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"We Can Rebuild Him. We Have the Technology…"

Originally Published MPMN January 2003

EDITOR'S PAGE

"We Can Rebuild Him.  We Have the Technology..."

Thirty years ago, the words in this headline sounded far-fetched when they were said in a voice-over during the opening credits of the television show, The Six Million Dollar Man. Back in the 1970s, Steve Austin amazed the TV-watching world with his fictional bionic replacement body parts. 

Fast-forward a mere three decades and bionics is a reality. A plethora of implantable devices that will make patients "better, stronger, and faster" are under development. But because they will be placed inside the human body, a major task for manufacturers is to make them compatible with their biological environments.

Scientists at the Space Vacuum Epitaxy Center at the University of Houston took on that challenge by developing artificial eyes composed of tiny ceramic photocells. The cells can detect incoming light and enable some previously blind patients to see. According to the researchers, ceramic microdetectors are not susceptible to biocompatibility problems encountered by earlier silicon versions, such as chip deterioration, eye contamination, and atrophy of the retina. The first human trials for these eyes are set to begin later this year.

Abiocor, an advanced medical system designed to fully sustain the body's circulatory system, was implanted for the first time in a human patient in July 2001. The initial clinical trial for the replacement heart is continuing with the aim of gaining approval to market the AbioCor to support patients with irreversible end-stage heart failure.

Other bionic devices on the horizon include implantable monitors that will track pressure in the brains of spina bifida patients who require fluid-draining shunts. A neurostimulation implant could tell paraplegics who have lost sensitivity in their bladders when to urinate. 

Devices that measure blood pressure inside the heart itself will also soon begin clinical trials. Data Sciences has developed a product that will include a home base station that reads a radio signal sent from the monitor. The data are then transmitted to the patient's doctor. Medtronic has created a similar device called Chronicle, which is already in clinical trials. 

Whether these innovations are successful will be determined largely by how compatible the devices are with their environment. And making sure that happens will be well worth the effort for manufacturers. 

According to a study by Clinica Reports on new developments in biomaterials, the medical device industry is entering an era in which these products are already playing a prominent role. "Decades of R&D and millions of dollars of capital investment are being rewarded by the advent of innovative biomaterial-containing devices..." states the report. The study, conducted in 2000, goes on to say that these devices have created a high growth market, valued in excess of $40 billion within the estimated total medical device industry. 

Orthopedics is one of the largest sectors for the use of biomaterials, both in terms of market value and product breadth. According to Millennium Research Group, the market was valued at more than $930 million in 2001, and the firm expects the market to grow by more than 25% annually over the next five years. The use of biomaterials in cardiac, reconstructive, and wound-care applications, and as polymer matrices for tissue engineering, will also almost certainly expand in the coming years.

To inform manufacturers about the latest methods and techniques in biomaterials, the upcoming MD&M West trade show will host two days of conference sessions on this topic alone. On Wednesday, February 19, morning and afternoon sessions will address issues related to designing better cardiovascular implants, including the development of drug-eluting stents, and tissue engineering.

Orthopedic topics that will be covered on Thursday, February 20, include papers on surface analysis, shape-memory thermoplastics, and the use of cross-linked polyethylenes in the production of wear-resistant hip prostheses. 

Manufacturers will also have the opportunity to meet with suppliers of biomaterials-related products and services among thousands of other exhibitors at the MD&M West exposition to be held February 19-21. More information about the show can be found starting on page 49.
With the number of biocompatible devices on the rise, another quote from The Six Million Dollar Man just might come true someday soon: "We have the capability to make the world's first bionic man."

Susan Wallace

Copyright ©2003 Medical Product Manufacturing News

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