Originally Published September 2000
EMDM Industry News
- Perlos Doubles Cleanroom Manufacturing Capacity for Healthcare Products
- Implantable Material Combines Best Properties of Silicone, Polyurethane
- Pill with a View
- In Brief
- Shows and Conferences
Perlos Doubles Cleanroom Manufacturing Capacity for Healthcare Products
Suppliers generally know what it will take to keep the customer satisfied next year, but they don't always take the time to consider how OEM demands may evolve in the years to come. When Perlos Oyj decided to add a new cleanroom manufacturing facility to its operations in Nurmijärvi, Finland, freewheeling speculation on future business paradigms was a key part of the planning process. The committee concluded that more was the mot d'ordre: suppliers offering more flexibility, more accelerated processes, and more-specific contamination control would be on the winning end of the bargaining table, they surmised. The recently completed 11,000-m2 cleanroom manufacturing facility, which doubles the company's capacity for medical- and pharmaceutical-related projects, was designed to meet these needs. Compromises that often plague expansion projects were never an issue, according to marketing manager Johan Lindqvist. "This facility was designed around the process, not vice versa," he says.
Perlos was involved in the development and production of AstraZeneca's Turbuhaler.
Although healthcare products represent only a portion of the company's business sectors—telecommunications, electronics, and automotive are the other primary activities—Perlos's expertise in the development and manufacture of drug delivery components has given the company a high profile with device and pharmaceutical OEMs. The firm contributed to the development and manufacture of the Turbuhaler, a drug delivery device marketed by Swedish pharmaceutical giant AstraZeneca, and Mirena, an insertion device for an intrauterine contraceptive marketed by Leiras.
Accustomed to working with regulated industries, Perlos has developed a sophisticated traceability system. "We can integrate a 100% inspection system of critical features into our assembly lines," notes Lindqvist. "Trending records that show what happened when with each batch can be produced," he adds, "and we perform continuous microbe testing during production." Monitoring processes and the level of contamination is all well and good, says Lindqvist, but it's better to determine the sources of potential contamination and seek ways to remove them from the clean environment. That realization prompted the company to go underground. "To minimize contamination potential, material handling is performed in the basement. A vacuum system pumps the material into the cleanroom where it is then processed," says Lindqvist.
Locating material handling in the basement also adds to the overall modular design of the facility, which enables the company to be more flexible in meeting customer needs, Lindqvist notes. "We control the environment to the level required by the client." The area is certified to Class 100,000, but "one module achieves Class 10,000 levels, although it is not classified as such," notes Perlos CEP Plastics division director Seppo Arento.
Flexibility has been one of the company's key assets as a supplier to the mobile phone sector. "Mobile phones have such a short life span that fast ramp up is critical," says Lindqvist. This will become a key issue for some device manufacturers as well, he adds, notably those making inhalers.
"With the development of the Internet and home-care devices, end-users will be more influential in the design of medical products. For instance, people don't want to walk around with bulky inhalers. They want products that look attractive and that have distinctive features," he says, comparing development of the next generation of devices to the frenetic pace of product differentiation within the mobile phone industry. Lindqvist considers Perlos to be perfectly positioned to capitalize on this paradigm shift. Not only does it have the proven R&D acumen and wide-ranging manufacturing capabilities to produce these devices, he stresses, but the company is able to accelerate ramp up and time to market.
"We call it total project management," says Lindqvist, a concept that describes not only the firm's vertically integrated services but its ability to partner effectively with OEMs from the product design phase. In addition to the manufacture and assembly of plastic components, Perlos offers substantial product development support, concurrent in-house design and manufacture of assembly lines and tooling, and a range of secondary postmoulding operations such as printing and surface treatments. A division devoted to connector production brings metals-processing expertise to the table, and the manufacture of automated assembly equipment on-site allows the company to accelerate ramp-up time. The cumulative effect of these capabilities and the opportunities they afford for concurrent operations, according to Lindqvist, can significantly speed a product's introduction to the marketplace.
The company's vertically integrated services and knowledge of the healthcare market can result in accelerated ramp up and time to market, according to the firm.
No matter how sound decisions are, Lindqvist adds, miscommunication can create costly mistakes and delays. To ensure unimpeded communication, the product manager who heads the project team is also the designated point of contact for the OEM. At Perlos, there is no barrier separating R&D and production, he adds, and clear channels of communication make sure that decisions are accurately and swiftly implemented.
The Finns, after all, know a little something about communication, adds Lindqvist, noting that Finland has the highest per capita number of mobile phones in the world. "And that is one more advantage of working with a supplier based in Finland. No matter what time zone you are in, we can always be reached."
—Norbert Sparrow
Implantable Material Combines Best Properties of Silicone, Polyurethane
The 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.
"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 UK 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.
Flexible and biostable, Elast-Eon can be extruded, moulded, or cast to produce a range of medical devices.
Because it is both flexible and biostable and can be processed by means of extrusion, moulding, or solvent-dip casting, Elast-Eon is suited for the manufacture of a variety of devices, according to Skalsky. Catheters, wound dressings, artificial arteries, orthopaedic implants, and cardiac pacing and defibrillation leads are among the applications Skalsky cites. —Norbert Sparrow
Pill with a View
Acamera-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 colour video signals as it embarks on a fantastic voyage through the stomach and small bowels. The sensor was developed by Photobit Corp. (Pasadena, CA, USA), a supplier of CMOS image sensors for use in a variety of applications.
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 an ingestible pill that measures a scant
A camera-carrying pill that transmits images of the digestive tract measures only
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 currently is undergoing clinical trials in the United States. Given hopes to obtain 510(k) clearance by the end of the year.
Photobit acquired the rights to high-performance image capture technology from NASA's Jet Propulsion Laboratory, also located in Pasadena, 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."
The sensor's small silicon die size (shown here enlarged) and its low power dissipation enabled development of a pill that provides an alternative to gastrointestinal endoscopy.
For more information, contact Photobit Corp., 135 N. Los Robles Ave., Pasadena, CA 91101, USA; phone: +1 626 6832200; fax: +1 626 6832220.
In Brief
HIMA Changes Name
The US-based Health Industry Manufacturers Association (HIMA) changed its name to the Advanced Medical Technology Association (AdvaMed) on 21 June. The surprise name change was implemented to reflect the association's goal of increasing patient access to technology, according to HIMA/AdvaMed president Pamela Bailey. Founded in 1974, HIMA/AdvaMed represents more than 800 manufacturers and was a key player in the passage of the US FDA Modernization Act. The association hopes the name change will raise its profile in Washington, allowing HIMA/AdvaMed to reach more consumers.
For more information, contact HIMA/AdvaMed, 1200 G St. N.W., Ste. 400, Washington, DC 20005, USA; phone: +1 202 7838700; fax: +1 202 7838750; e-mail: info@AdvaMed.org; Internet: http://www.advamed.org.
Faulhaber Group Comprises Global Network
Dr. Fritz Faulhaber GmbH (Schönaich, Germany), Minimotor S.A., (Croglio, Switzerland), and MicroMo Inc. (Clearwater, FL, USA) recently joined forces to form the Faulhaber Group. The group, which offers custom drive solutions for the medical and other sectors, announced its joint corporate design and trademark at the Industrie 2000 trade fair in Hannover in March. Each individual company provides a distinct area of expertise to the miniature drive industry. Dc micromotors are the specialty in Germany, while brushless dc motors, drive electronics, and precision gearheads are the focus in Switzerland. The US-based company will concentrate on electronic control systems and encoders. The group hopes the formation of its global network will shorten overall product development periods.
For more information, contact Minimotor S.A., 6980 Croglio, Switzerland; phone: +41 91 6113100; fax: +41 91 6113110; e-mail: info@minimotor.ch.
Mecmesin Ltd. Relocates
Mecmesin Ltd. (Slinfold, Sussex, UK), a designer and manufacturer of electronic force gauges, has moved its international headquarters. The company's new 16,000-sq-ft premises at Newton House will allow for an increased manufacturing capacity and improved research, design, and development facilities. Mecmesin will also continue to offer customized testing services at the new location. The firm offers testing services and equipment to the medical device industry.
For more information, contact Mecmesin Ltd., Newton House, Spring Copse Business Park, Slinfold, Sussex RH13 7SZ, UK; phone: +44 1403 799979; fax: +44 1403 799975; e-mail: info@mecmesin.com.
Tyco to Acquire Mallinckrodt
Tyco International (Pembroke, Bermuda) announced on 29 June that it will acquire Mallinckrodt (St. Louis, MO, USA), a manufacturer of monitoring and respiratory instrumentation, for about {4.5 billion in stock. Tyco, a diversified manufacturing company, has increased its market share in the healthcare industry over recent years with several acquisitions. After it acquires Mallinckrodt, Tyco Healthcare will reportedly be the second-largest manufacturer and distributor of medical devices worldwide.
For more information, contact Tyco International Ltd., The Zurich Centre, 2nd Floor, 90 Pitts Bay Rd., Pembroke HM 08, Bermuda; phone: +1 441 2928674; fax: +1 441 2959647.
—Jamie Graham
Shows and Conferences
Pressure-Sensitive Adhesives Seminar Announced
A seminar titled Pressure-Sensitive Adhesives: Materials, Testing, and Applications will be held 25–27 September in Zürich, Switzerland. Providing a comprehensive review of pressure-sensitive adhesives and release coatings technology, the conference will also address new developments in materials, testing techniques, and coating processes designed to optimize product performance.
For more information, contact Technomic Publishing Company, Inc., Program Division, 851 New Holland Ave., Box 3535, Lancaster, PA 17604, USA; phone: +1 717 2915609; fax: +1 717 2959637; e-mail: seminar@techpub.com.
Moulded Interconnect Devices Covered at MID 2000
The fourth international congress on moulded interconnect devices (MID) meets 27 and 28 September in Erlangen, Germany. The conference is organized by the Research Association 3-D MID e.V., and is designed to provide a platform for the exchange of experiences for MID developers, researchers, and potential users. While focussing on innovative products from various industries, the conference will also emphasize distribution of general knowledge about MID technology.
For more information, contact MID 2000 Conference Secretariat, Herrn Roland Meier, Egerlandstr. 7-9, D-91058 Erlangen, Germany; phone: +49 9131 8527177; fax: +49 9131 302528; e-mail: meier@3dmid.de.
Society for Experimental Mechanics Hosts TDM 2000
The third international conference on Mechanics of Time-Dependent Materials (TDM 2000) is scheduled for 17–20 September in Erlangen, Germany. The conference comprises keynote lectures that discuss the time-dependent properties of materials like ceramics, metals, and polymers. Organized by the Society for Experimental Mechanics (SEM), the conference includes a scientific programme, a minisymposium, and a social programme.
For more information, contact Helmut Münstedt, TDM 2000, Institut für Werkstoffwissenschaften, Friedrich-Alexander-Universität Erlangen-Nürnberg, Martensstr. 7, D-91058 Erlangen, Germany; phone: +49 9131 8528709; fax: +49 9131 8528321; e-mail: TDM2000@www.uni-erlangen.de.
Simultaneous Pharmaceutical Seminars in London
A seminar on pharmaceutical marketing and another devoted to the use of electronic media in clinical trials and data management will both be held at the Hatton Garden in London on 4 and 5 September. Speakers at Strategies in Pharmaceutical Marketing will discuss marketing tactics from a strategic and operational viewpoint. Integration of Electronic Media in Clinical Trials and Data Management will explore ways to reduce the number and duration of clinical trials needed for drug development using electronic media.
For more information, contact SMI Conferences, Number One, New Concordia Wharf, Mill St., London SE1 2BB, UK; phone: +44 171 8726000; fax: +44 171 8276001; e-mail: customer_services@smiconferences.co.uk.
