Create Innovation Ramps, Not Roadblocks, To Speed Review of New Devices
San Diego—Value analysis has become a holy grail in health care. But how can health care organizations introduce innovative techniques and technologies safely and cost-effectively?
These goals may sound simple, but as health care evolves and the marketplace for drugs and medical supplies becomes more saturated and complex, achieving them can be a challenge.
At the 2019 OR Business Management Conference, surgeons from the University of Texas MD Anderson Cancer Center, in Houston, shared how they transformed their institution’s value analysis process to foster innovation and improve safety.
“As we [at MD Anderson] became more innovative with procedures, we also wanted to assess safety even more stringently,” said Abigail Caudle, MD, MS, a breast cancer surgeon and the executive medical director of perioperative services at MD Anderson, who presented with Thomas Aloia, MD, FACS, the head of the Institute for Cancer Center Innovation and chief value and quality officer at MD Anderson.
Historically, the value analysis team at MD Anderson focused on financial value when assessing a new purchase request. No specific safety review occurred before surgeons demoed or trialed the new product. But in 2015, Dr. Aloia wanted to enhance the value analysis process, putting safety first.
“The key shift in the process is that we put the safety review in front of the business review,” Dr. Aloia said.
The purpose of this change was to encourage innovation and safety together. “Our division head called this process ‘facilitation of innovation,’” Dr. Aloia said. “That play on words got the idea off the ground by emphasizing how regulating new products could actually make it easier for surgeons to innovate.”
Dr. Aloia devised six key questions that all surgeons had to contemplate when submitting a new product request. These questions covered the rationale for the request, the documented outcomes in the literature or from other institutions, and potential conflicts of interest of the submitting party.
“The questions make sure the submitting surgeon really considers how exactly the new tool will improve patient outcomes or the efficiency of the OR,” Dr. Aloia said.
To improve the review process, Dr. Aloia and the continuous quality improvement team—which includes representatives from surgery, anesthesiology, infection control and nursing—developed an algorithm to delineate the course of action for evaluating and subsequently approving or denying a product request. After reviewing the evidence, the team decides to: 1) deny, if the product is deemed unsafe; 2) approve with institutional review board protection, if the product carries a high risk or has minimal safety data; 3) approve but include quality reporting measures, depending on benefit to patients; and 4) approve for practice. Once a product clears the safety review, the value analysis team crunches the numbers.
Drs. Aloia and Caudle said they initially experienced pushback from surgeons who were concerned this process would hinder innovation. “Physicians and patients come to MD Anderson to get the latest and greatest, perhaps even the thing in front of latest and greatest,” Dr. Aloia said. “Any sense that we’re slowing innovation or impeding it does not go over well, which is why branding this as a facilitation of innovation helped.”
These safety checks, however, have permeated the culture at MD Anderson. “I get emails from nurses asking if a device has had an innovation/safety review and if we can do a simulation of an upcoming case using the new tool,” Dr. Caudle said. “Everyone wants to make sure we introduce technology in a safe way.”
Simulating cases before using a tool for the first time has become an essential element of the process. Simulations involve a full walk-through of a case—which includes pinpointing any information technology issues and confirming the OR room setup and materials needed—to ensure the team knows what to expect and can work out any kinks before the patient arrives. As an additional safety precaution, the previously used device is always immediately available during the first few cases with the new item.
“Identifying and fixing inefficiencies beforehand has allowed the first cases with a new technology to go smoothly,” Dr. Aloia said.
In an analysis of safety outcomes before and after introducing the quality improvement process, MD Anderson went from patient complications in 10% of cases that involved a new device to no complications. Efficiency improved, as well: The new structure decreased the time between a device request and purchase from 124 to 51 days. The type and number of products evaluated during these two periods also were similar, suggesting that the improved outcomes were due to the new vetting process.
“By putting guardrails around the introduction of a new device, our safety outcomes improved and the speed of the approval process got faster,” Dr. Aloia said.
But, Dr. Aloia noted, innovation is not just about using new devices. “Most of the innovation we do is at the procedure level—using different setups, devices, teams, modalities—with items that are already purchased. Creating a safety culture that encourages dialogue, and a ‘stop the line’ if necessary, is key to minimizing the risk of harm that accompanies the introduction of most innovations,” he said.
MD Anderson has not yet analyzed the cost-effectiveness of this review process, but given the reduced complications and time between requesting and purchasing a device, Dr. Caudle believes the streamlined method has likely lowered costs, as well.
The crucial point we realized, Dr. Caudle said, is that “innovation and safety don’t have to be divergent; they can go hand in hand.”
Innovation in Context
Improving innovation and safety may require different strategies for different institutions. Last year, the Institute for Healthcare Improvement (IHI) published a white paper delineating broad innovative practices that health care organizations can tailor to their individual needs.
“The Innovations White Paper was written essentially to help organizations develop insights into how to become innovators themselves, how to learn about the innovations that are taking place around the world in health care delivery, … and how to adapt those innovations to their local contexts,” Kedar Mate, MD, IHI’s chief innovation and education officer and an assistant professor of medicine at Weill Cornell Medical College in Ithaca, N.Y., said in a video summary of the white paper he co-authored.
For some, innovation may mean adopting a “lean management” strategy to lower costs and improve patient care, essentially creating value by eliminating waste (Rambam Maimonides Med J 2013;4:e0007). To this end, IHI developed the Triple Aim framework to guide institutions in their efforts to enhance the patient experience while also reducing the cost of care.
For David Lehr, the chief information officer at Anne Arundel Medical Center (AAMC) in Annapolis, Md., innovation means encouraging people to step outside of their usual mindset. In 2017, Mr. Lehr launched an IT initiative at AAMC called DataBay to help bridge the disconnect between the big picture organizational viewpoint and the more siloed individual or departmental viewpoint. With DataBay, employees can look up official organizational data that they can use to understand current operations, make informed decisions, and ultimately drive evidence-based change.
Innovation in health care is about incorporating “everyone’s input in coming up with the best answers,” Mr. Lehr said.