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Biomedical Engineering Fuels Innovation in Combination Product Development

Tue, 03/11/2008 - 9:38am
The market for combination products is rapidly increasing in size and reaching across more medical sectors with each new advancement. Drawing inspiration from a variety of sources, including biomedical engineering, these devices are offering solutions to a host of medical challenges previously unresolved. This article reviews several markets in which these innovations are making an impact.

By Christine M. Ford

Christine M. Ford is event director of PharmaMedDevice. Since joining Reed Exhibitions in 1991, she has been involved in a variety of conference and event management positions within a range of event portfolios including technology, life sciences, and manufacturing. Ford can be reached at 203-840-5391 or cford@reedexpo.com.

While biomedical engineering is often difficult to define due to its broad nature, experts like Michael Drues, Ph.D., president of Vascular Sciences, often see it as a revolutionary science aimed at understanding how the body is designed to work and getting it to do what we want it to do, when we want to do it. Still, other experts would more quickly describe it as the convergence of various engineering disciplines within different aspects of life sciences.However it is foremost described, biomedical engineering is one area of science that is rapidly changing the medical, biotechnology and pharmaceutical landscape. Many innovations currently being developed using biomedical engineering are taking shape as combination products, which integrate a drug, a biologic, and/or a medical device into a single product.

While the field of biomedical engineering encompasses much more than combination products, many of today’s most promising areas of development combine biologic, pharmaceutical, and/or medical device components. Among the most notable biomedically engineered combination products are neuro-modulating devices, tissue-engineering technologies, and nanomedicines.

Because biomedical engineering encourages collaboration between various scientific disciplines, it is playing an increasingly important role in the development of new innovations as the medical, pharmaceutical, and biotechnology industries continue to converge. In fact, as a multidisciplinary science combining skill sets of several previously distinct areas, biomedical engineering can be seen as driving this convergence in many ways.

Biomedically engineered combination products can be both evolutionary and revolutionary in nature. For example, they can take the form of today’s second-generation drug-eluting stents as well as tomorrow’s “Star Trek-like” concepts that promise to deliver drugs to highly localized areas within the body using nano-motorized robots.

Combination Product Drivers

The combination product market is growing at a compound annual rate of 10%, and is expected to reach $9.5 billion by 2009.1 This growth is driven by a number of factors, including an aging population’s desire for superior or novel products, expiration of patents for blockbuster drugs valued at billions of dollars, and the fact that the medical device industry has proven to be extremely stable and growing. These drivers, coupled with the impact of generic competition on annual sales and the decline in novel drugs reaching the market, are further creating a demand for combination products.

Stimulating the Brain

Neuromedicine is one area where drug/device treatment options truly make sense. Neuromodulating devices are an excellent example of the biomedically engineered combination products now available to treat neurological disorders. Despite the fact that most neurological disorders are treated with pharmaceuticals, the brain is an electrical organ, and should be treated with an electrical approach.Like the benefits of combination products in general, neuromodulation has been effective in its ability to apply targeted stimulation to yield a clinical benefit, rather than taking a drug systemically.

In 2007, the neuromodulation market was estimated to be worth $1.8 billion market.2 This market includes spinal cord stimulators, cochlear implants, deep-brain stimulators, drug pumps, and vagus nerve stimulators, and has helped more than 300,000 people regain some level of normalcy in their lives.

Neuromodulation is not only one of the fastest-growing emerging technologies, but it is also one of the most promising. The market for neuromodulation devices is estimated to grow 20% per year and will likely maintain that growth for well over a decade.

In particular, deep brain stimulation (DBS), a common neuromodulation technology available from large device companies such as Medtronic and St. Jude Medical, will be a hot market in years to come. In fact, neurostimulation, which relies on devices that are similar in design to pacemakers and implantable cardiovascular defibrillators, will keep growing and gain wider use for a variety of applications.

DBS is already FDA-approved for treatment of tremors caused by Parkinson’s disease, is nearing approval for treatment of obsessive-compulsive disorder, and is in clinical trials as a therapy for depression. Some studies have shown DBS may also help control symptoms of Alzheimer's disease, paralytic muscle rigidity, epilepsy, Tourette syndrome, some addictions and various other conditions.

In addition, Cyberonics’s VNS (Vagus Nerve Stimulation) Therapy for pharmacoresistant epilepsy just marked its 10th anniversary of FDA approval. More than 45,000 patients worldwide have been implanted with VNS Therapy for both epilepsy and treatment-resistant depression combined. One of the biggest drivers in the adoption of neurotechnology therapies is the growing body of data and the adoption rate among physicians. There is a greater understanding of the types of patients for whom nonpharmacological options are appropriate.

Shrinking Technology Down

Nanotechnology is one of the fastest growing applications of biomedical engineering in the combination product realm. However, its name is not always an accurate descriptor because size is too limiting of a definition for this cluster of technologies. In other words, not all nanotechnologies fit neatly into the “nanometer” scale. Nanotechnology expert Raj Bawa, Ph.D., president at Bawa Biotechnology Consulting and adjunct associate professor at Rensselaer Polytechnic Institute, provides a more encompassing definition. He defines nanotechnology as the design, characterization, production, and application of structures, devices, and systems by controlled manipulation of size and shape at the nanometer scale (atomic, molecular, and macromoleculer scale) that produces structures, devices, and systems with at least one novel/superior characteristic or property.Nanomedicine, the medical application of nanotechnology, can make ordinary objects and drugs do extraordinary things. The applications of nanomedicine range from biomedical imaging to drug delivery and therapeutics. For example, an ordinary piece of silver exhibits amazing antibacterial properties when micronized or nanonized. This is due to the large surface area of micronized or nanonized silver in comparison to its overall mass.

One example of nanomedicine is the use of quantum dots (nanonized semiconductors) to destroy diseased cells in the human body. A classic approach involves coating these quantum dots with antibodies that specifically target and bind to antigens in or on diseased cells. An infrared light is then used to destroy the diseased cells and the quantum dots themselves, which, being of metallic composition would be harmful if they were to remain in the body. While still in development for nanomedicine applications, quantum dots have already proven effective in forensic investigations.

As an indication of the numerous nanomedicine applications, Freedonia Group predicts U.S. demand for nanotechnology-related medical products will increase by over 17% per year to $53 billion in 2011 and $110 billion in 2016. According to Bawa, the greatest short-term impact of nanomedicine is expected to be in therapies and diagnostics for cancer and central nervous system disorders.

Despite the tremendous promise of nanomedicine, there are some important safety implications developers must consider. For example, benign materials can become toxic when nanosized because microscopic particles tend to react more readily with human tissues and other substances. In addition, nanoparticles can enter the body and its vital organs much more easily than can larger particles.

To make matters more complicated, traditional safety-assessment methods are not adequate for nanomaterials, which might pose very different risks from those of the same materials at conventional size. Of the more than $1 billion the U.S. government spent last year on nanotech research, estimates indicate that only 1% to 4% went to risk assessment.3

Turning Silver into Medicinal Gold

As noted previously, silver has tremendous antimicrobial properties. However, its instability and low solubility have limited its usefulness. Nucryst Pharmaceuticals has overcome these challenges with its nanocrystalline silver, which is effective in killing vanocomycin- and methicillin-resistant pathogens common in hospital environments. The nanocrystalline form of silver enables antimicrobial action to take place in as little as 30 minutes, a considerable advantage over the performance of larger silver particles.Nucryst’s product, Acticoat, is a burn dressing impregnated with nanocrystalline silver. Because nanocrystalline silver stays active for at least a week, burn victims do not have to endure daily dressing changes. There are numerous other products on the market that incorporate nanocrystalline silver in one form or another. However, concerns regarding the environment, health, and safety of these products are now at the forefront.

A Quantum Leap Forward

Regenerative medicine or tissue engineering is another area of biomedical engineering that answers countless medical application needs. Regenerative medicine helps natural healing processes work faster, or uses special materials to re-grow missing or damaged tissue. For example, regenerative medicine is used to restore function and improve quality of life for patients with multiple sclerosis, cardiac damage, burns, Parkinson’s disease, and any condition where tissue needs to be regenerated. Typically, cells producing human growth hormone are grown on scaffolds and then surgically implanted in the body. Stem cells also play a critical role in many of the regenerative medicines under development.Because regenerative medicine biologically repairs tissue rather than simply preventing further damage, it truly represents a quantum leap forward in medicine.

Conclusion

While the biotechnology and medical industries are advancing rapidly, there is tremendous opportunity for greater innovation, especially when it comes to combination products. For example, while drug-eluting stents are implanted with great frequency, there are a great many more unrealized uses for these life-saving devices than keeping heart arteries open, such as using a stent to treat cancer by placing it upstream of a malignant tumor as a drug delivery device.The problem is that in many cases scientists and engineers pursue product redesign rather than true innovation. This is often because they are stymied by fear of product failure and difficulty in obtaining FDA approval. However, the convergence of the pharmaceutical, medical, and biotechnology industries is helping to overcome some of these bottlenecks. Product developers are pursuing true innovation to gain entry into new markets and extend patents by combining successful pharmaceutical drugs with biological or medical device components.

References

1 Richter, S., The Challenges of Testing Combination Products. Laboratory Equipment, March 2007; p. 16-19.

2 Conroy, S., Neurotechnology Offers Relief and Recovery. Medical Device & Diagnostic Industry, July 2007; p. 58-66.

3 Nanotechnology: Untold promise, Unknown Risk. Consumer Reports, July 2007.

Online

For additional information on the technologies and products discussed in this article, see MDT online at www.mdtmag.com and the following websites:

www.pharmameddevice.com

www.vascularsci.com

www.medtronic.com

www.sjm.com

www.cyberonics.com

www.nucryst.com

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