Knowledge Management Company Helps to Speed New Product Development

Originally Published MPMN November 2001

INDUSTRY NEWS

Knowledge Management Company Helps to Speed New Product Development

Engineers at a major medical device manufacturing firm had slammed into the proverbial wall trying to design a compliant and functional seal for a new heart valve. After six months of fruitless consultation with in-house and device industry experts, they turned to Sopheon Corp. (www.sopheon.com), a knowledge management and software services company headquartered in Minneapolis and with operations in the UK, Germany, and The Netherlands. Within a couple of weeks, a sealing solution was found . . . several leagues under the sea.

Designed to automate and streamline the new-product development process, a program recently introduced by Sopheon Corp. stores all project data in a central repository and allows users to access the company's extensive research services.

"In fact, the problem was solved by an individual who knew nothing about heart valves but who knew a whole lot about seals that operate in a high-pressure saline environment," says Sopheon CEO Andy Michuda. The man with the answer happened to be a submarine engineer. Sopheon's integration of Internet and software technology with human expertise enabled the new product development process to move forward.

For this particular project, Sopheon used specific search terminology to identify a unique set of sources who could collaborate with the OEM to solve the problem. It's an approach that doesn't come naturally to many companies, says Michuda. "We are all familiar with information overload when searching on the Internet. The trick is to allow the richness of the content to filter through," he says. Sopheon's advanced technology and the taxonomy it has developed over the years enable it to perform searches that produce meaningful results, according to Michuda. For the heart-valve seal, "we applied a terminology—high pressure, saline solution, seals—that allowed us to tap into expertise that had nothing to do with heart valves." Sopheon designs customized business-intelligence research portals that incorporate this capability.

"The portal's top two taxonomic layers are unique to each client and the business he is in," explains Michuda, who cites the example of a portal the firm might design for GE Lighting, which would look very different from one built for GE Medical. The highly integrated portals leverage Sopheon's industry-specific content repository and provide access to its army of analysts and experts. The firm has compiled a database of several thousand experts, approximately 2000 of whom are under contract to operate in a proprietary mode and who have made a commitment to respond to clients within 24 hours. Speed is a priority, notes Michuda. "As you know, the device industry is in a race to get its products to market. [Our objective] is to help companies win that race." To further this goal, Sopheon recently introduced Accolade, Web-based software that optimizes the new-product development process and integrates the firm's research portals and network of experts.

Michuda estimates that R&D engineers spend more than 50% of their time simply searching for answers. Accolade is a time-compression tool, according to Michuda, that not only automates and streamlines a knowledge-intensive business process, but provides instant access to experts from a range of disciplines to propel the thought process. "The expert network is a click-through component of the research portal that sits inside the software application," explains Ron Helgeson, vice president of corporate communications. "When the product engineer wrestles with questions about the most suitable material or adhesive to specify for a particular application or the most effective testing method to use, he or she can seamlessly tap into some of the best technical minds in the world for answers."

"We have a strong belief in smart software," adds Michuda. "Historically, this concept has taken us down the path of artificial intelligence, which has not had much success beyond some niche applications. We take real intelligence and integrate the human factor—the richness that comes from dialogue and collaboration—into our software."

Norbert Sparrow

Copyright ©2001 Medical Product Manufacturing News

Nanosensor Detects Single Molecules Using Small Wire

Originally Published MPMN November 2001

INDUSTRY NEWS

Nanosensor Detects Single Molecules Using Small Wire

A flexible molecular sensing system detects an array of analytes using a nanowire that measures 1/10,000 the width of a human hair. Developed by Nanosys Inc. (Cambridge, MA), the nanosensor incorporates specific capture molecules that detect ions, nucleic acids, and proteins in quantities as small as a single molecule. The sensor works like a semiconductor, using changes in electrical conductance to indicate when molecules are captured. Because the substances are measured directly, there is no need for chemical labels or optical equipment.

Small size is among the benefits the sensor offers medical device manufacturers. "This is the first sensor with dimensions close to the size of the substances it is used to detect," says president and CEO Larry Bock. Other benefits include the ability for single-cell detection and the measurement of individual binding events without amplification.

Zachary Turke

Copyright ©2001 Medical Product Manufacturing News

Microinjection Molder Can Produce Tiny Thermoplastic Parts

Originally Published MPMN November 2001

INDUSTRY NEWS

Microinjection Molder Can Produce Tiny Thermoplastic Parts

Murray's Sesame molder can produce miniature parts on a mass-production scale.

A new micromolding machine is capable of producing thermoplastic or silicone rubber parts measuring 0.05 to 20 mm3. The Sesame machine supplied by Murray Inc. (Buffalo Grove, IL; www.nanomolding.com) can mold 20 sesame seed–sized parts, each measuring 2 mm3 and weighing 0.0022 g, from a single plastic pellet. The machine is designed to provide fast throughput, controlled injection, and brief material residence time. Total injection time can be as short as 0.02 seconds for the full 40-mm stroke. Molded component wall sections can be as thin as 0.001 in. at pressures up to 50,000 psi. A pneumatically driven vertical plunger prevents material degradation during the plasticizing process. In addition, a plunger operated by a linear servo-driven motor performs injection of the material. A high- pressure valve separates these operations, and a nozzle shutoff valve prevents excess dripping from the nozzle. The Sesame offers a color touch screen PC interface for control of process variables and data collection. The pneumatically actuated machine is lubrication-free and is powered by 120 V ac to allow incorporation into cleanrooms.

Katherine Sweeny

Copyright ©2001 Medical Product Manufacturing News

Polymer System Allows Soft Overmolding onto Acetal

Originally Published MPMN November 2001

INDUSTRY NEWS

Polymer System Allows Soft Overmolding onto Acetal

This pressure-balancing valve is made of a polymer system from Ticona and Kraiburg Corp. that combines an acetal copolymer and a thermoplastic elastomer.

A specially crafted combination of acetal copolymer and thermoplastic elastomer allows the overmolding of soft surfaces onto acetal. Developed jointly by Ticona (Summit, NJ; www.ticona.com) and Kraiburg Corp. (Duluth, GA; www.kraiburg-tpe.com), the polymer system overcomes the inherent lubricity of acetal, allowing it to bond to seals, gaskets, and nonslip and energy-absorbing elements. The system combines Ticona's Celcon or Hostaform acetals with a tailored grade of Kraiburg's Themolast-K, an adhesion-modified styrene block copolymer. The bond between the materials, which is formed during a two-component molding process, exceeds the tear strength of the elastomer.

Applications for this technology include soft-grip surfaces for knobs, levers, handles, and rollers; strong and flexible film hinges and joints; and multifunctional components that simultaneously seal, absorb shock, and dampen sound. "This new system allows manufacturers to consolidate parts, which reduces handling and assembly costs," says Ticona marketing specialist John Caamano. "We estimate savings as high as 30% versus conventional assembly methods, especially for large or high-volume components." Increased design flexibility from the ability to mold in place hard-to-assemble components is also cited as a benefit.

Zachary Turke

Copyright ©2001 Medical Product Manufacturing News

Drug-Eluting Stents: The Race to Market Picks Up Speed

Originally Published MPMN November 2001

INDUSTRY NEWS

Drug-Eluting Stents: The Race to Market Picks Up Speed

This polymer-free stent from Cook Inc. is coated with a thin layer of the drug paclitaxel to reduce the occurrence of in-stent restenosis.

Positive clinical trial results for a drug-eluting stent from Cordis Corp. (Miami, FL; www.cordis.com) confirm the important role these devices will come to play in combating in-stent restenosis. Occurring in as many as 40% of angioplasty patients, in-stent restenosis is a serious threat to people recovering from coronary artery disease. Radiation or ultrasound procedures are typically used to prevent reblockage, but as the results of the Cordis study indicate, these treatments might soon be a thing of the past. Involving 238 patients, the randomized, double-blind trial demonstrated that a sirolimus-eluting stent completely prevented artery reclogging during a follow-up period of seven months. According to study leader Marie-Claude Morice, a zero restenosis rate has never been seen in any previous stent trial. "If confirmed," she adds, "a drastic change in the policy and strategies of revascularization will occur." This shift already seems to be in effect, however, as several other companies rush to get their drug-eluting stents to market.

STS Biopolymers (Henrietta, NY; www.stsbiopolymers. com) and B. Braun Medical (Bethlehem, PA; www.bbraun. com) are collectively developing a restenosis-preventing stent that is just beginning the FDA approval process. Incorporating STS Biopolymers' Medi-Coat drug-delivery coating, the device administers single or multiple drugs over controllable time periods ranging from days to weeks. The coating restrains the flow of liquid to ensure proper release rates and stabilizes the drug to allow sterilization. A special primer is used to permanently bond the coating to the stent. "The primer provides permanency without limiting flexibility," explains STS Biopolymers' product manager Heidi McIntosh. "The device can expand or contract, and the coating will not crack or flake."

Viewed under magnification, the microporous polyurethane coating of the stent being developed by Cardiotech International Inc. and Implant Sciences Corp. performs drug delivery and encourages tissue growth.

Currently undergoing clinical testing, a stent from Cardiotech International Inc. (Woburn, MA; www.cardiotech-inc.com) and Implant Sciences Corp. (Wakefield, MA; www.implantsciences. com) uses a microporous polyurethane coating to deliver the drug sirolimus and encourage tissue in-growth. "Our coating completely encapsulates the stent, not just the struts as is common with some devices," says Cardiotech CEO Michael Szycher. "This ensures uniform drug delivery to all the viable cells in the implant area." The microporous device incorporates holes into which endothelial cells can grow, thus speeding healing around the implant and increasing long-term blood compatibility.

A stent being developed by Cook Inc. (Bloomington, IN; www.cook-inc.com) is unique because it does not contain polymers. A proprietary process attaches a thin coating of the drug paclitaxel directly to the surface of this device. "Drug-eluting stents with polymer coatings sometimes suffer from bioreactivity issues," says spokesman David McCarty. "Since our device is metal, these concerns are eliminated." The company expects CE approval for one of its devices by the third quarter of 2002. American models are still being tested.

Other companies developing drug-eluting stents include Boston Scientific Corp. (Natick, MA; www.bsci.com) and Angiotech Pharmaceuticals Inc. (Vancouver; www. angiotech.com).

Zachary Turke

Copyright ©2001 Medical Product Manufacturing News

A New French Connection Lifts Barriers to Long-Distance Surgery

Originally Published MPMN November 2001

EDITOR'S PAGE

A New French Connection Lifts Barriers to Long-Distance Surgery

We all know what happened September 11. It's a date we won't soon forget. But on September 7, New York was the setting for another momentous event that did not receive the media attention it deserved. It's understandable that Operation Lindbergh got short shrift, but it's unfortunate nonetheless, because it represents a milestone in medical technology.

The outcome of Operation Lindbergh was the successful removal of a patient's gall bladder. That would be extraordinarily mundane were it not for the fact that the surgeon performed the procedure in New York City on a patient who was several thousand miles away in Strasbourg, France. Professor Jacques Marescaux, MD, of the European Institute of Telesurgery, assisted by New York–based physician Michel Gagner, controlled a robotic surgical system developed by Computer Motion Inc. by means of an end-to-end high-speed fiber-optic connection deployed by a subsidiary of France Telecom. The world's first telesurgical procedure was described by Computer Motion chairman and CEO Robert W. Duggan as an incipient step toward the "convergence of technology and medical science that will treat patients with less pain and faster recovery" regardless of their location.

Robotic surgery has made tremendous strides in recent years. Computer Motion announced on October 8 that its Socrates Robotic Telecollaboration system has been granted regulatory clearance by FDA. (Interestingly, the agency was forced to introduce a new category—Robotic Telemedicine Devices—to its medical device classification protocol to accommodate the system.) The da Vinci surgical robot, developed by Intuitive Surgical Inc., also was recently approved for clinical use by FDA, and several other systems are currently undergoing clinical studies. Elements of the Zeus Robotic Surgical system that was used in Operation Lindbergh have been cleared by FDA for use on patients, but it has yet to receive the agency's blessing for remote applications. The system has been granted the CE mark, however, clearing it for commercial distribution within the European Union.

But it is the advent of the telecommuting surgeon and long-distance surgery that is the truly novel aspect of Operation Lindbergh. In the past, telesurgical efforts have been thwarted by inadequate data transmission speeds: the surgeon needs to view the results of his actions in as close to real time as possible. By linking all of the equipment used in Operation Lindbergh over a high-bandwidth fiber-optic service transmitting 10 Mb/sec across the Atlantic Ocean, Equant North America achieved an average 150-millisecond delay. The time that elapsed between the surgeon's command to the robot and the visualization of his action on the monitor was for all intents and purposes imperceptible to the human eye. This achievement is all the more remarkable considering that this delay encompasses coding and decoding of the video image as well as signal transmission time.

"The demonstration of the feasibility of a transatlantic procedure is a richly symbolic milestone," commented Marescaux. "It lays the foundation for the globalization of surgical procedures, making it possible to imagine that a surgeon could perform an operation on a patient anywhere in the world."

Norbert Sparrow

Copyright ©2001 Medical Product Manufacturing News

FDA Web Site Update

Originally Published MDDI November 2001

A monthly review of new and notable additions to FDA's Web site.

Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance

This document, issued on October 5, 2001, supersedes both Guidance for Electrical Safety, Electromagnetic Compatibility, Mechanical Testing for Indwelling Blood Gas Analyzer Premarket Notification Submissions, issued June 28, 2000, and Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions, issued February 21, 2000. The document describes a means by which indwelling blood gas analyzers may comply with the requirement of special controls for Class II devices. Manufacturers attempting to establish that their device is substantially equivalent to a legally marketed indwelling blood gas analyzer device should demonstrate that the proposed device complies with either the specific recommendations of this guidance or some alternative control that provides equivalent assurances of safety and effectiveness.

Medical Device Reporting—Remedial Action Exemption; Guidance for Industry and FDA

Issued on September 26, 2001, this document supersedes MDR Guidance Document: Remedial Action Exemption E 1996001, dated July 30, 1996. The medical device reporting (MDR) regulation requires device manufacturers to report adverse events for products undergoing remedial action. This document offers guidance on requesting an exemption under 21 CFR 803.19 for reporting certain adverse events that involve device remedial action. FDA intends to grant this exemption to manufacturers when they provide information that indicates additional reports about a device that already has been the subject of a remedial action will not provide any significant new data.

Cancer Drug and Biological Products—Clinical Data in Marketing Applications; Guidance for Industry

This document provides recommendations for sponsors on data collection for cancer clinical trials submitted to FDA to support marketing claims in new drug applications, biologics license applications, or supplemental applications for new indications. Collected data should be sufficient to evaluate the safety and effectiveness of the treatment but need not include other data. This guidance is also intended for private investigators, cooperative cancer groups, contract research organizations, and others designing and conducting studies that later can be used in a marketing application for an anticancer drug or biological product. Because of the complexity of clinical trials and different data that should be included in different situations, the precise data for each trial cannot be specified in a guidance document. This guidance provides general principles for data collection and submission.

Presentation to Central New York Healthcare Central Service Professionals

This September 11, 2001, presentation by Office of Compliance staff describes FDA's current regulatory policy regarding facilities that reprocess single-use devices (SUDs). It also summarizes the regulations that now apply to reprocessors of SUDs and provides information on where to get questions answered.

Changes in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices

This site includes a letter, dated September 25, 2001, to hospital administrators and risk managers. The letter outlines changes in FDA's policy on the reuse of single-use devices (SUDs) that will affect hospital SUD reprocessors. FDA has extended the deadline for active enforcement to August 14, 2002, for the following postmarket requirements: medical device reporting, tracking, corrections and removals, quality system, and labeling.

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Premarket Submission Review and Quality System Inspections under United States/European Community Mutual Recognition Agreement

FDA is seeking public comment on the proposed collection of information by the agency regarding third-party premarket submission reviews and quality system inspections under the United States/European Community mutual recognition agreement. Written or electronic comments on the collection of information must be submitted to the agency by December 4, 2001.

Updated Information for Clinical Investigators

This site has been recently updated by CBER. Information is provided on participation of females in clinical trials and gender analysis of data in biologic product applications, clinical trials and institutional review boards, good clinical practice in FDA-regulated trials, HHS human research protections, and Center for Drug Evaluation and Research information for clinical investigators.

Radioallergosorbent Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s; Final Guidance

This document describes FDA's recommendations for data and information to be provided in 510(k) premarket notifications for radioallergosorbent test (RAST) methods for allergen-specific immunoglobulin E (IgE) test systems. RAST testing measures specific allergen antibodies and may aid in the diagnosis of various pulmonary disorders. The document has been modified to include allergens for which few patient samples are available.

Copyright ©2001 Medical Device & Diagnostic Industry

GE's Changing of the Guard

Originally Published MX November/December 2001

COVER STORY

GE's Changing of the Guard

Joseph M. Hogan, president and CEO of GE Medical Systems, rises to the challenge of leading one of industry's giants.

Interview by Greg Freiherr

For Joseph M. Hogan, speed is a way of life. In 16 years, Hogan has ascended from a marketing and product management position with GE Plastics (Pittsfield, MA) to being president and CEO of GE Medical Systems (GEMS; Waukesha, WI). Before taking the helm at GEMS, Hogan had only nine months following his April appointment as vice president of global e-business to get a handle on the company. One month later, he was named executive vice president and chief operating officer.
Photo courtesy GE Medical Systems

The rapid succession of appointments was part of a grooming process. Hogan had been handpicked as the successor to Jeffrey Immelt, who served as president and CEO of GEMS from 1997 to September 2001. Immelt was the odds-on favorite to succeed GE's legendary leader Jack Welch, and as Immelt rose, so would Hogan. The pieces fell into place in late November 2000, when Immelt was named to replace Welch and Hogan

A Big Fish

Originally Published MX November/December 2001

COVER STORY

Return to Article:
GE's Changing of the Guard

Internal development and corporate acquisitions have made GE Medical Systems (GEMS; Waukesha, WI) a major player in every market segment within the radiology sector. It is also a serious contender in such outside areas as patient monitors, which the company has lumped under the healthcare information technologies unit that it forged in 2000.

GEMS brings in about $8 billion per year, which amazingly amounts to a drop in the bucket compared to the $130 billion in revenues garnered each year by all of GE. In fact, GE has such a diverse array of products in its portfolio that some investors refer to the company as being its own index fund.

While it may seem that the medical business could easily get lost in such a massive portfolio, nothing could be further from the truth. GE Medical Systems is more than the accumulation of its annual revenues—more than a small fish in a big corporate pond. GEMS is uniquely tied into the political structure of GE. The company served as a springboard for GE's current chairman and CEO, Jeffrey Immelt,

Ensuring Blood Supplies in Uncertain Times

Originally Published MDDI November 2001

NEWS & ANALYSIS

Ensuring Blood Supplies in Uncertain Times

In the aftermath of the attacks on New York City and the Pentagon, an unprecedented number of Americans donated whole blood to help meet the needs of victims and rescuers alike. A few weeks later, radio personality Paul Harvey suggested inaccurately that millions of units would be "dumped" because of the donated blood's short shelf life of 42 days.

Listeners began calling the American Red Cross (ARC) to see if they had waited in long lines to donate blood that would be dumped. Callers were assured that the ARC has been freezing blood for 30 years. Harvey broadcast a clarification of his comments on a subsequent program.

The ARC explains that blood donated after September 11 was frozen if not immediately needed. The organization adds that it is working with FDA to improve freezing and thawing techniques that could improve blood services. The ARC also says it is assessing new technology to create an inventory of frozen blood that can be stored in a number of sites around the country and tapped in an emergency.

As part of this effort, the organization recently contracted with Haemonetics Corp. (Braintree, MA) to use the firm's latest blood freezing technology to expand its frozen blood storage capability. Like currently available techniques, Haemonetics' ACP 215 cell processing system allows red blood cells to be frozen for as long as 10 years and to thaw cells as needed. Previous technologies, however, required thawed blood to be used within 24 hours after thawing or be discarded. The company explains that by automating the blood freezing process in a closed-circuit disposable system that eliminates exposure to air or bacterial contaminants, the shelf life of thawed blood can be extended to 14 days.

Using a closed-circuit system, the ACP 215 cell processing device aids supply management by extending the shelf life of thawed blood to 14 days.

Prior to freezing, glycerol is added to the blood bag through sterile, plastic tubing to protect the cells from damage. The blood is then placed in a freezer for long-term storage. After defrosting the blood, the device pumps a cleansing agent into the bag to remove the glycerol, making the blood safe for transfusion to a patient.

James L. Peterson, Haemonetics' president and CEO explains that, "The enormously generous outpouring of donors created blood inventory levels that could be leveraged to maximize frozen blood programs." He believes that the firm's technology will enable blood collection and storage facilities to ensure adequate levels of blood availability. The concept of freezing blood supplies is particularly important in preserving units of rare blood types, collected at times of surplus, to keep in reserve for use during shortages.

The frozen blood market is estimated to be relatively small at present, representing a minor portion of all blood transfused in the United States. Haemonetics speculates that frozen blood programs have been limited by the short shelf life of thawed blood. The company notes, however, that the United States has experienced significant localized blood shortages in recent years as a result of either increased demand or decreased supplies. Such shortages emphasize the importance of developing methods for managing frozen blood inventories.

The company believes that within a few years this new generation of laboratory processing equipment and disposables will also be used for pathogen inactivation of red blood cells. The firm is collaborating with V.I. Technologies Inc. (Watertown, MA) to develop pathogen inactivation methods that can increase the safety of red cell units transfused to patients.

Copyright ©2001 Medical Device & Diagnostic Industry