Originally Published EMDM
September 2004
2004 MEDTEC IRELAND PREVIEW
One from the Heart |
Now in its fourth year, MEDTEC Ireland has established itself as the annual rendezvous for regional medical device OEMs. The two-day conference provides attendees with a world-class forum in which key manufacturing, research, and regulatory issues are explored in depth. The accompanying tabletop exposition enables them to network with global suppliers in a relaxed yet productive setting.
This year’s event will feature two keynote presentations. Les Weinstein, ombudsman at the Center for Devices and Radiological Health at US FDA, kicks off the first day. He will give an update on recent activities at the agency and discuss his role in resolving disputes between FDA and the companies it regulates. On day two, Brian Griffin, vice chairman of the department of cardiovascular medicine from the world-renowned Cleveland Clinic, will focus on cardiovascular device therapies. A point he will be stressing in his speech is the role that devices can play in the treatment of cardiovascular disease in the absence of new classes of drug therapy. This will be a homecoming of sorts for Griffin, who graduated from the National University of Ireland and fulfilled his internship and residency requirements at the University College Hospital in Galway.
During the two days, a number of other topics will be addressed, including the impact of EU enlargement on regulatory requirements, cardiovascular device testing, and the thorny issues surrounding combination products. Interviews with select speakers begin on this page.
Nearly 80 exhibitors are scheduled to participate in the tabletop exposition this year. The Galway region is a European centre of cardiovascular device manufacturing. It produces approximately one-quarter of all catheter-type devices used in Europe. Consequently, event organizer Canon Communications llc, which also publishes EMDM, has focused on recruiting exhibitors who offer components, equipment, and technologies relevant to the design and manufacture of next-generation stents, catheters, and related products.
MEDTEC Ireland will be held at the Radisson SAS hotel in Galway on 29 and 30 September. For the most current conference and exposition information, as well as registration and travel assistance, go to
www.medtecireland.com.
Session Explores Use of Nanoscale Surface Modification for Improving Biocompatibility
Rita Emmanouilido
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Biocompatibility is a key requirement for medical devices. In most cases, uncontrolled protein adsorption and cellular adhesion may lead to adverse biological responses, causing the device to fail. These events are related to the physicochemical properties of the interface or surface that exists between the device and the biological environment. “An essential part of designing new biocompatible materials is understanding the material-biology interface and modulating the so-called biointeractions,” says Peter Kingshott, senior scientist at the
Danish Polymer Center (Roskilde, Denmark).
In his presentation on Thursday, 30 September, Kingshott will discuss various surface modification methods. The use of plasma polymerization for the introduction of surface functional groups, methods for the immobilization of hydrophilic molecules, and nanostructuring techniques to create biomimetic polymer interfaces are among the technologies that will be explored.
Advanced surface characterization techniques will also be demonstrated as research tools in the design and optimization of surfaces. “It is very difficult to design a surface without actually being able to see what you have created,” says Kingshott. “By using surface-sensitive techniques we can actually see if our modifications have been successful. We can then use this process as a sort of feedback loop to create surfaces that have enhanced surface chemistry or topographic features.” Such techniques include x-ray photoelectron spectroscopy (XPS) and time-of-flight secondary ion mass spectrometry (ToF-SIMS) for chemical characterization of the outer few atomic layers.
The detection and identification of adsorbed proteins from complex biological media at sub-monolayer levels is also critical. Methods for doing so such as 125I-radiolabelling and matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS) will be covered.
Building Confidence into Manufacturing Processes with Statistical Methods
Norbert Sparrow
Building a coherent manufacturing process requires making fact-based decisions, says W. Heath Rushing, quality engineer at
Amgen (Longmont, CO, USA). “It’s that simple,” he adds. Getting to that point, however, may mean breaking some old habits, which is rarely easy. At MEDTEC Ireland, Rushing and coworker Daniel Weese will present an overview of statistical methods designed to build confidence into manufacturing processes. The daylong workshop is scheduled for Thursday, 30 September.
Many medical device manufacturers, in fact, are required to use statistical techniques. “It’s written into the quality system regulation,” says Rushing. Indeed, section 820.250 of Title 21 of the [US] Code of Federal Regulations states: “Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.” Manufacturers should not view this as a burden, stresses Rushing. “Process control and thorough characterization benefit the manufacturer. They provide a means to continuously decrease process variation, leading to more-capable processes and ultimately, less scrap.”
In the workshop, Rushing and Weese will provide hands-on training in statistical methods that are commonly used by world-class companies. “Statistical process control (SPC) is only part of the picture,” says Rushing. “There are methods that companies can and should use to develop meaningful acceptance criteria, to fully characterize manufacturing processes, to monitor and control processes, and to select appropriate sample sizes.
“Our examples will involve medical devices,” stresses Rushing. Amgen assembles medical devices for use with their drug products, he adds, “and we will draw upon our own experiences to illustrate the points we are making.”
At the end of the day, Rushing hopes to have made a few converts. “It always amazes me to learn how many device companies still rely on 100% inspection,” he notes. Statistical methods, Rushing adds, are the best way to kick that habit.
Tissue Engineering: The Next Generation
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Imagine going to a body shop, not to repair a dented bumper, but to replace a lost limb. Sound far-fetched? Not according to Peter X. Ma, professor at the
University of Michigan (Ann Arbor, MI, USA). At MEDTEC Ireland, he will explain how advances in tissue engineering may one day make regeneration of human body parts routine. His presentation is scheduled for Thursday, 30 September.
Tissue engineering involves the use of functional healthy cells from different sources to develop biological substitutes for the restoration or replacement of tissue function. “First we form materials into the shape or structure of the tissue or organ that we are trying to regenerate,” explains Ma. “These highly porous materials act as scaffolds. The cells grow into this porous structure and eventually become a tissue.” Once the scaffold has served its purpose, it degrades and disappears, leaving nothing foreign in the body.
Materials selection and fabrication techniques play a critical role in scaffold design. “The materials can be synthetic polymers, or they may be natural macromolecules from the human body or some other source,” says Ma. “We try to mimic the nanostructure of natural materials to promote a cell and material interaction that is similar to what happens in natural matrices.”
In his presentation at MEDTEC Ireland, Ma will elaborate on various scaffold fabrication technologies such as phase separation and 3-D pore architecture and will review the development of biomaterials. Biomimetic design, nanostructure techniques, and bioactive scaffolds will be emphasized. The applications of scaffolds for the engineering of various tissues such as bone, cartilage, blood vessels, and heart valves will also be explored.
New Frontiers in Digital Design and Manufacturing
Advances in 3-D digital technologies such as solid modeling, virtual prototyping, 3-D digitization, and rapid prototyping are revolutionizing the design and manufacture of numerous products. Low cost, speed, accuracy, and flexibility are among the many benefits for the manufacturing process. A daylong session at Medtec Ireland, chaired by Michael Murphy, coordinator of the Irish Rapid Design and Manufacturing Network, on Wednesday 29 September will examine the application of these technologies in the medical sector.
Following an overview of computer-aided design and rapid manufacturing technologies, Hans Hessel of the
Phonak Group (Stäfa, Switzerland) will explain how digital mass manufacturing is energizing the custom hearing aids market.
Other speakers at the session will explore the use of digital technologies in the design and manufacture of surgical instruments and prosthetic devices and explain how computational fluid dynamics can benefit, for example, the development of drug-eluting stents.
The session will wrap up with a discussion of related emerging trends in both device and tissue engineering. “Existing technologies enable the manufacture of custom components mostly for use outside the body,” says Murphy. In the future, he adds, it may be possible to achieve the same results with parts inside the body, such as a hip implant that’s a perfect custom fit.
Copyright ©2004 European Medical Device Manufacturer
