Cover Story: Technology – The Great Gender Equalizer

Technology: The Great Gender Equalizer - A look at trends in women's health

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by Matthew N. Skoufalos

One of the most powerful equalizers in any system is technology, and as medical equipment manufacturers work to improve their positions in an increasingly competitive and outcomes-based marketplace, some are considering the specific needs of women in their product development.

Differences in the way men's and women's health has been studied in the United States have been observable for decades. By way of example: prior to 1990, women were almost universally excluded from clinical research, despite accounting for more than 50 percent of the population, according to the Society for Women's Health Research (SWHR).

The issue is still in the air nearly a quarter-century later, when the Research for All Act, introduced in June 2014, calls for the separate analysis of "male and female animals, tissues, and cells in basic research," according to U.S. Representative Jim Cooper (D-TN), one of the sponsors of the legislation.

But one of the most powerful equalizers in any system is technology, and as medical equipment manufacturers work to improve their positions in an increasingly competitive and outcomes-based marketplace, some are considering the specific needs of women in their product development.

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Patient-centric care

Chief among women's health issues is breast cancer, second only to lung cancer in the leading causes of death in women. Among the most common trends in breast imaging is an increased multi-modality approach, said radiologist Jessie Jacob.

Jacob, the Director of Ultrasound at Northern California Women's Imaging Center and Vice President of Medical Affairs at U-Systems, a GE Healthcare Company, said the "one-size-fits-all" mammogram "doesn't find everything we want it to find" and "doesn't answer all the questions we want to figure out." As healthcare becomes more personalized overall, she said, device-makers "are having more of a patient-centric approach."

"[Individual] women are very different as far as their breast consistency, shape, size, family history, risk factors, personal history, biopsy results," Jacob said. "There's a lot of different things that come into play, and you can't really say one thing will fit for everybody."

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One ongoing concern in breast imaging, Jacob said, is dense breast tissue, an indicator of breast cancer risk that can be difficult to detect.

"When you have more glandular tissue than you have fatty tissue, it's very white on the mammogram," Jacob said. "The things we are looking for on the mammogram are also white. Radiologists are not able to tease out the glandular tissue from the mass."

Informing patients of their breast density has become a subject of statewide legislation that's pushing to a national level. Forty to 50 percent of all women are dense-breasted, and mammography may detect 65 percent fewer cancers because of that complication, Jacob said.

"Women are aware of breast cancer," she said. "They are aware they should get a mammogram. The majority don't necessarily know what dense breast tissue means."

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Manufacturers are working to develop technologies that can assist in providing greater information to patients while eliminating or avoiding the complications from scanning dense breast tissue — another driver of the multi-modality approach to breast imaging.

"I'm looking at things that will change [disease] management, change outcomes for the patient," Jacob said. "Molecular imaging definitely has a role … contrast-enhanced spectral mammography."

Some of these technologies, including MRI, are expensive, Jacob said; but the alternative — punch biopsy — can "turn every patient into a pincushion."

"I think that's why we need to have other technologies," she said. "We can't just have one answer for everything. Everybody should have the ability to have early-detected cancers. If you find a breast cancer in the early stage, the chance of survival is over 98 percent. That isn't something that should be given only to the elite few."

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Jacob admits that there is a de facto tiering of care, especially in women's health, where some procedures are reimbursable only as adjuncts to mammography. Moreover, she said, the majority of imaging centers in the country do not have fellowship-trained breast imagers to read breast imaging studies.

"There are many pockets where accessibility is a concern, so things like molecular breast imaging, or contrast-enhanced spectral mammography are going to help," Jacob said. "Automated breast ultrasound allows you to screen much larger volumes of patients, [too]."

But as alternative imaging methods become more widely available, providers are looking to offer a variety of experiences for patients beyond even the imaging modalities themselves. GE, for example, has developed a supplemental mammography device called the SensorySuite, which allows patients to modify their sensory environment to look, smell, and sound like a junglescape, seashore, or garden in order to help them relax during the examination.

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"What's our main concern when a patient comes in?" Jacob said. "That she's nervous, anxious; that it's not fun to have a mammogram. What can I do to have them relax? Making the experience better is very important [and] definitely improves compliance."

Other technological advancements in breast imaging will be those that help diagnose interval cancers, reduce patient recalls, and inconclusive mammograms, Jacob said.

"Any technology that addresses any of those needs, that's a promising technology," she said.

Platforms and enhancements

Jennifer Okken, Women's Health Products Manager at Siemens Healthcare in Allentown, Pa., said that given the variety of imaging modalities available and the frequency with which new improvements are made, manufacturers are favoring the development of platform systems that are upgradeable with next-generation technologies.

"As healthcare continues to change and we do more for less, this is the thing that all companies are looking into: how do we use the base platform and have companies do more than that?" Okken said.

Attachments for 3D breast imaging technologies can help address dose-reduction issues in patients while catching additional cancers and reducing patient callback rates, Okken said. Adjunctive ultrasound, which is typically more accurate than mammography or X-ray on women with dense breasts, is getting a boost from automated volume scanning technologies that can help cut exam times in half. Other improvements can even reduce the need for breast compression during mammography, which increases patient comfort while acquiring a better image.

"We've used technology to optimize the compression so that we can tell the technician so they're not over-compressing the breast," Okken said.

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Yet although supplemental imaging techniques add value from the perspective of patient customization, many of these technologies do not have reimbursement codes, which means patients must pay out of pocket for those procedures. Mammograms are still encouraged, Okken said, because "it's affordable and is the proven standard of care for breast cancer."

But if and when these additional modalities are approved for reimbursement, she said, manufacturers still don't know how that will affect clinical workflow for patients (i.e., who should get an MRI versus an ultrasound versus a standard mammogram).

"The out-of-pocket costs that we're seeing right now for breast tomosynthesis is $100-150 per patient," Okken said. "It absolutely affects how we develop equipment and how we submit these products to the FDA. As of today, the way vendors have it approved, it's as an adjunct to screening, not a replacement to screening. There's not enough data; there's not enough accessibility to patients."

What Okken believes is needed most is an effort to focus innovation on defining patient care pathways instead of introducing additional devices into a market that is saturated with different types of breast imaging technology.

"We have some customers offering one thing, others offering another, and patients get confused," she said.

"What we as vendors will continue to do is make what we have better," Okken added.

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Simulation and robotics

Despite the priority that breast cancer receives among women's health issues, Jeff Berkley argues that an improvement in surgical techniques — especially for procedures such as hysterectomies — can have just as profound an impact on health outcomes.

Berkley is the CEO and Founder of Mimic Technologies, which creates training and simulating software for the Da Vinci surgical robot (see a video demonstration below). He believes that women's healthcare can benefit from an emphasis on minimally invasive surgeries, particularly if the barrier of training surgeons is removed from the equation.

Click to View a Video Demonstration

"I personally think that the impact simulation can make on women's health is probably more profound than it would be on other disciplines," Berkley said.

"People have been doing laparoscopic hysterectomies since the 1970s, and yet there is still some resistance to adopting what is clinically a better approach," he added. "We feel a lot of this has to do with the fact that people don't have access to the training."

"It is an enabling technology," Berkley said, "but the reality is it hasn't been out that long, and even though a lot of robotics are being done for hysterectomies, endometriosis, and other surgeries, people are still going to try to make a comparison to laparoscopics. It's not an apples to apples comparison."

Robotics can allow surgeons to achieve "expert status" faster, Berkley said, and even carry advantages over the traditional laparoscopic approach. Wristed instruments allow greater access to tissue. A trimmer scales back motion to allow for greater precision and accuracy. Surgical robots even offer 3D vision.

But the key advantage, potentially, is that surgical robotics also offers the possibilities of simulation, which helps keep surgeons primed for practice.

"If you're a urologist, you might do three to seven prostatectomies a day," Berkley said; "but if you're an OB-GYN, you're very likely helping people deliver babies. It's not uncommon that a GYN may only do a surgery once a month. People are going to have less practice on the job and your skills can deteriorate pretty fast in a month."

"If you have 24-7 access to a simulator and you have some time between cases, or you want to simulate a case, you can maintain your skills," he said.

Practitioners who specialize in women's health can even develop patient-specific procedures, Berkley said, with the aid of augmented-reality "ride-along" training simulators that model similar cases and allow doctors to "almost participate in the case after the fact."

"You get to predict where you're going to grab the tissue and where it's going to be cut," he said. "You get to make clinical decisions going forward, and then you get to see if you did it right by seeing what the surgeon did."

"We can generate augmented reality content very fast, and rather than introduce [the doctor] to one patient, introduce them to hundreds of patients," Berkley said. "We can expose them to hundreds of scenarios."

It's a heady prediction, but Berkley foresees a future in which "some of the tools we have available for training [will] eventually merge with the real surgery," allowing doctors to "essentially do a rehearsal with the patient's anatomy or with a patient's anatomy that's very similar to the patient you're dealing with." He even believes that surgical performance assessments, which hospitals are beginning to track with their staff, will improve with greater access to surgical simulators.

What's next

The biggest question that still remains, looming over much of the U.S. healthcare system, is one of access. Technological solutions that address screening or surgical improvements may not find their way into the lives of patients who need them if they can't afford to pay out-of-pocket for these procedures, or if their closest health center doesn't offer them.

An August 2013 issue brief on the implications for women's access to care under the current healthcare reform laws published by the Kaiser Family Foundation showed that "just over half of uninsured women (53 percent) had incomes less than 138 percent of the federal poverty level."

The document also noted that "women with employer-based insurance are almost twice as likely as men to be covered as dependents," making them more vulnerable to losing their insurance should they become widowed, divorced, or if their husbands lose their jobs.

Furthermore, as women are "disproportionately low-income," they are "consistently more likely than men" to feel out-of-pocket costs as a barrier to care, causing them not to receive tests or buy medicine they might otherwise need. That doesn't even take into account that the leading causes of hospitalization, according to the report, are "childbirth and pregnancy-related conditions."

Until technology is leveraged to cultivate a solution to these broader, national issues, the standard of care cannot truly be elevated beyond the current environment of haves and have-nots, especially when women are so often placed in the latter camp.