Originally Published MDDI January 2005

NEWSTRENDS

Sherrie Conroy

Devices of the future must incorporate information technology, nanotechnology, and biosciences, according to an industry expert. "Biologics and nanotechnology are important to the future of devices," said Bill Van Antwerp, chief scientific officer for Medtronic MiniMed (Northridge, CA), at a recent nanotechnology conference.

Device companies must change in the next 10 years if they want to survive, he warned. They need new skills in molecular and cell biology, and they need to move from device-based thinking toward new areas of expertise. Most of the difficult issues in the next generation of devices will be in the interface, which means the interface disciplines are more important than ever.

Van Antwerp noted that molecular medicine is now driving the way patients are treated. Device companies, however, spend most of their time focused on mechanical and electrical systems because this is their expertise, he said. To get the optimal benefit of the convergence, he said, device companies must incorporate more biology.

Diabetes management, for example, presents one such opportunity for device companies. "Diabetes is a data-driven disease with management of the data on a day-to-day basis. Despite advances, the challenge is how to take the data and put it into daily living."

As industry trends move toward smaller, lower-power, sensor-driven devices, he said new sciences such as protein-based therapies present new targets and new opportunities. "These therapies will need delivery systems," he said. "Pills are not the only way for these therapies to be successful. Today, much of the electrical stimulation is based on old pulse-generation systems using new electrodes. Biologicals offer significant potential for improved outcomes with built-in intelligence." For example, he said that since diabetes uses beta cells, nanotechnology applications could define the biological device interface for diabetes management.

Gene therapy is another opportunity for device manufacturers. "Most gene therapy is done with retroviruses," he said. "There is an opportunity to use synthetic systems. Nanotech constructs can be used to get into tissues at the local site (for example, into the brain)." One possibility for device manufacturers, he said, is to find a way to get vectors in. Systems could be developed that use macro delivery devices such as pumps, which could be done with both viral and nonviral vectors (such as ultrasound, synthetic polymers, and virus-like synthetic vectors). "A totally synthetic system is better than a natural virus and much more likely to be better received by FDA," he said.

He noted, however, that a critical decision for device companies is how to move into these new areas. They may choose to buy other companies or develop in-house expertise. Options for device companies include single partnerships (such as Medtronic's partnership with Genzyme) or in-house integral programs, he said. Multiple partners for targeting the molecules of different disease states may also present opportunities. "It may take a smaller biotech partnering with a larger device company to get some of these new combination products to clinical trials."

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