray techniques that often capture unwanted objects in the image. Digital x-ray allows the use of image processing to remove obstructions such as bone, and enhance the image to provide a clearer picture of the desired area.A digital x-ray angiography image shows blood vessels on one side of the brain. The skull has been subtracted out of the image field using image-processing techniques.
Philips turned to Mercury for the critical image- processing system within the x-ray unit. Didier Thibaud, vice president and general manager of Mercury's Medical Business Group, explains "because the products are so complex, it can be difficult to have sufficient engineering and development staff with the skills necessary for all aspects of a new product. The logical solution is to outsource portions of the system development." Mercury Computer Systems was chosen, Thibaud continued, because it has "a proven history of developing technical solutions for medical imaging manufacturers."Mercury provides image-processing systems to leading medical imaging companies including GE Medical Systems and Siemens. Its products are used in medical diagnostic devices including magnetic resonance imaging, computed tomography, positron-emission tomography, and digital x-ray. —Jodi TriplettIn BriefMedicalbuyer.com (Johnson City, TN) and Medical Quest (Denver) have signed a multiyear strategic marketing alliance. Medicalbuyer.com is a business-to-business provider of healthcare products over the Internet; Medical Quest is an on-line source for Colorado healthcare provider information.... Following its recent acquisition by Quality Vision International Inc. (QVI), View Engineering Inc. (Simi Valley, CA) has reassumed its original corporate name and now functions as a wholly owned subsidiary of QVI. The move will enable View Engineering to focus on the metrology market.... Optim Inc. (Sturbridge, MA), a manufacturer of fiber-optic endoscopes and imaging products, has become the 15th corporate member of the Center for Advanced Fiber-Optic Applications (CAFA). CAFA serves as an independent, industry-led forum for technology development.... HSS Inc. (Hamden, CT) has announced the opening of a satellite office in Germantown, MD. HSS provides software systems for managing healthcare-related coding, reimbursement, and compliance data.... Parker Hannifin Corp. (Cleveland), which specializes in sealing technologies, is set to acquire Wynn's International (Orange, CA), a manufacturer of sealing media.... The Global Healthcare Exchange LLC (Chicago) announces that three medical device manufacturers have joined the newly formed Internet-based healthcare trading exchange: Ferno-Washington Inc., Sulzer Medica, and Integra Life Sciences Holdings Corp.... Newline Color Inc. (Fitchburg, MA), a manufacturer of specialized color concentrates and compounds for thermoplastics, is opening a warehouse in Santa Fe Springs, CA.... GE Lighting (Cleveland) was presented with the Ally of the Year award as part of the EPA's Green Lights Partnership program. The award is given each year to a company that has achieved high standards in energy efficiency and has incorporated strategic energy management into its business plans.... ITW Devcon (Danvers, MA) recently acquired Syon Corp. (Ashland, MA). ITW Devcon manufactures adhesives and sealants for OEMs. Syon Corp. is a producer and custom packager of adhesive systems. —Jodi Triplett