With the advent of new technology that augments human abilities, many are theorizing that the Fourth Industrial Revolution is finally here, which also affects medical devices in the healthcare field.
Wikipedia has it that the Fourth Industrial Revolution can be a range of new technologies that are fusing the physical, digital and biological worlds, and impacting all disciplines, economies, and industries. The revolution centers on emerging technology breakthroughs in fields such as artificial intelligence, robotics, the Internet of Things, autonomous vehicles, 3D printing, and nanotechnology.
At an international symposium at the Plaza Hotel, downtown Seoul, Wednesday designed to discuss the relationship between the newest trend and healthcare industry, experts stressed the need for the industry to change itself rapidly.
|Brian Kersten, vice president of Abbott Vascular Inc., speaks during a symposium on “changes in medical device regulatory science with the age of the Fourth Industrial Revolution,” held at Plaza Hotel, downtown Seoul, Wednesday.|
“Innovation devices within the fourth industrial revolution are transformative technology and unmet medical/public health need, significantly improving upon currently available treatments or diagnosing a condition for which no approved alternative treatment exists,” said Brian Kersten, vice president of Abbott Vascular Inc.
The company is a U.S. medical device company which develops, manufactures, and supplies equipment and solutions for the treatment of cardiac and vascular diseases to healthcare professionals worldwide.
Kersten stressed that patients’ need and timely regulatory review emphasize the need for innovative device regulations. Patients who require an alternative innovated treatment option need a way to get this as quickly as possible without compromising safety and efficacy. Innovative devices are novel, challenging and resource-intensive for both sponsor and regulatory agencies as they raise new technical and regulatory challenges, Kersten added.
He then presented his goal of introducing least burdensome approaches to evaluating medical device’s effectiveness while continuing to meet safety requirements.
“The U.S. Food and Drug Administration (FDA) interact with medical device manufacturers early in the development process,” Kersten said. “The FDA’s active engagement to working with stakeholders to reduce clinical trial burden can determine how to utilize expanded data to understand new technologies better and serve patients.”
Obtaining coverage and reimbursement are significant obstacles for innovative medical devices. Coverage with Evidence Development (CED), when integrated with FDA post-approval commitments, can be a cost-effective way to gather data on real-world use, he added.
Later in the day, Maggie Nixon, senior director of Intuitive Surgical Inc., lectured on surgical robotics, one of the many emerging technology breakthroughs the fourth industrial revolution created.
“Surgeons who use the robotic system find that for many procedures it enhances precision, flexibility, and control during the operation and allows them to better see the site, compared with traditional techniques,” Nixon said. “Often, robotics surgery makes minimally invasive surgery possible. There are less pain and blood loss, quicker recovery, and smaller, less noticeable scars which add to the patient value.”
Intuitive Surgical Inc., the maker of the da Vinci Surgical System, is the global technology leader in minimally invasive robotic-assisted surgery.
The da Vinci Surgical System was first introduced in 2000; a surgical system controlled by a surgeon that facilitates minimally invasive surgery with small incisions, wristed instruments and 3D-HD vision. Da Vinci Surgical Systems operate in hospitals worldwide, with an estimated 200,000 surgeries conducted in 2012, most commonly for hysterectomies and prostate removals.
“The current da Vinci Surgical System cannot – in any manner – function on its own, as it was not designed as an autonomous system and lacks decision-making software,” Nixon said. “Instead, it is intended merely to replicate the movement of the surgeon's hands with the tips of micro-instruments seamlessly, not to make decisions or move without the doctor's direct input.”
The simulation can offer the potential to objectively assess new surgeons’ competency and new skills and technique practice for surgeons. Robotic-assisted surgery is an extensional capability for humans, not replacing them, and will not carry out operations without guidance from human surgeons anytime soon, she added.
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