Innovation Disrupting the Standard of Care

The Barriers to Innovation in Medicine: A Call for Change

The barriers to the future of innovation in medicine are steep, wide, and expensive—many of them self-created. We are living in an unprecedented era where the mysteries of our bodies are being unraveled, and the technology to unlock, understand, and repair them is accelerating at an astonishing pace. Yet, against this juggernaut of progress, there is a deep undertow of entrenched paradigms and strongly held beliefs that threaten to stall innovation.

Understanding the Future Through the "Standard of Care"

To truly understand the future, we must first dissect the concept of the "standard of care." This term has deep historical roots, shaped by case law in the United States, which has, in turn, defined the parameters within which medical professionals operate. But what happens when these parameters, originally meant to protect, begin to hinder progress? We’ll also explore global standards of care and how they differ, offering a broader perspective on the challenges of innovation.

What is a Standard of Care?

?? Before the 1900s, the "standard of care" simply meant what was "customary." This notion was codified in the 1934 case Garthe v. Ruppert, where it was stated, “certain dangers have been removed by a customary way of doing things safely, this custom may be proved to show that [the one charged with the dereliction] has fallen below the required standard." The case of The T.L. Hooper, involving a tugboat that lost two barges because it lacked a radio to warn of an impending storm, added a significant layer to this concept. Justice Learned Hand noted, "A whole calling may have unduly lagged in the adoption of new and available devices. Courts must in the end say what is required; there are precautions so imperative that even their universal disregard will not excuse their omission."

These historical precedents underscore a critical point: what is customary may not always be sufficient. As innovation outpaces tradition, the standard of care must evolve, or it risks becoming an anchor dragging down progress. The ruling in Helling v. Carey (1974) reinforces this idea. Although the defendant initially won, the Supreme Court of Washington State ultimately ruled in favor of Ms. Helling, whose eyesight was lost due to untreated glaucoma. The court found that "the test was inexpensive and harmless, and should have been offered to the patient." These cases collectively suggest that innovation may necessitate standards that go beyond what is commonly done.

Global Standards of Care: A Comparative View

?? The standard of care is not a one-size-fits-all concept; it is deeply influenced by culture, geography, and available resources. In the United States, the pathway to treating a specific medical problem can differ significantly from Yale to Omaha, and from Los Angeles to Chicago. So much depends on the training program a physician attended, the available equipment, the setting (academic vs. rural), and the volume of cases performed. Effectiveness, therefore, may be achievable through different routes, influenced by where and when a patient seeks treatment.

Contrast this with the healthcare systems in countries like Japan, where a more conservative approach to innovation is often the norm, or in Germany, where rigorous, evidence-based standards govern medical practice. Understanding these global differences is crucial as we move towards a more interconnected world of healthcare.

Lessons Learned: The Case of Laparoscopic Surgery

??? In 2009, the leadership of many surgical specialties attended a meeting at the headquarters of Ethicon, Inc. in Cincinnati. By that time, the American Society of Metabolic and Bariatric Surgery had moved from performing over 90% of surgeries through open procedures in 2001 to over 90% laparoscopic procedures by 2009. This shift saved thousands of lives and significantly reduced complications. However, at this same meeting, the leaders of OB/GYN noted that most hysterectomies in the United States were still being performed through open surgery, despite the high complication rates. There was a long silence, followed by a significant challenge to the factors causing this paradox.

Today, OB/GYNs primarily perform hysterectomies using robotic procedures, which have dramatically improved safety by facilitating more precise operations in the pelvis. Yet, even now, women in rural settings are often told their fibroid is "too big" to be removed laparoscopically, while the laparoscopic or robotic procedure might be possible in an urban setting. The recovery and complication rates of open vs. laparoscopic surgery are significant, but these disparities persist due to variations in training, equipment availability, and other factors which may include the reluctance of the treating physician to acknowledge that they do not have that skill set.

Barriers to Innovation

?? Despite the clear benefits of innovation, several barriers stand in the way of its widespread adoption:

1. Bias Toward the Current Standard: The existing standard of care often becomes entrenched, not out of malice, but due to a lack of awareness or access to new developments. In surgery, for instance, we have moved from certification every 10 years to ongoing certification in an effort to stay current. However, there is still a bias toward the status quo. A recent example is the availability of GLP-1 therapy for managing obesity and related diseases versus bariatric surgery. Despite the clear benefits of GLP-1, many still default to older methods.
2. Financial Incentives: At every level of care in the U.S., financial considerations influence the treatment options a patient receives. Equity is not practiced consistently; instead, treatment often depends on luck, location, and the direction provided by insurance companies. This financial bias can also influence physician recommendations, as they may be inclined to suggest procedures that are more profitable.
3. Regulatory Hurdles: Regulatory bodies like the FDA are designed to protect patients, but they can also act as barriers to innovation. The process of conducting randomized, blind clinical trials—considered the gold standard in medicine—is time-consuming and expensive, often delaying the introduction of new treatments. For example, trials on mRNA vaccines for colorectal and pancreatic cancers were conducted in patients with late-stage disease, delaying their potential application in earlier stages where they could be more effective. However, efforts by the FDA, such as the Breakthrough Therapy Designation, aim to expedite the availability of groundbreaking innovations, offering new avenues for patients to access advanced treatments more quickly.

Patient Advocacy and the Role of Social Media

?? In today’s world, patients must be their own advocates, actively engaging with their health through social media and other platforms. While doctors may sometimes resist this shift—and it can be frustrating for them when patients come in with questions—it's essential for patients to take charge of their own health journeys as technology evolves. Expertise is becoming increasingly accessible, empowering patients to make informed decisions. With today's technology, each patient can now take control of their own data and make autonomous decisions about their health.

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?? Engagement Question: How do you believe the concept of "standard of care" should evolve with new medical technologies?

?? Engagement Question: Which country's healthcare model do you think leads in balancing innovation and patient care?