Originally Published EMDM September 2005
A NOTE FROM THE EDITOR
Salutary Disruptions
Not being an engineer, when I first came across the term "disruptive technology," I thought it might be a cyberpunk manifesto. Or maybe the conceit behind an installation at la biennale di Venezia. Now, of course, I know better. And I was reminded recently of its importance to those of us leading reality-based lives.
A disruptive technology is an innovation that eventually displaces an existing dominant technology. The inexorable rise of digital photography is a classic example, much to the chagrin of Kodak. The role of disruptive technology in healthcare was one of the themes addressed by David Jefferys in Berlin at a conference organized by the Regulatory Affairs Professionals Society.
A trained physician, Jefferys has been chief executive of the UK Medical Devices Agency and head of the devices sector of the UK Medicines and Healthcare Products Regulatory Agency. He is currently senior advisor on global regulatory affairs and global product development at Eisai Pharmaceuticals (Teaneck, NJ, USA). Given his audience, Jefferys tailored his remarks to the concerns of regulatory affairs professionals. But the issues he raised have a much broader scope.
"A profound change is taking place within the medical technology and healthcare environments," Jefferys told attendees. "The science base is changing, as is the technology." He cited microelectronics, biomaterials, and software as three sectors that are moving medical technology forward at warp speed. In addition, the phenomenon of convergence is challenging the idées reçues of conventional healthcare models.
"We are seeing several technologies come together in a new generation of medical devices and equipment," said Jefferys. The traditional distinction between pharmaceutical products and medical devices is blurring, he noted. "Somewhere in the middle of all that, a new sector of life sciences is emerging."
Convergence is most visible in drug-device combination products. This is a burgeoning market, a fact that has not gone unnoticed among pharmaceutical companies. About 30% of R&D spending in the drug industry is currently devoted to combination products, according to Jefferys.
But drugs and devices also will be directly competing for market share in ways that are unprecedented, stressed Jefferys. Parkinson’s disease, for example, may be treated by an implantable microstimulation device, a drug, or stem cell therapy, he suggested. The same holds true for the management of diabetes. The cardiovascular sector is, perhaps, the most striking example of how profoundly the healthcare environment is changing.
"We now have coated stents and angioplasty. Valve replacement is being done percutaneously," said Jefferys. "In the next five years, 90% of valve replacements will be done this way. This could profoundly change the delivery of cardiothoracic medicine," Jefferys announced. Neurosurgery is also headed in that direction. "Many procedures can be done through spinal navigation systems, so you won’t have to open the brain."
Developing a technology is only the beginning, however. As Jefferys pointed out, national health services must have the right people with the right skills to allow new procedures to gain traction. Without that component in the healthcare supply chain, the device industry won’t be able to sell its products because the users and purchasers of medical technology will want to stick with what they know. We must institute a mechanism of education and training, said Jefferys, to combat this mind-set. In a nutshell, "we need to be forward-looking."
That can be a challenge for regulatory affairs professionals, he noted. "We are reactive by nature, because our job is to ensure that processes are in compliance. You keep hearing how successful the new-approach directives have been," said Jefferys, acknowledging that they have worked admirably. But he cautions against complacency. "Dare I say it: in the devices sector we have fallen back a bit," said Jefferys. "We are in a different world today. To be brutally honest, we are not having the influence we should."
To regain that influence, regulatory affairs professionals and industry at large must face reality and establish a constructive dialogue with healthcare providers and health authorities, said Jefferys. "Disruptive technologies will profoundly change the healthcare delivery [model]. Have we had that debate?"
Perhaps not. And if you think there is no urgency, I have a state-of-the-art 35-mm camera collecting dust in my closet that I would like to sell you.
Copyright ©2005 European Medical Device Manufacturer
