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Why It Takes So Long to Develop a Medical Technology (Part 5)

Written by Mark Carol, MD
Published:

Physicians

As discussed in Part 4, professional support for intensity-modulated radiation therapy (IMRT) and robotic surgery was strong. Payments were the same, and the results were arguably better than the procedures they replaced. Patients liked the added sophistication of the technology, and perhaps most importantly, there was no paradigm shift involved in how patients were treated. Whole gland surgery was still being performed for prostate cancer when using the Da Vinci robot, and the treatment paradigm and radiobiological principles of radiation were the same for IMRT as for conventional radiation therapy. Finally, for both robotics and IMRT, although the instrumentation was different and there was a need to learn new user interface or instrument skills, the general techniques and principles of practice were the same as the procedures with which the physicians had prior experience.

Professional support for prostate focused ultrasound treatments, on the other hand, has been limited. Prior to US Food and Drug Administration (FDA) authorization, a small group of urologists who recognized the value of focused ultrasound for their patients took advantage of offshore and overseas opportunities to learn how to use, and then actually use, the technology that was usually provided by the manufacturer. However, after the technology was available in the US, the dynamics changed. Now urologists were faced with having to either purchase the technology themselves or find a third party, be it service provider or hospital, that would front the capital cost of the equipment so they could continue with their use of the technology. Third parties could only justify such capital expenditures if payments were sufficient for them to make a profit, and as discussed in a prior blog, focused ultrasound was still a “work in progress.”

Furthermore, as a treatment authorized for use in the US, focused ultrasound ablation of the prostate for cancer competed directly with robotic prostatectomy, the lifeblood of many urologists. Unlike the latter, which was an incremental advance over the more traditional laparoscopic prostatectomy and therefore a relatively straightforward segue for urologists, focused ultrasound required learning a completely new approach to the prostate, one much more reliant on computers than on pure surgical intervention. Focused ultrasound was being shown to be highly effective in delivering a focal treatment, an approach that was directly contrary to the traditionally taught need to remove the entire prostate. The combination of a technology requiring a new learning curve with a totally new way of thinking about managing disease made for a turbulent technology introduction.

Introduction

Clinical adoption of a new technology depends on positioning the technology so that it can be purchased by hospitals, used by physicians, and appreciated by patients. Purchasing depends on factors discussed in prior blogs (e.g., regulatory authorization allowing the device to be used and favorable coverage decisions providing payment for its use). However, to be a commercial success, the technology must be used, and this is mostly dependent on the treating physician. Getting clinicians to the point where they are supportive of technology acquisition and usage takes time and is influenced by professional society positioning, quality of clinical support and training for the technology, adequate reimbursement, patient demand, technology access, and the amount of effort required to adopt the new technology.

Level of Disruption

In general, surgeons are attracted to a new technology if it can be easily and quickly learned, then added to their existing practice with minimal disruption. If the potential contribution to their practice is great, rather than just sufficient to maintain the status quo, surgeons may even be willing to invest significant time and effort, and tolerate a disruption to their routine, to gain the competitive advantage new innovative technology offers. Innovation is seen as a symbol of higher quality of care by patients and a source of prestige, status, and distinction to the physician and the hospital using it. Innovation attracts research grants to hospitals and allows hospitals to offer potential “customers” a wider range of state-of-the-art technologies.

Practitioners can also push back against the introduction of new technology, especially if the financial benefit is minimal or nonexistent. When the technology is a natural outgrowth of what they are using already, where it improves their ability to deliver quality care, and where its use results in payments greater than, or at least no less than, those that exist currently, physician pushback can be minimal (and that which does exist will dissipate easily over time).

However, if the technology challenges the status quo, presents a paradigm shift in approach (where it is unclear whether a shift is required or valued), necessitates the learning of a new approach (or comes with a steep learning curve to become competent), challenges the surgeon’s hard-earned reputation of excellence with a status quo procedure, or results in a significant hit to the bank account, the pushback can be strong enough to derail the technology. Physicians become experts by practicing—performing the same procedure with the same tools on many patients. A totally new technology that requires a repeat of the educational steps they went through during their residency and early years in practice to gain competency may be viewed with disdain and fear, manifested by a reluctance to abandon that to which they have grown accustomed and on which they may have built their reputation. In addition, there is always a fear with the first use of new technology that clinical results may suffer during the learning curve common to all new technologies, leading to loss of future patients and potentially even lawsuits. These concerns fall more among “theoretical” issues than true ones, as the norm these days is for extensive training and handholding by vendors when installing new technology.

Professional Society Endorsement

This reluctance to adoption is compounded further if there is a lack of payment for the technology or lack of endorsement by the field’s professional society. While most practitioners will practice in the manner they feel best suited for their specific patient population, professional society endorsement provides good justification for the adoption of a new way of doing things. Lack of professional society endorsement, on the other hand, provides good cover for those practitioners who do not want to adopt the technology. Many who see the value in the new approach will use it regardless of the professional society position if the payment level is great enough. Those that fear the technology or find that the payment does not justify the work required to adopt it can justify their resistance to its use by quoting the society’s lack of endorsement.

If the physician is reluctant or determined not to employ the technology, its purchase by a hospital will be a waste of funds and create a potential obstacle in the physician/hospital relationship that could push the physician to take patients elsewhere. However, a surgeon’s support of and desire for new technology can pose a challenge to decision-makers at the hospital who are often forced to make timely decisions regarding the technology before there is definitive evidence of their clinical efficacy and economic merit.

Exposure to New Technologies

Even before use and support for the technology becomes an issue, the potential user must first be exposed to and learn about the technology. By virtue of it being new, there is often little written about it and a large presence may be lacking at professional society meetings due to cost of attendance by the manufacturer and paucity of clinical presentations. Getting the word out by whatever means possible, especially means that do not layer a cost on the physician, is a valuable first step in the long path to clinical adoption.

Physicians are notoriously difficult to reach. It used to be possible to buy them lunch or send them to an “educational program” where they could gain exposure to a nascent technology; these types of exposures are no longer permissible. Surgeons do not open mass mailings, are not receptive to cold calls or sales visits, and increasingly do not have the funds necessary to attend expensive off-shore meetings. Articles or interviews in professional newsletters and magazines are more likely to be seen, and guest lectures at grand rounds and general practitioner medical society meetings, where CME credits are being offered, can be a valuable means of education. This is especially the case with regional professional meetings, where the physician often has more time to spend with salespersons or knowledgeable colleagues and they also are getting CME credits for attending. In this day of virtual meetings that may be free of charge to the doctor and do not require them to travel, company-sponsored webinars and Foundation-based dedicated programs may be a good use of company time and resources.

Blurred Lines Between Specialties

There is another way physicians impact the success of a new technology, either accelerating the timeline for its clinical and commercial success or encouraging its demise. Often unknown to the public, physicians in the US struggle continuously to defend and expand their increasingly overlapping empires. As medical technology evolves and reimbursement diminishes, the traditional boundary lines separating specialties have become blurred. A lack of manufacturer appreciation for the existing boundaries, for how a new technology will be impacted by or impact them, can potentially break a new product.

Although many areas of the healthcare realm are impacted, radiology presents the most frequent zone of conflict. Historically, radiology focused on diagnostic imaging and was a physically distinct “department” within the hospital. As technology has evolved, and as image-guided intervention has taken over the surgical arena, radiology has come to find a role in a variety of therapeutic and invasive procedures inside and outside of the hospital environment. These roles are often in open conflict with more traditional purveyors of technology.

Many non-imaging specialties now employ procedures that rely on the use of technology traditionally only available in the radiology department. CT and MRI units can be found in operating rooms and cardiology suites. Radiation oncology has its own imaging devices for both treatment planning and treatment delivery, with devices that even include imaging built into the radiation delivery device. Surgeons are merging imaging information from radiology directly into their treatment delivery technology to more precisely target disease. Neurology groups buy their own MRI units, and obstetricians and gynecologists have added in-office ultrasound and mammography capabilities.

At the same time, radiologists are performing procedures that once would have been performed only by surgeons. Interventional radiologists use catheters and stents to treat patients with carotid artery disease in place of vascular surgeons who use a scalpel in the operating room. MRI-guided ablations, intracranial vascular procedures performed in a Cardiovascular Catheterization Laboratory, and fluoroscopic-guided tissue destruction are examples of treatments that now being performed competitively by interventional radiologists.

Even within surgery, technology is eroding conventional borders. Neurosurgeons used to treat carotid disease, which is now the almost exclusive purview of the vascular surgeon or interventional radiologist. Neurosurgeons and orthopedic surgeons routinely compete for spine procedures. Neurosurgeons and radiation oncologists compete for radiosurgical cases. General surgeons and surgical specialists compete for abdominal procedures. Thoracic surgeons and pulmonologists share some of the same territory in diagnosing and treating lung cancer. As CT lung cancer screening picks up, a greater number of small, early-stage lung cancers are being treated by pulmonologists endoscopically without any surgery, so the turf of the thoracic surgeon is eroding. Simultaneously, as insurers devise bundled payment strategies for patients based on their specific ailments, specialists are forced to share, or compete over, the same diminishing healthcare dollar.

If a new technology does not correctly target the end user in a way that is consistent with existing or evolving patterns of care, that technology may be doomed from the start. Physicians will protect their livelihoods and are ill-disposed to give up a revenue stream. Introducing a technology for patient treatment that will fall under the domain of a specialty different from the one that traditionally treats that patient may result in the technology not being used no matter how good it is.

Turf Wars

As a result, each specialty has become increasingly protective of its historical “turf” and more aggressive about identifying new domains in which to practice as others tread on that turf. The degree to which a new technology may exacerbate these conflicts between historical parties and players new to the party will play a factor in the adoption or resistance rates of the technology.

A case in point is the introduction of therapeutic focused ultrasound for the treatment of uterine fibroids. Focused ultrasound is performed in real time in an MRI unit and competes directly with procedures performed typically by gynecologists in an operating room or office setting. Unlike neurosurgeons and cardiac surgeons, who may have access to their own MRI units in offices or operating rooms, gynecologists depend on radiologists for MRI. The gynecologist does not really want to spend several hours in an imaging suite performing a procedure, and the interventional radiologist does not really need the gynecologist to perform the MRI-guided focused ultrasound ablation. However, the gynecologist controls the flow of patients and gynecologist-delivered fibroid treatments are a lifeblood of the profession. Without the gynecologist referring patients to the interventionist – and, in the process, showing a willingness to give up the revenue stream such patients provide – the procedure was doomed from the start.

It should be noted that this turf battle issue does not play out the same way across the world or even in different treatment settings within the same country. For instance, turf battles may be less of an issue at an institution in the US where all providers are on salary. This same reasoning is in part why some novel treatments, such as MRI-guided treatment of uterine fibroids, are more successful in Europe, where the bulk of medical care is government directed, with surgeons and other practitioners functioning as employees of the hospital system.

Payment and Compensation

Compensation certainly impacts uptake of a new technology, particularly in the US. Traditionally, the US model has been one of payment per procedure. As discussed in the blog on reimbursement, the Centers for Medicare and Medicaid Services (CMS) determines a payment level for a procedure based on the resources and time it takes to perform the procedure irrespective of outcome, and commercial carriers usually pay at a level that is somewhat based on the rate set by CMS. If a new procedure reduces the time and resources required to treat a disease, CMS will see a reduced facility cost associated with that procedure and may pay a lesser amount even if the outcomes are better. This may create a perverse incentive for the facility and the physician to use a procedure that pays more even if the results are not as good and creates a negative financial incentive for the facility and the physician to switch to the new procedure. If and when the US were to move to a disease-based treatment model where the payment was the same for treating a condition regardless of the technology used, new innovative technology that lowered cost while improving outcomes might have an easier path toward clinical acceptance (and even dominance) than is the case currently. Until that time, companies may find it challenging to get physicians to adopt better, less costly technology.

Mark Carol, MD, is a senior consultant at the Focused Ultrasound Foundation.

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