Technology Expands Medical Manufacturing

November 1, 2003
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Converging forces are transforming the industry.

Medical device engineers should consider getting their eyes checked. That's because the traditional line between devices and pharmaceuticals is blurring. New technology is converging with conventional designs to create hybrid products that were unforeseen just a few years ago.

The medical device industry will undergo a major transition during the next decade that will present challenges and opportunities for manufacturers. Devices will become less mechanical and more biological. Early signs of this fundamental shift are visible today with device-drug hybrids, such as drug-eluting stents. These new products dramatically enhance the performance of existing device technologies.

Some experts believe drug-eluting stents are just the tip of the iceberg. They predict that the fusion of drugs and devices will continue to grow.

"New products will serve a need for delivery of drugs, as opposed to drugs enhancing the performance of devices," predicts Patrick Driscoll, president of MedMarket Diligence (Foothill Ranch, CA). "There will be increased competition from the pharmaceutical and biotech industry, which will be producing more and more products that are directly competitive with medical devices

"Ultimately, many medical devices will be at great risk of obsolescence from biotech products," warns Driscoll. "The savvy manufacturer must look beyond established paradigms of what constitutes a medical device, and consider any and all innovations that improve its performance."

Devices will continue to be assembled with more complex materials, such as polymers and unique metal alloys. "Medical devices are increasingly being imbued with characteristics that make them biocompatible, and even bioresorbable, which increases their manufacturing cost," says Driscoll.

Biocompatible materials are synthetic or natural materials, other than drugs, that are used to replace or repair any body tissue or bodily function. Bioresorbable materials are used for bone replacement and implants.

Medical device manufacturers also are under pressure to change the way they design and assemble products to address sweeping changes in the marketplace, such as minimally invasive surgery and home health care. In addition, provider consolidation, health care reform and cost reduction pressures will reshape tomorrow's medical device landscape.

Cost constraints will continue to contribute to hospital cutbacks in medical device purchases. However, this trend should spur demand for preventative health care products and procedures.

With hospitals demanding faster and more reliable products, manufacturers need to develop devices that enhance workflow, productivity and cost savings. For instance, engineers must create products that are less dependent on operator skill and are easy to use for nurses with varying experience and skill levels.

"The user interface is critical," says Curt Anderson, president of Compass Product Design Inc. (Pleasanton, CA). "Designers are faced with the challenge of eliminating buttons and making products easier to use. Screens are getting bigger and the number of buttons and controls is shrinking." Touchscreens are very popular. Anderson claims there is a big demand for products that allow doctors to "diagram plays on-screen, like you see on Monday Night Football."



Aging Population

It's impossible to predict exactly what will happen in the future, but one thing is certain: More and more people are living to a ripe old age. "The aging baby boomer population will be increasing its health care needs," says Driscoll.

Indeed, by the year 2010, Americans will be living longer. For instance, the baby boom generation will begin to turn 65 in 2011. According to a recent study conducted by the Institute for the Future (Menlo Park, CA), the average life expectancy will be 86 years for women and 76 years for men by the end of this decade. One hundred years ago, the average life expectancy was 47 years.

Over the next 20 years, the fastest growing segment of the U.S. population will be those aged 55 and over. This demographic sector will constitute nearly 30 percent of the population in 2023, compared to approximately 21 percent in 2003.

By 2030, one in five people will be 65 or older. That population segment represented 13 percent of the U.S. population in 2000 and only 4 percent in 1900. According to the American Geriatrics Society (New York), the elderly population is projected to double over the next 30 years, growing to 70 million by 2030.

The elderly currently account for 23 percent of ambulatory care visits, 48 percent of hospital stays and 69 percent of home health services. People age 75 and older have an average of three chronic health problems, such as arthritis or heart disease, at any time and use five or more prescription drugs.

Because of this aging trend, the cardiology and orthopedic markets will continue to account for the largest share of the $50 billion U.S. medical device market. For instance, a recent study conducted by Frost & Sullivan Inc. (San Antonio) predicts that the cardiology market will grow at a rate of 14 percent from 2003 to 2005. Demand for orthopedic devices is expected to grow from $4.5 billion in 2003 to $7 billion by 2009.



The Heart of Technology

Cardiovascular disease is the leading cause of death in the United States. And, cardiology departments are the largest spenders within the health care world. Not surprisingly, cardiovascular devices represent a $14.7 billion worldwide market.

"The huge patient population, as well as high death rates, have encouraged medical device companies to concentrate their efforts in providing cures for cardiovascular diseases," says Dhiraj Ajmani, senior medical device industry analyst at Frost & Sullivan. "The market is expected to grow in the next decade as more patients are treated using technologically advanced devices."

Drug-eluting stents are one of today's hottest medical devices. In their first full year of availability, the product will generate sales of nearly $1 billion in the United States, predicts Kalorama Information (New York). The market is expected to reach $5 billion by 2005.

A drug-eluting stent is used for the minimally invasive treatment of coronary artery obstruction. The device is inserted into the artery with a catheter. Once in place, the stent expands to keep the artery open. The device is coated with an antiproliferative drug, which is released gradually into the arterial wall to suppress scar tissue formation within the stent and adjacent areas.

Nearly 1 million angioplasties are performed in the U.S. each year, and at least 80 percent of those procedures involve the use of a stent. Typically, 15 percent of the patients treated with traditional stents need a second procedure within 6 months because the blood vessel gets reclogged with scar tissue. Drug-eluting stents are popular because they reduce the need for repeat procedures to less than 5 percent of cases.

"There is an immense market need for next generation stent-delivered drugs," claims Oded Ben-Joseph, M.D., president of X-Cell Medical Inc. (New York). "Refinements in stent design, anti-restenotic drugs and stent coating technology promise to broaden the population of patients who will qualify for stent procedures, allowing them to be treated more effectively and earlier in the coronary disease process and extending their horizon of disease-free survival."

Earlier this year, Cordis Corp. (Miami Lakes, FL), a division of Johnson & Johnson (New Brunswick, NJ), unveiled Cypher, the world's first drug-eluting stent. Priced at $3,195 per stent, it costs approximately three times more than traditional bare metal stents that have been on the market for nearly a decade.

The stent's treatment process is controlled by a polymer coating that gradually releases the drug sirolimus into the vessel lining to prevent scar tissue growth. Cordis officials claim that patients treated with the Cypher stent have a greater than 95 percent chance of avoiding repeat treatment due to reblockage of the treated artery.

"Reblockage of coronary arteries has remained a stubborn obstacle to successful long-term patient treatment," says Brian Firth, M.D., a Cordis vice president. "Currently, restenosis occurs in [up to one-third] of patients who receive a bare metal stent." For every 100 patients treated with the Cypher stent in clinical trials, Firth claims that there were 19 fewer revascularization procedures and 25 fewer hospital admissions than with the conventional stent.

"Our goal is to treat a blockage one time, and one time only," notes Firth. "As we expand the range of stent lengths and continue to refine the techniques of stent implantation, we expect the cost-effectiveness of this device to improve even further."

The product has proved so popular that Cordis has had trouble meeting demand. And other manufacturers are scrambling to catch up. For instance, Boston Scientific Corp. (Natick, MA) is about to unveil a product called Taxus. Recent clinical trials indicate that the paclitaxel-eluting stent system will be a strong competitor to the market-dominating Cypher stent. Boston Scientific also claims that it can produce stents faster than Johnson & Johnson.

According to Martin Leon, M.D., chairman of the Cardiovascular Research Foundation (New York), "there is tremendous value with this integration of expertise in drug development, advanced carrier vehicles and futuristic stent platforms. There are exciting opportunities to expand stent-based drug delivery into other areas, such as plaque stabilization, angiogenesis and myogenesis therapies, and myocardial preservation after acute infarction."



New Hope for Old Bones

The future also looks bright for manufacturers of orthopedic devices. Recent advances in technology have made joint replacement therapies more effective and beneficial than ever.

"Technology advancement coupled with demographics are the key drivers for the orthopedic implants market," says Ajmani.

Minimally invasive orthopedic surgeries should generate long-term market growth for orthopedic implants. Spinal surgery and orthobiologicals will be the hot segments to watch in the coming years.

"Everybody is waiting for minimally invasive orthopedic surgeries to become a reality," says Ajmani. "A number of companies are developing innovative ways to perform less invasive hip and knee implant procedures."

For example, ReGen Biologics Inc. (Franklin Lakes, NJ) has developed techniques for regenerating tissue and restoring mobility for patients with knee injuries. Its next-generation collagen meniscus implant uses the human body's own healing process to grow new meniscus tissue and restore mobility for patients with meniscus loss.

The product uses a biopolymeric meniscus scaffold. "This resorbable matrix template and related technologies have the potential to be used for the treatment of various injuries and degeneration of other tissue structures, such as the intervertebral disc of the spine and articular cartilages of degenerated joints," claims the company CEO, Gerald Bisbee Jr., Ph.D.

According to Kalorama Information, the orthopedic biomaterials market will grow from $3 billion in 2003 to $6 billion by 2008. Companies such as Advanced Ceramics Research Inc. (ACR, Tuscon, AZ) are fueling that growth. Working in conjunction with the Office of Naval Research (ONR, Arlington, VA), ACR has developed an artificial bone capable of supporting new bone growth and porous enough to be absorbed by the body. Plasti-Bone is made from a biologically compatible plastic with a ceramic coating.

"ACR has taken technologies originally developed for the rapid prototyping of military parts and transitioned them into applications that will have widespread use across the medical community," says Ralph Wachter, ONR science manager.

In current absorbable orthopedic implant materials, the affected bone is in danger of becoming too weak before substantial mass loss of the implant. Patients often find bones too weak to carry any load long before significant amounts of bone have grown to replace the eroded prosthesis.

"An alternative to current implant technology is a two-stage implant material that is both load bearing and osteoconductive," says Wachter. "To achieve this, an interpenetrating network of osteoconductive material and strong, but degradable, biocompatible material is needed. In comparison to conventional prosthesis or scaffold manufacturing routes, rapid prototyping techniques allow implants to be prepared on site, layer by layer, with parts being custom fit to a patient's reconstructive needs."

The artificial bone can be custom-made to match the exact shape of a patient's bone. Computer-aided tomography or magnetic resonance imaging is used to get a picture of the good bone. That image is then converted to a "growth code"-a 3D virtual image-of the replacement bone segment needed. Using that data, rapid prototyping technology then creates a microporous calcium-phosphate-coated polymer bone, which is surgically implanted into the spot where the damaged bone has been removed. The calcium phosphate coating is very thin and allows the bone cells to attach themselves to the implant.

According to Wachter, what is left of the real bone attaches itself to the polymer bone after about 8 weeks. Then, the real bone begins to grow through the porous scaffold. As it does, it eats the scaffold, and the body naturally excretes the calcium phosphate material.



Minimally Invasive Devices

The medical device industry is witnessing a major shift from invasive surgical procedures to minimally invasive approaches. Thanks to new technology, more and more inpatient procedures are being replaced with outpatient procedures.

Frost & Sullivan's Ajmani says minimally invasive or less invasive surgery already forms roughly 50 percent of all the surgeries performed in the United States. That number is expected to increase to 75 percent by 2050.

"The advancement in technology of the instruments and devices used for minimally invasive surgeries is resulting in the development of new surgical techniques," says Ajmani. "The surgeries are becoming more predictable. They reduce hospital stays and lead to fast patient recuperation. Minimally invasive surgery is enticing patients to use a medical device rather than other therapies, such as [drugs]."

According to industry observers, there is endless opportunity for manufacturers to develop minimally invasive devices. "Everything is driven by insurance companies concerned over escalating costs," says Len Czuba, president of Czuba Enterprises Inc. (Lombard, IL). "If something can be done with less-invasive surgery, that will influence the medical device market. For instance, the industry is relying more heavily on diagnostic procedures that provide early detection of diseases."

Glucose monitoring is one of the most competitive categories of minimally invasive devices. Several innovative products have recently been unveiled, and many more are in development.

Pendragon Medical AG (Zurich, Switzerland) has developed a glucose sensor that is worn like a wristwatch. The Pendra continuously monitors blood glucose level without the need for a blood sample. The device enables diabetics to reduce the number of blood samples that they have to take.

According to Stephan Rietiker, M.D., CEO of Pendragon, the sensor is intended to supplement traditional testing methods. Pendra is based on impedance spectroscopy technology. "Glucose changes in blood are accompanied by significant conductivity changes," explains Rietiker. "These changes have a considerable effect on the electric polarization of cell membranes."

Pendra generates an electromagnetic field in megahertz frequency range. The field fluctuates according to the electrical conductivity of the body. A micro antenna in the device detects these changes and correlates them with changes in serum glucose.

Rietiker claims that his firm is the first company to apply impedance spectroscopy to follow glucose concentrations in real time. However, other manufacturers, such as Cygnus Inc. (Redwood City, CA), have developed watch-like monitoring devices that provide glucose readings continuously, automatically and noninvasively.

Other products under development include a "smart tattoo" that would be implanted under the skin and glow in the presence of glucose. Another device would rely on beams of near infrared light that would measure glucose levels in cell fluids just under the skin.

University of Pittsburgh researchers have developed their own noninvasive method to measure the glucose level in bodily fluids. Sanford Asher, a professor of chemistry, and David Finegold, a professor of pediatrics, have created a thin plastic sensor that changes color based on the concentrations of glucose.

"There has been an increasing demand for continuous, noninvasive glucose monitoring due to the increasing number of people diagnosed with diabetes mellitus, and the recognition that the long-term outcome of these patients can be dramatically improved by careful glucose monitoring and control," says Asher.

The sensor material would be worn like a contact lens. Patients will determine their glucose levels by looking into a mirror that is similar to those in makeup compacts, but with a color chart to indicate glucose concentrations. Patients can then easily compare the color of the sensing material with the colors on the chart.

According to Asher, the sensor changes from red, which indicates dangerously low glucose concentrations, to violet, which indicates dangerously high glucose concentrations. When the glucose level is normal, the sensor is green. The researchers are still determining the number of detectable gradations, but expect that it may be as high as the number of gradations provided by conventional finger-stick meters.

The University of Pittsburgh has licensed the patented technology to a startup company, which will engineer the material and commercialize it. Asher believes the technology could be incorporated into currently available commercial contact lenses, which would be replaced weekly.



On the Homefront

While the number of Americans over 65 is growing larger, the number of doctors, nurses and other health care providers is shrinking. The American Association of Colleges of Nursing (Washington, DC) predicts the shortage will intensify over the next two decades. For example, more than 800,000 new and replacement nurses will be needed by 2010.

As hospital staffing levels decline and the patient-to-caregiver ratio grows wider, monitoring has become a big challenge. The goal is to allow hospital staff to spend more time providing quality care to patients and less time taking vital signs.

Hoana Medical Inc. (Honolulu) has developed a device that allows noncontact measurement of vital signs, such as heart rate, respiration and the patient's position in the bed, eliminating the need for direct patient connections. By using the Lifeguard intelligent vigilance device, fewer floor nurses can monitor more patients between their normal bedside visits. The device uses passive sensory array technology to accurately measure basic physiology passively, without the use of traditional electrodes, leads, cuffs or canula.

The easy-to-use device integrates proprietary signal processing algorithms with a family of thin, pad-like data collection devices that produce an electrical signal in response to physiological stimuli. It passively measures critical information as the patient lies or sits upon these collection devices, providing accurate measurements even through clothing, gowns or sheets.

Hoana's product could also be adopted for home use. Home health care is becoming an important part of the medical device industry as insurance providers strive to reduce health care spending and as the American population ages. Examples of some home health care devices include ventilators and nebulizers, infusion pumps, blood glucose meters and apnea monitors.

"With home health care, not only are hospital expenses reduced, but the patient is provided care and comfort of home," says Frost & Sullivan's Ajmani. "Advancement in networking is expected to link a greater number of medical devices to physicians' offices and hospitals."

"As insurance companies continue to refuse to pay for long hospital stays, home health care will grow," adds Czuba. He says this trend will force engineers to make medical devices more user friendly. "There's a tremendous opportunity to make products more acceptable for the home environment," notes Czuba. For instance, the user interface becomes more critical. Home health care consumers also want products that are stylish and fit in to their home surroundings instead of looking cold and institutional.

Telemedicine, another form of home health care, allows patients to take more ownership and responsibility for their own health. Experts claim that it has the potential to significantly improve the quality of health care, in addition to increasing accessibility and efficiency.

Advances in telemedicine are enabling doctors to monitor patients from their desks, rather than by the traditional office visit. For instance, doctors treating heart disease can now log on to a special Web site to monitor the condition of patients fitted with implantable defibrillators. Using a special handheld antenna monitor that is run over the implanted device, patients collect data on their condition and the performance of their device. The monitor automatically downloads the data and sends it through a standard telephone connection directly to a secure network. Clinicians and family members can also access data from any Internet-connected computer.

"Remote patient monitoring, especially telecardiology, is poised to become an integral part of the health care market," says Chris Cherrington, a Frost & Sullivan health care analyst. "Initial acceptance has been stymied by the more conservative elements in the health care profession." Some individuals have expressed fear over litigation arising from misinterpretation or incorrect transmission of patient data.

"However, as information technology becomes increasingly reliable, affordable and more mainstream, this resistance is expected to weaken," Cherrington points out. Also, health insurance companies are expected to promote the use of telemedicine to reduce costs.

Cherrington predicts greater receptivity to remote patient monitoring technologies. For instance, telemedicine is currently popular in Europe. According to Cherrington, 1.5 percent of the 50,000 post-trauma cardiac patients in Europe are currently being remotely monitored. "By 2011, more than 4 million patients are expected to be remotely monitored," he points out.

Royal Philips Electronics (Amsterdam) is offering a service called Paxiva in Germany and Italy. The service links users to a team of qualified and experienced medical staff, under supervision of cardiologists, 24 hours a day, 7 days a week. Subscribers get an easy-to-use, accurate and portable handheld electrocardiogram (EKG) transmitter. This transmitter forwards a snapshot of their heart condition via telephone to a monitoring center.

Based on past data, the patient's health history and data from the current EKG transmission, the staff at the monitoring center can quickly evaluate the user's heart situation and provide advice, reassurance or emergency action.

"The success of this service is expected to motivate more widespread adoption of telecardiology among government and funding bodies," says Cherrington. "Paxiva's likely success is also poised to inspire a flurry of competing product launches."

Philips also recently unveiled a wearable, wireless system that provides remote monitoring. The device continuously monitors body signals, such as heart activity, to detect abnormal conditions. It is based on dry-electrode technology than can be built into common items of clothing, such as belts or undergarments. All the active electronics for the system are incorporated into a slim module that slips into a dedicated pocket of a garment.

"There is a real and unstoppable trend toward the joining of modern communications technology and medicine," claims Cherrington. He says the market needs "to achieve a critical mass of existing patients, to provide proof of the efficacy of telecardiology."

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