On the cover: This completely in-the-ear hearing aid is a product of miniaturization, one hot sector for medical device manufacturers in 2006.

A medical device manufacturer who maintains a clear understanding of trends in the marketplace will enjoy an advantage over an uninformed competitor. This exclusive report offers a look ahead at trends in 2006 from industry experts.

AT A GLANCE

• Leading edge technologies

• New innovations

• Products on the horizon

• 2006 and beyond

With the rapid emergence of new developments in medical device manufacturing, market trends change and evolve at a fantastic rate. New trends bubble to the surface as innovative products are released to the marketplace while older technologies fade out and take the associated techniques and procedures of performing a process with them. It is the successful manufacturer who is able to maintain a clear understanding of the current trends as well as to be able to efficiently adapt their business to prepare for those on the horizon.

With this in mind, Medical Design Technology has reached out to leaders in five different sectors that are of great interest to medical device manufacturers. These experts have shared their thoughts on what companies can expect for the upcoming year and beyond in the areas of combination products, electronic miniaturization, medical plastics, lean manufacturing, and nanotechnology.

Need for Combination Products

By Barry Sall

Barry Sall, an expert in strategic regulatory consulting for medical device and combination products, is a senior consultant at PAREXEL Consulting. He manages the preparation of FDA marketing applications for medical devices and provides regulatory assistance related to conducting clinical trials and assuring quality systems compliance. PAREXEL Consulting provides expertise in bio/pharmaceutical and medical device development to medical device manufacturers worldwide. He can be reached at 781-434-4742 or barry.sall@parexel.com.

The medical device industry can expect continued innovation in the combination products field during 2006. The spectacular success of drug-coated stents has attracted attention from a variety of sectors. Certainly, device developers will continue to consider the use of various drugs or biologic products to enhance the functionality of their devices. On the other hand, large pharmaceutical companies are beginning to forge alliances with device companies that bring specialized technology to the table. Big pharma’s main interests are personalized medicine including pharmacogenomics and a wide variety of novel drug delivery technologies. Both of these interests should enhance the safety and/or effectiveness of products in their pipelines, while expanding markets for device companies.

Combination products can involve much more than coating an implant with a drug. The entire field of personalized medicine, where a patient’s treatment is individually tailored to their own genetic makeup, must, by definition, involve combination products. Diagnostic devices must be used to determine the genetic makeup or phenotypic characteristics necessary to decide if a specific drug or biologic compound will be effective for a particular patient. A few of these drug/diagnostic combination products have been recently introduced to the U.S. market. Advances in technology combined with FDA’s efforts to propose practical regulatory approaches for these products should accelerate these development efforts in 2006.

Drug and biologic delivery devices are playing a greater role in the drug development process and 2006 should see the introduction of some of these technologies. Treatments such as gene therapy or stem cell therapy rely upon the physician’s ability to deliver potent product to the anatomical region where it can exert its effect. Many of these therapeutic agents are sensitive to degradation if delivered to the patient by conventional means such as a tablet or an intravenous injection; so new minimally invasive delivery devices must be used to ensure effective treatment.

Regulatory factors play an important part in combination product development. Although still evolving, FDA’s Office of Combination Products has published guidance documents and implemented systems that have made the development process more predictable. These efforts will certainly continue in 2006.

Combination products are highly diverse. The development process and life cycle for devices and drugs are quite different. Throughout 2006, developers of combination products will face challenges to meld drug and device development processes so that safe, effective, and profitable products are developed, while regulators develop mechanisms to efficiently evaluate them.

Increased Need for Electronic Miniaturization

Offering 25 years of experience in the medical device industry, Jim Ohneck, director of sales and marketing at Valtronic USA, has spent 13 of those years in product management. He has also been involved in senior management positions in start-up, high-tech medical companies since 1992. Valtronic, 6168, Cochran Rd., Solon, OH 44139, is a company that specializes in miniaturized medical electronic design and assembly. Ohneck can be reached at 440-349-1239 or johneck@valtronic.com.

By Jim Ohneck

As medical device companies continue to push the envelope to make their implantable devices smaller and less invasive, new trends are emerging within the electronics packaging industry to help meet this need. These trends include providing assistance to companies who desire to implement bare die packaging techniques such as chip on board (COB), flip chip (FC), or folded 3D design on a broader range of products to either reduce size or add features; making all the components within the electronic assembly biocompatible, eliminating the need for a titanium housing; and adding radio frequency (RF) capability to implants, enabling the downloading of data collected by the device.

The size of implantable medical devices, such as pulse generators, is usually driven by two aspects: the size of the electronic circuit board contained within the implant and the size of the power source or battery. Making implants significantly smaller and more comfortable for the patient is a current trend and requires employing bare die electronic packaging techniques, such as COB or FC within a folded flex or flex-rigid design. These packaging techniques give the designer considerably more space in which to work. This usually results in a smaller physical size and more features, typically improving the performance of the device. Any medical device company that wants to achieve a high degree of miniaturization is likely to employ a bare die packaging technique.

Beyond the standard fare of making existing devices smaller, another trend is to manufacture electronic drug delivery devices the size of a tiny pill that are implanted or swallowed. Besides the packaging and power source challenges, the material component is also a critical factor. Biocompatibility is extremely important, as well as the ability of the finished device to survive in a harsh environment, such as the stomach. Some new products currently in development will be placed directly into a part of the body with the printed circuit board and integrated circuitry isolated from the body tissue by only a biocompatible coating.

Finally, recognizing that almost every product in development now has some requirement to communicate with the outside world through RF technology is critical. This unfortunately can add to the physical size of the device. However, new methods for establishing communication with an implantable device employing techniques besides RF are being developed and should contribute to an overall reduction in size requirements.

While designing and manufacturing through-hole and surface mount electronic boards is common place, there are a limited number of companies that specialize in designing and manufacturing electronic circuits that employ chip on board, flip chip, or 3D folded designs. Medical device manufacturers are beginning to realize that to perform this type of design and assembly, close attention to not only the placement of components, but to the material science and mechanical structure of the printed circuit board is required. As a result, much of the miniaturizing design and manufacturing is being outsourced to companies who specialize in this area, a trend expected to continue through 2006 as well.

Advances in Medical Plastics

By Len Czuba

Len Czuba is the president of the Society of Plastics Engineers and principal at Czuba Enterprises Inc., 1105 E. Adams St., Suite 1034, Lombard, IL 60148. With 30 years of experience in polymer synthesis, compounding, and material development in the medical device industry, he formed Czuba Enterprises as a product design and development firm. He can be reached at 630-632-3560 or lczuba@aol.com.

The pace of new materials development is not slowing as some might have expected. In fact, the emergence of advanced miniaturization and the need to replace metal in implanted devices will drive an ever increasing appetite for new innovations. Advances in bioresorbable and biodegradable materials are powering a strong impetus in bone and skeletal treatments as well as offering even better, less invasive treatment procedures.

Another area of growth will be in the adoption of biopolymers to replace petroleum-based products. In the right application such as packaging pouches or trays, these new starch-based materials will give a more environmentally friendly flavor to otherwise non-degradable components.

Engineering polymers are continuing to evolve with many demonstrating properties that approach commonly used metals. The opportunity to make the next generation products MRI compatible offers strong incentives while replacement of metal in general will help an overall move toward the recycling of materials from used medical devices. A number of these same engineering polymers fulfill the specific requirements of device manufacturers as they continue to make devices smaller. The dimensions for components and structural parts are requiring the material properties to compensate for extremely reduced wall thickness. Many of these polymers offer not only superior physical properties but also have the excellent chemical resistance so often needed in clinical environments.

More of the material suppliers are looking at ways to help processors eliminate costs from the manufacturing process with creative use of new materials. For example, TPEs (thermoplastic elastomers) can be used to replace thermoset elastomer products. Newer TPEs and TPVs (thermoplastic vulcanizates) can be processed with standard injection molding machines and molds designed for thermoplastic materials. Furthermore, parts made from these newer materials usually cost less than the thermoset materials they replace, yet offer many of the same beneficial properties. Two-shot molding and in-mold assembly are other ways material technology can support new product innovation.

Finally, there is even good news for the users of commodity resins. Many of the traditional materials used to produce millions of components and thousands of devices are being upgraded with better catalyst systems, better antioxidants, improved colorants, and even lower cost alternatives in some cases. So contrary to a slow-down in new material technology development, an increasing rate of innovation related to polymers in medical devices during 2006 and beyond is most likely.

Lean Manufacturing Movement

By Kevin J. Duggan

An expert on implementing lean concepts in the medical device arena and other regulated environments, Kevin J. Duggan is the principal of Duggan & Associates Inc., 308 Cowesett Ave., West Warwick, RI 02893&#151an advanced lean educational and advisory firm. He is also a faculty member for the Lean Enterprise Institute, a non-profit education and research organization founded in 1997 to promote and advance the principles of lean thinking. Duggan can be reached at 401-826-2007 or kduggan@dugganinc.com.

As the medical device industry moves forward in 2006, embracing lean principles will be a must in order to competitively meet market demands. For example, the proven method of producing 100 heart pumps in a batch, putting them all through testing in a batch, then shipping the batch once a month to a distributor will lead a company to continue to produce the wrong products at the wrong time with only inventory or product shortages to cover the waste of overproduction. In order to respond to changing customer and market demands, medical device manufacturers will need to adopt moderate (lean value streams) to advanced lean principles (mixed model and shared resource flow) into their operations.

Many companies believe they are doing lean because they have strong 5’S (workplace organization) programs in place, use visual systems, and frequently run Kaizens (continuous improvement events). These are all excellent techniques but will not drive bottom line results. The true lean principles that transform a company include creating lean value streams that flow at the “pull” of the customer. These lean value streams are built using lean techniques that connect processes together for high quality and continuous flow. Techniques such as takt time (the rate of customer demand), one piece flow, first in first out (FIFO), every part every interval, scheduling only one process, and “pitch” (management time frame) create a lean value stream that enables the flow of product to the customer with very little waste. The result of this is high quality (flow cannot exist without high quality) product being produced in small batches at the rate of customer demand. In the heart pump example, a lean value stream may produce in a batch size of five and ship the right models every day, reducing the lead time from a month to a day.

In the year 2006, medical device manufacturers will realize what the aerospace industry learned earlier this decade—lean works in a highly regulated industry. Aerospace giants such as Boeing, Pratt & Whitney, Lockheed Martin, and others have implemented lean successfully, significantly reducing lead times and inventory, while also improving delivery times and producing higher quality products without compromising their regulatory requirements. This is something from which the medical device industry will certainly benefit.

Nanotechnology Has Arrived

By Bruce Gibbins, PhD

Bruce Gibbins, PhD is the chairman and CTO of AcryMed, 12232 SW Garden Pl., Portland, OR 97223. AcryMed, a company founded by Gibbins, is involved in the discovery of new processes and materials for tissue repair and wound care, as well as in manufacturing. A number of its products involve the use of nanotechnology. Gibbins can be reached at 503-624-9830 or bgibbins@acrymed.com.

Nanotechnology increasingly delivers on its promise to change the way we live. Once viewed as science fiction, it now contributes to many of our everyday tools. Cell phones are dependent on switches, display panels, and batteries of nanometric proportions to make them inexpensive, reliable, and durable. Materials at the nanometric scale display unique properties like catalysis, single electron transistors, spectral properties, large surface areas, and lower melting points that their bulk material counterparts don’t possess. These are in addition to the advantages that miniaturization has on functional capacity, cost, and reliability of products. After considering these factors, it isn’t a surprise that the medical device industry has been evaluating nanotechnology to contribute improvements to the design and effectiveness of healthcare products.

Nanotechnology embraces materials and components that are less than 100 nanometers (nm) in dimension. A particle of this diameter is less than 1/7,000 the size of an object that is visible to the naked eye. Making and assembling such small materials requires special equipment and environmental controls that prevent dust from being confused with parts in assemblies. Many of the tools needed for nanoscale fabrication and assembly are already available for manufacturing and quality testing of nano-containing healthcare products. Nanotechnology will benefit patients in areas such as medical devices, diagnostics, surface coatings, and drug delivery systems. Diagnostics is one area where the race is on to improve screening for diseases. In some prototypes already in testing, a single drop of blood flowing through miniature channels in credit card sized devices pass over nano-dots of detector chemicals. The nano-dot arrays are able to screen for more than 1,000 different substances at a time. The results, interpreted by a computer reader, may identify abnormalities long before clinical symptoms are present in the patient.

Nanotechnology in healthcare is not futuristic. Devices that use nanotechnology for infection control are already proceeding through the necessary clearances prior to marketing. More than two million patients acquire infections every year in U.S. hospitals and treatment can cost as much as $47,000 per patient. Many of these infections can be traced to the formation of biofilms&#151life threatening colonies of bacteria that are extremely difficult to kill once they form on implanted and indwelling medical devices. Catheters, central lines, monitoring leads, and stabilizing pins all penetrate the skin and thereby provide a tract for biofilms that can lead to deep seated infections. Silver is a material that manufacturers have increasingly turned to for effectively preventing biofilms on medical devices. The metal, one of the oldest antimicrobials, is a broad spectrum agent that has the unique ability to kill a wide range of organisms, including those resistant to antibiotics.

There are at least five companies in the U.S. that currently provide technology for the application of silver nanoparticles to medical devices. The methods include the use of a traditional sputter coating and ion plasma deposition for surface treatment, and the blending of nanoparticles of silver compounds into the materials during manufacturing. The newest process applies a uniform amount of silver nanoparticles over the surface of the device by an aqueous dip process, designed to render all surfaces, such as the lumen as well as the outer surface of devices (including catheters), resistant to biofilm formation. In the next 12 months, there will be a variety of medical devices that use antimicrobial silver in nano-scale dimensions to combat device related infections. In the next five years, numerous devices and drug delivery platforms will utilize one or more nano-dimensional components and treatments as an integral part of their design to increase efficiency in production, reliability in performance, and decrease in overall cost.

ONLINE

For additional information on the technologies and products discussed in this article, see the following websites:

• www.4spe.org
• www.acrymed.com
• www.dugganinc.com
• www.parexel.com
• www.valtronic.com