“The dogmas of the quiet past are inadequate to the stormy present.” President Lincoln
“What the cynics fail to understand is that the ground has shifted beneath them.” President Obama
On this, an historic inauguration week in the United States, where dogma and cynicism have been quieted for a brief and welcome moment, consider health care. Is the present very different from the recent past? Has the ground shifted? Will new solutions fill the vacuum of a broken system? Or is a new approach like intelligent medicine simply an innovator’s dream, with the barriers and limitations of physicians, payers, regulators and industry leading to yet another rude awakening? The answer: the transformation of health care is inevitable, and it is has already begun. That’s not a campaign slogan. It is a recognition of the shifting structure of needs, demands and power within the health care system.
To be sure, over the last twenty years change has been thwarted again and again by structural realities in health care that seem immune to progress. Among many, two stand out. First, the system reflects a culture of disease, not health. The payment and reimbursement structure is for office visits, procedures and interventions, while that for health, maintenance and prevention is limited. As a result, physicians need to treat as many patients as possible in face-to-face sessions, limiting the time, efficiency and quality of the average interaction significantly. Hospitals focus on investments that generate procedure and intervention-based revenues, and can actually be penalized financially by quality that keeps patients off the wards and out of the surgical suites. And medical product developers direct their innovation toward potential products that fit within this existing structure, such as expensive specialty drugs and surgical instruments that are focused on heroic, end-of-life care for a relatively small percentage of patients, not those struggling for years with the self-management of a chronic condition.
Second, in many ways the system rewards incrementalism, not breakthroughs. 
Medical product companies have been required to bring new drug and device products to market through a regulatory system based on narrowly defined trials in small, highly selected clinical populations that do not reflect the general population or how these products will be used in the real world. On approval, we have then been able to largely dictate pricing and use, broadening the intended market over time and generating enormous profits, with little post-approval surveillance on actual health benefit and potential safety issues. This combined with the event-driven financial structure discussed above means there has been little incentive to invest broadly in new models of product development, care delivery, product personalization and outcomes assurance.
But in recent years we have seen the elements of fundamental change building. Picture each of the key players and what they face in the stormy present. The FDA is an agency between a rock (pressure by patients and industry to speed important new product approvals for unmet medical needs) and a hard place (outrage in government, media and society when approved drugs turn out to cause harm not detected in clinical trials). To save itself, the agency is beginning to advocate for a new drug development paradigm that integrates modern molecular and information technology tools. For pharmaceutical and other medical product companies, pricing power has shifted dramatically beyond their control. Medicare and private insurers have increasingly sophisticated databases of real world product usage, outcomes and safety; regardless of what the clinical trials reported, payers are now determining on their own how valuable a new product is, whether or not they will allow coverage, and what price is justified. In response, pharmaceutical companies are now investing agressively in ways to personalize their products and build outcomes into the product systems themselves, in many cases using biomarkers, sensor-based devices and information technologies. For self-insured large employers, rising health care costs are unsustainable, leading to enormous political pressure to change the system and determine new models of care management, delivery and reimbursement. For physicians, particularly in primary care practice, the pressures of the current health care system and the inability to fully care for their patients in the way they desire, are also leading to movements for change. With all these pressures from within the box of the current system, the lid is beginning to open, and next generation health initiatives, technologies and solutions are beginning to break out.
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