Saturday, March 24, 2007

Clinial innovations - Innovation and Conservative Risk Taking - SHAPE Example

In an earlier blog, I said I would return from time to time to excerpts from The Daily Drucker (HarperBusiness, 2004). This handy little book contains daily entries consisting of excerpts of writings of late Peter D. Drucker, America’s most eminent managerial and social philosopher.

I have patterned mediinnovationblog.blogspot after Drucker’s work. Each day I make an entry based on something I write that day or something I’ve written in the past, always something that relates to innovation in health care.

What follows are: A) One of Drucker’s daily entries; B) One of my daily entries.

A) Drucker Daily Entry

Successful innovators are conservative

I once attended a university symposium on entrepreneurship at which a number of psychologists spoke. Although their paper disagreed on everything else, they all talked about an “entrepreneurial personality, which was characterized by a propensity for risk taking.” A well-known and successful innovator and entrepreneur who had built a process-based innovation into a substantial worldwide business in the space of twenty-four years was then asked to comment.

He said, “I find myself baffled by your papers. I think I know as many successful innovators and entrepreneurs as anyone, beginning with myself. I have never come across an ‘entrepreneurial personality.’ The successful ones I have know all have, however, one thing – and only one ting – incommon: they are not ‘risk takers.’ They try to define the tasks the risks they have to take and to minimize them as much as possible. Otherwise none of them would have succeeded.”

This jibes with my own experience. I, too, know a good many successful entrepreneurs. Not one of them has a “propensity for risk taking.” Must successful innovators in real life are colorless figures, and much more likely to spend hours on cash-flow projections than to dash off looking for “risks. They are not risk –focused”’ they are “opportunity focused.”

ACTION POINT: Determine which of your ideas the least risk and the most opportunity and focus on them.

B) Reece Entry

What I’m about to describe is a remarkable innovation that’s conservative, not risky, and destined for success. It’s a cardiovascular-pulmonary risk device, based on tweaking and modifying the current cardiac risk treadmill stress test but without the risk and with additional pulmonary and predictive risk software.

It’s not risky because:

1) it carries no risk for the patient;

2) it is based on five decades of research;

3) it has been tested and validated at the Mayo Clinic, which is not in the habit of recommending risky devices.

Catching Bad Behavior Early a Risky Proposition

Preventing predictable disease is a risky proposition. You can preach and teach, hector and lecture, fan flames of fear, and even ban bad behaviors in public places. As a general proposition, banning bad behavior is a good thing, but as Oliver Wendell Holmes, Jr. said, “I dare say that I worked off my fundamental formula on you that the chief aim of man is to frame general propositions and no general proposition is worth a damn.”

Nothing, it seems, can change bad behavior for everyone. Banning individual pleasurable behavior in a capitalistic society is a risky proposition, for it impinges on individual freedom. Public banning sound simple, but as alcohol and marihuana prohibition has taught us, defying banning is exciting and often leads to abuse.

Innovative Way to Influence Behavior Leading to Heart and Lung Disease

But there may be an innovative way out. One can measure the early physical effects of bad behavior. After all, whatever can measure can be understood – and managed. That is why the mantra of “metrics” marches through the minds of medical managers. The subjective becomes objective and understandable to common man.


Suppose you had a portable high tech – simple-to-use, economical, low-risk device – that could measure early bad behavioral effects, lack of fitness, early signs of heart and lung disease, engendered by smoking and obesity.

Suppose these “metrics” were objective, reproducible, and understandable to those doing the testing and those being tested. And suppose you could “quantify” chances for hospitalization and even early death, based on a large irrefutable database of hundreds of thousands of patients that have gone before you down the paths of preventable bad behavior. Now, that would be “Innovative,” with a capital “I.”

What I’m building up to is a new technology called SHAPE – Superior Heart and Pulmonary Technology. A group of four (who prefer to go unnamed for now until the scientific evidence is irrefutable) – an electrical engineer, an electrophysiologist, a software programmer, and a health care consultant – known as Cardiac Risk Assessment Associates, have been working in conjunction with the Mayo Clinic department of Cardiology, to develop a physiologically-sound, scientifically-based, and computer-predictive device for evaluating cardiopulmonary disease in multiple settings.

The device will be small, non-invasive, accurate, and will yield reproducible results. The device results from four or five generations of evolving cardiac and pulmonary testing devices. It is evolutionary as well as revolutionary, and it may prove to be effective for detecting early disease, modifying or preventing behavior that led to heart or lung dysfunction, and measuring responses to behavior change or therapy.

Here is how the four associates explain their device.

Cardiac Risk Analysis Associates (CRAA) had developed an advanced cardio- pulmonary testing procedure called SHAPE (Superior Heart and Pulmonary Evaluation). It is non-invasive, convenient, safe, and economical. The test is designed to evaluate and quantify a person’s cardiac and respiratory efficiency not unlike the stressful and risk-prone procedures presently performed in the specialists’ medical offices of today.

The technology represents the next generation of cardio-pulmonary function evaluation. The device includes a stair step, a mask with sensors, an analyzer and a dedicated laptop computer.

The test utilizes inspired and expired gas analysis measured against workload and time. It utilizes newly developed components of pulmonary testing and computerized software and display that result in proxy indicators of organ health and predictive diagnostics.

SHAPE measures the functional “fitness” of a patient’s heart, lung and vascular systems as these organs work together to support activities of daily living, functionality capacity, and one’s capacity for exercise. Its convenience and low costs allows monitoring of therapeutic response to medications, exercise and patient compliance. Additionally, the device is used as a diagnostic screen for cardiac pacing implantation and the calibration and recalibration of such.

The test is a technological advancement over present pulmonary and peak exercise stress testing. As technology advances, SHAPE affords a ‘better, faster, safer, easier, cheaper’ alternative solution to yesterday’s practices. It is designed for use in a primary healthcare setting, utilizing paraprofessionals. It is deemed risk-free and requires a minimum of space while in use or in storage. The device is self-calibrating and requires the patient to perform only a minimum exertion over one’s resting heart rate.

Primary care and health screening is in present need of objective measures of functional heart-lung diagnostics. Present day cardio-pulmonary testing is costly to the system and resides in the domain of the specialists. Early diagnosis and control of obesity and complications due to sedentary life styles are major drivers of costly disease and attendant chronic disease. SHAPE enables early objective classification of preventable disease.

SHAPE provides predictive data for physician evaluation of patient risk for morbidity, mortality and future hospitalization

If you’re like me, you may think of innovation as something new – some revolutionary breakthrough. However, in the real world of health care, most breakthroughs come from evolutionary rather than revolutionary changes, or from combining past technologies to form a new innovation to address some current health crisis.

The Crisis – Deaths from Health and Lung Disease

Consider deaths from vascular or lung disease as that crisis. In 2004, the four leading causes of death were heart disease, 654,092, cancer 550, 270, stroke 150,147, and chronic obstructive lung disease, 123,884. Of these deaths, more than 400, 000 are related to smoking.

The Need for a Device Combining Heart and Lung Testing

These statistics indicate the need for some innovative device to test for heart and pulmonary disease in its early reversible stages, particularly in smokers – the number one environmental preventable cause of death.

Would it not be of great benefit to the health system, then, for some device that had some of the following characteristics?

• Something of no risk to individual subjects while the testing is being carried out.
• Something not requiring the presence of a physician in attendance during testing.
• Something mobile and small that could be used in multiple settings – the physician’s office or a health club.
• Something less expensive than current testing devices.
• Something combining heart and lung testing.
• Something that could measure both cardiac and pulmonary fitness.
• Something sensitive enough to measure early heart or lung damage from lifestyle behaviors that could be stopped...
• Something that could be repeated often and that could measure the response to therapy.
• Something based on large predictive databases that would indicate future risks of hospitalization or death.
• Something derived and modified from existing proven technologies...

Current Common Testing Methods

With regard to the last point,

• The principle device currently used for testing for health disease has been cardiac stress testing, using a treadmill, and sometimes driving the subject to near exhaustion to check for cardiogram changes indicating cardiac ischemia from coronary artery disease. The type of testing carries the risk of inducing fatal arrhythmias while on the treadmill, requires a physician in attendance, requires bulky space-occupying equipments, and lacks sensivity to detect early cardiac and pulomonary diseases in one setting.

• In the office pulmonary testing , physicians often rely upon a spirometer, an apparatus for measuring the volume of inspired and expired air in the lungs. The output produced by a spirometer is called a kymograph trace. From this, vital capacity, tidal volume, breathing rate and ventilation rate (tidal volume x breathing rate) can be calculated. From the overall decline on the graph, the oxygen uptake can also be measured.

What If’s

What if practicing physicians and concerned patients had access to such a small device – consisting of nothing more or less than a stair step, a mask with sensors, a gas analyzer, and a laptop computer – to replace current equipment used for cardiac stress testing?

What if. this device accurately evaluated integrated heart and pulmonary function and distinguished between the two; estimated efficiency of these two vital organs after two or three steps up a stair step?

What if the device yielded an evaluation of heart and lung function within 15 minutes; produced quantitative prognostic information, based on a database carrying information from thousands of previous patients, such as risk of death and risk of hospitalization; could be repeated at will with no risk to the patient; was less expensive than current cardiopulmonary testing; proved to be superior to existing “gold standards” – cardiac ultrasound for assessing left ventricular function at rest and cardiac pulmonary exercise tests for assessing functional capacity during exercise.

Well, such a device may soon exis.

A word of caution. A blog, this blog in particular, isn’t a scientific report. It is, however, based on solid speculation and documentation about an exciting innovation, resting on data generated by fifth generation devices for measuring heart and lung function. It shows the power of informed and evolutionary innovation.

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