ALLPCB
Background
Today, implants are an effective treatment for many cardiac conditions, and medical electronics companies are developing and deploying a range of new devices. In the future, much research and development will focus on the brain. A research group has suggested that targeted electronic neural stimulation could produce beneficial effects across a wide range of conditions, from addiction to epilepsy, Parkinson's disease and depression.
Market trends
"I think we are at the vanguard of an era," said Christopher Chavez, director at a neurostimulation company acquired by St. Jude Medical in 2005. The company estimated that the neurostimulation implant business rose from $24 million in 2000 to about $320 million in the most recent year Chavez cited. Across the industry, the current neuroimplant market is roughly $2 billion, and he projected it could grow to about $3.9 billion by 2014 at double-digit rates.
Regulatory approvals and clinical applications
To date the U.S. Food and Drug Administration has approved neurostimulators for eight indications. "We believe penetration in each target application is below 10%, and there are another 10 potential uses awaiting approval," Chavez said. For implant manufacturers, this represents an opportunity to demonstrate reliable clinical outcomes. Many basic science findings have already aided applications such as smoking cessation or cardiac stent procedures, including reductions in the need for heart transplants.
Clinical research and unanswered questions
Approximately one third of global health issues involve the nervous system, and that proportion is expected to increase as lifespans lengthen. Medtronic has developed devices for treating Parkinson's disease and is developing a range of neural implants intended for obsessive-compulsive disorder, depression, epilepsy, migraine, urinary incontinence, certain types of pain and degenerative disorders, according to chief scientist Richard Kuntz.
Earlier in the year, Medtronic reported closed-loop animal trials of a system that can automatically listen to and respond to brain waves. Neurostimulator testing has shown efficacy, although many aspects of basic brain science remain mysterious. For example, video has shown depressed patients who did not respond to electroconvulsive therapy smiling when stimulated by neural implants. "This is a little strange," Kuntz said. "We really don't know how it works, because we are dealing with some of the most complex physiology in the human body."
Alternative approaches and gene-based therapies
Jonathan Sackner-Bernstein, director at an FDA collaborating center, presented alternative ideas at an IEEE bioengineering conference forum on deep brain stimulation. "You still have to perform brain surgery to install an implant, and I am sure many people do not want a scar on their skull," he said, calling for more thorough innovation in gene therapy.
Many researchers believe the future may ultimately favor biological therapies. "We need to think differently, develop gene-controlled cells, programmable pacemakers, and teach neural tissue to beat autonomously," said Joseph Smith, vice president of emerging technologies at Johnson & Johnson Services.
Miniaturization and leadless designs
For companies such as Medtronic, a more immediate engineering challenge is reducing the size of current cardiac implants, typically around 10 cc, and eliminating leads that cause most failures. "We believe it is possible to shrink these devices to 1 cc and make them leadless, which would allow the device itself to be placed inside the heart," said Rebecca Bergman, vice president of new therapies at Medtronic. The plan is to test prototypes in animals and address these issues in the near term.
Closed-loop drug delivery and implantable therapeutics
Others foresee further directions for implants. Mir Imran, who developed the first implantable cardiac defibrillator, said the next major revolution will be implantable closed-loop drug delivery systems. "There are therapeutic proteins and peptides, but they must be delivered directly to the brain because the gut destroys them," he noted.
When drugs are delivered systemically, side effects can be significant. Closed-loop systems that sense a drug need and deliver the correct dose could be critical for breakthrough devices such as an artificial pancreas for diabetes. Imran said he is investigating up to five different implant concepts, has acquired the implant manufacturer Modulus, and is encouraging it to act as an OEM for devices he expects will be designed by organizations that were once small companies and startups.
Manufacturing and industry structure
Today most implants are produced by large vertically integrated companies, such as Medtronic and St. Jude Medical, which control most of the design. "If you want to develop an implant now, you have to contact dozens of manufacturers to integrate all the components," Imran said. "In the end you spend three times the time and ten times the money to get the result you want."
