Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
Gaze Into a Future Where New Technologies Deliver Better Outcomes with the Promise of Lower Cost
The long-ballyhooed revolution in healthcare comes down to money. U.S. spending on healthcare is projected to balloon within a decade, from the total $3.1 trillion a year recorded for 2014, to $5.5 trillion by 2024, according to the U.S. Centers for Medicare and Medicaid Services. Or, to look at it another way, healthcare will rise to 20% of spending in the U.S. economy in 2024 from 17.7% in 2014.
Reducing that anticipated spending, as discussed across every healthcare specialty in recent years, has been behind the push by payers, providers, and others away from fee-for-service, volume-driven healthcare. In its place a system driven by decisions reflecting professional consensus informed by clinical evidence is predicted to emerge.
Technology is expected to play no small role in that change by delivering improved care at reduced costs. But as GE Chairman and CEO Jeffrey R. Immelt told attendees a few weeks back at the Radiological Society of North America 2015 Annual Meeting, technology will also need to be accompanied by information and analytics, with all three harnessed into new business models that reduce what payers and providers spend on care.
“We’re going to be working on this the rest of our lives in terms of how to improve healthcare outcomes, costs, and quality,” Immelt said. “Everyone who is in the healthcare industry today has to learn how to grow and take cost out at the same time. They have to learn how to produce great patient outcomes, and do so productively. And that is never going to go away.”
Below are 10 trends that are likely to reshape healthcare in coming years, if not starting in 2016 based on a spot-check of recent journal articles, public announcements, news reports, and commentaries in GEN and elsewhere. GEN’s last look at such trends, in 2013, revealed several that have indeed transformed healthcare for better or worse in the years since, from gene therapy to six-figure drugs.
Progressing beyond the applications highlighted by GEN a few years back, 3D printing has continued moving toward healing patients. 2015 saw more successful 3D printing of body parts and limbs than ever: In September, a 54-year-old cancer patient in Spain became the world’s first person to receive a 3D-printed titanium sternum and rib implant, made by Anatomics using the 3D printing facility of Australia’s Commonwealth Scientific and Industrial Research Organization, to replace part of his rib cage. In November, Stratasys and The Jacobs Institute in Buffalo, NY, joined physicians at Kaleida Health’s Gates Vascular Institute and biomedical engineers at the University at Buffalo to design a 3D-printed model of a brain used in repairing the brain aneurysm of a 49-year-old woman from Fillmore, NY. Despite Q3 revenue declines by Stratasys and 3D Systems, which face slowing sales and new competition from 2D printing giants—as well as speculation about layoffs—the 3D printing market is still expected to expand; Wohlers Associates last year projected the industry will grow from $3.07 billion in 2013 to $21 billion-plus by 2020.
Assisted suicide, which supporters call “aid in dying” or “death with dignity,” gained further legal traction in 2015. California became the fifth U.S. state—and the largest—to allow the practice after Gov. Jerry Brown signed into law the End of Life Option Act on October 5, though the group Seniors Against Suicide filed papers to place the issue on the 2016 statewide ballot through a referendum. Supporters, led by Compassion & Choices, stepped up efforts to enact similar death-with-dignity laws in New York, Massachusetts, and elsewhere. As of 2015, bills authorizing assisted suicide have been introduced in more than half of U.S. states. They face opposition from groups that contend that the practice is an immoral taking of human life and instead advocate for patient-centered care that supports the value and dignity of dying people. However, aid in dying won another key legal victory in Canada when its highest court reversed a two-decade-old decision banning physician-assisted suicide for mentally competent but terminally ill patients.
Big Data Analytics
Big players are increasingly involving themselves in big data. In November, the U.S. Department of Health and Human Services joined OptumLabs, the healthcare research and innovation center co-founded by health services business Optum and Mayo Clinic. HHS agencies gained access to big data from OptumLabs, which provides holistic views of populations and patient care by linking de-identified medical claims with clinical data. Two months earlier, in September, Quest Diagnostics joined software company Inovalon to launch Data Diagnostics™, a suite of hundreds of real-time patient-specific data analyses that clinicians can order individually at point of care to identify gaps in quality, risk, utilization, and medical history insights. According to Stoltenberg Consulting’s Third Annual Health Industry Outlook Survey, a 51% majority of IT leaders listed as their key hurdle to big data analytics a pair of unresolved questions: What data should be collected? And how much? Stoltenberg found 84% of those surveyed had questions about the type, quantity, and use of healthcare data.
Healthcare’s march toward basing treatment decisions on evidence has moved well past the Affordable Care Act into medical practice, and even teaching. Kaiser Permanente said in December that the medical school it will open in 2019 in Southern California—exact location to be announced—will integrate evidence-based medicine (EBM) into its coursework along with technology, decision making, teamwork, and mobile health. Among recent results linked to EBM practices: The Pennsylvania Health Care Cost Containment Council, a state agency, reported that the Keystone State’s hospitals saved $694 million from 2012 through December 1, 2014, through declines in preventable harm (37%) and all-cause readmissions (26%), results they call “nothing short of remarkable.” But in a December editorial published in the journal Evidence-Based Medicine, Faina Linkov, Ph.D., of University of Pittsburgh School of Medicine and colleagues opined that EBM alone is insufficient; it should evolve beyond the priorities of physicians and underwriters to “focus on patient welfare and inclusion of patients’ values and preferences in decision-making.”
Gene editing moved beyond CRISPR-Cas9 with the publication in September of a new CRISPR-based technology, CRISPR-Cpf1. Two months later, Chinese researchers said they used CRISPR genome modification to double the muscle mass of dogs. As is typical for new technologies, the pace of innovation is far ahead of the ability of courts and scientists to address the thorniest issues. A major legal battle is underway on ownership of the first CRISPR patent that pits Feng Zhang, Ph.D., of the Broad Institute and MIT against Jennifer Doudna, Ph.D., of the University of California, Berkeley, and Emmanuelle Charpentier, Ph.D., of the Helmholtz Centre for Infection Research. Also underway is the effort to forge consensus on the ethics of human germline editing, overseen by the National Academy of Sciences and National Academy of Medicine. The academes held the International Summit on Human Gene Editing in December, which will be followed up in February by the first gathering of data for a consensus study expected to be completed late in 2016.
The ability to generate genomic data continues to outpace the ability to interpret all that information. Brendan Frey, president and CEO of Deep Genomics, posited in December that the gap also poses four potential future opportunities for entrepreneurs. He wrote in TechCrunch that in addition to data generation and storage, they include software that can address how genetic modifications impact molecular and biological processes involved in disease; data organization, brokering and visualization; and precision medicine through new diagnostics and therapies, covered by insurance. Researchers continue to run into unexpected gene variants: In December, researchers found 52 variants associated with age-related macular degeneration (AMD), based on a study of genes from more than 33,000 individuals published in Nature Genetics. Also in December, researchers from the Broad Institute and Massachusetts General Hospital published results in Nature of a study revealing a new biological mechanism behind cancer based on brain tumors carrying mutations in the isocitrate dehydrogenase (IDH) genes. The challenge of mutations was also discussed recently by Magnus Ingelman-Sundberg, Ph.D., of the Karolinska Institute and colleagues in articles published in December in the journals Pharmacogenetics and Genomics and Trends in Pharmacological Sciences. Using the 1000 Genomes Project and the Exome Sequencing Project, the researchers examined genes that encode the CYP450 enzymes linked to drug metabolism and found more than 6,000 mutations, more half of which were new and more than 90% rare.
Apple shook up the business of health apps in March when it released its open-source Apple ResearchKit™ software framework, designed to enable doctors and researchers to gather data more frequently and more accurately from participants via iPhone apps. Among the initial five apps unveiled at the same time was Asthma Health, developed by LifeMap Solutions—which partnered with the Icahn School of Medicine at Mount Sinai—to track data from asthma patients for Icahn Mount Sinai’s Asthma Mobile Health Study. More than 8,600 were enrolled by the time initial results were released in September. ResearchKit also offers apps for autism, breast cancer, cardiovascular diseases, diabetes, epilepsy, melanoma, and Parkinson’s disease—just a few of more than 50,000 apps now available. In December, Apigee released survey results in which 60% of all U.S. adult smartphone users (and 71% of millennials) said apps and their smartphones had changed the way they managed their health and wellness. One key concern remains FDA regulation: The agency in August issued a report restating that its focus is “the riskiest forms of medical device software.” However, at deadline, the FDA had yet to issue final guidance on the regulation of decision-support software, fueling speculation that the agency is awaiting action from Congress on a framework for mHealth regulation.
Unlike Karel Capek’s influential play “R.U.R.,” where robots drive the human race into extinction, today’s automatons specialize in helping people, especially in healthcare. The granddaddy of healthcare robots, the da Vinci® Surgical System, has brought minimally invasive surgery to more than 3 million patients worldwide since launched in 1999, according to developer Intuitive Surgical. In addition to surgical robots, there are physical therapy robots, noninvasive radiosurgery robots, hospital and pharmacy robots, and social robots that entertain patients with singing and dancing. Other robots help care for elderly patients. In Japan, where senior citizens account for a quarter of the population, the government said last month it will build 10 centers to promote development of robots that give older people a greater sense of independence. Those robots are expected to assist seniors with bathing, monitoring whereabouts, walking, and disposal of waste. In November, Carnegie Mellon University spotlighted a robotic leg prosthesis intended to help amputees avoid the tripping and stumbling often associated with leg prosthetics. MarketsandMarkets projected in November that the medical robot market will nearly triple by 2020 to $11.4 billion, from an estimated $4.2 billion this year—far above the research firm’s estimate last year of nearly $3.8 billion by 2018.
Years of hype about the promise of telemedicine is steadily translating into increased use of remote medicine by doctors and patients. Healthcare Information and Management Systems Society’s Analytics’ 2015 Telemedicine Study, issued in September, found a 3% increase from 2014 in the number of healthcare providers using telemedicine solutions and services. The most widely used technology, webcam/video, was used by 70% of providers surveyed, up from 58% a year ago. One hurdle to telemedicine’s growth going beyond technology began to fall in 2015, after the Federation of State Medical Boards in May created the Interstate Medical Licensure Compact Commission to administer the Interstate Medical Licensure Compact. The compact—enacted in 12 U.S. states and under consideration in eight others—creates a streamlined process for medical licensure for physicians interested in practicing medicine in multiple states. Also making progress state-by-state is legislation requiring insurers to cover telemedicine services, with eight states passing such laws this past year, raising the number to 32 states (plus the District of Columbia).
Even though his company shelled out $2 billion in 2014 to acquire virtual reality startup Oculus VR—whose Rift VR system is set to be released in Q1 2016—Facebook CEO Mark Zuckerberg cautioned investors during its third-quarter earnings conference call in November that the technology will likely take years to generate significant investor activity. While gaming is the most obvious market, Zuckerberg said, VR technology will grow by offering video and immersive experiences in numerous contexts. Healthcare providers are among those working to incorporate the technology. Tufts Medical Center has partnered with digital marketing firm Primacy to plan for the eventual use of VR technology to introduce patients to the facility and clinical staff before they undergo surgery or some other procedure. The VR technology will also enable doctors to explain the medical equipment they are using and obtain patient consent when implemented. No integration date has been set. Startup EchoPixel said in December it plans to bring its True 3D VR system to healthcare through collaboration with Hewlett-Packard spinout HP Inc. and aimed at enabling doctors to examine images of patient tissue and organs. The U.S. Army treats soldiers with Post-Traumatic Stress Disorder at Germany’s Landstuhl Regional Medical Center with the Virtual Reality Exposure Therapy (VRET) system donated in 2014 by the Wounded Warrior Project.