In a field like interventional radiology, innovative new devices and procedures are created with regularity. Authors Steinberger et al. describe interventional radiology as “a specialty founded by tinkerers, with a history of disruptive innovation that has yielded countless new ways of delivering care … free of dogmatic convention.”1 The profession prides itself on this culture of innovation, which SIR describes as “life-changing medicine, breakthrough technology and limitless potential.” Procedures that once seemed radical, such as chemoembolization and radioembolization, are now widely accepted and have brought improved health outcomes and quality of life to scores of patients.
But with so many new approaches being developed every year, how do interventional radiologists best assess these innovations for adoption? As Everett M. Rogers wrote in the fourth edition of his seminal work, Diffusion of Innovations, “An innovation presents an individual or an organization with a new alternative or alternatives, with new means of solving problems. But the probabilities of the new alternatives being superior to previous practice are not exactly known by the individual problem solvers.”2
In an environment of constant invention, there will be innovations that come and go, and there will be those that successfully find widespread adoption. There are certainly some interventional radiology procedures that have been shown, over time, to be less effective than had originally been hoped. This phenomenon applies to any innovative, rapidly evolving medical specialty—of which interventional radiology might be the best example.
IRs, then, must perform a balancing act when considering which devices and treatments to adopt, guided by information, experience and the needs of the patient.
Inspiration for innovation
The inventiveness of IRs has been measured and documented, in a seminal work published in the Journal of Vascular and Interventional Radiology (JVIR) in 20133. Kieran J. Murphy, MD, FSIR, and colleagues revealed that 457 members of SIR (9 percent of members in 2013) held 2,492 patents or patent filings—an average of more than five per individual.
“Often, ideas come from individual patient example, when an IR comes up with something novel,” says Timothy P. Murphy, MD, FSIR, managing partner at Summa Therapeutics. “Innovation comes organically from the ground up. It can come from anybody.”
Indeed, studies have shown that 80 percent of scientific instrument innovations originated with physician users and that 57 percent of pharmaceuticals’ new uses originated through clinical practice.4
When is it appropriate to try something new? IRs can follow a decision-making process that considers the severity of the disease and the availability of alternative treatments. “Practitioners may try something new if there are no other really good options—an example of compassionate use,” says Clifford Weiss, MD, FSIR, medical director of The Johns Hopkins Center for Bioengineering, Innovation, and Design. “Everything in between is a judgement call.”
Once an IR generates an idea, Dr. T. Murphy urges them to continue to investigate their innovations through individual device exemptions, or IDEs, issued by the U.S. Food and Drug Administration.
“I believe that innovation should come organically from the ground up,” he says. “If, as a specialty, we wait for innovation to occur in a top-down way, either from people organizing clinical trials or, more commonly, industry developing new devices and trying to get them validated, then we’re really leaving a lot of potential innovation on the table. If we wait until something is ready for randomized clinical trials, then there’s going to be a lot less innovation. We must keep in mind that there is harm in slowing down innovation.
“People are generally too hesitant or reluctant, possibly because of the regulatory climate that surrounds industry,” Dr. T. Murphy adds. “But I would encourage them to be more aggressive about pursuing new treatments, new devices or new procedures because that’s the way we can help people the most.”
However, Suresh Vedantham, MD, FSIR, professor at Mallinckrodt Institute of Radiology, cautions against being too ambitious: “The FDA’s 510K approval process is inherently problematic. The barriers to get a device on the market are so low that many ineffective devices get approved. Once their device is approved, companies have no financial incentive to put them at risk by studying them in trials—so physicians just start using them.”
When considering new devices or procedures to add to the repertoire, many IRs prefer to wait for the results of clinical trials. “Clinical trials do exactly what they’re supposed to do,” says Dr. Weiss. “We must let science lead the way. We tend to get very excited about preliminary data, but the data drives what we do. It takes patience to defer treating people with promising innovations.”
Dr. Vedantham adds, “Rigorously studying something (even in small pilot studies) can help us more confidently make the adjustments that ultimately lead to effective devices/therapies. Right now people make adjustments in clinical practice, but they are based on their own anecdotal experiences (which can be biased too).”
“At the end of the day, we need clinical data to support the decision to adopt a new treatment,” says Sudhen B. Desai, MD, director of research for the IR section at Texas Children’s Hospital. Dr. Desai also serves on the board of directors for the Society of Physician Entrepreneurs (SoPE), which helps doctors bring their innovative ideas to market. “Clinical adoption is the pinnacle achievement for an innovation.”
Acceptable failure
Failure is an essential—and beneficial—corollary to innovation. Just as with technology startups, the rate of failure for new devices and procedures is high. “The reality is that any new innovative procedure entering a new area of therapy has a high chance of failure, but these procedures also provide us with examples from which to learn,” says Dr. Weiss. “It’s a natural occurrence. Most startups fail before they ever have an impact in the world.”
One such example is the treatment of chronic cerebrospinal venous insufficiency (CCSVI), initially seen as potentially beneficial for patients with multiple sclerosis.5 Some interventional radiologists added it to their practice. Others were hesitant. Still others insisted the treatment was a sham. Eventual results from clinical trials found no significant benefit, and the procedure has since largely faded from view.
“The procedure was propagated based on early data,” says Dr. T. Murphy. “This is the nature of innovation.”
Dr. Weiss adds, “It looked promising, and before it got to trial a number of centers started doing it, and some people got hurt. That’s an example of not doing the necessary, expensive trials to find out whether it was effective.”
Dr. Vedantham believes that the key to introducing a new procedure or device is Institutional Review Board (IRB) review: “It is true that the nature of device-based procedures relies on cases in order to refine the techniques and learn what has the best chance of working in a clinical trial, and that this dependency poses challenges. However, the problem with CCSVI was that many practitioners jumped on the opportunity quickly, seeing a chance to help patients suffering with a disabling condition. I am sure they tried to select patients carefully and took precautions to ensure their safety, but this route of development can leave patients without the protections that occur when you accept independent IRB oversight.”
Renal denervation for hypertension provides another example. Two initial studies showed significant blood pressure benefit; however, four years later, the formal clinical trial failed to meet its efficacy endpoint. In an interview, one device company CEO acknowledged the uncertain nature of innovation, saying that an occasional failure “comes with the territory.”6
“Renal denervation moved quickly and excitingly because it was a huge clinical problem and a very promising technological solution that looked like it was going to be fantastic,” says Dr. Weiss. “They did their initial trial, which showed promise, but the clinical trial did exactly what it was supposed to do.”
In the case of a medication to raise high-density lipoprotein (HDL), one pharmaceutical manufacturer invested $1 billion. Eventually, randomized controlled trials showed that it did raise HDL, but it also lowered survival due to several off-target effects, such as raising blood pressure.7
As a final example, renal artery angioplasties and stents were done for years until studies showed that modern medication provided just as much benefit.8
Success stories
Even long-established procedures had to start somewhere. “UFE is an outstanding example of moving quickly to study something with IRB oversight, even as clinical practice evolved,” notes Dr. Vedantham. “Over 10–15 years, a major registry and three randomized trials were completed, ensuring that fibroid patients were protected even while quality information was learned.”
Dr. Desai cites the more recent example of yttrium-90 (Y-90), which was reengineered after initial introduction and has since enjoyed systematic, multidisciplinary integration. “It has taken Y-90 15 years to get to this point, but now it is a common part of oncology practice. Embraced for its role in treating two histologically specific carcinomas, it is now being used to treat other cancers,” he says.
Whether or not an innovation succeeds in the long run may rely largely on the degree to which it meets an authentic need. In Competing Against Luck: The Story of Innovation and Customer Choice, Harvard professor Clayton Christensen writes that companies must know what job their customers want their products to do.9 Steinberger et al. describe “needs push” innovation, which “emphasizes a deep understanding of unmet clinical needs on which to build unique solutions.”1
An innovation’s potential for widespread use depends on its endorsability, says Dr. Desai. “A device or procedure must meet a need, but it also must be engaging to make people what to try it.” It’s the difference, he says, between redesigning the mousetrap and just building a better one.
Even though a new device may meet a true need, however, the number 1 reason for failure is timing, according to Rania Nasis, MD, MBA, chief medical officer for Element3 Health and a SoPE board member. “Inventors must learn how to read the market, understand how to position themselves and test their ideas,” she says.
Maintaining patient focus
In conclusion, says Dr. Weiss, some innovative therapies are going to make it and some will not: “The key is to make sure that you are doing the right thing for your patient at all times, that you are weighing the data that exists and making the best judgement based on clinical decision making rather than financial decision-making. You want to make sure that the patient—and the best possible care for that patient—is foremost in your mind.”
References
[1] Steinberger, J.; Denend, L.; Azagury, D.; Brinton, T.; Makower, J.; Yock, P. “Needs-Based Innovation in Interventional Radiology: The Biodesign Process.” Tech Vasc Interv Radiol 2017 Jun; 20(2):84–89.
[2] Rogers, Everett M. Diffusion of Innovations, 4th Ed. New York: The Free Press, 1995.
[3] Murphy, Kieran J.; Elias, Gavin; Jaffer, Hussein; Mandani, Rashesh. “A Study of Inventiveness among Society of Interventional Radiology Members and the Impact of Their Social Networks.” J Vasc Interv Radiol 2013; 24:931–937.
[4] policymed.com/2013/10/the-significant-physician-contribution-to-the-development-of-medical-devices.html
[5] Zamboni, P.; Galeotti, R.; Menegatti, E.; Malagoni, A.M.; Tacconi, G.; et al. Chronic cerebrospinal venous insufficiency in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry. 2009;80:392–399.
[6] massdevice.com/medtronic-ceo-id-do-ardian-corevalve-acquisitions-all-over-again.
[7] Tanne, Janice Hopkins. “Pfizer stops clinical trials of heart drug.” BMJ, 2006 Dec 12. Accessed at ncbi.nlm.nih.gov/pmc/articles/PMC1702474.
[8] Liang, P.; Hurks, R.; Bensley, R.P.; Hamdan, A.; Wyers, M.; Chaikof, E.; Schermerhorn, M. “The rise and fall of renal artery angioplasty and stenting in the United States, 1988-2009.” J Vasc Surg, 2013 Nov 58(5). Accessed at ncbi.nlm.nih.gov/pmc/articles/PMC3791161.
[9] Christensen, Clayton. Competing Against Luck: The Story of Innovation and Customer Choice. New York: HarperBusiness, 2016.
