Nerac Medical Device Analysts Examine Trends and Technologies

With innovations in nanotechnology, advances in cellular and genetic research, and developments in surgical tools to meet the demand of new procedures, 2008 is shaping up as an exciting year. There are even new applications for medical devices being built into exercise equipment. Nerac Medical Device Analysts surveyed the industry and this is what caught their attention.

Neurotechnology: Expect double-digit growth to accelerate

With more than one-third of the U.S. population suffering from neurodegenerative disorders such as Parkinson’s, anxiety, or Alzheimer’s disease, these disorders are expected to soon overtake cancer as the No. 2 killer of Americans, behind only heart disease.

Drug therapy and other pharmaceutical-based treatments do not seem to provide successful stand-alone solutions for many neurological disorders. Neurostimulation devices, on the other hand, are becoming increasingly more reliable as standard treatment options for many chronic neurological disorders. These devices can be used to change or override the body’s natural neural response to achieve different therapeutic benefits, including pain management, seizure control, or muscle contraction.

Currently, over 450 private and public companies are developing technologies or researching treatments for central nervous system disorders. Some companies are focusing particularly on developing devices and technologies that address brain-related injuries and illnesses, the largest unmet medical market segment in neurotechnology.

With advances in technologies and an aging population as a favorable demographic factor, the neurotechnology market is expected to grow further within the next few years. Overall, neurotech industry revenues rose close to 10 percent in 2006, and with more than 2 billion people affected by brain-related disorders across the world, the current global market of $120 billion is forecast to generate even more revenue next year.

-Marco Bafan

Minimally Invasive Surgery: Creating demand for new devices

New surgical procedures involving techniques that require minute incisions offer patients less trauma to the body, shorter hospital stays and fewer complications. These minimally invasive surgical procedures also require a variety of new surgical tools, which means developing instruments designed for this type of surgery presents a critical opportunity for medical device companies.

As the number of minimally invasive surgeries (MIS) increases, the need for more specialized medical devices also increases. According to an article in Today’s Surgicenter titled, “Minimally Invasive Surgery: Continued Growth Opens New Doors,” the annual growth rate of this market is estimated at 7.5 percent between 2006 and 2011, based on a global MIS device and instrument market value of about $13 billion in 2006. The US market alone is estimated to reach $11 billion by 2011.

Currently, novel devices for improved access and more sophisticated tools for cutting, ablating, or capturing diseased tissue are undergoing patent review, in development, or in manufacture. And because MIS requires refined surgical site visualization, surgeons are particularly interested in high-definition monitors, improved light sources, and specialized miniature cameras.

In the near future, expect to see even more introductions of improved surgical instruments and auxiliary devices such as irrigation and drainage devices for minimally invasive surgery.

—Helga Weires

Artificial Skin: Cellular and genetic research sets stage for growth

Cellular and genetic research is setting the stage for explosive growth in all tissue engineering applications, especially artificial skin and skin substitutes. According to a 2007 MarketResearch.com report, the potential for all tissue engineering and organ regeneration applications will exceed $85 billion by 2016, in the United States alone. The current market is estimated at $4 billion to $6 billion worldwide.

These bioengineered products are being developed from several types of tissue matrices derived from epithelial, epidermal or even acellular sources. Initially developed as graft replacements (autograft, allograft, and xenograft) in burn applications, they are now being used effectively in advanced wound management solutions for the treatment of chronic venous and diabetic ulcers. Artificial skin has also been developed as testing models for drugs and cosmetics, replacing live animal models.

Already, several tissue-engineered products have been approved for market, including several skin replacement and cartilage substitute products. Organogenesis, Inc. of Massachusetts pioneered the field of tissue engineering and has been the world’s most successful regenerative medicine company. Its Apligraf product, the first mass-produced tissue-engineered product to gain FDA approval and maintain profitability, is successfully treating patients with diabetic foot ulcers and venous leg ulcers. Organogenesis is expanding its position as the premier regenerative medicine company by establishing a European headquarters in Switzerland and undertaking aggressive commercialization strategies throughout Europe and Asia.

Another pioneering company, Advanced Tissue Science, Inc. of La Jolla, CA, which recently was acquired by Smith & Nephew, was the first to get a tissue-engineered skin product to the market. Genzyme, Cryolife, Regeneration Technologies, Tutogen, Integra, and TEI Biosciences have also successfully brought tissue-engineered products to the market. Other significant players include BioTissue Technologies, Co.Don, Ortec International , Anika Therapeutics, Chondros, Inc., Fibrogen, Inc., Isto Technologies, Tepha, and Aastrom Biosciences.

All this activity would seem to support Medtech Insight’s estimate that this segment of tissue engineering will grow to $481 million in 2014 from $195 million in 2004. The coming year will likely see more activity. Integra Life Sciences has 15 FDA pre-market approvals for dermal replacements. And keep an eye on start-ups such as Advanced Biohealing Inc., which recently received $25.5 million in financing and successfully launched its Dermagraft product this year, while also beginning clinical trials on another product known as Celaderm.

―Ron Sills

Dental Devices: Nanotechnology is finding new applications

Nanotechnology is making its way into the dental profession, promoting osseointegration of implants or prostheses and to provide unique drug-delivery systems. And applying nanotechnology to dentistry is just one dental device trend expected to gain momentum in 2008 and beyond.

Robotics are being developed to assist navigation during surgical procedures and implant placement. And immediate-loading implants are currently at the forefront of dental implant innovation devices. Lasers, which have been used extensively for tooth whitening and restorative procedures, are now branching out to include endodontic applications. These are just a few of the most innovative technologies that are transforming the dental device industry.

One technology that should develop significantly in 2008 deploys various imaging technologies, such as CAD/CAM for computerized solutions, three-dimensional imaging/scanning, and cone beam CT scanning to help design customized solutions for prosthetics and implants. Taking three-dimensional images of the patient’s mouth greatly increases the ease of creating dentures, bridges, implants, prosthetics, and orthodontic devices and provides a more precise method of creating a device that fits comfortably.

Meanwhile, cone beam CT also has attracted considerable attention as a new diagnostic imaging technique. The assessment of fractured endodontic instruments and the planning of endodontic surgery present challenges that conventional radiography cannot meet successfully.

—Donna Mitchell-Magaldi

Exercise equipment: Going high tech by incorporating sophisticated devices

Treadmills with heart rate monitors, exercise bikes that store our power output, steppers that connect to our favorite video games and record total steps. Just about everyone into fitness these days has some kind of electronic device to improve workouts. At first glance, these may appear to be unnecessary gadgets, but with the busy lives people now lead, having a way to monitor the amount of exercise you get each day benefits doctors and patients alike.

The humble pedometer now counts up to 1 million steps, interfaces with your computer, has a clock, and incorporates a nine-day memory to record daily and weekly totals. You no longer need to clip it to your belt. It works just as well in your pocket or bag. It even resets automatically at night and records distance and calories burned.

Equipment manufacturers have recently introduced sophisticated activity monitors, worn as water-resistant wrist watches that include capacitive accelerometers that convert whole body electrical pulse data into energy consumption based on workload intensity and active steps. It also features an altimeter, barometer, full function watch, cumulative calories, and consumption rate per hour for the whole body. In other words, this watch is smart and “knows” if you’re going uphill or if you’re walking or running. Heart rate monitors are now wrist computers, too, and include all of the above, along with important accessories like GPS sensors and wattage sensors for the crank of your bicycle. And you can download all the data wirelessly to a computer for long-term storage and analysis.

Exercise equipment is an important new trend in medical devices. According to the World Health Organization, less than a third of us are achieving enough physical activity each day. So having a means to monitor activity is the first step in knowing where we can make daily changes to improve our health.

In ’08, we should begin to see exercise monitors and equipment increasingly being used by non-athletes at their doctors’ request. With these devices, doctors and therapists will be able to see what the patient is achieving and prescribe an appropriate level of activity. This opens a whole new market for these devices. They can be owned by physicians and therapists and rented out to patients for short-term use, making it even easier for them to monitor the amount of exertion patients put out on a weekly or monthly basis.

—Deborah Schenberger, Ph.D.